A CUSTOMER IN THE US REPORTED THAT THEY RECEIVED AN OVERQUANTIFIED PATIENT RESULT WITH THE CAP-CTM HIV-1 ASSAY AS COMPARED WITH THE PREVIOUS RESULTS OBTAINED WITH COBAS AMPLICOR HIV-1 MONITOR TEST (CA-HIM). THE CUSTOMER DATA SHOWED THAT THE PATIENT'S RESULTS WITH THE CA-HIM WERE (B)(4) FROM (B)(6) 2005 TO (B)(6) 2007. WITH THE CAP-CTM HIV-1 ASSAY, THE PATIENT RESULTS ARE (B)(4). THERE WAS A TEST RUN REPORTED WITH THE CAP-CTM HIV-1 ASSAY WHICH GENERATED A RESULT OF (B)(4) FOR THIS PATIENT, WHICH IS HIGHER THAN TYPICALLY EXPECTED IT WAS STATED IN THE COMPLAINT THAT THERE WAS A CHANGE IN PATIENT TREATMENT MADE, BUT IT IS UNKNOWN IF THIS WAS DUE TO OBTAINING THE RESULT OF (B)(4).
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Patient 1
IT IS EXPECTED THAT THERE WILL BE INSTANCES IN WHICH THE CAP/CTM HIV-1 TEST YIELDS MEASUREABLE TITERS FOR PATIENT SAMPLES THAT HAD PREVIOUSLY BEEN UNDETECTED OR LESS THAN THE LIMIT OF DETECTION WITH THE CA-HIM TEST . IN THESE CASES, IT HAS BEEN DETERMINED THAT THE CAP-CTM HIV-1 ASSAY IS PERFORMING AS INTENDED. FOR THE HIGHER THAN EXPECTED RESULT OF (B)(4), IT IS PLAUSIBLE THAT THIS RESULT MAY HAVE BEEN A TRUE "BLIP" IN VIRAL LOAD, WHICH IS A KNOWN PHENOMENON THAT CAN OCCUR WHEN MONITORING HIV-1 PATIENTS. FURTHER INFORMATION REGARDING THIS RESULT WAS REQUESTED BY THE CUSTOMER, BUT NOT PROVIDED. WITHOUT ANY FURTHER INFORMATION BEING PROVIDED, IT IS NOT POSSIBLE TO ASSESS WHETHER THE RESULT GENERATED MAY HAVE BEEN EXPECTED