Kabir Senjuti, Choudhury Sabrina, Uddin Mohammad Khaja Mafij, Ather M D Fahim, Rahman Syed Mohammad Mazidur, Modak Pronab Kumar, Shanchay Mohammad Samsuddoha Sarker, Rahman Tanjina, Ahmed Shahriar, Banu Sayera
Infectious Diseases Division, icddr,b, Mohakhali, Dhaka, Bangladesh.
Graduate Research Assistant, University of Virginia, Charlottesville, VA, USA.
J Clin Tuberc Other Mycobact Dis. 2025 Jul 14;40:100552. doi: 10.1016/j.jctube.2025.100552. eCollection 2025 Aug.
Performance of OMNIgene.SPUTUM (OM-S) for transporting sputum was evaluated.
This exploratory study was conducted during January-December 2019 at four near and one distant healthcare-facilities of Dhaka. Smear-positive pulmonary TB patients' sputa were collected, divided into 'OM-S untreated' and 'OM-S treated' portions, and transported to testing laboratory, Dhaka, on same-day from near-sites, and through courier from distant-site for smear-microscopy, culture, and Xpert MTB/RIF (Xpert) testing. Subset of 'OM-S treated' sample was tested with Xpert without centrifugation. Test results of all portions were compared in between.
Total 444 participants were enrolled (near-sites:198, distant-site: 246). All test results were comparable in both portions for near-sites. For distant-site, smear-microscopy's positivity was reduced by 4.1 % in 'OM-S treated', Xpert showed 100 % concordance in both portions, and culture was higher in 'OM-S treated' than 'OM-S untreated' (92.3 % vs 89.4 %; p = 0.288). Primary contamination rate in 'OM-S treated' was lower than 'OM-S untreated' (2.0 % vs 9.8 %; p < 0.05). For all sites, median (IQR) time-to-culture positivity was 35 (28, 42) days in both portions. Xpert positivity was 99 % concordant in 'OM-S treated' regardless of centrifugation.
OM-S is safe for sputum transportation. OM-S mixed sputum can be tested with Xpert and culture. Further studies can validate findings and assess cost-effectiveness.
评估了OMNIgene.SPUTUM（OM-S）用于运送痰液的性能。
这项探索性研究于2019年1月至12月在达卡的四个近处和一个远处的医疗机构进行。收集涂片阳性的肺结核患者的痰液，分为“未处理的OM-S”和“处理过的OM-S”部分，并于同一天从近处站点运送到达卡的检测实验室，从远处站点通过快递运送，进行涂片显微镜检查、培养和Xpert MTB/RIF（Xpert）检测。“处理过的OM-S”样本的子集未经离心用Xpert进行检测。比较了所有部分的检测结果。
共纳入444名参与者（近处站点：198名，远处站点：246名）。近处站点的两个部分所有检测结果均具有可比性。对于远处站点，“处理过的OM-S”中涂片显微镜检查的阳性率降低了4.1%，Xpert在两个部分显示出100%的一致性，并且“处理过的OM-S”中的培养阳性率高于“未处理的OM-S”（92.3%对89.4%；p = 0.288）。“处理过的OM-S”中的主要污染率低于“未处理的OM-S”（2.0%对9.8%；p < 0.05）。对于所有站点，两个部分培养阳性的中位（IQR）时间均为35（28，42）天。无论是否离心，“处理过的OM-S”中Xpert的阳性率一致性为99%。
OM-S用于痰液运输是安全的。OM-S混合痰液可以用Xpert和培养进行检测。进一步的研究可以验证研究结果并评估成本效益。
