Arrayit Corporation (ARYC)

[raspaman]

This FDA policy opened the door for ARYC fingerstick testing for Corona:

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the
Public Health Emergency. Full link far below

Excerpt taken:

Serological Diagnostics
FDA defines SARS-CoV-2 serological diagnostic tests as tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. FDA recommends that the following validation studies be conducted for a SARS-CoV-2 serological assay:
· Cross-reactivity/Analytical Specificity
· Class Specificity
· Clinical Agreement Study

The clinical agreement study is intended to establish the performance characteristics (e.g., sensitivity/PPA, specificity/NPA) of the test. FDA recommends that clinical accuracy should be established on human specimens from patients with microbiologically confirmed COVID-19
infection

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