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Manuscript Checklist (link to PDF)
CONSORT Checklist (link to PDF)
For further guidance on manuscript submission, consult the ‘Submitting a New Manuscript’ section of our Information for Authors. You can also find a link to the information in the upper left corner of each submission page at http://submit.clinchem.org/.
Other good resources include the CBE Style Manual (1) or, as needed, The ACS Style Guide: A Manual for Authors and Editors (2) and the American Medical Association Manual of Style (3).
Source Files
Uploading a paper as a PDF file normally would be a good way to upload a paper to a website. However, Clinical Chemistry (and other medical journals) use tracking software which requires use of 'source files' or original creation files -- Word documents and eps or tif image files -- to properly load information for review onto the website.
As an example, one of the features of the online system links references to Medline. As this is a valuable tool for both editors and reviewers, the author needs to upload a Word document source file in order to allow this to occur. If a PDF is uploaded, the HTML reference field, which the reviewers use to view citations, will remain empty.
IMRAD Organizational Structure
Clinical Chemistry uses the IMRAD Organizational Structure with a Title Page and Structured Abstract at the beginning. The body of the paper includes: Introduction, Methods, Results and Discussion.
Acknowledgements, References, Tables, Figure Legends and Figures should appear at the end of the manuscript, on separate pages and in that order.
An overview of the "IMRAD format" can be found in a handout from the Writing Center of the University of Wisconsin at Madison at http://www-math.science.unitn.it/LRM3D2/report.htm.
There are links there to more detailed explanations of each of the headings.
General Guidelines
Contributions should meet the following criteria:
We use standard 8.5 X 11 paper.
Use 1 inch margins and double spacing throughout the entire manuscript.
Do NOT use headers or footers on each page (such as author name, manuscript title or institution), but do include page numbering.
Line numbering is not required but is acceptable.
Use the International System of Units (SI) (4) consistently throughout. Values expressed in conventional units may be added in parentheses after the value in SI units.
Define all nonstandard abbreviations the first time they are used in the text and (if used more than two times) in a single entry after the abstract. Avoid unnecessary new abbreviations. For terms used fewer than four times, do not introduce an abbreviation.
A list of standard abbreviations that may be used without definitions is available in the ‘Standard Abbreviations’ section of the Information for Authors, found in a link at the top of each submission page at http://submit.clinchem.org/ .
Space in the print journal is limited and authors are expected to present their work concisely and neatly.
Special limits apply to certain manuscript types (see length guidelines in the ‘Submitting a New Manuscript’ section of our Information for Authors found in a link on the upper left corner of each submission page at http://submit.clinchem.org/).
Additional data, images, or method details may be submitted as supplemental data for online publication only. This is a useful tool, allowing authors to meet print space restraints while still including all pertinent information.
The Cover Letter, which should be entered in the Cover Letter field on the Manuscript Metadata Page only, indicates that the manuscript acknowledges all sources of support for the work including gifts or loans of equipment, gifts of reagents, financial assistance, grants, contracts, consultantships, etc. Do not include it in the text of your manuscript.
Other potential sources of financial conflicts of interest, including stock ownership and patents, should be indicated in this letter.
This is also the area where authors can indicate their willingness to pay (or not) for color images.
Title page
Prepare the title page on the first page with the authors’ first and last names, in that order. Include complete author names and affiliations for all authors.
List the mailing address, telephone number, fax number, and e-mail address of the corresponding author. Identify the corresponding author with an asterisk.
Provide a title and a short (50 characters only) ‘running title’.
Avoid extraneous words and phrases in your title, such as ‘Studies on’ and ‘Investigation of.’ Keep in mind that titling your manuscript is like writing a newspaper headline—providing as much information in as few words as possible.
If submitting a full Article, include a subject heading on the top left corner of the page. (See ‘Journal Categories’ under the ‘Submitting a New Manuscript’ section of the Information for Authors, found in a link at the top of each submission page at http://submit.clinchem.org/).
Provide a list of abbreviations, in order cited, at the bottom of the title page of the manuscript.
If your manuscript source file contains no title page, the PDF file that is used by reviewers does not contain one. Please make sure to add the title page to your Word document.
Gene Nomenclature
Following the list of nonstandard abbreviations on the title page, provide a separate list titled “Human Genes" that includes all genes discussed in the paper. For each gene, indicate the gene symbol and gene name approved by the HUGO Gene Nomenclature Committee (http://www.genenames.org/)
Include other name(s) that are used in the paper or are widely used in the literature for the gene.
