Instructions to Authors

• Overview
• Editorial Policies
• Standards for Reporting Scientific Data
• Tools for Diagnostic Accuracy
• Peer Review Process
• Types of Submissions
• Manuscript Preparation
• Online Submission and Tracking
• Manuscript Transfer
• Post-Acceptance
• JALM Editorial Office

Overview

The Journal of Applied Laboratory Medicine (JALM), issued bi-monthly, is published online by the Association for Diagnostics & Laboratory Medicine (ADLM). The journal welcomes contributions that showcase research on clinically relevant laboratory medicine topics as well as those that provide commentary on laboratory practice.

Laboratory medicine professionals play an essential role on healthcare teams by providing vital guidance so patients get the care they need. With JALM, ADLM aims to help lab professionals discover new adaptive solutions to patient health problems and to drive innovation in the field. This journal will expand on the scope of the cutting-edge research by focusing on translational laboratory medicine studies. JALM will also consider for publication submissions on laboratory methods, management, best practices, stewardship and appropriate test utilization. Additionally, it will provide a forum for discussion of policy, guidance, and regulatory issues that impact the field.

Submissions of the following nature are welcomed:

• Case studies
• Basic materials or principles
• Analytical techniques
• Molecular diagnostics
• Test utilization or testing-related health or financial outcomes
• Instrumentation
• Data processing
• Statistical analyses of data
• Clinical investigations in which laboratory testing has played a major role
• Laboratory animal studies of physiological problems of human disease

Contributions should consist of subject matter that is original and advances the state of knowledge of laboratory medicine, and conclusions that are justified from the design of the experiments and the data presented. The information must be sufficiently detailed to permit replication of the work by a competent worker in the field. Lastly, the writing must be clear, concise, and grammatically correct.

All JALM submissions, correspondence, and reviews must be in English. Equal consideration is given to original manuscripts in English from any country, regardless of membership in the Association. It is, however, advised that all non- English-speaking authors enlist the aid of a colleague skilled in the English language to ensure correct language usage before submission. Submissions must adhere to the current International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.

Manuscript content and writing responsibility remains with the author; however, several professional writing/editing services are available to assist authors. JALM neither endorses any editing service nor is responsible for any services performed. Please visit the Language Services page for a list of resources.

Contributions may be submitted via ScholarOne Manuscripts. Please contact the Editorial Office via e-mail should you have any questions or need assistance: [email protected]. Please also visit OUP's Journals authoring pages for information about publishing in an Oxford Academic journal.

Editorial Policies

• Confidentiality
• Originality
• Disclosures/Conflict of Interest
• Author Contribution Requirements
• Artificial Intelligence (AI)
• Ethical Considerations
• Preprints

Confidentiality

Submitted manuscripts are considered confidential and embargoed from the time of submission. In compliance with the Embargo Policy, no information beyond what is contained in the Abstract can be made public before the manuscript has been published. Manuscripts containing a substantial amount of overlapping information that has been previously published or made available to the readership through other venues are ineligible. Meeting abstracts are not generally considered a prior publication but should be disclosed; for more information on JALM’s originality requirements and what constitutes prior publication, please read the Originality section below.

The Confidentiality and Embargo Policies require that, prior to the embargo being lifted, all authors of the research are not allowed to:

Publish the information or provide it to others who may publish or disseminate it through other venues.
The corresponding author is responsible for conveying this information to all parties.

Originality

Manuscripts must contain original material that is not already available elsewhere. Authors may submit and present abstracts (i.e., oral or poster presentations) of their research in open, scientific meetings.

The title page and cover letter should include a statement verifying the originality of the work, and disclose any previous abstracts, presentations, reports, or publications that contain material that might be perceived to overlap with the current submission. If a similar publication exists, the authors should upload a copy as a supplemental file as part of the submission process, and justify why their submission is considered non-overlapping and novel. If applicable, authors should cite any previously published or closely related work within the text.

JALM will not accept for review any manuscript that is currently under review at another journal.

JALM follows the guidelines from the International Committee of Medical Journal Editors (ICMJE) section on Overlapping Publications.

Disclosures/Conflict of Interest

The Journal requires all authors to disclose any potential conflict of interest at the point of submission. It is the responsibility of the corresponding author to ensure that conflicts of interest of all authors are declared to the Journal.

The authors should provide a concise and accurate statement listing all funding sources from any time period and disclosing any conflicts of interest relevant to the study that have occurred within the past 3 years. Authors without conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject of their manuscript, should include a statement of no such interests at the end of the manuscript. Failure to include this information in the manuscript may delay evaluation and review of the manuscript.

In addition to including a statement of conflict of interest in the manuscript, the authors are required to complete a Conflict of Interest form during submission. Each co-author should individually assess and complete the form. A form must be submitted even if there are no conflicts of interest to disclose, in which case the Conflict of Interest form and manuscript should state “none declared.” The corresponding author will be required to upload a form for each author at submission.

Each author is expected to disclose any relevant financial relationships held personally within the past 3 years. Any companies or proprietary entities producing scientific services, which have an investment, licensing, or other commercial interest in the subject matter under consideration in the submitted manuscript, must be disclosed. A conflict of interest exists when the position, activities, or relationships of an individual, whether direct or indirect, financial or non-financial, could influence or be seen to influence the opinions or activities of the individual. Any author employed by a manufacturer who submits an article describing their employer's innovations is expected to list their employment in the disclosures as a potential conflict. For more information, refer to OUP’s definition of conflict of interest.

Such information is held in confidence while the manuscript is under review and does not influence the editorial decision on reports of research; upon acceptance, relevant information is added to the manuscript for publication. The Journal follows the COPE guidance for any undisclosed conflict of interest that emerges during peer review, production, or after publication.

Authors of editorials are expected to be free of significant financial associations (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) with companies that may be affected by topics discussed in the manuscript and must also complete a full disclosure at the time of submission.

The American Medical Writers Association (AMWA) recognizes the valuable contributions of biomedical communicators to the publication team. Biomedical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships. In all aspects of the publication process, biomedical communicators should adhere to the AMWA code of ethics.

Author Contribution Requirements

General Guidelines

JALM follows the recommendations for authorship set out by International Committee of Medical Journal Editors (ICMJE). In accordance with these recommendations, manuscripts are considered for publication with the understanding that each listed author must meet the following 4 criteria:

1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work
2. Drafting the work or revising it critically for important intellectual content
3. Final approval of the version to be published
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Contributors who do not meet all 4 criteria for authorship should be named in the Acknowledgments. The submitting author assumes full responsibility that all authors listed in the manuscript have met the required criteria of eligibility for authorship and that nobody who qualifies for authorship has been omitted from the list. Individual author contributions can be described in detail using the CRediT taxonomy during submission.

Author limits may be imposed for certain submission types. Please review the specific requirements for your submission type. Please list only the allowed number of authors in the author list, with the remaining contributors listed in an Acknowledgment. Exceptions may be made at the discretion of the editor.

If more than one author should be considered as the first authors, or as the corresponding authors, please indicate this clearly in a footnote on the first page of the manuscript.

Artificial Intelligence (AI)

Natural language processing tools driven by artificial intelligence (AI), such as ChatGPT or Large Language Models, do not qualify as authors, and the Journal will screen for them in author lists. The use of AI (for example, to help generate content, write code, or process data) should be disclosed both in cover letters to editors and in the Methods or Acknowledgments section of manuscripts. Please see the COPE position statement on Authorship and AI for more details.

CRediT

The Journal uses the contributor roles taxonomy (CRediT), which allows authors to describe the contributor roles in a standardized, transparent, and accurate way. Authors should choose from the contributor roles outlined on the CRediT website and supply this information upon submission. You may choose multiple contributor roles per author. Any other individuals who do not meet authorship criteria and made less substantive contributions should be listed in your manuscript as non-author contributors with their contributions clearly described.

Changing the Author List

Any change in authors and/or contributors after initial submission must be approved by all authors. This applies to additions, deletions, change of order to the authors, or contributions being attributed differently. If a change is made to the author list after submission or during any revision, the submitting author must send an e-mail to [email protected] explaining the reason for the change. Each author, including the author to be added or removed, will be required to sign an Author Change form indicating their agreement. Any additions or deletions must be made in the electronic submission record as well as on the manuscript itself and are subject to approval by the editor. 

Group Authorship

If you are including the name of a group or consortium in your author list, please clearly identify the group members who can take credit and responsibility for the work as authors by listing them in a footnote or at the end of the manuscript. Please also provide email addresses for each listed group member, either in the manuscript or by emailing [email protected]. All members of the group named as authors should meet all four criteria for authorship, including approval of the final manuscript, and they should be able to take public responsibility for the work and should have full confidence in the accuracy and integrity of the work of other group authors. They will also be required as individuals to complete the author disclosure and contribution forms. This is in accordance with the recommendations of the ICMJE.

