The most likely cause for the discrepancy observed is due to the sample having a low viral load, probably from a patient with a low titer or from lab cross-contamination, or differences in the testing methods.Note that samples near or below the lod of the test may generate wavering results on repeat testing.This is a run-specific issue and the reagent is performing as expected.
|
In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer alleged a discrepant result for a single patient while using the cobas sars-cov-2 & influenza a/b test on the cobas liat system.The alleged sample initially generated a positive result for sars-cov-2 (negative for influenza a/b).The same patient sample was retested on another cobas liat and generated the same result.The same patient sample was retested on another assay (eplex) and generated a negative result for sars-cov-2 unknown which results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.
|