Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia

Chuan Min Tao, Yunjung Cho, Kee Peng Ng, Xiaoxu Han, Eun Jee Oh, Saat Zainah, Mohd Zain Rozainanee, Lan Lan Wang

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: The Elecsys® HIV combi PT assay was developed to allow earlier detection of HIV infection with increased sensitivity and specificity. Objectives: To validate the assay for screening and reliable early detection of HIV-1 infection in Asia. Study design: Samples tested reflected those routinely screened in Asia and comprised: HIV-1 antigen lysate (25 samples) and antibody (20 samples) dilutions; seven HIV-1 seroconversion panels (46 samples); 39 patient samples from early infection; 183 known-positive sera; HIV-1 p24 antigen sensitivity panel (seven samples); >500 routine clinical samples per center. The Elecsys® HIV combi PT assay was compared with fourth- (ADVIA Centaur® HIV combo, ARCHITECT® HIV combo, Elecsys® HIV combi) and third-generation (VIRONOSTIKA® HIV Uni-Form II Plus O, Zhuhai Livzon Anti-HIV EIA, Serodia® Particle Agglutination) assays commonly used in the region. Results: Overall, the Elecsys® HIV combi PT showed superior or similar sensitivity to the comparators for detecting all subtypes. The assay correctly identified all positive samples, including those taken soon after infection, and detected seroconversion at a similar or shorter time interval than the comparators. The analytical sensitivity of Elecsys® HIV combi PT for HIV-1 p24 antigen was 0.90IU/mL, which was lower than reported previously. The assay showed good specificity (99.86%) that was superior or equivalent to the other fourth-generation assays tested. Conclusions: These robust data demonstrate the good subtype inclusivity of the Elecsys® HIV combi PT assay and its suitability for screening and reliable early detection of HIV infection in Asia.

Original languageEnglish
Pages (from-to)221-226
Number of pages6
JournalJournal of Clinical Virology
Volume58
Issue number1
DOIs
Publication statusPublished - 2013 Sep 1

Fingerprint

HIV Infections
HIV-1
HIV
HIV Core Protein p24
HIV Antigens
HIV Seropositivity
Agglutination
Infection
Sensitivity and Specificity
Antibodies
Serum

Keywords

  • Asia
  • Assay
  • Elecsys HIV combi PT
  • Sensitivity
  • Specificity

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia. / Tao, Chuan Min; Cho, Yunjung; Ng, Kee Peng; Han, Xiaoxu; Oh, Eun Jee; Zainah, Saat; Rozainanee, Mohd Zain; Wang, Lan Lan.

In: Journal of Clinical Virology, Vol. 58, No. 1, 01.09.2013, p. 221-226.

Research output: Contribution to journalArticle

Tao, Chuan Min ; Cho, Yunjung ; Ng, Kee Peng ; Han, Xiaoxu ; Oh, Eun Jee ; Zainah, Saat ; Rozainanee, Mohd Zain ; Wang, Lan Lan. / Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia. In: Journal of Clinical Virology. 2013 ; Vol. 58, No. 1. pp. 221-226.
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AU - Tao, Chuan Min

AU - Cho, Yunjung

AU - Ng, Kee Peng

AU - Han, Xiaoxu

AU - Oh, Eun Jee

AU - Zainah, Saat

AU - Rozainanee, Mohd Zain

AU - Wang, Lan Lan

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AB - Background: The Elecsys® HIV combi PT assay was developed to allow earlier detection of HIV infection with increased sensitivity and specificity. Objectives: To validate the assay for screening and reliable early detection of HIV-1 infection in Asia. Study design: Samples tested reflected those routinely screened in Asia and comprised: HIV-1 antigen lysate (25 samples) and antibody (20 samples) dilutions; seven HIV-1 seroconversion panels (46 samples); 39 patient samples from early infection; 183 known-positive sera; HIV-1 p24 antigen sensitivity panel (seven samples); >500 routine clinical samples per center. The Elecsys® HIV combi PT assay was compared with fourth- (ADVIA Centaur® HIV combo, ARCHITECT® HIV combo, Elecsys® HIV combi) and third-generation (VIRONOSTIKA® HIV Uni-Form II Plus O, Zhuhai Livzon Anti-HIV EIA, Serodia® Particle Agglutination) assays commonly used in the region. Results: Overall, the Elecsys® HIV combi PT showed superior or similar sensitivity to the comparators for detecting all subtypes. The assay correctly identified all positive samples, including those taken soon after infection, and detected seroconversion at a similar or shorter time interval than the comparators. The analytical sensitivity of Elecsys® HIV combi PT for HIV-1 p24 antigen was 0.90IU/mL, which was lower than reported previously. The assay showed good specificity (99.86%) that was superior or equivalent to the other fourth-generation assays tested. Conclusions: These robust data demonstrate the good subtype inclusivity of the Elecsys® HIV combi PT assay and its suitability for screening and reliable early detection of HIV infection in Asia.

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KW - Assay

KW - Elecsys HIV combi PT

KW - Sensitivity

KW - Specificity

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