RE:RE:RE:RE:RE:RE:No brainerHere is the Template Title for those who want to read the DOCs for themselves.
The Laboratory use only performance NPA and PPA are the same as for Prescription use Non-Lab use..
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Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use
This template (the “template”) provides FDA’s current recommendations concerning what data and information should be submitted to FDA in support of a pre-EUA/EUA submission for a molecular or antigen diagnostic test for SARS-CoV-2 for use in a non-laboratory setting. Such settings are likely to include a person’s home or certain non-traditional sites such as offices, sporting events, airports, schools etc. This template does not apply to home collection kits.
As outlined in Section V.A. and V.B. of the FDA guidance document Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), FDA recommends that the following validation studies be conducted for a SARS-CoV-2 molecular or antigen diagnostic assay: Limit of Detection, Clinical Evaluation, Inclusivity, Cross-reactivity, Usability and Flex Studies. This template is intended to help manufacturers provide these validation data and other information to FDA, but alternative approaches can be used. This template reflects FDA’s current thinking on the topic, and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should means that something is suggested or recommended, but not required. For more information about EUAs in general, please see the FDA Guidance document: Emergency Use Authorization of Medical Products and Related Authorities.
TheeRook wrote: Just read the FDA docsl
6. Performance
For non-prescription (OTC) tests intended for use in non-laboratory settings, FDA
recommends that tests have a PPA and NPA as follows:
Positive Percent Agreement (PPA) ≥90% for asymptomatic and symptomatic
Negative Percent Agreement (NPA) ≥99% (LB >95%)
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For use guided by a Doctor
Symptomatic Patient Testing (prescription use only)
For symptomatic use only tests, FDA recommends that the test have a PPA and NPA as follows:
Positive Percent Agreement (PPA) ≥80% for symptomatic
Negative Percent Agreement (NPA) ≥99% (LB >95%)
stockboy200017 wrote: It doesn't matter what type of test it is, antigen or antibody, 84.6 accuracy is not good!!!