Approval has been gained for raw material improvements to the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test device with 30-month expiration dating. We explain why managed translation to customers with matched kit controls is required and highlight how this has been captured in the Package Insert with an updated Seroconversion data table.
We evaluated the performance of the Modified Avidin Replacement OraQuick ADVANCE Rapid HIV-1/2 Antibody Test in-order to complete design validation. In the commercially available seroconversion panels the results were compared to the current, approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test and to the laboratory based enzyme immunoassay (3rd Generation EIA) data. This was determined by comparison of the first consecutive reactive specimen, at the 20-minute read time, in the panel series to the respective FDA-approved EIA test results provided by the vendor Certificate of Analysis (CofA).
Results are shown for the streptavidin process improvements lots in comparison to the current product in six commercially sourced Anti-HIV low / mixed titer panels, together with a commercially available worldwide panel. A total of two hundred and one (201) seroconversion panel member samples from 23 seroconversion panels were evaluated; the 95% Confidence Intervals (95% CIs) for the Modified Avidin Replacement devices overlap and are within the 95% CIs range of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Tests, demonstrating the OraQuick ADVANCE Rapid HIV-1/2 Antibody Tests are consistent with the performance being comparable to that of 3rd Generation EIA). To compensate for the clearer test line resolution, Kit Controls will be formulated at a higher dilution to give the equivalent line strength to the current, approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.
The Modified Avidin Replacement OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performance was comparable to that of current, approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. This change will require the preparation of matched Kit Controls as the improved device readability will be evident to customers. The seroconversion data demonstrates comparability to 3rd generation automated assays with the delay day difference recorded as within 1.48 days.
OraSure Technologies, Inc.: