The employee who experienced the needlestick was administered anti-viral medication based on the inconsistent (b)(6) results between methods for samples from the patient associated with the needlestick.No (b)(6) results were provided for the employee.The interpretation of results section of the instructions for use states: "specimens with an index value greater than or equal to 1.0 are considered initially (b)(6) for p24 antigen and/or antibodies to (b)(6) and/or (b)(6) and should be retested in duplicate.After centrifugation at 10,000 x g for 10 minutes.If one or both of the duplicates are (b)(6), the specimen is repeatedly (b)(6) by the (b)(6).Note inadequate centrifugation may result in a higher rate of repeat (b)(6) results that must be investigated using supplemental tests for (b)(6) and/or (b)(6) and/or p24 antigen.Repeatedly (b)(6) specimens must be investigated using supplemental tests for (b)(6) and/or (b)(6) and/or p24 antigen.In specimens giving indeterminate supplemental test results, testing of a subsequent sample drawn at a later date (such as 1-6 months) is recommended.For individuals who are confirmed (b)(6) for antibodies and/or p24 antigen, appropriate counseling and medical evaluation should be offered and is considered an important part of testing for antibody to (b)(6) and (b)(6) and/or p24 antigen." the cause for the discordant (b)(6) results is unknown.Siemens received two samples from the customer.The samples were tested with (b)(6) lots 117180 and 117192.The samples were (b)(6) with both lots of reagents sid (b)(6), chiv lot 117180, 0.950 index; chiv lot 117192, 0.393 index.Sid (b)(6), chiv lot 117180, 0.923 index; chiv lot 117192, 0.491 index.Siemens did not reproduce the customer's results.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the false (b)(6) results, siemens cannot rule out pre-analytical factors such as inadequate centrifugation, or a sample specific issue.Siemens' service went on site and completed a total service call.The system was checked and qc was in range.No issues were found.No further investigation required.
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