APTIMA COMBO 2 ASSAY

Additional Manufacturer Narrative

THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE THE SAMPLE AS A CONFIRMED FALSE RESULT. THE INITIAL CT-NEGATIVE RESULT WAS REPORTED TO THE CLINICIAN, BUT THE RESULT WAS CORRECTED AFTER RETESTING THE FOLLOWING DAY. THE CUSTOMER DID NOT INFORM HOLOGIC WHETHER THE INITIAL CT-NEGATIVE RESULT WAS REPORTED TO THE PATIENT OR IF THE PATIENT RECEIVED ANY TREATMENT FOR CT INFECTION. HOLOGIC REVIEWED THE LOGS AND FOUND NO HARDWARE, KIT CHEMISTRY, OR KINETICS ISSUES. THE ASSAY IS WORKING AS INTENDED. THE SAMPLE IN QUESTION LIKELY HAD LOW TARGET THAT DID NOT AMPLIFY DURING INITIAL TESTING. HOLOGIC COMPLETED A RISK ASSESSMENT AND DETERMINED THAT THE ISSUE SHOULD CAUSE MINIMAL IMPACT TO THE PATIENT AS THE RESULT SHOULD BE CONSIDERED IN CONJUNCTION WITH ALL RELEVANT CLINICAL DATA.

Description of Event or Problem

THE CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED ONE DISCREPANT AC2 RESULT USING ASSAY LOT 544905 RUN ON PANTHER INSTRUMENT SN (B)(6). THE SAMPLE IN QUESTION INITIALLY RESULTED CT-NEGATIVE AND GC-POSITIVE (329 RLUS) ON (B)(6) 2023. THE CUSTOMER RETESTED THIS SAMPLE ON (B)(6) 2023 AS PART OF THE LAB'S QA PROCESS OF RETESTING POSITIVE AC2 SAMPLES THAT HAVE AN RLU VALUE LESS THAN 1000. THE CUSTOMER IS AWARE THE AC2 PACKAGE INSERT (PI) INSTRUCTS OPERATORS TO REPORT THE FIRST VALID RESULT FOR EACH ANALYTE. THE CUSTOMER RETESTED THE SAME SAMPLE TUBE AND CONFIRMED THE SAMPLE WAS STORED ACCORDING TO THE AC2 PI IN BETWEEN TESTS. UPON RETEST, THE SAMPLE RESULTED CT-POSITIVE AND GC-POSITIVE (2365 RLUS).