COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM

Additional Manufacturer Narrative

ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED, THE DATA SHOWED TRUE AMPLIFICATION FOR THE POSITIVE RESULT FOR FLU A TARGET. THE INVESTIGATION INDICATED THAT NO SYSTEMIC PRODUCT PROBLEM WITH THE REAGENT WAS IDENTIFIED. THE DISCREPANCY MAY BE DUE TO SAMPLE-SPECIFIC ISSUES SUCH AS COLLECTION, HANDLING, AND INHIBITION. DUE TO INHERENT DIFFERENCES BETWEEN TECHNOLOGIES, ONE HUNDRED PERCENT AGREEMENT BETWEEN THE RESULTS SHOULD NOT BE EXPECTED AS WAVERING RESULTS MAY OCCUR. NO RSV TARGET WAS DETECTED WHEN THE SAME SAMPLE WAS TESTED ON BOTH COBAS LIAT ANALYZERS. NO ABNORMALITIES WERE OBSERVED FOR THE CURVES OF THAT TARGET. THEREFORE THE DISCREPANCY BETWEEN THE COBAS LIAT AND ABBOTT PLATFORMS IS MOST LIKELY DUE TO TECHNOLOGY DIFFERENCES.

Description of Event or Problem

A CUSTOMER FROM CHILE ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHILE USING THE COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR INFLUENZA A. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT COBAS LIAT WHICH GENERATED A NEGATIVE RESULT FOR ALL TARGETS. THE SAME SAMPLE WAS ALSO RETESTED ON ANOTHER PLATFORM (ABBOTT) WHICH GENERATED A NEGATIVE RESULT FOR INFLUENZA A AND A POSITIVE RESULT FOR THE RSV TARGET. THE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE.