COBAS AMPLICOR CT/NG TEST FOR C. TRACHOMATIS

Description of Event or Problem

CUSTOMER REPORTED A PERIOD OF SPECIMENS THAT WERE NEGATIVE FOR CHLAMYDIA TRACHOMATIS WITH THE ROCHE MOLECULAR SYSTEMS COBAS AMPLICOR CT/NG TEST, BUT POSITIVE WITH AN ALTERNATE METHOD.

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED ROCHE MOLECULAR SYSTEMS WITH SAMPLES FROM THE SPECIMEN IN QUESTION. ROCHE MOLECULAR SYSTEMS, INC. INVESTIGATED THE CUSTOMER'S ALLEGATIONS AND CONFIRMED THAT THE SPECIMENS TESTED NEGATIVE FOR CHLAMYDIA TRACHOMATIS. FURTHER INVESTIGATION DETERMINED THAT THE SPECIMENS CONTAINED A MUTATED STRAIN OF C. TRACHOMATIS. THIS MUTATION RESULTED IN THE DELETION OF APPROXIMATELY 350 BASE PAIRS FROM THE REGION WITHIN THE CRYPTIC PLASMID DNA COVERED BY THE TEST'S PRIMERS / AND OR PROBE. RMS IS CONTINUING OUR INVESTIGATION TO BETTER UNDERSTAND THE PROVALENCE, AND GEOGRAPHIC DISTRIBUTION OF THE MUTATED STRAIN. THE PACKAGE INSERT WILL ALSO BE MODIFIED TO REFLECT THE RARE, BUT POSSIBLE OCCURRENCE OF MUTATIONS THAT COULD IMPACT THE TEST'S PERFORMANCE.