APTIMA COMBO 2 ASSAY

Description of Event or Problem

INITIAL/FINAL. ON (B)(6) 2021 A CUSTOMER FROM (B)(6), REPORTED RECEIVING (B)(6) RESULTS WHEN TESTING A SAMPLE WITH THE APTIMA COMBO 2 (AC2) ASSAY AND THE APTIMA CHLAMYDIA TRACHOMATIS (ACT) ASSAY. THE CUSTOMER INITIALLY TESTED THE PATIENT URINE COLLECTED IN AN APTIMA URINE SPECIMEN COLLECTION KIT ON (B)(6) 2021 IN THEIR PANTHER FUSION INSTRUMENT WITH THE AC2 ASSAY AND OBTAINED A (B)(6) RESULT. THE SAMPLE WAS THEN FROZEN FOR STORAGE, THEN THAWED ON (B)(6) 2021 AND USED AS A SAMPLE FOR THEIR VALIDATING THEIR LEADER HC+ MANUAL PLATFORM, WHERE THEY TESTED WITH THE ACT ASSAY AND OBTAINED A (B)(6) RESULT. THE SAMPLE WAS RETESTED ON EACH PLATFORM/ASSAY AND THE CUSTOMER CONFIRMED THEIR INITIAL RESULTS. PER HOLOGIC'S REQUEST, THE CUSTOMER SENT THE SAMPLE TO HOLOGIC FOR ANALYSIS. FOLLOWING THE IN-HOUSE CONFIRMATORY TESTING, THE RNA FROM THE SAMPLE WAS EXTRACTED AND SEQUENCED TO COMPARE TO KNOWN CT VARIANTS. ON (B)(6) 2021, SEQUENCING FOUND THAT THE SAMPLE MATCHES THE SEQUENCE OF THE PREVIOUSLY IDENTIFIED (B)(6). OF NOTE, THIS SAMPLE IS THE FIRST INSTANCE THE (B)(6) IDENTIFIED IN THE US. PER RISK ASSESSMENT, THERE IS NO INDICATION THAT THE PRODUCT IS NOT PERFORMING AS INTENDED OR IS MALFUNCTIONING. A (B)(6) IN THE AC2 ASSAY CT TARGET SEQUENCE MAY LEAD TO AN INCORRECT RESULT (B)(6) OR A (B)(6) RESULT. THE RISK ASSOCIATED WITH A (B)(6) IN THE AC2 ASSAY CT TARGET SEQUENCE IS AN INCORRECT RESULT (B)(6). AS A WORST-CASE SCENARIO, A RISK ASSESSMENT WAS PERFORMED BY HOLOGIC WHERE IT WAS DETERMINED THE PROBABILITY OF OCCURRENCE OF HARM FROM AN UNRECOGNIZED (B)(6) RESULT IS ASSESSED TO BE REMOTE, JUSTIFIED BY THE FOLLOWING. THERE HAVE BEEN MULTIPLE RECENT MANUSCRIPTS DESCRIBING (B)(6) IN EUROPE. THESE MANUSCRIPTS WERE PUBLICLY AVAILABLE PRIOR TO THE COMPLAINT AND HAVE MADE OTHER CUSTOMERS COGNIZANT OF THE POSSIBILITY OF (B)(6) THAT MAY IMPACT AC2 ASSAY PERFORMANCE. PER THE AC2 ASSAY PACKAGE INSERT, "RESULTS FROM THE APTIMA COMBO 2 ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER LABORATORY AND CLINICAL DATA AVAILABLE TO THE CLINICIAN." OVERALL, THERE ARE ONLY SIX KNOWN (B)(6) SAMPLES THAT HAD A (B)(6)UTILIZED IN THE AC2 ASSAY IN THE UNITED STATES. FOR PERSPECTIVE ON POTENTIAL PREVALENCE, HOLOGIC HAS SOLD OVER (B)(4)AC2 TESTS IN THE UNITED STATES SINCE OCTOBER 2018. IN ADDITION, SEVERAL RECENT PUBLICATIONS HAVE DEMONSTRATED COMPARABLE PERFORMANCE OF THE AC2 ASSAY WITH OTHER MANUFACTURERS' ASSAYS. BASED ON THE MOST RECENT GUIDELINES PUBLISHED BY THE CDC, THE TREATMENT FOR A (B)(6)INFECTION DOES NOT OVERLAP WITH TREATMENT FOR (B)(6) INFECTION. THEREFORE, WHILE TREATMENT MAY BE ADMINISTERED FOR PATIENTS DIAGNOSED WITH A (B)(6) INFECTION, AN UNDETECTED (B)(6) INFECTION MAY NOT NECESSARILY BE TREATED.