COBAS® SARS-COV-2 & INFLUENZA A/B

Additional Manufacturer Narrative

ON 29-OCT-2024, DATA WAS PROVIDED CONTAINING THE ALLEGED DISCREPANT RESULTS FOR 13 PATIENT SAMPLES. 7 PATIENT SAMPLES GENERATED A DISCREPANT RESULT FOR THE INFLUENZA B TARGET. 6 PATIENT SAMPLES GENERATED A DISCREPANT RESULT FOR THE INFLUENZA B AND SARS-COV-2 TARGETS. THE INVESTIGATION IS COMPLETE AND REVEALED THAT MICROLEAKS FROM POSITIVE SAMPLES COULD POTENTIALLY INTRODUCE INTERNAL CONTAMINATES. THE FALSE POSITIVE RATES OBSERVED ARE WITHIN THE CLAIMS WITHIN THE IFU.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS LIAT ANALYZER WAS (B)(6). INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES TESTED WITH THE COBAS SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM. IT WAS REPORTED THAT THE SAMPLES INITIALLY GENERATED POSITIVE RESULTS. IT IS UNCLEAR WHICH TARGETS WERE POSITIVE. THE RETESTED SAMPLES GENERATED NEGATIVE RESULTS USING ANOTHER METHOD (IN-HOUSE OR GENEXPERT).

Additional Manufacturer Narrative

ALTHOUGH DATA WAS NOT PROVIDED, AN INVESTIGATION SHOWED THAT THERE WAS NO ISSUE WITH THE HARDWARE OF THE ANALYZER OR THE REAGENT. THE MOST LIKELY CAUSE OF THE DISCREPANCY OBSERVED IS A LOW-LEVEL POSITIVE SAMPLE. FURTHERMORE, SAMPLE-TO-SAMPLE VARIABILITY CAN OCCUR DUE TO WHEN THE SAMPLE WAS COLLECTED IN RELATION TO THE DISEASE COURSE (PRE-SYMPTOMATIC, OR AS INFECTION DESCENDS TO THE LUNGS/OR PATIENT RECOVERS), HOW THE SAMPLE WAS STORED BEFORE TESTING (SAMPLE DEGRADATION), OR INADEQUATE SAMPLE COLLECTION, OR POTENTIAL CROSS-CONTAMINATION.