In the text, we encourage use of the approved gene symbol (in capital italics) to conserve space and to avoid ambiguity.
Provide a structured abstract of 250 words or less, on a separate page after the title page. Please present your abstract with separate headings of Background, Methods, Results, and Conclusions.
The Background section should state the context and rationale for the study, usually in two sentences.
The Methods section should contain the reproducible steps used to carry out the study
The Results section should contain numerical data and appropriate statistical information.
The Conclusions section should follow from the presented results and be objectively verifiable; avoid qualitative words such as “good", and use “acceptable" only in reference to explicit criteria for acceptance.
Paste a copy of the Abstract, or the first few paragraphs for Letters to the Editor and Editorials, into the Abstract field on the Manuscript Metadata page as well as including it in the manuscript after the title page.
Letters to the Editor and Editorials do not require a structured abstract; enter the first few paragraphs into the Abstract Metadata section.
Your abstract should represent your entire paper, listing the highlights only, and should be written and inserted after the paper is completed.
The abstract is used by editors, reviewers and readers to determine interest in your manuscript and is, in some ways, the most important part of your paper. The abstract of a published paper often determines whether it will be read.
Courier, Helvetica, Times New Roman, or Symbol fonts (for non-text characters) are the only fonts that will convert correctly in the PDF for review. DO NOT use other fonts.
All text should be in 12 point font.
Authors should take care that Asian or European character fonts have not been included as they cannot be read by all systems. You will need to replace these fonts with Courier, Helvetica, Times New Roman, or Symbol fonts in order for our reviewers to correctly assess your paper.
Please use Symbol as the font for your special non-text characters. To do so, in your Word document, highlight each character in turn and select the Insert menu option at the top of the toolbar. Choose Symbol, thereby changing the font of each special character to the right font that should maintain and reproduce after conversion to PDF. Insert the correct character.
Provide full corporate names of manufacturers of materials.
Reference call-out numbers in the text should be typed on the line, in parentheses and underlined (example (1) (2) (3) (4)) in contrast to the way they appear in the Journal.
Use SI units throughout the text (and in the tables and figures). Conventional units may be added 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 or were in accordance with the current revision of the Helsinki Declaration and whether subjects gave informed consent.
The purpose of the introduction is to explain why the paper was written (and to get readers interested enough to read further).
Briefly describe (in about one and a half pages):
The Introduction should not include methods, results or conclusions of your study (which have been summarized above in the abstract).
Be selective in citing the literature (and be sure to read the cited papers).
Be brief or you will risk losing the reader’s interest.
Materials and Methods
Identify the apparatus used and provide the name of the manufacturer and the model number if multiple versions exist. Do not list locations (City, State, or Country) of suppliers.
For modified or newly created equipment, provide enough detail for the reader to duplicate the construction.
Do not list steps but write a dialogue about what was done, why and how. Remember that your work will be read by other scientists who understand the basic skills of science, you do not need to add unnecessary material (e.g., null hypothesis, we poured the solution slowly)
Describe the roles, if any, of funding organizations (such as granting agencies or corporate sponsors) in
For those areas (a, b, c and d) in which the funding organization had no role, state this explicitly in the manuscript.
Do not try to interpret meaning at this stage, only summarize the data collected.
Use tables and figures as graphics of summarized data.
Order results logically, and do not lead with the least important findings.
Summarize the key finding verbally (without repeating numerical results such as means and p-vales), and place it in context of previous work. How does it advance the field?
Repeat for secondary findings.
Indicate conclusions that can be drawn from the data.
Indicate limitations of the study. For clinical studies, address problems of generalization such as spectrum bias and verification bias.
Suggest areas for future work if appropriate.
Indicate here all conflicts of interest and acknowledge financial support, gifts, technical help, or other assistance, including that rendered by a company in evaluation of a product. (For gifts, do indicate the relevant locations for the company.) Place this information in a paragraph preceding the references.
Please see the http://submit.clinchem.org.
Formatting the Reference List
As an example, the reference style should appear as follows:
1. Smith ML, Jones JG. Hybridization of radioactive DNA to the DNA of cytological preparations. Proc Natl Acad Sci U S A 1929;64:500-4.
Label the reference section with the title References with NO additional punctuation. This References title is how the system recognizes the reference section and extracts the text for linking to Medline.
Number references in the order of their appearance in the text and list them in numerical order in the section titled "References" placed after the text and any acknowledgements.
Do NOT alphabetize.
Do NOT use italic or boldface type in the reference citations.
