Draft:Parallelism (laboratory test)
 | Review waiting, please be patient.
This may take 3 months or more, since drafts are reviewed in no specific order. There are 2,472 pending submissions waiting for review.
Where to get help
How to improve a draft
You can also browse Wikipedia:Featured articles and Wikipedia:Good articles to find examples of Wikipedia's best writing on topics similar to your proposed article. Improving your odds of a speedy review To improve your odds of a faster review, tag your draft with relevant WikiProject tags using the button below. This will let reviewers know a new draft has been submitted in their area of interest. For instance, if you wrote about a female astronomer, you would want to add the Biography, Astronomy, and Women scientists tags. Editor resources
Reviewer tools
|
Parallelism (laboratory test)[edit]
Definition of Parallelism for a laboratory test[edit]
This section is about parallelism in a specific type of test done in a laboratory. These tests, called quantitative laboratory tests, figure out how much of a substance is in a sample[1]. For instance, they might measure how much glucose is in a blood sample. No matter the method used, we have to figure out the unknown concentration in the sample by comparing it to a known standard. We do this mathematically using regression analysis. For the mathematics to be right, the serial dilution curve of the substance in the sample has to match up with the dilution curve of the standard. So, in laboratory tests, parallelism means there is a similar relationship between the substance being measured (like a biomarker) and the signal from the standard.
Regulatory authorities[edit]
Regulatory authorities such as the Food and Drug Administration (FDA) and European Medicines Agency, (EMA) have made presence of parallelism mandatory for the approval of a test used in medicine and provided guidelines (free download from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m10-bioanalytical-method-validation-step-5_en.pdf). These guidelines spell out that "Parallelism demonstrates that the serially diluted incurred sample response curve is parallel to the calibration curve."
Determination of parallelism[edit]
Parallelism of a laboratory test can be determined visually or statistically[2]. Each method has there advantages and limitations. For people without a statistical background the visual assessment is likely more intuitive[1].
Presence of parallelism[edit]
Presence of parallelism is important for the reliable and accurate reporting of data. In routine laboratory practise parallelism can frequently be demonstrated for at least a partial range of the analyte[3]. Therefore partial parallelism plots give a quick visual answer. An example is given for presence of parallelism comparing the dilution curve of a reference standard with the dilution curve of several samples. All horizontal lines in the figure are parallel between the red vertical reference lines[2].
Absence of parallelism[edit]
Absence of parallelism is a problem because calculations may not be valid. An example for lack of parallelism is shown. The sample dilution curves are not parallel to the horizontal dilution curve of the reference standard.
References[edit]
- ^ a b Plikaytis, B D; Holder, P F; Pais, L B; Maslanka, S E; Gheesling, L L; Carlone, G M (October 1994). "Determination of parallelism and nonparallelism in bioassay dilution curves". Journal of Clinical Microbiology. 32 (10): 2441–2447. doi:10.1128/jcm.32.10.2441-2447.1994. PMC 264081. PMID 7814480.
- ^ a b Pum, Joachim (2019). "A practical guide to validation and verification of analytical methods in the clinical laboratory". Advances in Clinical Chemistry. 90: 215–281. doi:10.1016/bs.acc.2019.01.006. ISBN 978-0-12-817179-0. PMID 31122610.
- ^ a b c Petzold, Axel (January 2024). "Partial Parallelism Plots". Applied Sciences. 14 (2): 602. doi:10.3390/app14020602.