Ethical Considerations

JALM strives to publish only trustworthy, high-quality scientific research and to ensure that all authors are properly credited for their own work and ideas. In order to ensure the highest ethical standards, JALM adheres to the recommendations from the International Committee of Medical Journal Editors (ICMJE) and the Committee on Publication Ethics (COPE) for guidance on policies and procedures regarding scientific misconduct. Misconduct including, but not limited to, the following is strictly prohibited and will result in immediate removal of a paper from consideration by the journal.

Duplicate Submissions

Submissions that are under review or that have been previously published with another journal.

Duplicate Publications and Plagiarism

Manuscripts that have substantial overlap with a manuscript that has already been published, without proper citation. Manuscripts will be evaluated using iThenticate plagiarism detection software prior to publication.

Preprints

Authors retain the right to make an Author’s Original Version (preprint) available through various channels, and this does not prevent submission to the journal. For further information see our Online Licensing, Copyright and Permissions policies. If accepted, the authors are required to update the status of any preprint, including your published paper’s DOI, as described on our Author Self-Archiving policy page.

JALM will consider submitted papers that have had a previous version posted on a noncommercial preprint server on a case-by-case basis. In examining submissions with an existing preprint, the editors will consider such factors as whether the submitted manuscript will add meaningful new information to the literature.

If a previous version of your paper has been posted as a preprint, you will be prompted at submission to provide the following information:

• Name of the preprint server
• Preprint DOI
• Link to the preprint

Standards for Reporting Scientific Data

• Description of Analytical Methods and Results
• Statistics
• Studies with Human Subjects
• Inclusive Language
• Animal Studies
• NIH Funding/Open Access Requirements
• Checklist for the Description of Sequence Variants at the Human Genome Variation Society

Description of Analytical Methods and Results

Manuscripts describing the development and evaluation of the performance of methods and instruments should discuss linearity, imprecision, repeatability, reproducibility, analytical specificity, recovery, lower limit of detection, limit of blank, comparability with other analytical methods, lower limit of quantification and reference interval(s). Some clinical data are usually needed.

Document the analytical advantages of the new or modified method over existing methods.

Analytical method validations should conform to the protocols and requirements in the Center for Drug Evaluation and Research (CDER) Guidance for Industry: Bioanalytical Method Evaluation, 2001 (1).

Calibration curves and linearity: Data for these studies should be analyzed by linear regression analysis (if a linear response is obtained) and should include the slope, intercept, r2, standard error, standard deviation of residuals, and the standard deviations of the slope and intercept.

Standard deviations of repeated points may be included.

In preparing nonlinear calibration curves, authors may use any objective, statistically valid method but must specify the method used (see, e.g., (2)).

Imprecision. Studies must be conducted at multiple concentration levels that are clinically relevant using an appropriate sample/specimen matrix. Study should reflect the level of complexity found in field practice. Clinical Laboratory Standards Institute (CLSI) document EP05-A3 (3) contains detailed description and instruction for conducting precision studies. This document or an equivalent scientific approach should be used for reporting imprecision.

One method for estimating both within-run and total standard deviations is the analysis of variance experiment described in CLSI document EP05-A3 (3), which calls for two replicates per specimen per run and two runs per day for 20 days. This permits separate estimation of between-day and between-run, within-day standard deviations, as well as within-run and total standard deviations.

For acceptable alternatives that include only one run per day, see the cited document.

Indicators of Accuracy ("Trueness"): Accuracy (or “trueness” in the recent nomenclature) of a new method can be estimated by (a) analyses of certified Reference Materials by the new method or (b) comparisons of results of a new method with results of a Reference Method. These are the only accepted approaches to trueness. When neither is available, other evidence relevant to the ability of the method to measure the substance and the measurand is needed. Recovery studies involve analyses after known amounts of analyte are added to the biological fluid on which the determination will be performed. Recovery of added analyte should be calculated [(final concentration – initial concentration)/added concentration], not the observed final concentration as a proportion of expected final concentration.

Interference studies should be performed to assess the effects of common interferents, including lipid particles, hemoglobin, bilirubin, and metabolites depending on the context of the study. Exogenous materials, such as ingredients of blood collection containers (tubes) and commonly used or commonly co-administered drugs that might interfere with the determination, should also be tested for interferences. Selection of materials to test should be guided by an understanding of the chemistry and physics of the measuring system. Thus chemicals that are structurally similar to the substance or measurand should be tested to assess the selectivity of the method. (The term “selectivity” is preferred over specificity; selectivity can be quantified.) In characterizing non-spectrophotometric methods, chemicals that may interfere in the detection system should be studied more intensively than chemicals that are historically important for interference in spectrophotometric methods.

Comparison-of-methods studies should compare results by the new or proposed method with those by a reference-quality method or other generally accepted analytical method for which assay performance is documented (5, 6).

It is desirable to test 100 to 200 different samples from patients who have been selected to include a wide variety of pathologic conditions and to present a range of values for the analyte that includes those likely to be encountered in routine application.

For a table of the required number of samples, see Linnet (7).

If regression analysis is used for statistical evaluation of the data, supply slopes and intercepts (and their standard deviations) and standard deviations of residuals (Sy|x, often called standard errors of estimates). Unbiased (e.g., Deming) regression is typically required (8). A program to perform Deming regression is available online as a supplement from this journal (9).

The correlation coefficient has limited utility and should not be used as a basis for determining the method performance. Residuals plots [e.g., Bland-Altman (10, 11)] are often useful formats for reporting data.

The terms “analytical sensitivity” and “detection limit” are commonly confused. The International Union of Pure and Applied Chemistry defines analytical sensitivity as the ability of an analytical procedure to produce a change in signal for a defined change of the quantity. This is often visualized as the slope of the calibration curve and this term should not be used to represent any other analytical characteristic.

Limit of Blank (LOB), limit of detection (LOD) and limit of quantitation (LOQ). Studies should be designed according to the principles delineated in CLSI document EP-17-A2. The typical criteria for ascertaining the LOQ is the analyte concentration that can be measured with acceptable accuracy, with imprecision of less than 20%. Other scientifically sound, valid approaches can also be used, e.g. methodology described by Linnet (12).

Analytical quality: Results obtained for the performance characteristics should be compared objectively with well- documented quality specifications, e.g., published data on the state-of-the-art performance required by regulatory bodies such as CLIA 88, or recommendations documented by expert professional groups (13).

Reference population and interval (normal range): Depending on the conclusions of the accuracy studies, modification of an accepted reference interval may be indicated. Description of the reference interval study should include details about sampling; selection of subjects, including their number, age, race and ethnicity, and sex distribution; the statistical method for summarizing the results (14); and other factors that would influence the values obtained.

Mass spectrometric assays must be evaluated for matrix effects (ion suppression or enhancement) (15, 16).

Chromatograms: Chromatograms from gas-liquid and liquid chromatography should usually be presented so that readers can see the efficiency of the separation and observe the resolution from interferents in the matrix. Similar images are often needed for electrophoretic separations.

Enzyme activities: Enzyme activities may be expressed in international units (U) or katals. Temperature and other key assay features must be described in the text or by reference to a published method.

When first mentioned in the text, enzymes (whether measured by activity or mass assays) must be numbered (EC no.) in accordance with the recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology on the Nomenclature and Classification of Enzymes (17).

References:

1. Center for Drug Evaluation and Research (CDER) Guidance for Industry: Bioanalytical Method Evaluation, 2001.
2. Linnet K, Boyd JC. Selection and analytical evaluation of methods – with statistical techniques. In: Burtis CA, Ashwood ER, Bruns DE. Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. St. Louis: Saunders, 2006: 353-407.
3. CLSI. Evaluation of precision of quantitative measurement procedures, 3rd Edition. CLSI document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
4. NCCLS Tentative Guideline EP5-T. User evaluation of precision performance of clinical chemistry devices. Wayne, PA: National Committee for Clinical Laboratory Standards, June 1984.
5. Carey RN, Garber CC. Evaluation of methods. In: Kaplan LA, Pesce AJ, eds. Clinical chemistry. Theory, practice and correlation, 2nd ed. St. Louis: CV Mosby, 1989:290–310.
6. Koch DO, Peters T Jr. Selection and evaluation of methods. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry, 2nd ed. Philadelphia: WB Saunders, 1994:508–25.
7. Linnet K. Necessary sample size for method comparison studies based on regression analysis. Clin Chem 1999;45:882–94.
8. Linnet K. Evaluation of regression procedures for methods comparison studies. Clin Chem 1993;39:424–32. 
9. Martin RF. General Deming regression for estimating systematic bias and its confidence interval in method-comparison studies. Data supplement. GDR: Executable program for general Deming regression calculations and graphics. 
10. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10. 
11. Altman DG, Bland JM. Commentary on quantifying agreement between two methods of measurement. Clin Chem 2002;48:801-2. 
12. Linnet K, Kondratovich M. Partly nonparametric approach for determining the limit of detection. Clin Chem 2004;50:732-40.
13. Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999;45:321–3. 
14. Solberg HE. Establishment and use of reference values. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry, 4th ed. St. Louis: Saunders, 2006:425–48.
15. Annesley TM. Ion Suppression in Mass Spectrometry. Clin Chem 2003;49:1041-44. 
16. Matuszewski BK, Constanzer ML, Chavez-Eng CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS.MS. Anal Chem 2003;75:3019-30. 
17. International Union of Biochemistry and Molecular Biology, Nomenclature Committee. Enzyme nomenclature 1992. San Diego: Academic Press, 1992:862pp.

