Medecins Sans Frontières, Southern Africa Medical Unit, Cape Town, South Africa.
Medecins Sans Frontières, Access Campaign, Geneva, Switzerland.
PLoS One. 2018 Mar 2;13(3):e0193577. doi: 10.1371/journal.pone.0193577. eCollection 2018.
HIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms.
Whole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe. Sputum samples were collected from all individuals suspected of TB. GeneXpert testing was reserved for all EID, all TB suspects and priority HIV VL at each site. Blood samples were further sent to centralized laboratories for confirmatory testing. GeneXpert polyvalent testing results and patient outcomes, including infrastructural and logistical requirements are reported. The study was conducted over a 10-month period.
The fully automated GeneXpert testing device, required minimal training and biosafety considerations. A total of 1,302 HIV VL, 277 EID and 1,581 MTB/RIF samples were tested on a four module GeneXpert platform in each study site. Xpert HIV-1 VL testing was prioritized for patients who presented with advanced HIV disease, pregnant women, adolescents and suspected ART failures patients. On average, the study sites had a GeneXpert utilization rate of 50.4% (Gutu Mission Hospital), 63.5% (Murambinda Mission Hospital) and 17.5% (Chimombe Rural Health Centre) per month. GeneXpert polyvalent testing error rates remained lower than 4% in all sites. Decentralized EID and VL testing on Xpert had shorter overall median TAT (1 day [IQR: 0-4] and 1 day [IQR: 0-1] respectively) compared to centralized testing (17 days [IQR: 13-21] and 26 days [IQR: 23-32] respectively). Among patients with VL >1000 copies/ml (73/640; 11.4%) at GMH health facility, median time to enhanced adherence counselling was 8 days and majority of those with documented outcomes had re-suppressed VL (20/32; 62.5%). Median time to ART initiation among Xpert EID positive infants at GMH was 1 day [IQR: 0-1].
Implementation of near point-of-care GeneXpert platform for integrated multi-disease testing within district and sub-district healthcare settings is feasible and will increase access to VL, and EID testing to priority populations. Quality management systems including monitoring of performance indicators, together with regular on-site supervision are crucial, and near-POC test results must be promptly actioned-on by clinicians for patient management.
在许多高负担国家/地区，HIV 病毒载量和早期婴儿诊断技术仅限于集中式实验室检测，导致结果周转时间长，患者流失。GeneXpert（Cepheid，加利福尼亚州，美国）是一种多用途的近点护理平台，广泛用于 Xpert MTB/RIF 诊断。本研究旨在评估新的 GeneXpert 平台中整合 HIV VL、EID 和 MTB/RIF 检测的操作可行性。
在津巴布韦的三个农村医疗设施中，从因常规 HIV VL 检测而接受治疗的患者中采集全血样本，并从因 EID 检测而接受治疗的婴儿中采集 DBS 样本。从所有疑似结核病的患者中采集痰样。GeneXpert 检测仅用于每个地点的所有 EID、所有 TB 疑似病例和优先 HIV VL。进一步将血液样本送往中央实验室进行确认检测。报告了 GeneXpert 多用途检测结果和患者结局，包括基础设施和后勤要求。研究在 10 个月内进行。
全自动 GeneXpert 检测设备需要最少的培训和生物安全考虑。在每个研究地点的四个模块 GeneXpert 平台上共检测了 1302 份 HIV VL、277 份 EID 和 1581 份 MTB/RIF 样本。Xpert HIV-1 VL 检测优先用于患有晚期 HIV 疾病、孕妇、青少年和疑似 ART 失败患者的患者。平均而言，研究地点的 GeneXpert 利用率为每月 50.4%（古图使命医院）、63.5%（穆兰比丁使命医院）和 17.5%（奇姆博姆农村保健中心）。所有地点的 GeneXpert 多用途检测错误率均保持在 4%以下。与集中式检测相比（分别为 17 天 [IQR：13-21]和 26 天 [IQR：23-32]），在 Xpert 上进行的分散式 EID 和 VL 检测具有更短的总中位数 TAT（1 天 [IQR：0-4]和 1 天 [IQR：0-1]）。在 GMH 医疗机构中，VL >1000 拷贝/ml 的 640 名患者中有 73 名（73/640；11.4%），增强依从性咨询的中位时间为 8 天，大多数有记录结局的患者 VL 再次受到抑制（20/32；62.5%）。在 GMH，Xpert EID 阳性婴儿的 ART 起始中位时间为 1 天 [IQR：0-1]。
在地区和次地区医疗保健机构中实施近点护理 GeneXpert 平台进行多疾病综合检测是可行的，将增加对优先人群的 VL 和 EID 检测。质量管理制度，包括监测绩效指标，以及定期现场监督至关重要，近点检测结果必须由临床医生及时采取行动，以进行患者管理。
