Ann Lab Med.  2013 Nov;33(6):420-425. 10.3343/alm.2013.33.6.420.

Reduction of the HIV Seroconversion Window Period and False Positive Rate by Using ADVIA Centaur HIV Antigen/Antibody Combo Assay

• Lee K
• Park HD
• Kang ES

• KMID: 1711315
• DOI: http://doi.org/10.3343/alm.2013.33.6.420

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.

Keyword

HIV; HIV Combo assay; Seroconversion; Window period; Specificity

MeSH Terms

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
HIV Antibodies
HIV Core Protein p24
Reagent Kits, Diagnostic

Figure

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  Fig. 1 Flow chart for patient selection, according to the conventional HIV testing scheme.

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  Fig. 2 Bleed days of first HIV-positive case in four seroconversion panels by HIV assays. Each positive result on the HIV p24 antigen assay is indicated with a diamond (♦).Abbreviations: Ag, antigen; CHIV, HIV antigen/antibody Combo; EHIV, HIV 1/O/2 enhanced antibody.

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