Statistics

Describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to verify the reported results.

When possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty.

Avoid sole reliance on statistical hypothesis testing, such as the use of P values, which fails to convey important quantitative information.

When appropriate, confidence intervals should be presented; see, e.g., Harris (1), Henderson (2), and references therein.

References:

1. Harris EK. On P values and confidence intervals (why can't we P with more confidence?) [Editorial]. Clin Chem 1993;39:927-8.
2. Henderson AR. Chemistry with confidence: should Clinical Chemistry require confidence intervals for analytical and other data? [Opinion]. Clin Chem 1993;39:929-35.

Studies with Human Subjects

JALM's policy regarding studies with human subjects adheres to the recommendations from the International Committee of Medical Journal Editors (ICMJE). All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration. All authors should seek approval to conduct research from an independent local, regional, or national review body (e.g., ethics committee, institutional review board). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the local, regional, or national review body explicitly approved the doubtful aspects of the study. Approval by a responsible review body does not preclude editors from forming their own judgment whether the conduct of the research was appropriate. For transparency to the reader, authors should include the following in the manuscript: 1) the name of the institution or institutional review board (IRB) providing human ethics review, 2) the study number or review board identifier, and 3) the outcome of that review (for example, full or expedited review approval with or without waiver of patient consent).  The manuscript will be returned to the authors if ethics review details are not included in the submission.

Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, will not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Authors should obtain and archive written patient consent forms in accordance with local regulations or laws and will be required to attest in writing upon submission that they have received and archived written patient consent.

Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are de-identified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning. When informed consent has been obtained, this will be indicated in the published article. Please note if informed consent has been received in the Materials and Methods section of the submitted manuscript.

Inclusive Language

Language used in manuscripts should avoid bias. Authors should carefully consider the language used with regard to categories including age, sex, gender, race/ethnicity, and/or socioeconomic status.

Age-based bias should be avoided. Rather than terms such as “elderly” or “aged,” authors are recommended to use specified ages and distribution or more precise descriptors such as “less than [<]” or “greater than [>].” For example,  “subjects less than 1 year of age” or “subjects greater than 65 years.”

Sex should be used for describing biologic differences between male, female, and intersex. Gender should be used for describing self-identification, psychological, social and/or cultural factors. Sex should not be used interchangeably with gender. Whenever possible, avoid the use of sex- or gender-specific pronouns. Consider the use of gender-neutral terms such as “they” or “them.”

Specific terms for sexual orientation such as “lesbians” or “gay men” should be used instead of the term “homosexuals.” The use of sexual behavior descriptions such as “men who have sex with men,” “MSM,” “women who have sex with women,” “WSW,” or “bisexual people” may be considered. However, the journal recognizes that data may be derived from sources that have historically used other terms; the use of alternative terms should be described in the methods.

Race and ethnicity are social constructs. In studies that report race and/or ethnicity, the data source and method of identification should be described. For example, the data source could be an electronic medical record, laboratory information system or public database. The method of identification in the data source should be specified (e.g., subject self-identification). Description of a reference interval study should include details about sampling; selection of subjects, including their number, age, race and ethnicity, and sex distribution; the statistical method for summarizing the results; and other factors that would influence the values obtained. When race and ethnicity are reported, they should be capitalized (e.g., Asian, Black, Latino, White). Racial and ethnic descriptions are preferred as adjectives instead of nouns (e.g., Asian participants is preferred over Asians). Combinations of race/ethnicity with geography should not be hyphenated (e.g., Asian American is preferred over Asian-American). The terms “multiracial” and “multiethnic” may be used when the subpopulations are defined; the term “mixed race” should not be used. Overly broad terms that should be avoided include “people of color,” “Black, Indigenous, and people of color (BIPOC),” “Black, Asian, and minority ethnic (BAME),” and Black and minority ethnic (BME).”

Avoid the use of “non-” categories for statistical comparison. For example, rather than a comparison between “White” and “non-White,” the categories could be “White” and “Racial/ethnic minority groups.” If an “Other” category is used, additional details of the research subjects in this category should be provided. Generally, abbreviations for race/ethnicity should be avoided if possible; however, abbreviations may be used in tables and figures.

For socioeconomic status, terms such as “low-income” or “limited-income” are preferred over “the poor” or “the unemployed.” For disease state, describe patients as having a disease rather than being diseased. The language should be focused on the person/patient instead of the disease. For example, the preferred terminology is “patients with a BMI of [BMI range]” or “patients affected by obesity” instead of “the obese.”

See the “Text” section in these author guidelines for additional recommendations on the use of race and/or ethnicity in biological interpretation.

For further reading, guidance on inclusive language, and preferred terms, see the AMA Manual of Style, 11th Edition, Section 11.12: Inclusive Language.

Animal Studies

JALM's policy regarding studies reporting experiments on animals adheres to the recommendations from the International Committee of Medical Journal Editors (ICMJE). When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. Further guidance on animal research ethics is available from the International Association of Veterinary Editors’ Consensus Author Guidelines on Animal Ethics and Welfare.

NIH Funding/Open Access Requirements

The National Institutes of Health (NIH) has implemented its "Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research." This policy requests that authors reporting research that is funded (in whole or part) by a current NIH grant submit to NIH PubMed Central (PMC) manuscripts after they have been peer reviewed and accepted for publication in scientific journals. The “accepted manuscript” is the version of the manuscript after the author’s final revision but before post-acceptance editing and copyediting. The Policy is available online at https://publicaccess.nih.gov.

The policy requests that the release date to the public be within 12 months after the official date of final publication. JALM’s policy is to make all content publicly available 12 months after the publication date. 

All papers published under an open access license will be automatically deposited to PubMed Central. Any paper funded by the NIH should have NIH clearly listed as a funder, and those papers will be automatically deposited to PubMed Central with a 12-month embargo.

Checklist for the Description of Sequence Variants at the Human Genome Variation Society

Requirements for the description of sequence variants.

Tools for Diagnostic Accuracy

• Studies of Diagnostic Accuracy (STARD)
• Outcomes Studies (CONSORT)
• Minimum Information about a Microarray Experiment (MIAME)
• Minimum Information about Quantitative Real-Time PCR Experiments (MIQE)
• Estimated Glomerular Filtration Rate (eGFR)

Studies of Diagnostic Accuracy (STARD)

STARD 2015 Statement

STARD Checklist

The Standards for Reporting Diagnostic Accuracy Studies (STARD) statement first appeared in 2003 (1, 2) and was updated in 2015 (3).

For studies of diagnostic accuracy of tests, complete the STARD Checklist for Evaluations of Diagnostic Accuracy. Upload the completed form at submission.

The STARD statement (3) provides guidance helping authors to modify their manuscript as needed to provide the requested information. Guidelines include:

• Provide literature reference(s) describing the evaluated test(s) and criterion "gold standard" test(s) or include detailed descriptions of them.
• Follow accepted methodologic standards including the following:
  • Specify spectrum of evaluated patients (age and sex distributions, eligibility criteria, and summary of symptoms or disease stage).
  • Analyze pertinent subgroups of subjects (e.g., symptomatic and asymptomatic patients).
  • Avoid verification bias (usually by application of a "gold-standard" test to all subjects rather than to a clinically selected subset).
  • Categorize test results and patients independently to avoid reviewer bias (usually by performance of tests with blinding to patient information and vice versa).
  • Provide confidence intervals (or SE) for indices of diagnostic accuracy such as sensitivity/specificity, likelihood ratios, and areas under receiver-operating characteristic (ROC) curves (4).
  • Indicate the number of indeterminate test results and their use (if any) in further data analysis.
  • Provide laboratory data on analytical imprecision of the test (usually day-to-day CV at two or more concentrations) or reproducibility of observer interpretation (e.g., for a visually read, dichotomous [positive/negative] test).
• A flow diagram is strongly recommended (3).
• When evaluating diagnostic accuracy in clinical studies, simple testing of the significance of differences between mean values of patient groups (e.g., by Student’s t-test) provides insufficient information to assess diagnostic accuracy.
• Scatter plots of data, calculations of diagnostic sensitivities and specificities and their confidence intervals (4), and use of approaches such as ROC curves (5), cumulative distribution analyses (6), likelihood ratios (7), and discriminant analysis (8) provide information that is appropriate to specific situations.
• Confidence intervals should be provided (3).
• Discussions of predictive values in illustrative settings may be useful additions to assess the potential clinical utility of tests.
• Analysis of serial measurements requires special attention (9).

