APTIMA COMBO 2 ASSAY
Received Aug 1, 2019 · Event occurred Jul 8, 2019
Report 2024800-2019-00009 · MDR key 8853232
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Viral Infection
- Viral Infection
Narrative
Description of Event or Problem
HOLOGIC WAS INFORMED THAT BASED ON THE FIELD SAFETY NOTICE IN EUROPE, THE CUSTOMER RE-TESTED 16 SAMPLES TESTED FROM (B)(6) 2019. OF THE 16 SAMPLES RE-TESTED, 5 CONFIRMED POSITIVE WITH ACT ASSAY. 1 OF THE FIVE CASES WAS ELIMINATED FROM SEQUENCING AS IT WAS IDENTIFIED THAT THIS CAME FROM A TREATED PATIENT THAT WAS RETESTED TOO EARLY. THE REMAINING 4 POSITIVE ACT SAMPLES WERE SENT FOR SEQUENCING AND WERE CONFIRMED TO BE THE FINNISH CT STRAIN. THEY LABORATORY PROVIDED THE FOLLOWING DETAILS FOR THESE 4 SAMPLES: 4 DIFFERENT PATIENTS, ALL BORN IN THE 90S, 3 WOMEN, 1 MAN, 2 FROM "(B)(6)", 1 FROM (B)(6), 1 FROM (B)(6). HOLOGIC 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.