Reduction of the HIV seroconversion window period and false positive rate by using ADVIA Centaur HIV antigen/antibody combo assay.

Abstract

BACKGROUND:

Early diagnosis of HIV infection reduces morbidity and mortality. Fourth-generation HIV detection assays are more sensitive because they can detect p24 antigen as well as anti-HIV antibodies. In this study, we evaluated the performance of a new fourth-generation ADVIA Centaur HIV antigen/antibody combo (CHIV) assay (Siemens Healthcare Diagnostics Inc., USA) for early detection of HIV infection and reduction of false positive rate.

METHODS:

Four seroconversion panels were included. The third-generation ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay (Siemens Healthcare Diagnostics Inc., USA) and fourth-generation CHIV assay were used to test each panel for HIV infection. The presence of antigen was confirmed using HIV p24 antigen assay. To evaluate false-positivity and specificity, 54 HIV false-positive and HIV-negative serum samples from 100 hospitalized patients and 600 healthy subjects were included.

RESULTS:

COMPARED TO THE EHIV ASSAY, THE CHIV ASSAY HAD A SHORTER WINDOW FOR THREE OF THE SEROCONVERSION PANELS: a difference of 10 days and two bleeds in one panel, and 4 days and one bleed in the other two panels. Only 34 of the 54 (63%) samples known to yield false-positive results by EHIV assay had repeatedly yielded reactive results in the CHIV assay. One of the 600 healthy subjects had a false-positive result with the CHIV assay; thus, the specificity was 99.85% (699/700). CHIV accurately determined the reactive results for the HIV-confirmed serum samples from known HIV patients and Korea Food & Drug Administration (KFDA) panels.

CONCLUSIONS:

The new fourth-generation ADVIA Centaur HIV assay is a sensitive and specific assay that shortens the serological window period and allows early diagnosis of HIV infection.

• Authors: Kyunghoon Lee, Hyung-Doo Park, Eun-Suk Kang
• Journal: Annals of laboratory medicine (Ann Lab Med) Vol. 33 Issue 6 Pg. 420-5 (Nov 2013) ISSN: 2234-3814 [Electronic] Korea (South)
• PMID: 24205491 (Publication Type: Comparative Study, Journal Article)

Chemical References

• HIV Antibodies
• HIV Core Protein p24
• Reagent Kits, Diagnostic

Topics

• False Positive Reactions
• Female
• HIV Antibodies (blood, immunology)
• HIV Core Protein p24 (blood, immunology)
• HIV Seropositivity (diagnosis)
• Humans
• Male
• Pregnancy
• Reagent Kits, Diagnostic
• Republic of Korea
• Sensitivity and Specificity
• Time Factors