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American Society for Clinical Laboratory Science. American Society for Clinical Pathology.
National accrediting Agency for Clinical Laboratory Sciences. First time users: - Register here. Use your UTMB email address. It is desirable to test to 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. 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. 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.
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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. Additional considerations related to this topic are presented by Linnet Analytical quality: Results obtained for the performance characteristics should be compared objectively with well-documented quality specifications, e.
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 , 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.
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. All authors should seek approval to conduct research from an independent local, regional, or national review body e. 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.http://kinun-mobile.com/wp-content/2020-10-28/qowy-what-is-the.php
Quick Guide to Clinical Chemistry, 2nd Edition | bayrosunvestlep.ml
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. Please note if informed consent has been received in the Materials and Methods section of the submitted manuscript.
When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. The policy applies to manuscripts accepted for publication in Clinical Chemistry on or after May 2, The policy requests that the release date to the public be within 12 months after the official date of final publication.
For more information or to request open access publication, contact the Editorial Office at clinchemed aacc. If an author chooses to submit an accepted manuscript to PMC, he or she will be asked to indicate when that manuscript should be made available to the public. All copyright restrictions apply. This version of the manuscript may contain factual errors that were detected during the post-acceptance editing phase.
Data, text, conclusions, tables, and figures may all differ from the published version available at www. The final published version is the Clinical Chemistry article. Clinical Chemistry assumes no responsibility for earlier versions. This may not be duplicated or reproduced, other than for personal use or within the rule of 'Fair Use of Copyrighted Materials' section , Title 17, U.
Code without permission of the copyright owner, AACC. The AACC disclaims any responsibility or liability for errors or omissions in this version of the manuscript or in any version derived from it by the National Institutes of Health or other parties. Authors may contact Clinical Chemistry via e-mail at clinchemed aacc.
Do not send the checklist via e-mail or upload it as supplemental material. The STARD statement 3 provides guidance helping authors to modify their manuscript as needed to provide the requested information. Guidelines include:. The CONSORT statement 1 , although designed for randomized controlled trials and used for therapeutic rather than diagnostic interventions, is recommended as an often-useful guide. For questions, contact Clinical Chemistry via e-mail at clinchemed aacc.
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. MIAME is neither a dogma nor a legal document - it assumes a cooperative data provider and a fair reviewer.
A PDF version for all essential components of the checklist can be obtained by the link above. Authors are also encouraged, but not required, to include the additional desirable items of the MIQE guidelines 1.
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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:. The guidelines require not only delineation of what was done, but presentation of evidence that validates the method used.