DIAZYME LABORATORIES DIAZYME DZ-LITE SARS-COV-2 IGG

Description of Event or Problem

I AM DIRECTOR OF THE (B)(6) HOSPITAL MEDICAL CENTER. WE RUN COVID-19 SEROLOGY ON SEVERAL DIFFERENT PLATFORMS FOR CLINICAL CARE AND RESEARCH PROJECTS. WE ARE CONCERNED ABOUT THE DIAGNOSTIC ACCURACY OF THE DIAZYME IGG AND IGM ASSAYS. WE NOTED SIGNIFICANT DISCREPANCIES BETWEEN OUR IN-HOUSE DEVELOPED IGG AND IGM ELISAS (SPIKE PROTEIN), DIASORIN IGG AND IGM CLIA ASSAYS (SPIKE), AND DIAZYME IGG AND IGM CLIA ASSAYS (SPIKE/NUC). WE RAN ~30 TESTS ON BOTH THE DIASORIN AND DIAZYME AND FOUND THEY ONLY CORRELATE ~60% OF THE TIME. WE THEN RAN 5 CLINICAL SAMPLES WITH HIGH IGG TITERS ON OUR IN-HOUSE ELISA ON BOTH DIASORIN AND DIAZYME IGG ASSAYS. DIASORIN CORRECTLY IDENTIFIED ALL 5 PATIENTS. THE DIAZYME ONLY IDENTIFIED 3/5 AS POSITIVE. WE HAD THE MACHINE EVALUATED BY DIAZYME ENGINEER, CHANGED REAGENT LOT, CHANGED STARTER, ETC. AND THE RESULTS WERE CONSISTENTLY WRONG. THE ENGINEER MENTIONED THEY HAVE BEEN SEEING ISSUES WITH THE TESTS, AND THAT THE CAUSE HAS NOT BEEN CONSISTENT. THAT THERE WAS A BAD LOT OF REAGENT. THE FINALLY, WE REACHED OUT TO OUR COLLEAGUE (B)(6) IN (B)(6), WHO HAS BEEN USING THE TEST CLINICALLY FOR ABOUT 1 MONTH. HE REPORTED THAT HIS TECHS STARTED EXPRESSING CONCERNS ABOUT THE TEST SINCE AROUND (B)(6) (POTENTIAL FALSE POSITIVES). IN SUMMARY, WE HAVE SIGNIFICANT CONCERNS ABOUT THE QUALITY AND VALIDITY OF THE IGG AND IGM TESTS FROM DIAZYME. WE WILL HAPPILY SHARE OUR DATA AND SAMPLES IF THAT WOULD BE HELPFUL. THANK YOU FOR YOUR TIME AND ATTENTION. SINCERELY, (B)(6) MD. FDA SAFETY REPORT ID# (B)(4).