COBAS AMPLISCREEN HCV TEST, V2.0 US IVD

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

Description of Event or Problem

A CUSTOMER IN THE US FILED A COMPLAINT ALLEGING THAT A DONOR SAMPLE GENERATED (B)(6) RESULT WHEN USING THE COBAS AMPLISCREEN HCV TEST, V 2.0 , LOT P17021. SINGLE DONOR TESTING ON PLASMA FROM A LIVING DONOR GENERATED A (B)(6) RESULT ON (B)(6) 2013 WITH THE COBAS TAQSCREEN MPX TEST. CONFIRMATORY TESTING WITH THE COBAS AMPLISCREEN PLATFORM GENERATED (B)(6) RESULTS ON (B)(6) 2013 FOR (B)(6). SEROLOGY TESTING WITH THE ABBOTT PRISM TEST GENERATED A (B)(6) RESULT. THE COBAS AMPLISCREEN HCV TEST WAS THEN RUN ON (B)(6) 2013, AFTER RECEIVING THE SEROLOGY (B)(6) RESULT, AND GENERATED (B)(6) RESULT. ALL TESTING WAS PERFORMED ON THE SAME TUBE. THE BLOOD UNIT WAS NOT RELEASED FOR DONATION.

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER FILED A COMPLAINT ALLEGING THAT A DONOR SAMPLE GENERATED A (B)(6) RESULT WHEN USING THE COBAS AMPLISCREEN (CAS) HCV TEST, V 2.0 , LOT P17021. THE SAMPLE WAS (B)(6) USING THE COBAS TAQSCREEN MPX TEST AND WAS (B)(6) SEROLOGY POSITIVE. NO DATA FILES WERE PROVIDED FOR REVIEW, AS THEY WERE NO LONGER AVAILABLE. SAMPLES WERE REQUESTED FOR INVESTIGATIVE TESTING BUT WERE NOT PROVIDED. ACCORDING TO THE COBAS TAQSCREEN MPX TEST PACKAGE INSERT (M/N 04788362001-06EN, DOC REV. 6.0, 1/2013) AND CAS (B)(6) V2.0 PACKAGE INSERT (M/N 05120713001-03EN, DOC REV 2.1 3/2011), THE LIMIT OF DETECTION (LOD) FOR (B)(6) IS 11 IU/ML WITH THE MPX AND 21 IU/ML WITH THE CAS (B)(6) (MULTIPREP SPECIMEN PROCESSING). THE SIGNIFICANT LOD DIFFERENCES NOTED BETWEEN MPX AND CAS (B)(6) MAY EXPLAIN THE RESULT DISCREPANCIES OBTAINED BY THE CUSTOMER WHEN TESTING THE COMPLAINT DONOR SAMPLE WITH BOTH TESTS. GIVEN THAT THE MPX TEST IS MORE SENSITIVE THAN THE CAS (B)(6) TEST, LOWER VIRAL CONCENTRATIONS CAN BE DETECTED WITH MPX INCLUDING CONCENTRATIONS THAT ARE BELOW THE RANGE OF DETECTION OF THE CAS (B)(6) TEST. UNFORTUNATELY, ALTHOUGH REQUESTED IN MULTIPLE OCCASIONS, THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION TO CONFIRM IF A LOW TITER MAY HAVE CAUSED THE DISCREPANT RESULTS OBSERVED IN THIS COMPLAINT. RETAIN TESTING OF COMPLAINT BATCH P17021 DISPLAYED VALID AND ACCEPTABLE RESULTS. NO FALSE NEGATIVE RESULTS WERE GENERATED DURING TESTING. ALL RESULTS MET QC RELEASE VALIDATION AND ACCEPTANCE CRITERIA. BASED ON THE INFORMATION AVAILABLE, NO PRODUCT NONCONFORMANCE WAS IDENTIFIED. (B)(4).