HIV Ag/Ab Combo Rapid Test (Whole Blood/Serum/Plasma)
The HIV Ag/Ab Combo Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV-1, HIV 2, and p24 antigen in whole blood, serum or plasma specimen.
1 performance Data
1.1 The result on CHINA CFDA Panel
1.2 Sensitivity
All HIV-I antibody and/or HIV P24 antigen positive plasma, serum, whole bloods, are collected from several CDC and hospitals; All HIV-2 positive plasma are bought from SeraCare US and Biomex GmbH.
Types | ONE STEP HIV Ag/Ab Combo Rapid Test (Colloidal Gold) | ||
Positive result | Total specimens | Sensitivity | |
HIV-1positive plasma | 483 | 483 | 100% |
HIV-1positive serum | 64 | 64 | 100% |
HIV-1positive whole blood | 100 | 100 | 100% |
HIV P24 antigen positive plasma | 13 | 13 | 100% |
HIV-1positive finger blood | 25 | 25 | 100% |
HIV-2 positive plasma | 20 | 20 | 100% |
Total | 705 | 705 | 100% |
1.3 Potential interference
Types | ONE STEP Anti-HIV Ag/Ab Combo Rapid Test | ||
Negative result | Total specimens | Specificity | |
Bilirubin with a concentration below 146.7 µmol/L | 10 | 10 | 100% |
Triglyceride with a concentration below 8.74mmol/L | 10 | 10 | 100% |
Hemolysis with a Hb concentration exceed 6.5g/L | 19 | 20 | 95% |
Anti-HCV positive | 20 | 20 | 100% |
Anti-HAV positive | 10 | 10 | 100% |
HBsAg positive | 20 | 20 | 100% |
Anti-HEV positive | 20 | 20 | 100% |
Anti-HTLV I/II positive | 20 | 20 | 100% |
Anti-CMV IgM | 5 | 5 | 100% |
Rheumatoid factor | 20 | 20 | 100% |
Total | 154 | 155 | 99.35% |
Note: Hemolysis with a Hb concentration exceed 6.5g/L may act the determine of the results. Other detection method is suggested.
1.4 Interfering Substances
Analytes were spiked into negative plasma and serum pools (ELISA confirmed) and low positive plasma and serum specimens (ELISA confirmed) at the concentrations listed. The specimens were tested in triplicate with 3 lots of test devices. Visual interpretations were made at 10 and 20 minutes after specimen application. The results are presented in Table 2 below.
Conclusion: No substances showed any interference with the test. There were no differences observed between the results at 10minutes and the results at 20 minutes.
1.5Cross-Reactivity
HCG pregnancy, HCV+, Syphilis, HbsAg+, Mono+, Lipemic, Icteric, Hemolysis and RF factor+ specimens were confirmed by ELISA test and clinical diagnostic result and tested with the HIV Ag/Ab Combo Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma). Visual interpretations were made at 10 and 20 minutes after specimen application. The results are presented in Table 3 below.
Conclusion: There was no cross-reaction with HCG pregnancy, HCV+, Syphilis, HbsAg+, Mono+, Lipemic, Icteric, Hemolysis and RF factor+ specimens at 20minutes.
