Project HOPE, United States and Africa, PO Box 13395, Addis Ababa, Ethiopia.
Ministry of Health, National TB Program, Lilongwe, Malawi.
BMC Infect Dis. 2019 May 16;19(1):424. doi: 10.1186/s12879-019-4070-8.
The study was conducted in a remote sputum sample collection sites and GeneXpert® MTB/RIF testing centers to detect Mycobacterium tuberculosis in Malawi. The main purpose of the study was to evaluate whether sputum samples stored and transported with OMNIgene®•SPUTUM (OM-S) medium perform comparably to the routine cold-chain stored and transported samples for GeneXpert testing to detect Mycobacterium tuberculosis.
Two sputum samples from each of 362 tuberculosis suspects were randomly assigned to the OMNIgene treated (OM-S group) or the standard-of-care group (SOC; transported via cold chain). All specimens were tested at regional GeneXpert testing sites using the expectorated (raw) sputum protocol. Demographic, clinical, transport/storage and Xpert data were recorded for each specimen pair. Agreement between the SOC and OM-S groups' Xpert results was evaluated using Cohen's kappa analysis.
Mean patient age was 42.3 years (range 2-79 years), 77% of patients were female, and 80% were HIV-positive. Mean transport/storage time was 6.7 days (range, 0-29 days). The rates of MTB positivity for the OM-S and SOC groups were comparable (11.8 and 11.2%, respectively), inter-test agreement was "very good" (κ = 0.97), and overall percent agreement was 99%. Two specimen pairs (both mucoid, one 13 days transport, one 1 day transport) had discordant Xpert results.
OM-S-treated sputum specimens can undergo multi-day ambient-temperature storage as well as transport and yield Xpert results comparable to those of cold-chain-transported samples in Malawi.
本研究在偏远的痰标本采集点和 GeneXpert® MTB/RIF 检测中心进行，以检测马拉维的结核分枝杆菌。本研究的主要目的是评估 OMNIgene®•SPUTUM（OM-S）介质处理的痰标本与常规冷链保存和运输的用于 GeneXpert 检测的标本相比，是否能同样用于检测结核分枝杆菌。
从 362 例疑似结核病患者中，随机抽取每个患者的 2 份痰标本，分别分配到 OMNIgene 处理组（OM-S 组）或标准护理组（SOC；通过冷链运输）。所有标本均在区域 GeneXpert 检测点使用咳痰（原始）痰检测方案进行检测。记录每对标本的人口统计学、临床、运输/储存和 Xpert 数据。使用 Cohen's kappa 分析评估 SOC 组和 OM-S 组的 Xpert 结果之间的一致性。
患者平均年龄为 42.3 岁（范围 2-79 岁），77%的患者为女性，80%为 HIV 阳性。平均运输/储存时间为 6.7 天（范围 0-29 天）。OM-S 组和 SOC 组的 MTB 阳性率相当（分别为 11.8%和 11.2%），检测间一致性为“极好”（κ=0.97），总符合率为 99%。有 2 对标本（均为黏液性，1 对运输 13 天，1 对运输 1 天）的 Xpert 结果不一致。
OM-S 处理的痰标本可以在室温下储存多日，并进行运输，可获得与马拉维冷链运输样本相当的 Xpert 结果。
