Description of Event or Problem · 1
ROCHE COBAS AMPLICOR HAS SINCE 2006 GIVEN CONTINUOUS FAILED CHLAMYDIA TRACHOMATIS QC FAILED RUNS WHERE THE POSITIVE INTERNAL QC RUNS NEGATIVE. CONSEQUENTLY THE COMPANY DID NOTHING TO HELP WITH PROBLEMS AT MANY SITES ACROSS NORTH AMERICA INCLUDED UNTIL FEBRUARY 2007 - KNOWN LABS INCLUDE 1 LAB IN ANOTHER COUNTRY, SOME IN THE US. ATTEMPTS TO REPEAT RUNS WERE SOMETIMES SUCCESSFUL, SOMETIME, NOT. WHEN ROCHE FINALLY STEPPED IN, THEY DETERMINED THAT THERE WAS A PROBLEM WITH HOW LONG PATIENT SAMPLES SAT IN THE DENATURATION REAGENT ON THE INSTRUMENT, EVEN THOUGH WE MADE NO CHANGES TO THE INSTRUMENT PREVIOUSLY. ROCHE GAVE A SOLUTION -WORK-AROUND TO CHANGE THE INSTRUMENT TO RUN INTERNAL QC FIRST FOLLOWED BY NEISSERIA GONORRHEA AND THEN CHLAMYDIA TRACHOMATIS. ORIGINALLY THE CHLAMYDIA TRACHOMATIS RAN FIRST, FOLLOWED BY NEISSERIA AND THEN INTERNAL QC.- THIS IMPROVED THE QC FOR CHLAMYDIA, BUT HAS SINCE CREATED A VERY LARGE INCREASE IN PT NEISSERIA POSITIVE RESULTS AND INTERNAL CONTROL FAILURES ON PT SAMPLES. A HIGH PERCENTAGE OF THE NEISSERIA RESULTS ARE NOT CONFIRMING BY ANOTHER AMPLIFIED METHOD -TMA- NOR HAVE THEY BEEN ABLE TO CONFIRM THEM BY OTHER LABS WHO HAVE COBAS AMPLICORS WHO HAVE NOT CHANGE THE WORKFLOW OF THEIR COBAS AMPLICORS. ALSO, WE HAVE SEEN A SHARP DECREASE IN CHLAMYDIA TRACHOMATIS POSITIVE RESULTS ON PTS. WE QUESTION FALSE NEGATIVE NOW VS. FALSE POSITIVE PREVIOUSLY. DATES OF USE: 2006 - 2007. DIAGNOSIS OR REASON FOR USE: CHLAMYDIA TRACHOMATIS/NEISSERIA.