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在老挝人民民主共和国开展的结核病主动发现活动中,使用 Xpert MTB/RIF 和 Xpert Ultra 对痰液进行联合检测。

Pooled testing of sputum with Xpert MTB/RIF and Xpert Ultra during tuberculosis active case finding campaigns in Lao People's Democratic Republic.

机构信息

Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.

National Tuberculosis Control Center, XJ7F+P5F, Vientiane, Lao People's Democratic Republic.

出版信息

BMJ Glob Health. 2022 Feb;7(2). doi: 10.1136/bmjgh-2021-007592.

Abstract

INTRODUCTION

Active case finding (ACF) of individuals with tuberculosis (TB) is a key intervention to find the 30% of people missed every year. However, ACF requires screening large numbers of individuals who have a low probability of positive results, typically <5%, which makes using the recommended molecular tests expensive.

METHODS

We conducted two ACF surveys (in 2020 and 2021) in high TB burden areas of Lao PDR. Participants were screened for TB symptoms and received a chest X-ray. Sputum samples of four consecutive individuals were pooled and tested with Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) (Xpert-MTB/RIF) (2020) or Xpert-Ultra (2021). The agreement of the individual and pooled samples was compared and the reasons for discrepant results and potential cartridge savings were assessed.

RESULTS

Each survey included 436 participants, which were tested in 109 pools. In the Xpert-MTB/RIF survey, 25 (sensitivity 89%, 95% CI 72.8% to 96.3%) of 28 pools containing MTB-positive samples tested positive and 81 pools containing only MTB-negative samples tested negative (specificity 100%, 95% CI 95.5% to 100%). In the Xpert-Ultra survey, all 32 (sensitivity 100%, 95% CI 89.3% to 100%) pools containing MTB-positive samples tested positive and all 77 (specificity 100%, 95% CI 95.3% to 100%) containing only MTB-negative samples tested negative. Pooling with Xpert-MTB/RIF and Xpert-Ultra saved 52% and 46% (227/436 and 199/436, respectively) of cartridge costs alone.

CONCLUSION

Testing single and pooled specimens had a high level of agreement, with complete concordance when using Xpert-Ultra. Pooling samples could generate significant cartridge savings during ACF campaigns.

摘要

简介

主动病例发现(ACF)是发现每年漏诊的 30%结核病(TB)患者的关键干预措施。然而,ACF 需要对数量庞大、阳性结果可能性低(通常<5%)的个体进行筛查,这使得使用推荐的分子检测方法成本高昂。

方法

我们在老挝人民民主共和国高结核病负担地区进行了两项 ACF 调查(分别在 2020 年和 2021 年进行)。参与者接受了结核病症状筛查,并接受了胸部 X 光检查。连续四个个体的痰液样本混合后,用 Xpert 分枝杆菌结核(MTB)/利福平(RIF)(Xpert-MTB/RIF)(2020 年)或 Xpert-Ultra(2021 年)进行检测。比较了个体样本和混合样本的一致性,并评估了不一致结果的原因和潜在试剂盒节省。

结果

每个调查都包括 436 名参与者,共检测了 109 个混合样本。在 Xpert-MTB/RIF 调查中,28 个含有 MTB 阳性样本的混合样本中,有 25 个(敏感性 89%,95%置信区间 72.8%至 96.3%)呈阳性,而 81 个仅含有 MTB 阴性样本的混合样本呈阴性(特异性 100%,95%置信区间 95.5%至 100%)。在 Xpert-Ultra 调查中,所有 32 个含有 MTB 阳性样本的混合样本均呈阳性(敏感性 100%,95%置信区间 89.3%至 100%),而所有 77 个仅含有 MTB 阴性样本的混合样本均呈阴性(特异性 100%,95%置信区间 95.3%至 100%)。仅使用 Xpert-MTB/RIF 和 Xpert-Ultra 进行混合检测可分别节省 52%和 46%的试剂盒费用(分别为 227/436 和 199/436)。

结论

使用 Xpert-Ultra 时,单独检测和混合检测样本具有高度一致性,完全一致。在 ACF 活动中,混合样本可以节省大量试剂盒成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/21ec/8845188/1e24853e9ea1/bmjgh-2021-007592f01.jpg

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