References:

1. STARD Group. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD statement. Clin Chem 2003;49:1-6. 
2. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Clin Chem 2003;49:7-18. 
3. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. STARD 2015: An updated list of essential items for reporting diagnostic accuracy studies. Clin Chem 2015;61:1446–52. 
4. Harper R, Reeves B. Reporting of precision of estimates for diagnostic accuracy: a review. BMJ 1999;318:1322-3. 
5. Zweig MH, Campbell G. Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine [Review]. Note that in Figs. 4-12 in this paper, the labels for the x-axis at the top and bottom are reversed. The (correct) dual labeling of the x-axis solves the problem of whether to plot specificity or 1 - specificity on the x-axis. Clin Chem 1993;39:561-77. 
6. Krouwer JS. Cumulative distribution analysis graphs-an alternative to ROC curves [Technical Brief]. Clin Chem 1987;33:2305-6.
7. Albert A. On the use and computation of likelihood ratios in Clinical Chemistry. Clin Chem 1982;28:1113-9. 
8. Solberg HE. Discriminant analysis. Crit Rev Clin Lab Sci 1978;9:209-42.
9. Matthews JNS, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Br Med J 1990;300:230-5.

Outcomes Studies (CONSORT)

Outcomes studies (CONSORT)

The CONSORT statement (1), although designed for randomized controlled trials and used for therapeutic rather than diagnostic interventions, is recommended for guidance.

For questions, contact JALM via e-mail at [email protected].

References:

1. Moher D, Schulz KF, Altman DG for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. www.consort-statement.org.

Minimum Information about a Microarray Experiment (MIAME)

The MIAME Checklist can be found at http://fged.org/projects/miame.

MIAME describes the minimum information about a microarray experiment that is needed to enable interpretation of the results of the experiment unambiguously and potentially to reproduce the experiment.

The MIAME checklist is a description of MIAME principles designed to help authors, reviewers, and editors of scientific journals meet MIAME requirements and to make microarray data available to the community in a useful way.

MIAME is neither a dogma nor a legal document - it assumes a cooperative data provider and a fair reviewer.

Minimum Information about Quantitative Real-Time PCR Experiments (MIQE)

MIQE Checklist

For studies that include quantitative real-time PCR experiments, complete the MIQE checklist for evaluation of qPCR experiments and upload during electronic submission. The full text of the MIQE guidelines is available online

Recommended nomenclature should be used, including:

• qPCR for quantitative real-time PCR
• RT-qPCR for reverse transcription quantitative real-time PCR
• reference genes instead of housekeeping genes
• hydrolysis probes instead of TaqMan® probes
• dual hybridization probes for HybProbes® (LightCycler®) probes
• quantification instead of quantitation
• Cq instead of Ct, Cp, or TOP
• quantification cycle instead of threshold cycle or crossing point

Authors are also encouraged, but not required, to include the additional desirable items of the MIQE guidelines (1). The MIQE guidelines are intended to help authors plan, perform and present qPCR experiments. They are also a guide for reviewers and editors to judge the quality of qPCR data. Incomplete information may be grounds for manuscript rejection. Use of Supplemental Data is encouraged as necessary. The most common errors in performing and reporting qPCR data include:

• Not enough information for others to replicate the experiment, including how the nucleic acid was prepared, reverse transcribed, and amplified. Primer sequences are required. Probe sequences are strongly encouraged especially in methods manuscripts, but their omission may be acceptable in clinical manuscripts if they are commercially available as products.
• Inadequate storage and/or nucleic acid preparation, leading to poor nucleic acid quality and variable results.
• Suboptimal primers for reverse transcription and/or PCR resulting in low yield, specificity and/or PCR efficiency.
• Inappropriate analysis of data.
• Use of a single reference gene in RT-qPCR without justification (2).

The guidelines require not only delineation of what was done, but presentation of evidence that validates the method used. For example, these include evidence of RNA integrity and purity, PCR specificity, calibration curves and calculations of PCR efficiency and limits of detection. At the option of the editor, MIQE requirements may be relaxed in reports using qPCR arrays, although all manuscripts will be judged on their relative merit, and the relative merit of a manuscript using qPCR increases as compliance with the MIQE guidelines increases.

References:

1. Bustin SA, Benes V, Garson JA, Hellemans J, Huggett J, Kubista M, Mueller R, Nolan T, Pfaffl MW, Shipley GL, Vandesompele J, Wittwer CT. The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin Chem. 2009 Apr;55(4):611-22.
2. Vandesompele J, De Preter K, Pattyn F, Poppe B, Van Roy N, De Paepe A, Speleman F. Accurate normalization of real-time quantitative RT-PCR data by geometric averaging of multiple internal control genes. Genome Biol. 2002 Jun 18;3 (7):RESEARCH0034.

Estimated Glomerular Filtration Rate (eGFR)

For studies including estimated glomerular filtration rate (eGFR), the manuscripts should use the CKD-EPI 2021 refit equations without the race variable where possible. When an alternative equation is used, this should be accompanied by an explanation in the methods section (for example, “CKD-EPI 2021 refit equation is not validated for this population”).

The equation for age ≥18 years in a single expression for eGFRcr is:

eGFRcr= 142×min(Scr/κ, 1)a×max(Scr/κ, 1)−1.200×0.9938Age×1.012 [if female]
where κ = 0.7 (females) or 0.9 (males)
a = −0.241 (female) or −0.302 (male)
Scr = serum creatinine in mg/dL; divide by 88.4 for creatinine in µmol/L
Age (years)
The coding for implementing the single equation is nuanced. The “min(Scr/κ, 1)” factor indicates the minimum of Scr/κ or 1.0 and “max(Scr/κ, 1)” indicates the maximum of Scr/κ or 1.0.

See Inker LA, Eneanya ND, Coresh J, et al. New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. N Engl J Med 2021 Nov 4;385:1737-49. 

Peer Review Process

All submissions are reviewed by the Editor-in-Chief and the Deputy Editor before being assigned to an Associate Editor. Based on editorial judgment, some submissions are rejected initially without external review.

Submissions that are recommended for external review will follow JALM’s single-blind review peer-review process. This means that authors do not know the identity of the reviewers.

Associate Editors may select external reviewers using a database of experts, use reviewers recommended by the authors, or make their own reviewer selections. Reviewers provide comments for Associate Editors and the authors, as well as a decision recommendation. Upon receiving the comments, the assigned Associate Editor will make a decision recommendation to the Editor-in-Chief and Deputy Editor who will ultimately make the final decision.

If a review is required, authors may expect to learn of the editorial decision (acceptance, revision, or rejection) in approximately 4 weeks, depending on the turnaround time for reviews.

Upon completion of review, the decision will be e-mailed to the corresponding author along with instructions for accessing the reviewers' comments online.

The author will receive one of the following decisions:

Reject: The editors did not select your manuscript for publication. Many factors contribute to acceptance including, but not limited to, the following:

• Importance of the research to the field of clinical chemistry
• The quality of the study; adequacy of data and statistical analysis
• The novelty of the work
• The priority of the work to JALM and its readership
• If an author disagrees with the editorial decision, cordial inquiry is invited through the online Manuscript Processing System. The response must be timely and include a detailed rebuttal.

Revision: The editors believe that your article contained information of potential importance but a number of issues were raised. If you believe that you can address the issues raised, the editors would be willing to reconsider your manuscript but cannot guarantee acceptance, particularly if you cannot address the concerns. To revise your manuscript, click the link provided in the revision request email, or log into ScholarOne and enter your Author Centre, where you will find your manuscript title listed under "Manuscripts with Decisions."  Under "Actions," click on "Create a Revision."

Acceptance: The editors selected your manuscript for publication. Additional information will be provided regarding embargo policies and the production process.

Types of Submissions

• Article
• Case Study / Commentary
• Correction
• Editorial
• Focused Report
• Laboratory Reflections
• Letter to the Editor / Reply
• Mini-Review
• Opinion
• Point/Counterpoint
• Review
• Special Report

Article

Research or scientific articles are submitted directly from authors. There are no restrictions on topics that are considered for publication, as long as the subject matter is original and relates experimentally or theoretically to the field of laboratory medicine. The information must be sufficiently detailed not only to enable readers to understand and appreciate the material presented, but also to permit replication of the work by other scientists in the field.

Articles should contain a structured abstract limited to 250 words and formatted to include separate headings of: Background, Methods, Results, and Conclusions. An Impact Statement should appear after the abstract. The main text should not exceed 3,500 words. The manuscript should have no more than 40 references and a total of 6 tables and/or figures. Supplemental data are encouraged for Articles.

Articles should list no more than 20 authors, with any additional contributors listed in the Acknowledgments. Although exceptions are rare, you may email [email protected] detailing each author's contribution to your submission, which will be forwarded to the editor.

Authors may submit short videos to complement their Articles. Videos can be used to illustrate a laboratory technique, hardware prototype, or clinical presentation that would benefit from such an addition, or to visually communicate to the reader novel features, special steps in a procedure, pitfalls, or other information that may not be easily conveyed through text or a figure. Videos should be of high quality, no more than 5 minutes in length, and submitted as .mp4 files. Do not send proprietary file types such as .wmv (Windows Media) and .rm (Real Media) files.

