West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China.
J Clin Virol. 2013 Sep;58(1):221-6. doi: 10.1016/j.jcv.2013.05.012. Epub 2013 Jun 26.
The Elecsys® HIV combi PT assay was developed to allow earlier detection of HIV infection with increased sensitivity and specificity.
To validate the assay for screening and reliable early detection of HIV-1 infection in Asia.
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.
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 0.90 IU/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.
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.
Elecsys® HIV combi PT 检测法的开发旨在提高灵敏度和特异性，从而更早地检测 HIV 感染。
验证该检测法在亚洲用于筛查和可靠的早期 HIV-1 感染检测的适用性。
检测的样本反映了亚洲常规筛查的情况，包括：HIV-1 抗原裂解液（25 份）和抗体（20 份）稀释液；7 份 HIV-1 血清转换检测套组（46 份）；39 份早期感染患者样本；183 份已知阳性血清；HIV-1 p24 抗原灵敏度检测套组（7 份）；每个中心>500 份常规临床样本。Elecsys® HIV combi PT 检测法与该地区常用的第四代（ADVIA Centaur® HIV combo、ARCHITECT® HIV combo、Elecsys® HIV combi）和第三代（VIRONOSTIKA® HIV Uni-Form II Plus O、珠海丽珠 Anti-HIV EIA、Serodia® Particle Agglutination）检测法进行了比较。
总体而言，Elecsys® HIV combi PT 对所有亚型的检测敏感性优于或等同于对照检测法。该检测法正确识别了所有阳性样本，包括感染后不久采集的样本，并在与对照检测法相似或更短的时间内检测到血清转换。Elecsys® HIV combi PT 检测 HIV-1 p24 抗原的分析灵敏度为 0.90IU/mL，低于之前的报道。该检测法显示出良好的特异性（99.86%），优于或等同于其他测试的第四代检测法。
这些强有力的数据表明 Elecsys® HIV combi PT 检测法具有良好的亚型包容性，适用于亚洲地区的筛查和可靠的早期 HIV 感染检测。
