Omar Shaheed V, Peters Remco P H, Ismail Nazir A, Jonkman Kelly, Dreyer Andries W, Said Halima M, Gwala Thabisile, Ismail Nabila, Fourie P Bernard
Department of Medical Microbiology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
Centre for Tuberculosis, National TB Reference Laboratory, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
Trop Med Int Health. 2016 Jun;21(6):776-82. doi: 10.1111/tmi.12701. Epub 2016 May 16.
To assess the performance of an innovative method of transporting sputum to centralised facilities for molecular detection of Mycobacterium tuberculosis: using a swab to inoculate sputum in a transport medium, PrimeStore(®) Molecular Transport Medium (PS-MTM).
Two sputum specimens were obtained from suspected patients with tuberculosis (TB) at rural healthcare facilities in South Africa. A swab was taken from each specimen and placed into PS-MTM, prior to it being processed by either liquid culture or Xpert MTB/RIF assay (Xpert).
A total of 141 patients (including 47 with laboratory-confirmed TB) were included in this analysis. M. tuberculosis was detected at 29% by culture and 29% by Xpert, whereas 31% tested positive by IS6110 real-time PCR of PS-MTM from the culture and 36% from the Xpert-paired specimen. Concordance between the method under evaluation with culture was 82% (McNemar, P = 0.55) and 84% (McNemar, P = 0.05) for Xpert. Stratified by culture result, the detection rate by IS6110 real-time PCR of PS-MTM was similar to Xpert for patients with positive culture (P = 0.32), but significantly higher if culture was negative (P = 0.008).
These results suggest that swab collection of sputum into PS-MTM for transport is a promising method for diagnosis of TB in rural healthcare settings, thereby potentially improving the options available for molecular diagnosis of TB in countries incapable of applying decentralised high-tech molecular testing.
评估一种将痰液运送至集中设施以进行结核分枝杆菌分子检测的创新方法的性能：使用拭子将痰液接种于转运培养基PrimeStore®分子转运培养基（PS-MTM）中。
从南非农村医疗机构疑似结核病患者处获取两份痰液标本。在通过液体培养或Xpert MTB/RIF检测（Xpert）进行处理之前，从每份标本中取拭子并置于PS-MTM中。
本分析共纳入141例患者（包括47例实验室确诊的结核病患者）。培养法检测结核分枝杆菌的阳性率为29%，Xpert检测法的阳性率为29%，而PS-MTM的IS6110实时PCR检测中，培养配对标本的阳性率为31%，Xpert配对标本的阳性率为36%。所评估方法与培养法的一致性为82%（McNemar检验，P = 0.55），与Xpert检测法的一致性为84%（McNemar检验，P = 0.05）。按培养结果分层，PS-MTM的IS6110实时PCR检测对于培养阳性患者的检出率与Xpert检测法相似（P = 0.32），但对于培养阴性患者则显著更高（P = 0.008）。
这些结果表明，将痰液用拭子采集至PS-MTM中进行转运是农村医疗机构诊断结核病的一种有前景方法，从而可能改善无法应用分散式高科技分子检测的国家进行结核病分子诊断的选择。
