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 language | English |
|---|---|
| Pages (from-to) | 221-226 |
| Number of pages | 6 |
| Journal | Journal of Clinical Virology |
| Volume | 58 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2013 Sep 1 |
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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 journal › Article
}
TY - JOUR
T1 - Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia
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
PY - 2013/9/1
Y1 - 2013/9/1
N2 - 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.
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.
KW - Asia
KW - Assay
KW - Elecsys HIV combi PT
KW - Sensitivity
KW - Specificity
UR - http://www.scopus.com/inward/record.url?scp=84881554017&partnerID=8YFLogxK
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U2 - 10.1016/j.jcv.2013.05.012
DO - 10.1016/j.jcv.2013.05.012
M3 - Article
VL - 58
SP - 221
EP - 226
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
SN - 1386-6532
IS - 1
ER -