Case Study / Commentary

Case Studies are submitted directly from authors. These articles are intended to be educational, with the goal of helping to develop or improve problem-solving skills. Case Studies may report unusual (although not necessarily rare) biochemical manifestations of disease, atypical presentation of disease, situations where the laboratory helped in making or clarifying a diagnosis, or information that would be helpful in understanding the pathophysiology of a disease. The case should read as a bit of a mystery or diagnostic dilemma. The case title and case description should not disclose the diagnosis.

Ideally, Case Studies should include a final diagnosis based on the evidence presented, illustrate a new diagnostic strategy, or recommend a more cost-effective approach to clinical management.

A Case Study should not include an abstract. It should, however, include a case description followed by the case discussion, limited to 1,500 words total. References are limited to 10, and the tables and figures are limited to 2 in total. Authors should include 3-5 brief Questions to Consider regarding the case that would stimulate discussion and learning about the disease state. The author should also list up to 5 Educational Points at the end of the manuscript. The questions and points are not included in the manuscript count of 1,500 words. Supplemental data are not permitted for Case Studies. No more than 5 authors should be listed.

An accompanying Commentary (by invitation only) will further discuss the case and its educational value.

Correction

Corrections are unique and will be considered on a case-by-case basis. Authors are encouraged to contact the Editorial Office at [email protected] should they wish to submit a Correction or should they find a printer error that needs correcting.

Editorial

These are typically invited submissions. Editorials provide opinions and observations by an expert in the field about the subject matter or content of a scientific paper published in JALM. In addition to further educating readers on a selected topic, Editorials are designed to stimulate readers to formulate their own opinions about a paper and its value to the field. In some cases, Editorials may also be independent opinions and observations about a controversial topic or changes taking place in the field.

Editorials are limited to 1,500 words. They should not include an abstract. References are limited to 15, and tables and figures are not permitted. No more than 5 authors should be listed. Supplemental data are not permitted for Editorials.

Focused Report

The Focused Report category is intended for concise method evaluation contributions and succinct clinical manuscripts. All Focused Reports will undergo peer review. Submissions in this category should contain four sections: Abstract (structured, no more than 250 words), Introduction, Methods, Results, and Discussion. An Impact Statement should appear after the abstract. They should be no more than 1,500 words in length with a maximum of 20 references and a total of no more than two tables and figures. Figures and tables should not be multipart (i.e., Fig. 1A, 1B, 1C, Part 1, Part 2). No more than 5 authors should be listed. Supplemental data are permitted for Focused Reports.

In some instances, editors may request that a submission of another article type to JALM be decreased to meet the requirements of a Focused Report.

Laboratory Reflections

The Laboratory Reflections section contains additional features in areas of interest to readers. Submissions will be considered in the following categories:

Technical Tips: Advice on practical solutions to technical challenges and unmet needs that are encountered in the laboratory practice.

Pay it Forward: A place to share information on topics such as advice, experience, and resources for mentoring, training, teaching, having visitors in your laboratory, and contact with others in the field. "Pay It Forward" is an expression that describes the action of the recipient of a good deed who passes the benefit on to others as a way of repaying the original benefactor.

Professional Insights: This section will include contributions from forward-thinking individuals in the field who wish to share their vision, intuitions, experience, and perceptions with JALM readers and the laboratory medicine field.

Celebrating Milestones: This section celebrates the important moments and individuals note-worthy to the field of clinical chemistry. 

Submissions to Laboratory Reflections are limited to 750 words and should not include an abstract. Laboratory Reflections should list no more than 5 authors. The references are limited to 5, and only 1 table or figure is permitted. Supplemental data are not permitted.

Letter to the Editor / Reply

Letters are submitted directly from authors and can be used to report an observation or to discuss a previously published original Article. Letters in response to papers other than Articles or Case Studies will not be considered for publication. Letters report observations on interferences, suggestions to improve test performance, or other observations that are of importance to the wider audience. A Reply to a Letter may also be solicited by the editors. The one figure or table provided should be concise and should not be multipart (i.e., Fig. 1A, 1B, 1C, Part 1, Part 2).

A Letter to the Editor is limited to 750 words. It should not include an abstract. The references are limited to 5, and only 1 table or figure is permitted. Supplemental data are not permitted for Letters to the Editor.

A Reply is limited to 750 words. It should not include an abstract. The references are limited to 5, and only 1 table or figure is permitted. Supplemental data are not permitted for Replies.

Letters to the Editor and Replies should list no more than 8 authors, with any additional contributors listed in the Acknowledgments. Although exceptions are rare, you may email [email protected] detailing each author's contribution to your submission, which will be forwarded to the editor.

In some instances, editors may request that a submission of another article type to JALM be decreased to meet the requirements of a Letter to the Editor.

Mini-Review

Mini-Reviews may be submitted directly by authors or invited by the journal. Mini-Reviews are intended to provide a general overview of a topic. Basic information is provided, along with selected references that can aid the reader in obtaining additional information about the subject. The use of illustrative figures or tables is encouraged.

A Mini-Review article should consist of a structured abstract limited to 250 words with headings of Background, Content, and Summary. An Impact Statement should appear after the abstract. The text should not exceed 3,500 words. The manuscript should have no more than 40 references and a total of 4 tables and/or figures. Supplemental data are encouraged for Mini-Review articles.

Mini-Reviews should list no more than 5 authors, with any additional contributors listed in the Acknowledgments. Although exceptions are rare, you may email [email protected] detailing each author's contribution to your submission, which will be forwarded to the editor.

Opinion

Opinions may be submitted directly by authors or invited by the journal. They present the belief or personal view of the author(s) on a specific topic. An opinion implies a conclusion thought out yet open to dispute. Opinion articles are often a formal expression by an expert of his/her judgment or advice. Unlike Editorials and Letters to the Editor, Opinion articles do not comment on, or refer to, specific papers published in this or any other journal.

An Opinion should not include an abstract and is limited to 1,500 words, 15 references, 1 table or figure, and no more than 5 authors. Supplemental data are not permitted for Opinions.

Point/Counterpoint

These articles are typically invited submissions from experts in a selected discipline and provide different viewpoints on a topic that may be controversial, lacks consensus in the scientific community, or may be of high public interest. In most cases an author or group of authors is asked to write the first half of the article, describing the importance of the topic, challenges to be addressed, current limitations, and/or unmet needs. A second author or group of authors is invited to provide a “Counterpoint” discussion of a different viewpoint or critical factors.

Point/Counterpoint submissions should not include an abstract. The manuscript is limited to 1,500 words, 15 references, and 1 table or figure. Supplemental data are not permitted for Point/Counterpoint.

Review

Reviews may be submitted directly by authors or invited by the journal. Reviews are intended to provide comprehensive coverage of a topic, including background clinical or analytical information, the relevance and importance of the subject matter, and potential future directions. The use of illustrative figures or tables is encouraged.

A Review article should consist of a structured abstract with headings of Background, Content, and Summary limited to 250 words. An Impact Statement should appear after the abstract. The text should not exceed 5,000 words. The manuscript should have no more than 100 references and a total of 6 tables and/or figures. Exceptions to the reference count may be made at the discretion of the editor. Supplemental data are encouraged for Review articles.

Reviews should list no more than 15 authors, with any additional contributors listed in the Acknowledgments. Although exceptions are rare, you may email [email protected] detailing each author's contribution to your submission, which will be forwarded to the editor.

Special Report

Special Reports may be submitted directly by authors or invited by the journal. The types of papers that would be considered include consensus reports, guideline development, position statements, or evidence-based recommendations on test utilization or quality specifications. The editors may also decide to classify other miscellaneous submissions under this heading.

A Special Report should consist of a structured or unstructured abstract limited to 250 words. The main text should be no more than 5,000 words. The manuscript should have no more than 40 references and a total of 6 tables and/or figures. Supplemental data are permitted for Special Reports.

Special Reports should list no more than 20 authors, with any additional contributors listed in the Acknowledgments. Although exceptions are rare, you may email [email protected] detailing each author's contribution to your submission, which will be forwarded to the editor.

Manuscript Preparation

• General Guidelines
• Submission/Publication Fees
• Journal Categories
• Title Page
• Abstract
• Impact Statement
• Text
• Acknowledgments
• References
• Tables
• Figure Captions
• Figures
• Supplemental Data 
• LaTex
• Availability of Data and Materials
• Data Citation

Manuscript Guidelines

• MS Word document (.doc or .docx) is required for all submissions. 
• If your submission is in LaTeX format, please refer to the instructions for LaTeX.
• All figures must be uploaded separately as Image Files; for guidance on accepted formats see below. Figures are limited to 4 panels or parts per figure.
• All submissions must be double-spaced, 1 inch margin, twelve-point font size in Arial, Helvetica, Times New Roman and Symbol font (for non-text characters).
• All submissions must be page numbered.
• All submissions must have line numbers included in the text.
• Do not use headers or footers.
• Use standard abbreviations and define all nonstandard abbreviations.
• All submissions require a title page.

