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Evaluation of a Rapid in vitro Diagnostic Test Device for HIV 1.2 Rapid Test Kits

Zhang Lei*, Yang Feng, Zhu Junzhe

Objective: The aim of this evaluation report was to explore the reliability and performance of the All Test HIV 1.2 Rapid Test Kits for the qualitative detection of antibodies to Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2) in serum or plasma to aid in the diagnosis of HIV infection.

Method: Run a rapid in vitro diagnostic test device for detection of HIV 1.2 Rapid Test Kits in Serum or Plasma and compare to a leading commercial ELISA HIV test using clinical specimens for validation of the performance.

Results: The results show that the relative sensitivity of the HIV 1.2 Rapid Test Kits in Serum or Plasma is >99.9% and the relative specificity is 99.8%.

Conclusion: The HIV 1.2 Rapid Test Kits (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV-1 and/or HIV-2 in serum or plasma specimens. The test utilizes latex conjugate and multiple recombinant HIV proteins to selectively detect antibodies to the HIV 1.2 in serum or plasma.