Gous Natasha, Scott Lesley, Berrie Leigh, Stevens Wendy
Department of Haematology and Molecular Medicine, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
National Priority Program of the National Health Laboratory Services, Johannesburg, South Africa.
PLoS One. 2016 Dec 16;11(12):e0168244. doi: 10.1371/journal.pone.0168244. eCollection 2016.
Expansion of HIV viral load (VL) testing services are required to meet increased targets for monitoring patients on antiretroviral treatment. South Africa currently tests >4million VLs per annum in 16 highly centralised, automated high-throughput laboratories. The Xpert HIV-1 VL assay (Cepheid) was evaluated against in-country predicates, the Roche Cobas Taqmanv2 and Abbott HIV-1RT, to investigate options for expanding VL testing using GeneXpert's random access, polyvalent capabilities and already established footprint in South Africa with the Xpert MTB/RIF assay (207 sites). Additionally, the performance of Xpert HIV-1VL on alternative, off-label specimen types, Dried Blood Spots (DBS) and whole blood, was investigated.
Precision, accuracy (agreement) and clinical misclassification (1000cp/ml) of Xpert HIV-1VL plasma was compared to Taqmanv2 (n = 155) and Abbott HIV-1 RT (n = 145). Misclassification of Xpert HIV-1VL was further tested on DBS (n = 145) and whole blood (n = 147).
Xpert HIV-1VL demonstrated 100% concordance with predicate platforms on a standardised frozen, plasma panel (n = 42) and low overall percentage similarity CV of 1.5% and 0.9% compared to Taqmanv2 and Abbott HIV-1 RT, respectively. On paired plasma clinical specimens, Xpert HIV-1VL had low bias (SD 0.32-0.37logcp/ml) and 3% misclassification at the 1000cp/ml threshold compared to Taqmanv2 (fresh) and Abbott HIV-1 RT (frozen), respectively. Xpert HIV-1VL on whole blood and DBS increased misclassification (upward) by up to 14% with increased invalid rate. All specimen testing was easy to perform and compatible with concurrent Xpert MTB/RIF Tuberculosis testing on the same instrument.
The Xpert HIV-1VL on plasma can be used interchangeably with existing predicate platforms in South Africa. Whole blood and DBS testing requires further investigation, but polyvalency of the GeneXpert offers a solution to extending VL testing services.
为实现监测接受抗逆转录病毒治疗患者的更高目标，需要扩大HIV病毒载量（VL）检测服务。南非目前每年在16个高度集中的自动化高通量实验室中检测超过400万次VL。针对国内的对照检测方法罗氏Cobas Taqman v2和雅培HIV-1 RT，对Xpert HIV-1 VL检测法（赛沛公司）进行了评估，以研究利用GeneXpert的随机接入、多用途能力以及其通过Xpert MTB/RIF检测法（207个检测点）在南非已有的业务范围来扩大VL检测的选项。此外还研究了Xpert HIV-1 VL在替代的、非标签标本类型，即干血斑（DBS）和全血上的性能。
将Xpert HIV-1 VL血浆检测的精密度、准确性（一致性）和临床错误分类（1000拷贝数/毫升）与Taqman v2（n = 155）和雅培HIV-1 RT（n = 145）进行比较。在DBS（n = 145）和全血（n = 147）上进一步测试Xpert HIV-1 VL的错误分类情况。
在标准化冷冻血浆样本组（n = 42）上，Xpert HIV-1 VL与对照平台显示出100%的一致性，与Taqman v2和雅培HIV-1 RT相比，总体相似性CV百分比分别低至1.5%和0.9%。在配对血浆临床样本上，与Taqman v2（新鲜样本）和雅培HIV-1 RT（冷冻样本）相比，Xpert HIV-1 VL偏差较低（标准差0.32 - 0.37log拷贝数/毫升），在1000拷贝数/毫升阈值时错误分类率为3%。Xpert HIV-1 VL在全血和DBS上的错误分类（向上）增加了高达14%且无效率增加。所有样本检测操作简便且与同一仪器上同时进行的Xpert MTB/RIF结核病检测兼容
血浆中的Xpert HIV-1 VL可在南非与现有的对照平台互换使用。全血和DBS检测需要进一步研究，但GeneXpert的多用途性为扩大VL检测服务提供了一个解决方案。
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