Do NOT use the Microsoft Word numbering tool. Number each reference manually with the numeral, a period and a space. Example:
1.
2.
Year, volume, and page numbers should be listed (delete redundant numbers, for example 1234-1235 should be1234-5).
Do NOT include months in parentheses, i.e., Proc Natl Acad Sci U S A 1929;64 (3) :500-4
Use inclusive page numbers for articles and book chapters.
Indicate if one-page articles are abstracts, letters, or editorials, after the title but before the abbreviated journal name and page number (See # 3 under ‘examples of reference format’ below).
For articles with more than seven authors list the first six and then type et al. For seven or fewer authors, list them all.
Abbreviate journal names as indicated at PubMed. This is necessary for electronic linking of citations to PubMed. For the correct journal abbreviations go to http://www.ncbi.nlm.nih.gov/entrez/linkout/journals/jourlists.cgi?typeid=1&type=journals&show=ALL&operation=Show
After you submit the manuscript, you will be given an opportunity to see the linking of references to PubMed. References that fail to link usually have an error in the punctuation or an error in the abbreviated journal name.
Please repair those errors in your manuscript, as errors that prevent linking are annoying to your first readers: the editors and reviewers. Examples of reference format are as follows:
Journals
Books and monographs (except serial volumes, which are treated as journals)
Internet sources should include the author (if any), the title of the site, the URL (web address), and the date accessed.
Publish-Ahead of Print should include the author, the title of the paper, the DOI number or the URL (web address), and the date accessed.
In Press References
In press references cited in the references 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. This is important as these materials are needed for the peer review process.
If they are not received, the manuscript will be returned to the author until these materials can be obtained. In press reference materials are required before the review process can proceed.
Include citations of unpublished abstract books, manuscripts in preparation, personal communications, and manufacturers' information in the text, not in the reference section.
Provide written permission for any personal communication. These materials should be uploaded as Supplemental Data on the ‘Supplemental File Upload’ page.
Extra figures and tables to appear online only can also be uploaded here. Brevity is an important factor in print journals and using online Supplemental Data is a good way to include more data.
Reference to Unpublished Work
Authors citing in-press papers of which they are not authors, personal communications, or other unpublished work related to the manuscript must submit with their manuscript a letter from the individuals concerned, confirming the work and giving permission for the citation.
If any of the authors’ unpublished manuscripts submitted to other journals are cited in the manuscript submitted to Clinical Chemistry or may be critical to its evaluation, a copy of each unpublished manuscript must be included with the original submission as Supplemental Data.
Personal communications, unpublished work, and manuscripts that have not been accepted must be cited parenthetically in the text and not as numbered references.
Reference Linking
The on-line submission and reviewing system uses a reference linking tool for displaying references in hyperlinked HTML format as an aid for reviewers and editors, who can simply click on the link to view the reference.
This linking also provides a check on the format and accuracy of reference citations.
Correct linking of references depends on strict adherence to Journal style.
The system will NOT be able to extract references from PDFs uploaded as a manuscript source file. If you are submitting a PDF and your references HTML page is completely or partially blank, then we suggest you upload your original word-processing document and have our system generate the PDF.
The linked HTML reference list is provided as a resource for the reviewers and editors of your paper, but, like the cover letter, will not be published should your manuscript be accepted.
Proofing the Reference List
One of the features of the online system links references to Medline and the references appear linked in the HTML References field. As this is a valuable tool for both editors and reviewers, you will need to correct your Reference section so that most of the listings link to PubMed.
When proofing your manuscript prior to final submittal, please make sure the references appear correctly in the references field in the Manuscript Conversion section of the Submission Approval page.
Please make the necessary corrections to your manuscript file and re-upload the file by clicking on the ‘Reupload your Manuscript’ button on the ‘Submission Approval’ page.
Your paper will go through the conversion process again and then you can view the HTML references section again before approving it.
You can repeat this process as many times as you like until you are satisfied your submission is the way you wish it to be.
Note: All parts of the manuscript must be checked off and approved on the system before the paper will be sent to our office. Until you approve the manuscript and receive the final confirmation email, the Clinical Chemistry editorial office has not received your manuscript.
When manuscripts are at ‘ready to proof’ stage, this means that you can edit the manuscript and make any changes by re-uploading various parts of your submission.
Please understand that once an item is uploaded, it is converted into HTML language and cannot be edited online. The only way you can change something is by making changes to the original document and re-uploading the manuscript and images and allowing them to go through the conversion process again--replacing what was there before. You can do this conversion as many times as needed. Please take the extra time to make sure the manuscript is properly entered using Journal style.