Reporting of Concentration Units:

Analyte concentrations will be expressed in the text in the traditional mass unit (mg/dL, ng/ml, and so forth) followed by the SI unit in parentheses. Exceptions would include those analytes in which SI units are used globally, such as electrolytes (use mmol/L for sodium, potassium, chloride, and CO2 values), or cases in which the traditional unit and the SI unit differ by only a factor of 1000 in both the numerator and denominator (e.g., ng/mL vs µg/L). In such cases, the unit of measure consistent with common practice will be used.

The unit of measure mg/L should be used only when referring to SI units or when national or international guidelines require or recommend that the concentration of an analyte be expressed in that unit of measure, such as for high-sensitivity C-reactive protein. The unit of measure U/L will be used for most enzyme activities.
Only traditional units will be used for tables and figures in the printed version of a report; SI conversion factors will be provided in legends. All tables and figures will also be presented in SI units. These tables and figures will be made available in online supplements to published articles and letters. Authors will provide both versions before final acceptance of a manuscript. SI units are available at Bureau International des Poids et Mesures.

Supplemental Data are accepted for online publication only and are limited by submission types (See Types of Submissions for details).

Follow the guidelines for length restrictions, abstract, reference, table and figure, and supplemental data limits as outlined in the chart below:

*Word limit consists of the body of the manuscript only; it does not encompass the title page, abstract, acknowledgments, references, tables, figure legends, figures, or Case Study Question and Points.

**Structured abstracts contain the headings (1) BACKGROUND, (2) METHODS, (3) RESULTS, (4) CONCLUSIONS for all applicable article types except for Reviews and Mini-Reviews. Abstracts for Reviews and Mini-Reviews contain the headings (1) BACKGROUND, (2) CONTENT, (3) SUMMARY.

***If a figure accompanies the paper, the image should not be multipart (i.e., Fig. 1A, 1B, 1C, Part 1, Part 2).

Submission/Publication Fees

Authors are not required to pay submission fees in order to submit their work to JALM.

JALM offers the option of publishing under either a standard license or an open access license. Please note that some funders require open access publication as a condition of funding. If you are unsure whether you are required to publish open access, please do clarify any such requirements with your funder or institution.

Should you wish to publish your article open access, you should select your choice of open access license in our online system after your article has been accepted for publication. You will need to pay an open access charge to publish under an open access license.

Details of the open access licenses and open access charges.

OUP has a growing number of Read and Publish agreements with institutions and consortia which provide funding for open access publishing. This means authors from participating institutions can publish open access, and the institution may pay the charge. Find out if your institution is participating.

Please note that you may be eligible for a discount to the open access charge based on society membership. Authors may be asked to prove eligibility for the member discount.

Journal Categories

Articles are grouped in the journal according to subject. Upon submission, authors are required to select the journal category that best describes their manuscript from the list indicated below:

• Molecular Diagnostics and Genetics
• Evidence-Based Laboratory Medicine and Test Utilization
• Hemostasis, Coagulation, and Thrombosis
• Proteomics and Protein Markers
• Cancer Diagnostics
• Coagulation
• Lipids, Lipoproteins, and Cardiovascular Risk Factors
• Drug Monitoring and Toxicology
• Hematology
• Endocrinology and Metabolism
• Point-of-Care Testing
• Automation and Analytical Techniques
• Informatics and Statistics
• Laboratory Management
• Health Equity and Access
• General Laboratory Medicine
• Animal Laboratory Medicine
• Clinical Immunology
• Clinical Microbiology
• Pediatric Laboratory Medicine
• Nutrition
• Cardiac Markers
• Cancer, Renal, and Other Disease Biomarkers
• Neurology
• Infectious Disease
• Other Areas of Laboratory Medicine

Title Page

The first page of the manuscript should include the following information:

• Full title of submission, which should include only generic, not trade, names when describing a test, assay, etc.
• Running head of fewer than 50 characters (including spaces)
• List of all authors (first name, middle initial, and last name, in that order)
• Names of each author’s institution and an indication of each author’s affiliation
• Name, address, telephone and fax number, and e-mail address of the corresponding author
• 3-5 Keywords (note that keywords provided on the title page of the manuscript will be used for publication purposes)
• Any previous presentation or web description of the manuscript
• List of abbreviations, in order cited
• List of any “Human Genes" discussed in the paper. For each gene, indicate the gene symbol and gene name approved by the HUGO Gene Nomenclature Committee. Include other name(s) that are used in the paper or are widely used in the literature for the gene.

Abstract (Structured and Unstructured)

Structured abstracts should be formatted to include separate headings of: Background, Methods, Results, and Conclusions. For Mini-Review and Review articles the headings should be: Background, Content, and Summary. Both structured and unstructured abstracts are subject to a limit of 250 words.

Unstructured abstracts do not require separate headings.

Case Study, Editorial, Letter to the Editor, Reply, and Opinion submissions do not require an abstract.

In addition to appearing at the beginning of the manuscript, abstracts must be uploaded to the abstract field of the Manuscript Metadata page online upon submission.

Impact Statement

Article, Review, Mini-Review, and Focused Report submissions should include an Impact Statement in the main manuscript, immediately following the Abstract. The Impact Statement should be no more than 100 words and should address the following:

• Describe the population of patients that will benefit from the information presented
• Explain how the evidence presented in the manuscript will better characterize the issue
• Inform readers on how the manuscript contributes to the advancement of knowledge in the field of study

Text

The body of the manuscript should be written as concisely as possible and must not exceed the manuscript category word limits described herein. All pages must be double-spaced and all lines numbered. The body of the paper should include: Introduction, Materials and Methods, Results and Discussion.

Introduction - why was the study undertaken?
Materials and Methods - how was the study done?
Results - what did the study find?
Discussion - what might it mean, why does it matter, what next?
Full corporate names of manufacturers of materials should be utilized (omit Inc., Co., GmbH and similar words). After the first mention, use a shorter name (e.g., for Bio-Rad Laboratories, use Bio-Rad). Only the manufacturer’s name should be used, unless the item in question was a gift, in which case the city, state, and e-mail or website of the company should be included.

Reporting of Concentration Units: Analyte concentrations will be expressed in the text in the traditional mass unit (mg/dL, ng/ml, and so forth) followed by the SI unit in parentheses.

Use of human subjects requires a statement in the text indicating whether the procedures followed were approved by your institution's responsible committee (Institutional Review Board or Ethics Committee) or were in accordance with the current revision of the Helsinki Declaration and whether subjects gave informed consent. For transparency to the reader, authors should include the following in the manuscript: 1) the name of the institution or institutional review board (IRB) providing human ethics review, 2) the study number or review board identifier, and 3) the outcome of that review (for example, full or expedited review approval with or without waiver of patient consent). 

The criteria should be described for the inclusion and exclusion of human subjects and/or their derived samples. Sex should be used for describing biologic differences between male, female, and intersex. Gender should be used for describing self-identification, psychological, social and/or cultural factors. Sex should not be used interchangeably with gender.

The source of a study subject’s race and/or ethnicity (e.g., electronic medical record, laboratory information system) as well as the method of classification (e.g., patient self-identification) should be provided. If the categories of race/ethnicity in the data source (e.g., electronic medical record) do not match the Journal’s style, the categories from the original data source should be used in the manuscript; the additional information on the original data source should be explained in the methods section. Authors should exercise caution when analyzing and/or providing biological interpretations or conclusions based on race and/or ethnicity. Historically, laboratory medicine has had many reported associations between race and health outcomes; however, these associations have oversimplified or ignored multiple confounding variables including social determinants of health, as well as other socioeconomic, structural, institutional, cultural, demographic, or other factors. Thus, discerning the contributing role of each of these factors is difficult. If an author includes race and/or ethnicity-based analysis or the derivation of algorithms/scores, then the author must provide an accompanying justification of the analysis in the methods and an explanation of the broader applicability to individual patients in the results and discussion.

Accession numbers for data sets or sequence reads that have been deposited in a public database should be provided in the Materials and Methods section of the text.

Where applicable, a ClinicalTrials.gov identifier for a registered clinical study should be listed both at the end of the abstract and at the first mention of the trial acronym in the main text.

Acknowledgments

Acknowledgments are limited to 60 words and should follow the main text of the manuscript directly above the reference section in a separate paragraph heading labeled “Acknowledgments.” They should not appear as footnotes.

Do not include financial support, or other disclosure/conflict of interest information in the Acknowledgment. This information should be included in the Author Disclosure/Conflict of Interest form. If you include research funding in the Acknowledgment, you must specify which author or authors received the funding or if the funding was given to the group or institution. Editorial staff will transfer this information to the disclosure section prior to publication if the paper is accepted.

References

References should appear in a separate section directly following the body of the manuscript. The section must be labeled “References” with no additional punctuation. In-text citations should correspond to the numbered references in this list and should be formatted as follows: (1) or (1, 2).

