Zhejiang Gongshang University, China
Research Article
Evaluation of a Rapid in vitro Diagnostic Test Device for HIV 1.2 Rapid Test Kits
Author(s): Zhang Lei*, Yang Feng and 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.. View More»