Stevens Wendy, Erasmus Linda, Moloi Matsidisho, Taleng Thabo, Sarang Somaya
University of the Witwatersrand and the National Health Laboratory Services, Johannesburg 2000, South Africa.
J Clin Microbiol. 2008 Dec;46(12):3941-5. doi: 10.1128/JCM.00754-08. Epub 2008 Oct 15.
The new Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test offers advanced automation for the detection of human immunodeficiency virus type 1 (HIV-1) RNA and DNA in dried blood spots (DBS) and whole blood. An analytical evaluation using an HIV-1 secondary standard yielded limits of detection of 514, 710, and 1,090 HIV RNA copies/ml for EDTA plasma, whole blood, and DBS, respectively. The precision and reproducibility of HIV-1 detection was equivalent for DBS and whole blood. Inclusivity was demonstrated for a reference panel of HIV-1 subtypes A to N. A clinical evaluation of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test was performed at a center for routine diagnostics in Johannesburg, South Africa, using 1,013 clinical specimens from HIV-1 exposed children. The Amplicor HIV-1 DNA test v1.5 with the MagNApure DNA isolation procedure was used as the reference method. A total of 995 valid results for whole blood with both methods yielded 691 and 303 concordant negative and positive results for the Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test, respectively. For the 800 valid DBS specimen results, 495 and 300 concordant negative and positive results were obtained, respectively. The resulting clinical specificities and sensitivities of the new test were 100% and 99.7% for whole blood and DBS, respectively. The new test was characterized by its robustness, enhanced automation, and improved sample throughput. The Cobas AmpliPrep/Cobas TaqMan HIV-1 Qual test will support early, reliable diagnosis of HIV in children in routine laboratory settings.
新型Cobas AmpliPrep/Cobas TaqMan HIV-1定性检测为在干血斑（DBS）和全血中检测1型人类免疫缺陷病毒（HIV-1）RNA和DNA提供了先进的自动化技术。使用HIV-1二级标准品进行的分析评估得出，对于乙二胺四乙酸（EDTA）血浆、全血和DBS，HIV RNA的检测限分别为每毫升514、710和1090个HIV RNA拷贝。HIV-1检测在DBS和全血中的精密度和可重复性相当。已证明该检测对HIV-1 A至N亚型的参考样本具有包容性。在南非约翰内斯堡的一个常规诊断中心，使用来自暴露于HIV-1的儿童的1013份临床标本，对Cobas AmpliPrep/Cobas TaqMan HIV-1定性检测进行了临床评估。使用带有MagNApure DNA提取程序的Amplicor HIV-1 DNA检测v1.5作为参考方法。两种方法对全血共获得995个有效结果，其中Cobas AmpliPrep/Cobas TaqMan HIV-1定性检测分别有691个和303个一致的阴性和阳性结果。对于800份有效的DBS标本结果，分别获得495个和300个一致的阴性和阳性结果。新检测在全血和DBS中的临床特异性和敏感性分别为100%和99.7%。新检测的特点是稳健性强、自动化程度提高且样本通量增加。Cobas AmpliPrep/Cobas TaqMan HIV-1定性检测将有助于在常规实验室环境中对儿童进行早期、可靠的HIV诊断。