Note: All parts of the manuscript must be checked off and approved on the system before the paper will be sent to our office. Until you approve the manuscript and receive the final confirmation email, the Clinical Chemistry editorial office has not received your manuscript.
In the case that your references are not hyperlinked to their respective papers, please be sure that your reference format follows the format dictated by our Manuscript Preparation pages. Books and more obscure references will not be hyperlinked. DOI numbers and access dates of websites are acceptable.
References cannot be edited directly in the manuscript; any changes must be made by re-uploading your corrected manuscript file during the proofing stage. They can, however, be edited slightly in the HTML field, although this will not correct the references in your manuscript.
You may insert an HTML break ( <P> ) after citations that you do not think will be linked because they do not exist in Medline or in a journal hosted by HighWire Press; for example, citations for books, papers in press, personal communications, etc.
Figure captions and subcaptions must be listed together on a page separate from the figure panels, after the references section and tables and before the figure panels.
If a figure has been published previously, acknowledge the original source and submit, as supplemental data, written permission from the copyright holder to reproduce the material.
Color
The costs of publishing color illustrations (figures and/or tables) in print will be borne by the author. Costs are $1500 for the first image and $500 for each subsequent color figure, or parts of figures.
Please note the author agreement to pay in the cover letter.
If a manuscript is accepted, the author will be billed for color publication costs unless the author requests that the figure be printed in black and white.
Use SI units. Conventional units may be shown in addition. Conversion factors may be added to the legend.
Authors may contact the Editor to discuss undue hardship. Every effort is made to ensure that no meritorious manuscript is declined for lack of funds.
Color versions of figures may be provided for publication in the on-line Journal at no extra charge, with the figures produced in black and white in the print journal. Please notify staff in the cover letter if you wish to have your color figures for online publication only.
Tables must be uploaded embedded/inserted into the text document and not uploaded as separate files. Your manuscript will be returned to you if the tables are uploaded separately.
Number tables consecutively with Arabic numerals.
Define abbreviations used.
Use SI units.
Conventional units may be added in parentheses (Conversion factors may be added in a footnote).
Place Tables after the References section in the manuscript.
Most common word processing formats are acceptable for creating your table. Please insert each table, on its own page, into the manuscript following the References section and before the figure legends.
Do NOT upload tables as PDFs or as graphic files. Data other than chemical structures cannot be imported into tables from other programs.
Spreadsheet generated tables should be reconfigured using the Word table-building tool and placed in the word-processing document.
Type each table and its brief caption on its own page.
Indicate explanatory footnotes with superscript lowercase italic letters in alphabetical order, reading across the table.
Give every column a heading with clearly defined units as appropriate.
Please make sure your table is clearly labeled to avoid confusion in production or in the reading of the table.
Color tables will be considered for publication. As is the case with color figures, the costs of publishing color illustrations (figures and/or tables) will be borne by the author. Costs are $1500 for the first color table and $500 for each subsequent color table, or part thereof.
Please note the author agreement to pay in your cover letter.
The author will be required to bear the full cost of their preparation and publication, invited contributions excepted. The charge for the first color table is $1500. Subsequent color tables or parts of tables are $500 each
Provide a legend for each figure in the manuscript.
Clearly label each figure.
Published figures are reduced to I column (85mm) or 2 columns (176mm) in width. If, at that width, the figure symbols or lettering cannot be read, re-letter them in a larger type size.
Use initial capitals and lower case letters and a sans serif type face (this is a sans serif type face).
Acceptable image file formats for print publication are .eps and .tif, at resolutions of 300 or 600 dots-per-inch (dpi). Further, more detailed specifications can be found on our print publication vendor’s page at http://cpc.cadmus.com/da/guidelines.asp, and must be submitted as independent files, not embedded within a word processing document.
Microsoft PowerPoint (.PPT) files are also acceptable, but the graphics contained within them must have embedded fonts and one image per slide, one slide per file.
To embed fonts in PowerPoint: open each PowerPoint file, choose Tools, Options, then the Save tab, and click embed TrueType fonts and make sure the ‘embed all characters’ button is checked. This will help your PowerPoint file convert more easily to PDF.
If necessary, GIF, JPEG, PDF, and embedded figures may be used for initial submission and review; however, authors are advised to create and keep print-quality files on hand, as they will be required upon first revision of the manuscript.
