Understanding Test Validation and Performance Verification
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Hello POC Friends,
I am wondering if anyone in the POC universe has a good resource for understanding test validation and verification. I have gone through quite a few powerpoints online and know the basics of accuracy, precision, AMR, ect, but am looking to see if there are any materials that would be useful for POC testing (i.e. cover qualitative, quantitative, and semi quantitative assays).
Thanks in advance,
-Dean Derhaag MS, MLS
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If you have access to EP Evaluator, it covers a lot of the subject matter you are interested in.
IT explains what they mean.
Statistics wise, Westgard has a site that can help you understand a lot of these subject matter too.
Just Google it ! It will not say POC only but related subject.
Dean,
CLSI has many documents on test validation and verification. CLSI document EP19 provides a roadmap of all of the CLSI documents and when they are used. You can download
EP19 for free from CLSI’s website.
While the CLSI documents are not specific for POC tests, they are applicable to any quantitative test. EP12 is specific for qualitative tests. Unfortunately, there is
not yet a CLSI document for semi-quantitative tests.
Unfortunately, only EP19 is free. EP12 is $180 and there is EP05 for Precision of Quantitative processes for $180. I don’t understand why we have to pay to
keep our labs compliant.
Using the EP documents is completely voluntary. They are meant to be tools to help you with compliance; their use is not required by any accreditor.
Often, representatives from the accrediting agencies participate in the development of the EP documents. So you know that if you choose to follow the EP documents, the methods that you use for validation and verification will be acceptable to the accreditors.