Reduction of the HIV Seroconversion Window Period and False Positive Rate by Using ADVIA Centaur HIV Antigen/Antibody Combo Assay.
10.3343/alm.2013.33.6.420
- Author:
Kyunghoon LEE
1
;
Hyung Doo PARK
;
Eun Suk KANG
Author Information
1. Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. eskang@skku.edu
- Publication Type:Original Article ; Comparative Study
- Keywords:
HIV;
HIV Combo assay;
Seroconversion;
Window period;
Specificity
- MeSH:
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
- From:Annals of Laboratory Medicine
2013;33(6):420-425
- CountryRepublic of Korea
- Language:English
-
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.
