Sysmex Journal International

2017Vol.27 No.1


Comparative Study on HIV Screening Test Reagents Focusing on Lumipulse Presto-HIV Ag/Ab


Shigekazu FURUKI*1, Yoshimi WAKUI*1, Fumiaki UEMICHI *1, Kyoichi OGATA*1,
Takeshi HAGIWARA*1,2, Yasuyuki YAMAMOTO*2, Takashi SUZUKI*2, Kagehiro AMANO*2, Katsuyuki FUKUTAKE*1,2 and Ko YAMANAKA*3

*1 Central Clinical Laboratory Division, Tokyo medical University Hospital
*2 Department of Clinical Laboratory Medicine, Tokyo Medical University
*3 Shinjuku Higashiguchi Clinic


The number of individuals infected with HIV is currently still increasing in Japan. Therefore, the early diagnosis of HIV infection with a focus treatment and preventative measures is a top public health imperative.

With regard to the history of HIV screening tests, enzyme-linked immunosorbent assay (ELISA) was developed as the first technology using the 1st-generation reagent in the U.S. in 1985, and the detectable antibody was limited only to HIV-1 IgG antibody. Afterward, HIV-2 was discovered, and HIV-2 IgG antibody was added to the antibodies that the 2nd-generation reagent could detect. As a result of subsequent repeated improvement, the 3rd-generation reagent could detect IgM antibody along with IgG antibody. Over the 30 years after development of the 1st-generation reagent, researchers have made efforts to further shorten the false-negative window period and succeeded in development of the 4th-generation reagent which can detect HIV-1 p24 antigen. This newest screening test reagent can simultaneously detect both HIV antigen and antibodies. Since the window period for screening tests using 1st-generation reagent ranged from about 45 to 60 days, and the 4th-generation reagent has markedly shortened this time to about 26 days there has been an increasing number of institutions starting to use the new reagent.

According to "2008 Medical Diagnostic Guidelines for HIV-1/2 Infection" jointly published by the Japanese Society for AIDS Research and Japanese Society of Laboratory Medicine, the screening test with the 4th-generation HIV screening reagent is recommended as the assay for the early period of infection.

Recently, we conducted a performance assessment of the Lumipulse Presto HIV-Ag/Ab comparing three reagents produced by different manufacturers and reported the results. The present study was performed with the approval of the Ethical Review Committee for Medical Researches and the permission of the President of Tokyo Medical University.


HIV Screening Test, 4th-Generation Reagent, Lumipulse Presto HIV-Ag/Ab, Window Period


This article is translated and republished from Japanese Journal of Medicine and Pharmaceutical Science Vol.71 No.7 2014. (issued in Japan) (Acceptable secondary publication)