Instructions to Authors
ALL AUTHORS: PLEASE READ
Clinical Chemistry has moved to a new submission and manuscript tracking system.
ALL NEW SUBMISSIONS: Please submit your paper at https://mc.manuscriptcentral.com/clinchem.
IF YOU HAVE A SUBMISSION ALREADY UNDER REVIEW IN OUR OLD SUBMISSION SITE: Please continue to access https://submit.clinchem.org to track and manage your paper. DO NOT create a new submission in ScholarOne. Your paper will continue to be handled (including all future revisions and reviews) through https://submit.clinchem.org until a final decision is made.
Information about submitting via ScholarOne can be found here. ScholarOne FAQs and comprehensive instructions can be found at https://clarivate.com/webofsciencegroup/support/scholarone-manuscripts/faqs-help/.
Additionally, all authors are now required to complete the ICMJE Conflict of Interest form. The corresponding author should direct all co-authors to download and complete the form prior to submission. The corresponding author will be asked to upload one form for each author during the submission process.
Overview
Clinical Chemistry, issued monthly, is published in print and electronically by the American Association for Clinical Chemistry (AACC) in partnership with Oxford University Press. The journal welcomes contributions, either experimental or theoretical, in the field of laboratory medicine. It is the leading forum for peer-reviewed, original research on innovative practices in today’s clinical laboratory. In addition to being the most cited journal in the field, Clinical Chemistry has the highest Impact Factor among journals of clinical chemistry, clinical (or anatomic) pathology, analytical chemistry, and the subspecialties, such as transfusion medicine and clinical microbiology.
Submissions of the following nature are welcomed:
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 chemically oriented problems of human disease
Contributions should consist of subject matter that is original and significantly advances the state of knowledge of clinical chemistry, 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.
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 native-English speaking colleague to correct English 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.
All Clinical Chemistry submissions, correspondence, and reviews must be in English. Manuscript content and writing responsibility remains with the author; however, several professional writing/editing services are available to assist authors. Clinical Chemistry does not endorse any editing service nor is Clinical Chemistry responsible for any services performed. These include but are not limited to:
www.bioedit.co.uk
www.bioscienceeditingsolutions.com
www.biosciencewriters.com
www.bluepencilscience.com
www.bostonbioedit.com
www.charlesworthauthorservices.com
www.editage.com
www.enago.com
www.journalexperts.com
www.prof-editing.com
www.sciencedocs.com
www.stallardediting.com
www.hzlxsw.com
Contributions may be submitted via the ScholarOne Manuscripts. Please contact the Editorial Office via e-mail (clinchemed@aacc.org) should you have any questions or need assistance. Please also visit https://academic.oup.com/journals/pages/authors for information about publishing in an Oxford Academic journal.
Standards for Reporting Scientific Data
Description of Analytical Methods and Results
Statistics
Studies with Human Subjects
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, analytical specificity, recovery, lower limit of detection, 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 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 include estimates of "within-run" and "total" standard deviations (2). Each should be determined at low, normal, and above-normal concentrations with use of specimens that are in an appropriate biological matrix.
One method for estimating both within-run and total standard deviations is the analysis of variance experiment described in NCCLS EP5-T (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 analyte (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 components of uremic plasma. Exogenous materials, such as ingredients of blood collection containers (tubes) and commonly used or commonly coadministered 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 analyte 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 (4, 5).
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 (6).
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 (7). A program to perform Deming regression is available online as a supplement from this journal (8).
The correlation coefficient has limited utility. Residuals plots [e.g., Bland-Altman (9, 10)] are often useful. On the horizontal axis, plot the mean of results by the two studied methods, not the result of one method.
Analytical sensitivity and detection limit: These terms 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.
The limit of detection (LOD) is defined as the lowest concentration or amount of an analyte that can be reliably identified as being qualitatively present in the sample. The limit of quantification (LOQ) is defined as the lowest concentration or amount of analyte that can be reproducibly quantified in a sample. The most acceptable criteria for ascertaining the LOQ is the concentration of analyte that can be measured with an imprecision of less than 20% and a deviation from target of greater or less than 20% (1). The operational definition of the LOD and LOQ must be supplied by the author. Additional considerations related to this topic are presented by Linnet (11).
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 (12).
Reference 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, and sex distribution; the statistical method for summarizing the results (13); and other factors that would influence the values obtained.
Mass spectrometric assays must be evaluated for matrix effects (ion suppression or enhancement) (14, 15).
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 (16).
References:
Center for Drug Evaluation and Research (CDER) Guidance for Industry: Bioanalytical Method Evaluation, 2001.
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.
NCCLS Tentative Guideline EP5-T. User evaluation of precision performance of clinical chemistry devices. Wayne, PA: National Committee for Clinical Laboratory Standards, June 1984.
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.
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.
Linnet K. Necessary sample size for method comparison studies based on regression analysis. Clin Chem 1999;45:882–94.
Linnet K. Evaluation of regression procedures for methods comparison studies. Clin Chem 1993;39:424–32.
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.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10.
Altman DG, Bland JM. Commentary on quantifying agreement between two methods of measurement. Clin Chem 2002;48:801-2.
Linnet K, Kondratovich M. Partly nonparametric approach for determining the limit of detection. Clin Chem 2004;50:732-40.
Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999;45:321–3.
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.
Annesley TM. Ion Suppression in Mass Spectrometry. Clin Chem 2003;49:1041-44.
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.
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:
Harris EK. On P values and confidence intervals (why can't we P with more confidence?) [Editorial]. Clin Chem 1993;39:927-8.
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
Clinical Chemistry'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 as revised in 2013. 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.
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.
……
更多详情：
https://academic.oup.com/clinchem/pages/General_Instructions