Keep in mind that, even though a PDF is acceptable for a first submission, it will have to be replaced if the manuscript is accepted. In addition, the Clinical Chemistry system generates a PDF file for review from the source files uploaded by the author. Creating a PDF from a PDF can be problematic (See the ‘Reference Linking’ section of the Information for Authors, found in a link at the top of each submission page at http://submit.clinchem.org/.
In the case that publication quality electronic figure files cannot be provided, acceptable publication prints are: for halftones, glossy prints; for line drawings, glossy prints or laser prints on coated (nonabsorbent) laser-printer paper or drawings in black India ink on tracing paper.
Figures printed with dot-matrix printers are NOT acceptable.
Figures, electronic or otherwise, should be redesigned or recreated if they do not appear sharp and clear on paper.
Authors are advised to test print electronic files before submitting them for publication. Verify that symbols and lettering will be legible when the figure is reduced to one column (85 mm) or two columns (176 mm) wide. Letters should be 8\10 points when reduced, subscripts at least 6 points. Use a medium (not bold) sans serif (Swiss, Helvetica, Arial) font.
Lowercase lettering with an initial capital is preferred.
Use abbreviations appropriate for journal style (e.g., mL and mmol/L, not ml and mM).
Use a period (full stop), not a comma, to indicate decimal position.
If an author’s image for print is uploaded as a Supplemental Data File, it will not appear in the PDF for review and the reviewers will assume it is Supplemental Data for online publication only (Supplemental Data does not appear in print).
Supplemental Data too large for print publication or exceeding the bounds of the manuscript type may be submitted with a manuscript for inclusion in the online version of Clinical Chemistry.
Submitting additional data, images, or method details as Supplemental Data for online publication only is a useful tool, allowing authors to meet print space restraints while still including all pertinent information. Files intended for online publication only should be uploaded as the type "Supplemental Files" at http://submit.clinchem.org/, and referred to in the text with the phrase ‘See Supplement Data’.
If an author’s manuscript, images or tables for print are uploaded as Supplemental Data Files, they will not appear in the PDF for review and the reviewers may be confused as to their purpose.
Supplemental Data information 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 URL of the Web site. The Supplemental Data will appear along with the manuscript in the online version as well.
Cross Reference your Submission
If any apply, please see the following pages from our Information for Authors before submitting your manuscript to Clinical Chemistry. The Information for Authors can be found in the upper left corner of every submission page at http://submit.clinchem.org/.
Overview
Recent Changes and Updates
To Register with the Clinical Chemistry Manuscript Submission System
Changing Contact Information and Password
Changing Username
Author Requirements
Types of Manuscripts
Journal categories
Standard Abbreviations
Using the Online Submission and Tracking System
Using Copy and Paste
Submitting a New Manuscript
Preparing your Text for Submission
Preparing your Tables for Submission
Preparing your Images for Submission
Preparing your Supplemental Data for Submission
Submitting a Revised Manuscript
Submitting a Reply
Submitting a Resubmission
To Submit a Rebuttal
Withdrawing a Manuscript
Studies of Diagnostic Accuracy (STARD)
Outcomes Studies (CONSORT)
Minimum Information about a Microarray Experiment (MIAME)
Checklist for the description of sequence variants
Description of Analytical Methods and Results
Copyright
Permissions and Reprints
Papers Ahead of Print
Types of Decisions Rendered by a Clinical Chemistry Editor
Manuscript Upload Size Limitations
Other Resources
Problems using the system
Contact the Clinical Chemistry Editorial Office
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.
Calibration curves and linearity. Data for these studies should be subjected to 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., Ref. (5)).
Imprecision. Studies must include estimates of "within-run" and "total" standard deviations (5). Each should be determined at low, normal, and above-normal concentrations with use of specimens that are in an appropriate biological matrix.
One method of estimating both within-run and total standard deviations is the analysis of variance experiment described in NCCLS EP5-T (6), 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 (7, 8).
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 (9).
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 (10). A program to perform Deming regression is available on-line as a supplement from this journal (11).
The correlation coefficient has limited utility. Residuals plots [e.g., Bland-Altman (12, 13)] are often useful. On the horizontal axis, plot the mean of results by the two studied methods, no 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.
Detection limit (or limit of detection) is defined as the lowest concentration or quantity of an analyte that can be detected with a stated reasonable uncertainty for a given analytical procedure. The operational definition of this limit must be supplied by the author: e.g., the concentration at a signal-to-noise ratio of 10 or the concentration corresponding to a signal 3 SD above the mean for a calibrator that is free of analyte. This is also called the limit of the blank.
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 (14).
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 (15); and other factors that would influence the values obtained.
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).
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