COBAS® HIV-1 (192T)

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. BECAUSE THE RESULTS WERE REPRODUCIBLE AS TARGET NOT DETECTED (TND) WITH THE ROCHE ASSAY AND THE ABBOTT COMPETITOR TEST CONFIRMED A TITER OF 30000CP/ML W/ SEROLOGY RESULTS POSITIVE, THE ISSUE WAS FOUND TO BE CONSISTENT WITH A MUTATION WHICH FALLS UNDER THE PRIMER AND PROBES OF THE ROCHE ASSAY. PER PRODUCT LABELING FOR THE ASSAY: THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF A VIRAL GENOME COVERED BY COBAS® HIV-1 MAY AFFECT PRIMERS AND/OR PROBE BINDING RESULTING IN THE UNDER-QUANTITATION OF VIRUS OR FAILURE TO DETECT THE PRESENCE OF VIRUS.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR APPROXIMATELY 14 PATIENTS. SPECIFIC DATA WAS PROVIDED FOR ONE PATIENT. ON (B)(6) 2024, THE HIV RESULT ON THE COBAS 6800 (PLASMA SAMPLE) WAS TARGET NOT DETECTED (TND) WHILE THE HIV ANTIGEN RESULT FROM AN IMMUNOLOGY ASSAY (SERUM SAMPLE) WAS POSITIVE. FOR CONFIRMATION, THE PATIENT'S SERUM SAMPLE WAS SENT FOR TESTING AT ANOTHER LAB VIA WESTERN BLOT. THE RESULT WAS CONFIRMED TO BE POSITIVE WITH A HIGH CONCENTRATION OF ANTIGEN AND ANTIBODY. THE ABBOTT HIV QPCR RESULT WAS APPROXIMATELY 30000 COPIES. ON (B)(6) 2024, THE PLASMA SAMPLE WAS REPEATED USING COBAS® HIV-1 (192T) ON THE C6800 AND THE RESULT WAS TARGET NOT DETECTED (TND).

Additional Manufacturer Narrative

THE COBAS 6800 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.