Pooling sputum samples for Xpert® MTB/RIF and Xpert® Ultra testing for TB diagnosis.

IF 1.3 Q4 RESPIRATORY SYSTEM Public Health Action Pub Date : 2023-03-21 DOI:10.5588/pha.22.0052

J S Bimba, O A Adekeye, V Iem, T T Eliya, I Osagie, K Kontogianni, T Edwards, J Dodd, S B Squire, J Creswell, L E Cuevas

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Abstract

Background: The use of molecular amplification as-says for TB diagnosis is limited by their costs and cartridge stocks. Pooling multiple samples to test them together is reported to have similar accuracy to individual testing and to save costs.

Methods: Two surveys of individuals with presumptive TB were conducted to assess the performance of pooled testing using Xpert® MTB/RIF (MTB/RIF) and Xpert® Ultra (Ultra).

Results: A total of 500 individuals were tested using MTB/RIF, with 72 (14.4%) being MTB-positive. The samples were tested in 125 pools, with 50 pools having ⩾1 MTB-positive and 75 only MTB-negative samples: 46/50 (92%, 95% CI 80.8-97.8) MTB-positive pools tested MTB-positive and 71/75 (94.7%, 95% CI 86.9-98.5) MTB-negative pools tested MTB-negative in the pooled test (agreement: 93.6%, κ = 0.867). Five hundred additional samples were tested using Ultra, with 60 (12%) being MTB-positive. Samples were tested in 125 pools, with 42 having ⩾1 MTB-positive and 83 only MTB-negative samples: 35/42 (83.6%, 95% CI 68.6-93.0) MTB-positive pools tested MTB-positive and 82/83 (98.8%, 95% CI 93.5-100.0) MTB-negative pools tested MTB-negative in the pooled test (agreement: 93.6%, κ = 0.851; P > 0.1 between individual and pooled testing). Pooled testing saved 35% (MTB/RIF) and 46% (Ultra) of cartridges.

Conclusions: Pooled and individual testing has a high level of agreement and improves testing efficiency.

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集中痰液样本进行 Xpert® MTB/RIF 和 Xpert® Ultra 检测，以诊断结核病。

背景：分子扩增技术在结核病诊断中的应用受到成本和试剂盒库存的限制。据报道，将多个样本集中在一起进行检测与单独检测具有相似的准确性，并能节省成本：方法：对推定肺结核患者进行了两次调查，以评估使用 Xpert® MTB/RIF（MTB/RIF）和 Xpert® Ultra（Ultra）进行联合检测的效果：共有 500 人接受了 MTB/RIF 检测，其中 72 人（14.4%）为 MTB 阳性。这些样本在 125 个样本池中进行了检测，其中 50 个样本池中有⩾1 个 MTB 阳性样本，75 个样本池中只有 MTB 阴性样本：在联合检测中，46/50（92%，95% CI 80.8-97.8）个 MTB 阳性样本池检测出 MTB 阳性，71/75（94.7%，95% CI 86.9-98.5）个 MTB 阴性样本池检测出 MTB 阴性（一致性：93.6%，κ = 0.867）。使用 Ultra 检测了另外 500 份样本，其中 60 份（12%）为 MTB 阳性。对 125 个样本池中的样本进行了检测，其中 42 个样本 MTB 阳性，83 个样本 MTB 阴性：在联合检测中，35/42（83.6%，95% CI 68.6-93.0）个 MTB 阳性样本池检测出 MTB 阳性，82/83（98.8%，95% CI 93.5-100.0）个 MTB 阴性样本池检测出 MTB 阴性（一致性：93.6%，κ = 0.851；单个检测与联合检测之间的 P > 0.1）。联合检测节省了 35%（MTB/RIF）和 46%（Ultra）的试剂盒：结论：联合检测和个体检测具有高度的一致性，并能提高检测效率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Public Health Action RESPIRATORY SYSTEM-

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期刊介绍： Launched on 1 May 2011, Public Health Action (PHA) is an official publication of the International Union Against Tuberculosis and Lung Disease (The Union). It is an open access, online journal available world-wide to physicians, health workers, researchers, professors, students and decision-makers, including public health centres, medical, university and pharmaceutical libraries, hospitals, clinics, foundations and institutions. PHA is a peer-reviewed scholarly journal that actively encourages, communicates and reports new knowledge, dialogue and controversy in health systems and services for people in vulnerable and resource-limited communities — all topics that reflect the mission of The Union, Health solutions for the poor.