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Validation of Anti-HCV Assay

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Validation of Anti-HCV Assay Posted: Thu Jan 14, 2016 11:37 am
I am the Lead Medical Technologist at a large physician office laboratory. The lab is currently in the process of bringing Anti-HCV testing in-house. We are running into one big stumbling block during the validation process: finding positive Anti-HCV samples in our patient population. We've reached out to our reference hospital, and they only have about 4% of their Anti-HCV tests positive per year!

Has anyone else ran into this issue? Can anyone give advice on what type of samples we could use - Proficiency Samples, QC, or purchased samples from large reference labs like Quest or Mayo? Any COLA-approved ideas are welcomed! Thanks!
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samanthatreutel
 
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Re: Validation of Anti-HCV Assay Posted: Fri Jan 15, 2016 2:20 pm
In a POL we typically perform at a minimum a 20 sample patient correlation. Sometimes it is very difficult to get that proper mix of low, normal and high patient test results to make your correlation data acceptable if all your patient values fall with the normal range.

There are no exact guidelines in the COLA manual for verification of performance standards for new testing. If you review VER5 R, VER6 R , VER7 R and VER8 R, it just states that you must perform system validations for Accuracy, Precision, Reportable Range and Reference Range. There is no exact process listed. Although it is always good lab practice to perform correlation studies of patient samples you could utilize linearity products and controls to validate these studies.

With that said, you brought up several good alternative sources of known values such as proficiency testing samples or samples from a high volume reference laboratory.

In a 20 patient sample correlation, it is our opinion if you can get 5 positive patient samples in your mix this would be sufficient. Validation of reference ranges are pretty simple in this instance as a patient should always be Negative if they are normal.
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Susan.Cramer
 
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