WHEN USING HIVAB HIV-1/HIV-2 (RDNA) EIA, THE CUSTOMER OBTAINED AN INITIAL REACTIVE RESULT (ABSORBANCE >2.000) ON A PATIENT SAMPLE. UPON DUPLICATE REPEAT TESTING, NEGATIVE RESULTS (ABSORBANCES -0.002 AND -0.003) WERE OBTAINED AND REPORTED. A SATELITE FACILITY, THAT FORWARDED THE PATIENT SAMPLE TO THE CUSTOMER FOR SUPPLEMENTAL TESTING, HAD OBTAINED HIV 1/2 REACTIVE RESULTS. ADDITIONALLY, THE PATIENT IS HIV-1 POSITIVE BASED ON PREVIOUS TESTING AND IS BEING TREATED FOR HIV AT AN AIDS CLINIC. WESTERN BLOT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND WAS POSITIVE. UPON RETESTING THE PATIENT SAMPLE, THE CUSTOMER OBTAINED REPEATEDLY REACTIVE RESULTS.
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Patient 1
ABBOTT DID NOT PERFORM ANY TESTING SINCE THE CUSTOMER BELIEVES THAT CONJUGATE INADVERTENTLY DID NOT GET ADDED TO THE TWO REPLICATES THAT PRODUCED NON-REACTIVE RESULTS. A PROCEDURAL ERROR WAS IDENTIFIED AS THE CAUSE OF THE NON-REACTIVE RESULTS THAT WERE OBTAINED AT THE CUSTOMER'S FACILITY AND NO FURTHER INVESTIGATION WAS NECESSARY. THIS ISSUE IS ADDRESSED IN THE HIVAB HIV-1/HIV-2 (RDNA) EIA PACKAGE INSERT (COMMODITY 68-0158/R12). REFER TO ASSAY PROCEDURE, SECOND INCUBATION, STEP 8. THIS IS THE FINAL REPORT.