Article: Consideration for the validation of clinical laboratory methods in nonclinical fields

This article published by Minomo, et. al., describes an approach for validating clinical laboratory tests for animal studies.  It comes from a large group of companies and institutes, and looks at an area essential for safety testing of new therapies in GLP safety studies. An area that likely has a rich publication history, but one I’ve not had much exposure to. I’m more familiar with the majority of the regulations and guidelines (e.g., CLSI documents) address human clinical laboratories.

 

Here, the authors note the absence of guidelines for laboratories testing the biomarkers and clinical chemistry of animal samples.  I was going to write the clinical lab testing of non-clinical samples, but the lack of clarity on the use of “clinical” could confuse the issue. The article considers a number of guidelines from human drug research and clinical lab assay validation to define recommendations for assay validations.  These recommendations cover the expected key parameters and looks at whether they are from an in vitro diagnostic kit vs. tests using investigational reagents vs. a lab developed test:

1) Specificity, selectivity;

2) Accuracy, trueness;

3) Precision;

(1) Repeatability;

(2) Intermediate precision;

4) LOD, LOQ;

5) Linearity, parallelism;

6) Range;

7) Robustness;

8) Stability;

9) Traceability and uncertainty.

 

If you are working in this space or using data from such tests, it is a worthwhile read.

 

Bioanalysis (2022) 14(21), 1337–1348  DOI: 10.4155/bio-2022-0178