• Italic or boldface type is prohibited in the referenced citations.
• List and number the references in the order that they appear in the text.
• Do not use the MS Word document numbering tool. Number each reference manually with the numeral and a period, followed by a space.
• For articles with more than seven authors, list the first six authors followed by "et al." For seven or fewer, list all authors.
• Authors’ names are inverted (last name, first/second initial). Do not add periods or commas within an individual author name; however, separate author names with a comma and end the author list with a period (Smith J, Doe JJ, Adams B.).
• Capitalize only the first word of the title or subtitle, and any proper names that are part of the title. The title should end with a period.
• The Journal names should be abbreviated as indicated at PubMed. For a list of journal abbreviations, please visit: LinkOut Journals.
• Do not add a period after the journal abbreviation, but continue with a space followed by the year.
• The year should be followed by a semicolon and then the volume number, which is followed by a colon and then the page numbers. Delete redundant numbers, for example 1998;12:231-45.
• Do not include the months in parentheses; this information is not needed.
• Use inclusive page numbers for articles and book chapters.

Abstract and supplement numbers should be provided, if applicable. Citations of unpublished abstract books, manuscripts in preparation or under review, personal communications, and manufacturers’ information should only be cited in the text and should not appear in the reference list. Unpublished material should be cited in the text as “unpublished observations,” and written permission from the source is required. Personal communications should also be listed parenthetically and should contain the first initial and last name of the contact as well as the month and year of the communication. A copy of written permission from the contact to use the communication must also be provided. Published manuscripts and manuscripts that have been accepted and are pending publication should be cited in the reference list.

In-press references cited in the reference list must be accompanied by a copy of the cited manuscript and a letter of acceptance, or a complete author proof from the publisher. These resources should be uploaded as supplemental data along with the manuscript and other print materials.

JALM style is available in the Endnote reference formatting program. Endnote users please note that the reference output from Endnote may not be exact and should still be checked carefully against the examples listed below. In particular, journal names may not be abbreviated correctly in the output. If you have used PubMed for journal name abbreviations, it is recommended that you take the following steps:

• Open the output style for The Journal of Applied Laboratory Medicine.
• In the settings along the left of the style window, select Journal Names.
• Set the Journal Names option to "Don't Replace."
• Then, use "File - Save As" to save a copy with a new name.

Refer to the Endnote Help Center for further assistance.

Reference Style:

Journal article with seven or fewer authors:

1. Vermeersch P, Mariën G, Bossuyt X. A case of pseudoparaproteinemia on capillary zone electrophoresis caused by geloplasma. Clin Chem 2006;52:2309-11.

Journal article with more than seven authors:

2. Fiechtner M, Ramp J, England B, Knudson MA, Little RR, England JD, et al. Affinity binding assay of glycohemoglobin by two-dimensional centrifugation referenced to hemoglobin Alc. Clin Chem 1992;38:2372–9.

Abstract:

3. Hortin GL, King C, Kopp J. Quantification of rhesus monkey albumin with assays for human microalbumin [Abstract]. Clin Chem 2000;46:A140-1.

Editorial:

4. Demers LM. New biochemical marker for bone disease: is it a breakthrough? [Editorial]. Clin Chem 1992;38:2169–70.

Letter to the Editor:

5. Davey L, Naidoo L. Urinary screen for acetaminophen (paracetamol) in the presence of N-acetylcysteine [Letter]. Clin Chem 1993;39:2348–9.

Book Chapter:

6. Rifai N, Warnick GR. Lipids, lipoproteins, apolipoproteins, and other cardiovascular risk factors. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry and molecular diagnostics. 4th Ed. St. Louis (MO): Elsevier Saunders; 2006. p. 903-81.

Thesis:

7. Haughton MA. Immunonephelometric measurement of vitamin D binding protein [MAppSci thesis]. Sydney, Australia: University of Technology, 1989:87pp.

Books and Monographs (serial volumes should be treated as journals):

8. Harrell FE Jr. Regression modeling strategies. New York (NY): Springer; 2001.

Published Ahead of Print:

9. Milbury CA, Li J, Makrigiorgos GM. PCR-based methods for the enrichment of minority alleles and mutations. [Epub ahead of print] Clin Chem February 6, 2009 as doi:10.1373/clinchem.2008.113035.

Supplement:

10. Castelli WP. Lipids, risk factors and ischaemic heart disease. Atherosclerosis 1996;124 Suppl:S1-9.

Internet Source:

11. US Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments (Accessed November 2023).

Tables

Tables are considered text. They should appear embedded as part of the submission directly following the reference section. Each table should appear on an individual page. Manuscripts will be returned to authors if the tables are uploaded as separate table files. (Manuscripts will not be returned for this reason if tables have been uploaded as supplemental data or if they are to be considered figures, in the special circumstances described below.)

Each table should be clearly labeled and numbered consecutively with Arabic numerals (Table 1, Table 2, etc.). The abbreviations used must be defined. As with the text, reporting of concentration units consists of analyte concentrations expressed in the text in the traditional mass unit (mg/dL, ng/ml, and so forth) followed by the SI unit in parentheses.

Tables should not be divided into parts. Separate parts (Table 1A, Table 1B, etc.) will be considered separate tables and will count toward your overall table/figure count.

Table captions should be limited to 60 words.

Each column of an individual table must have a heading and be clearly defined. Indicate explanatory footnotes with superscript lowercase italic letters in alphabetical order.

Tables will be converted into a standard format for publication. Large or complex tables or tables that include graphic elements should be submitted as figures or as supplemental data for online publication only. The Editor may choose to make any table supplemental as he/she deems necessary.

If a table has been published previously, acknowledge the original source in the table caption. You must obtain written permission from the copyright holder to reproduce the table and upload this permission as supplemental data. Please specify whether the table has been exactly reproduced or adapted from the original source, and provide a copy of the original table if it has been adapted. Even if the table has been modified, it may still require a permission. Any costs associated with table permissions will be borne by the author. Contact the editorial office at [email protected] if you are not sure whether permission is needed.

Figure Captions

Figure captions and sub-captions must be listed together on an individual page directly following the tables or the references if the submission does not include tables. Each figure requires a figure caption and should be clearly labeled (Figure 1, Figure 2, etc.). Multi-panel figures and figures with parts (a, b, c, etc.), should be distinctively labeled (Figure 1A, Figure 1B, Figure 2A, etc.).

Figure captions should be limited to 60 words. The abbreviations used in the figure must be defined. 

If a figure has been published previously, acknowledge the original source in the figure caption. You must obtain written permission from the copyright holder to reproduce the figure and upload this permission as supplemental data. Please specify whether the figure has been exactly reproduced or adapted from the original source, and provide a copy of the original figure if it has been adapted. Even if the figure has been modified, it may still require a permission. Any costs associated with figure permissions will be borne by the author. Contact the editorial office at [email protected] if you are not sure whether permission is needed.

Figures

All figures must be uploaded separately as image files. Preferred formats are .tif, .tiff, .bmp, and .eps. Formats including .jpeg, .jpg, .gif, .pdf, and .ppt are accepted if of adequate quality. If uploading .ppt images, the graphics must contain embedded fonts with one image per slide, one slide per file. Note that the use of .ppt format is discouraged, as figures render differently when opened in different versions of the software. Line drawings should be provided as vector graphics if possible. Figures are limited to 4 panels or parts per figure. Each image should have a resolution of 600 dots-per-inch (dpi). More detailed specifications can be found on our print publication vendor’s page at KGL Digital Art Support.

The submission system is designed to retrieve the manuscript file and separate image file(s) and combine or merge the files into an individual Portable Document Format (.PDF) for reviewing purposes. It is the responsibility of the author to verify the quality of the image file(s) after the conversion to PDF. It may be necessary to alter the individual image file (s) to ensure the content is not lost or misconstrued in the merged PDF.

Submissions will be returned to authors if the figures are embedded within the manuscript file and not uploaded separately or if the figures have become illegible in the merged PDF.

Do not place unnecessary graphics, such as borders, in or around your figure. Pay particular attention to the quality of the lines, symbols, and patterns. Published figures are reduced to 1 column (85mm) or 2 columns (176 mm) in width. If, at that width, the figure symbols or lettering are not clear, you will need to increase the font size. Letters should be 8-10 points when reduced, and subscripts no less than 6 points. Initial capitals and lower case letters and a medium (not bold) sans serif font are required. European PI, Helvetica, Mathematical PI, Times Roman, and Symbol fonts are Type 1 PostScript fonts supported by our printer for the creation of digital art figures.

The x-axis and y-axis should be clearly labeled, and the units of measurements given. This includes using decimal points instead of commas, italicizing species or gene symbols, and using U.S. English.

Figure accessibility and alt text

Incorporating alt text (alternative text) when submitting your paper helps to foster inclusivity and accessibility. Good alt text ensures that individuals with visual impairments or those using screen readers can comprehend the content and context of your figures. The aim of alt text is to provide concise and informative descriptions of your figure so that all readers have access to the same level of information and understanding, and that all can engage with and benefit from the visual elements integral to scholarly content. Including alt text demonstrates a commitment to accessibility and enhances the overall impact and reach of your work.  

