Performance Assessment of a Newly Developed Rapid Diagnostic Reagent for Human Immunodeficiency Virus

Kansenshōgaku zasshi. The Journal of the Japanese Association for Infectious Diseases
Itsuhiro NakagiriTakashi Sugihara

Abstract

Extremely early diagnosis of human immunodeficiency virus (HIV) infection has been considered highly important for its treatment. We conducted a performance assessment of a newly developed rapid diagnostic reagent for HIV by using a fourth-generation immunochromatographic assay (Alere HIV Combo). We used whole-blood, plasma, and serum samples obtained from 250 Japanese adults who visited the Kawasaki Medical School Hospital and underwent HIV screening tests. We also used 12 types of commercial HIV-1 sero- conversion panels and World Health Organization standard antigens. This method, which has a detection sensitivity of 100% and a specificity of 99.3%, was as accurate as the chemiluminescent immunoassay (CLIA) method. In a sensitivity test using seroconversion panels in the early phase of infection, the mean duration until positive conversion was 19.3 days. With this method having a high detection sensitivity for HIV-1p24 antigen, the results from whole-blood samples were the same as those from plasma and serum samples. Therefore, it can be considered as a useful rapid measurement method for general practice.

References

Jan 13, 2010·Archives of Internal Medicine·Pragna PatelUNKNOWN Centers for Disease Control and Prevention Acute HIV Infection Study Group
Feb 6, 2013·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Silvia FaraoniValeria Ghisetti
Feb 9, 2013·Journal of Virological Methods·Marieke BrauerSimnikiwe H Mayaphi

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