Antigen and Antibody Testing
Rapid test kits in general and those testing for antibodies in particular offer important information for the gradual relaxation of social distancing measures. The holy grail is a test that can be done at home (much like a home pregnancy test), or, at minimum, a test that can be done in a CLIA (Clinical Laboratory Improvement Act) waved facility. These are tests that don’t require complex lab personnel and equipment. Unfortunately many rapid antibody test kits have been released with very limited efficacy. The FDA has granted EUA (emergency use authorization) to several antibody tests; however they are all require testing of serum or plasma in a complex lab. GPD Health only supplies tests with EUA, and eagerly await the first reliable test that can be broadly distributed to the public via non-complex testing facilities. Note that even testing done at a lab and with a blood test should have FDA EUA under Policy C (see “FDA Testing “Guidance” linked below). Please contact us for further information.
John’s Hopkins Serology-Based Testing - Global Progress Tracker
