COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2009 A PATIENT SPECIMEN TESTED (B)(6) FOR CHLAMYDIA TRACHOMATIS DNA; HOWEVER, WHEN THE PATIENT SPECIMEN WAS RETESTED ON (B)(6) 2009, THE PATIENT SPECIMEN TESTED (B)(6) FOR (B)(6) DNA. NO DATA, TREATMENT INFORMATION OR KIT LOT INFORMATION WAS PROVIDED AND, AS INDICATED BY THE AFFILIATE OFFICE, THE CUSTOMER INDICATED THAT THIS INFORMATION WOULD NOT BE PROVIDED. ADDITIONALLY, THE SAMPLE TESTED WAS A THINPREP(R) SPECIMEN AND THE CUSTOMER DID NOT SPECIFY IF THE TEST WAS BEING PERFORMED WITH THE OPTIONAL INTERNAL CONTROL.

Additional Manufacturer Narrative

THE CUSTOMER DID NOT PROVIDE ANY INFORMATION WITH REGARD TO THE FOLLOWING: WHETHER THE PATIENT WAS SYMPTOMATIC OR ASYMPTOMATIC, WHETHER ANY TREATMENT WAS ADMINISTERED, ANY PATIENT HISTORY INFORMATION, ANY INFORMATION PERTAINING TO ADDITIONAL/CONFIRMATORY TESTING (IF PERFORMED), ANY KIT LOT INFORMATION, OR WHETHER THEY WERE PERFORMING THE COBAS(R) AMPLICOR(R) CT/NG TEST WITH THE OPTIONAL INTERNAL CONTROL. ADDITIONALLY, THERE WAS NO INDICATION OF ANY ADVERSE IMPACT ON THE PATIENT'S HEALTH. NOTE: ALTHOUGH ROCHE HAS NOT VALIDATED THE USE OF THINPREP(R) SPECIMENS WITH THE COBAS(R) AMPLICOR(R) CT/NG TEST, HOLOGIC (FORMERLY CYTYC CORPORATION), THE MANUFACTURER OF THINPREP(R), HAS VALIDATED THE USE OF THIS SPECIMEN-TYPE WITH THE ROCHE COBAS(R) AMPLICOR(R) CT/NG TEST. AS INDICATED WITHIN THE PRODUCT LABELING, THE COBAS(R) AMPLICOR(R) CT TEST IS A QUALITATIVE IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF (B)(6) PLASMID DNA. RESULTS FROM THE TEST SHOULD BE INTERPRETED WITH CONSIDERATION OF ALL CLINICAL AND LABORATORY FINDINGS. ADDITIONALLY, THE CLINICAL PERFORMANCE, SPECIFIED WITHIN THE PRODUCT LABELING, FOR FEMALES DEMONSTRATED A SENSITIVITY OF 94.9-95.9% (DEPENDANT ON ASYMPTOMATIC/SYMPTOMATIC AND THE USE OF AN INTERNAL CONTROL) AND A SPECIFICITY OF 98.0-98.5% (DEPENDANT ON ASYMPTOMATIC/SYMPTOMATIC AND THE USE OF AN INTERNAL CONTROL). THEREFORE, BASED ON THE CLINICAL PERFORMANCE DATA, WITHIN THE PRODUCT LABELING, FALSE RESULTS MAY BE GENERATED.ALTHOUGH IT WAS REPORTED THAT A THINPREP(R) SPECIMEN TESTED (B)(6) FOR (B)(6), THE SPECIMEN WAS NOT RETURNED FOR EVALUATION, AND THEREFORE, ROCHE COULD NOT PERFORMING INVESTIGATIVE TESTING TO EITHER CONFIRM OR REFUTE THE CUSTOMER'S ALLEGATION. ADDITIONALLY, THERE WAS NO CONFIRMATORY TESTING DATA PROVIDED BY THE CUSTOMER THAT SUPPORTS THEIR ALLEGATION OF A (B)(6) TEST RESULT FOR (B)(6). BASED ON THE TEST CLAIMS, IT IS PLAUSIBLE THAT THIS ISSUE COULD EITHER BE A (B)(6) OR A (B)(6) TEST RESULT. THE MEDICAL IMPACT ASSOCIATED WITH THIS REPORTED ISSUE WAS ASSESSED:IF THE TEST RESULT WAS FALSE NEGATIVE: (B)(6), THE INDIVIDUAL WOULD RECEIVE ANTIMICROBIAL TREATMENT THAT ACCOUNTS FOR BOTH INFECTION WITH CT AND NG FOLLOWING CDC GUIDELINES. HOWEVER, IF THE TEST RESULT WAS FALSE NEGATIVE FOR CT AND TRUE NEGATIVE FOR NG, IN AN OTHERWISE ASYMPTOMATIC PATIENT, THE INFECTION MIGHT BE SPREAD TO SEXUAL PARTNERS, THE DISEASE MAY PROGRESS, RESULTING IN A MORE SEVERE CLINICAL SYNDROME INCLUDING CHRONIC PELVIC INFLAMMATORY DISEASE AND INFERTILITY. ASSOCIATED RISKS ARE TRANSMISSION OF INFECTION TO NEWBORN, ECTOPIC PREGNANCY (POTENTIALLY FATAL), AND INCREASED RISK OF HIV TRANSMISSION. IF THE PATIENT WAS SYMPTOMATIC, MOST PHYSICIANS, REGARDLESS OF THE COBAS® AMPLICOR® CT/NG TEST RESULT, WOULD TREAT THE PATIENT WITH ANTIBIOTICS. IF THE TEST RESULT WAS FALSE POSITIVE: (B)(6). IF THIS ISSUE WERE TO RECUR AND THE PATIENT WAS SYMPTOMATIC, MOST PHYSICIANS, REGARDLESS OF THE COBAS(R) AMPLICOR(R) CT/NG TEST RESULT, WOULD TREAT THE PATIENT WITH ANTIBIOTICS; THE POTENTIAL SIDE EFFECTS OF ANTIMICROBIAL TREATMENT ARE MINOR AND RANGE FROM GASTROINTESTINAL INCONVENIENCE TO DIARRHEA. IF THIS ISSUE WERE TO RECUR AND THE PATIENT WAS ASYMPTOMATIC, AND THE PATIENT'S TEST RESULTS WERE REPORTED AND INTERPRETED AS POSITIVE FOR CT, THE PATIENT WOULD RECEIVE UNNECESSARY TREATMENT AND PSYCHOLOGICAL HARM (BEING CONSIDERED A CARRIER OF A SEXUALLY-TRANSMITTED DISEASE); THE POTENTIAL SIDE EFFECTS OF ANTIMICROBIAL TREATMENT ARE MINOR AND RANGE FROM GASTROINTESTINAL INCONVENIENCE TO DIARRHEA. NO KIT LOT(S) INFORMATION WAS PROVIDED; THEREFORE, EVALUATION/INVESTIGATION OF THE KIT LOT(S) UTILIZED BY THE CUSTOMER COULD NOT BE PERFORMED. BASED ON THE LIMITED INFORMATION AVAILABLE, THERE IS NO INDICATION OF A MALFUNCTION OF THE COBAS(R) AMPLICOR(R) CT/NG TEST OR OF A FAILURE OF THE TEST TO MEET PERFORMANCE CLAIMS. LOT NOT PROVIDED.