APTIMA COMBO 2 ASSAY

Description of Event or Problem

(B)(6), DEPARTMENT OF LABORATORY MEDICINE, CLINICAL MICROBIOLOGY, FACULTY OF MEDICINE AND HEALTH, (B)(6) REPORTED TWO APTIMA AC2 SAMPLES THAT HAD BEEN SEQUENCED AND CONFIRMED THE FINISH VARIANT THAT IS CURRENTLY UNDER INVESTIGATION BY HOLOGIC. THE FINISH VARIANT IS NOT PICKED UP BY THE APTIMA AC2 TEST GENERATING A CT/GC NEGATIVE RESULT, BUT IS POSITIVE IN AN APTIMA CT RE-TEST. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.

Description of Event or Problem

FINAL REPORT. MAGNUS UNEMO, DEPARTMENT OF LABORATORY MEDICINE, CLINICAL MICROBIOLOGY, FACULTY OF MEDICINE AND HEALTH, ÖREBRO UNIVERSITY REPORTED TWO APTIMA AC2 SAMPLES THAT HAD BEEN SEQUENCED AND CONFIRMED THE FINISH VARIANT THAT IS CURRENTLY UNDER INVESTIGATION BY HOLOGIC. THE FINISH VARIANT IS NOT PICKED UP BY THE APTIMA AC2 TEST GENERATING A CT/GC NEGATIVE RESULT, BUT IS POSITIVE IN AN APTIMA CT RE-TEST.

Additional Manufacturer Narrative

A NEW CHLAMYDIA TRACHOMATIS (CT) VARIANT HAS BEEN IDENTIFIED THAT AFFECTS THE DETECTION OF CT BY APTIMA COMBO 2® ASSAY ON BOTH TIGRIS® (CATALOG NUMBER 301130) AND PANTHER® INSTRUMENTS (CATALOG NUMBERS 302923, 301130 AND 303094). FURTHER, IT IS CONFIRMED THAT THE MUTATION RESIDES IN THE REGION OF THE GENOME DETECTED BY THE AC2 PROBE (IN THE 23S RRNA GENE) WHICH IS DISTINCT FROM THE REGION (16S RRNA GENE) TARGETED BY THE ACT PROBE. THEREFORE, THE PERFORMANCE OF THE ACT ASSAY IS NOT AFFECTED BY THIS MUTATION. HOLOGIC IS PREPARING A FIELD SAFETY CORRECTIVE ACTION (FSCA) IN EUROPE RELATED TO THIS INCIDENT. CURRENTLY HOLOGIC IS IN THE PROGRESS OF FINALIZING THE GUIDANCE THAT WILL BE PROVIDED THROUGH THE FIELD SAFETY NOTICE (FNS). THE FSCA REPORT WILL BE SUBMITTED TOGETHER WITH THE DRAFT OF THE FSN.