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 from the us alleged a discrepant result for a single patient while using cobas® sars-cov-2 & influenza a/b nucleic acid test for use on the cobas® liat® system.No harm was alleged.The alleged sample initially generated a positive sars-cov-2 result but was negative when repeated on a different platform.The initial positive result was not released.An investigation was conducted which did not identify any product problem.A review of the customer data revealed that the original patient sample was most likely near or below the limit of detection (lod).Very low viral load specimens that are near the assay lod may not generate consistent results upon repeat testing according to expected statistical variances in detection.Furthermore, true assay performances may be present and discrepant results can occur for a subset of samples when comparing results of the cobas® liat® system and less sensitive test methods.
|