Alt text is applicable to all images, figures, illustrations, and photographs. 

Alt text is only accessible via e-reader and so it won’t appear as part of the typeset article. 

Detailed guidance on how to draft and submit alt text. 

JALM is committed to making content accessible to all readers. All color figures should be formatted so that their meaning will also be clear in black and white (i.e., using patterns or shades of gray in place of colors).

Authors may be asked to revise figures to improve accessibility. Oxford University Press provides detailed recommendations  for making your artwork as accessible as possible. When preparing your figures, please consider the following general principles:

• Meaning should not be communicated only through color—avoid referring to color in the manuscript as the only cue to meaning. Use other cues such as text labels or varying pattern.
• Exaggerate lightness differences between foreground and background colors. An online color contrast tool such as WebAIM  can assist with optimizing contrast.
• In line graphs, have a label next to the plot line (with or without leader line, as necessary); use different stroke styles (e.g., solid, dashed, dotted); and use different symbols for data points.
• In bar graphs, label individual bars so the reader does not need to rely on perceiving colors in the legend; use a color palette with high contrast between shades; use patterns or textures with, or instead of, color; and ensure there is sufficient contrast between the bars, and between the bars and the background.
• Do not use color for typography unless absolutely necessary—it is best to use black text on a white background.

Supplemental Data

Figures or tables too large for print, manuscript material that exceeds the limitation for the specific submission type, or appendices should be submitted for online publication only. These files should be marked and uploaded separately as supplemental files during submission and should be referenced within the text as supplemental data (i.e., "See Supplemental Table 1", "See Supplemental Figure 1", etc.). Supplemental files must be labeled consecutively (i.e., Supplemental Table 1, Supplemental Table 2, Supplemental Figure 1, Supplemental Figure 2, etc.).

When labeling your files and referencing them within the main text, please keep in mind the preferred naming conventions for supplements. “Supplemental” is preferred over “Supplementary,” and the word “Data” is not necessary in table or figure titles (i.e., “Supplemental Table 1,” not “Supplemental Data Table 1” or “Supplementary Table 1”). If all supplemental materials are contained in a single file, that file should be referred to as "Supplemental Data." The filename you provide will be used to label the file at publication, so please use a clear and descriptive filename.

Captions for the supplemental data should be uploaded as a separate supplemental file or embedded within the supplemental data/table/figure file. Do not include the supplemental captions in your manuscript file.

Please be advised, supplemental data are permitted for Article, Mini-Review, Review, and Special Report submissions only. Manuscripts of all other types with supplemental data will be returned to authors.

Supplemental data will be reviewed as part of the manuscript and will be evaluated for its importance and relevance.

If accepted and posted online, the supplemental data will be referenced in the text of the print article directing readers to the website.

LaTeX

If your submission is in LaTeX format, please submit your manuscript file as a pdf at initial submission. If your paper is accepted, the journal will reach out to you with instructions to upload your LaTeX files prior to publication.

Availability of Data and Materials

Where ethically feasible, JALM strongly encourages authors to make all data and software code on which the conclusions of the paper rely available to readers. We suggest that data be presented in the main manuscript or additional supporting files, or deposited in a public repository whenever possible. For information on general repositories for all data types, and a list of recommended repositories by subject area, please see Choosing where to archive your data.

Data Citation

JALM supports the Force 11 Data Citation Principles and requires that all publicly available datasets be fully referenced in the reference list with an accession number or unique identifier such as a digital object identifier (DOI). Data citations should include the minimum information recommended by DataCite:

• [dataset]* Authors, Year, Title, Publisher (repository or archive name), Identifier

*The inclusion of the [dataset] tag at the beginning of the citation helps us to correctly identify and tag the citation. This tag will be removed from the citation published in the reference list.

Online Submission and Tracking

• ScholarOne Manuscripts
• Registering
• Changing Contact Information and Password
• ORCID
• Troubleshooting

ScholarOne Manuscripts

JALM uses the ScholarOne Manuscripts manuscript submission, tracking, review, and publishing system. All submissions should be entered in ScholarOne.

For help with submissions during regular business hours, contact JALM via e-mail at [email protected].

Registering

If you previously had an account with us, you may already be registered in ScholarOne. Please visit ScholarOne and click the “Reset Password” link.

If the system is unable to find an account under your email address, you will need to click “Create an Account.” Please complete all required fields to complete your registration.

Always use the same e-mail when accessing the system. Multiple e-mail addresses will cause repeated registrations and the creation of multiple accounts, which could lead to future system access problems.

Changing Contact Information and Password

E-mail addresses, passwords, and other contact information can be modified at any time by clicking "Personal Info" from the gray navigation bar at the top of any page within the manuscript processing system, then E-mail / Name, Address, or User ID & Password.

Feel free to contact the Editorial Office via e-mail ([email protected]) should you need assistance.

ORCID

Authors are encouraged to register with ORCID and associate their ORCID iDs with their accounts in ScholarOne. Authors may create or link an ORCID iD during account creation, or at any time under "Edit My Account," following the instructions provided.

The ORCID iD will populate automatically during manuscript submission for all listed authors who have linked their accounts to a valid identifier. Authors who wish to link an ORCID must update their own individual accounts; submitting authors are not permitted to add ORCID iDs on behalf of their co-authors. Unauthenticated ORCIDs included as text in the manuscript file will not be published.

Please see more information about ORCID.

Troubleshooting

Please see FAQs and Help for more extensive help.

Manuscript Transfer

Authors of a manuscript rejected by Clinical Chemistry will receive a decision email with detailed instructions on how to easily transfer their paper to JALM. Should the author choose to do so, they may revise their manuscript (addressing any Clinical Chemistry reviewer comments) and transfer their paper to JALM as detailed in the instructions provided in the email.  Authors will have 30 days to complete the transfer. After agreeing to the transfer, authors will need to log in to the JALM submission site to access the transferred manuscript and complete the process.

The following information will be transferred from Clinical Chemistry to JALM:

• Title, author list, and manuscript details 
• Manuscript, figure, and supplemental files
• Author disclosure forms

Authors should address any reviews received from Clinical Chemistry but are otherwise not required to reformat their manuscripts in order to have their initially transferred submissions considered by JALM.

Important points regarding the transfer process:

• It remains an author’s decision to transfer their rejected or rapidly rejected paper from Clinical Chemistry to JALM. No papers will be transferred on behalf of authors by editorial staff. Follow all emailed instructions carefully to complete the process.
• Once transfer is complete, a new JALM manuscript ID will be assigned. Authors must access the new JALM manuscript to complete the transfer.
• The transfer of a paper to JALM does not guarantee review. All submissions are reviewed by the Editor-in-Chief before being assigned to an Associate Editor. Based on editorial judgment, some submissions may be rejected initially without external review.

Post- Acceptance

• Copyright
• Proofs
• Disclaimers
• Permissions and Reprints
• Advance Articles

Copyright

Upon acceptance, all authors are required to read and sign the Copyright Transfer Agreement. Each author will receive an email from Oxford Academic inviting them to sign a statement confirming that the manuscript does not contain material for which publication would violate any copyright or other personal or proprietary right of any person or entity. U.S. Federal employees will need to be identified. Each author must be registered with our online submission system to access, read, and electronically sign the copyright agreement.

Manuscripts will be held until all copyrights are received. In the event that copyrights are not received, the manuscript will not be published.

Manuscripts will not be prohibited from publication solely on the basis of a web-posting of a talk at a medical or scientific meeting that presents all or part of the content of the submitted manuscript.

Authors are expected to retain – for a minimum of 3 years after publication – the raw data from laboratory or clinical studies and to present these data upon request of the Editor if the data are contested.

Authors are expected to identify to the Editor any other manuscripts (in print, accepted, have been submitted, in preparation) that relate to the submitted manuscript, especially if any patients or results are described in both.

Questions related to the possibility of perceived redundant publication or fragmentation of results should be directed to the Editor.

Proofs

To find out the status of your accepted paper in the publication process, including when you can expect to receive your proof, please email [email protected].

Disclaimers

Manuscripts published in JALM reflect the individual views of their authors and, in the absence of a statement to the contrary, not the views of the institutions with which the authors are affiliated. The contents of advertisements or articles are not to be construed as official statements, evaluations, or endorsements by the Editor-in-Chief or ADLM.

Permissions and Reprints

JALM is copyrighted by ADLM. Permission to reproduce copyrighted material for scholarly or commercial use can be requested from Oxford University Press by submitting a permissions request via RightsLink from the article landing page.
Please see the Oxford University Press Rights & Permissions  website for more details.

E-mail: [email protected]

Advance Articles

Accepted articles are published online after copy editing and author review of corrected proofs.

JALM Editorial Office

The Journal of Applied Laboratory Medicine
900 Seventh Street, NW
Suite 400
Washington, DC 20001
United States

[email protected]
(202) 857-0717

Kristen Hauck, Director, Publications: [email protected]
Heather Drought, Managing Editor: [email protected]

Please include the corresponding author's e-mail address and the manuscript number on all correspondence.