Pooling sputum for Xpert MTB/RIF and Xpert Ultra testing during the Covid-19 pandemic in Lao People's Democratic Republic.
Pooling sputum for Xpert MTB/RIF and Xpert Ultra testing during the Covid-19 pandemic in Lao People's Democratic Republic.
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DOI：
10.1371/journal.pgph.0000116
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发表时间：
2022
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Covid-19全球大流行限制了获得结核病分子诊断的机会，国家规划正在努力维持基本服务。汇集方法（一起检测多个样本）可以减少结核病诊断所需的药筒数量和工作人员时间，但尚未在大流行期间进行试验。我们进行了两次独立的横断面调查。使用expert - mtb /RIF或expert - ultra检测由四个痰样本组成的痰池。将合并和单独的结果进行比较，以确定一致性的水平。每次调查包括840名参与者和210个游泳池。在Xpert MTB/RIF调查中，77/81（敏感性95.1%,95%CI 87.8%-98.6%）阳性样本包含≥1个阳性样本池为MTB阳性，4/81 （4.9%,95%CI 1.4%-12.2%）为MTB阴性。所有含有mtb阴性样本的129/129池均检测为mtb阴性（特异性100%，95%CI 97.2%-100%），一致性为98.1% （Kappa: 0.959）。在Xpert-Ultra调查中，70/70（灵敏度100%，95%CI 94.9%-100%）包含≥1个mtb阳性样本的池检测为mtb阳性，140/140（特异性100%，95%CI 97.4%-100%）仅包含mtb阴性样本的池检测为mtb阴性，一致性为100% （Kappa: 1）。单独使用Xpert-MTB/RIF和Xpert-Ultra进行集中测试，仅墨盒成本就节省了38.3%和41.7%（分别为322/840和350/840）。与expert - mtb /RIF和expert - ultra相结合的汇集方法具有与单独测试相似的性能，并且可以减少所需的墨盒数量。由于各国在大流行期间面临实验室采购困难，这些效率有助于维持库存和维持基本服务，并将在大流行后节省成本和时间。
The global Covid-19 pandemic has limited access to molecular TB diagnostics and National Programmes are struggling to maintain essential services. The pooling method (testing several samples together) could reduce the number of cartridges and staff time needed for TB diagnosis but has not been tested within the pandemic. We conducted two independent cross-sectional surveys. Pools composed of four sputum samples were tested using either Xpert-MTB/RIF or Xpert-Ultra. Pooled and individual results were compared to determine the level of agreement. Each survey included 840 participants and 210 pools. In the Xpert MTB/RIF survey, 77/81 (sensitivity 95.1%, 95%CI 87.8%-98.6%) pools containing ≥1 positive sample tested MTB-positive and 4/81 (4.9%, 95%CI 1.4%-12.2%) tested MTB-negative. All 129/129 pools containing MTB-negative samples tested MTB-negative (specificity 100%, 95%CI 97.2%-100%), with 98.1% agreement (Kappa: 0.959). In the Xpert-Ultra survey, 70/70 (sensitivity 100%, 95%CI 94.9%-100%) pools containing ≥ 1 MTB-positive sample tested MTB-positive and 140/140 (specificity 100%, 95%CI 97.4%-100%) pools containing only MTB-negative samples tested MTB-negative, with 100% agreement (Kappa: 1). Pooled testing with Xpert-MTB/RIF and Xpert-Ultra saved 38.3% and 41.7% (322/840 and 350/840, respectively) in cartridge costs alone. The pooling method with Xpert-MTB/RIF and Xpert-Ultra has similar performance to individual testing and can reduce the number of cartridges needed. These efficiencies can facilitate maintenance of stocks and sustain essential services as countries face difficulties for laboratory procurement during the pandemic and will provide cost and time savings post-pandemic.