Kelly-Cirino Cassandra D, Curry Patricia S, Marola Jamie L, Helstrom Niels K, Salfinger Max
DNA Genotek, 3000 - 500 Palladium Drive, Ottawa, ON, Canada, K2V 1C2.
Mycobacteriology Laboratory, National Jewish Health, 1400 Jackson St, Denver, CO, USA.
Diagn Microbiol Infect Dis. 2016 Nov;86(3):273-276. doi: 10.1016/j.diagmicrobio.2016.08.013. Epub 2016 Aug 16.
OMNIgene®•SPUTUM (OM-S) is a sputum transport reagent designed to work with all tuberculosis diagnostics and eliminate the need for cold chain. The aim of this preliminary study was to assess the compatibility of OM-S-treated sputum with the Xpert® MTB/RIF assay. Fifty-five characterized sputa from the FIND TB Specimen Bank were used. Compatibility of OM-S was assessed for both Xpert sample preparation methods: H.1 protocol (sediment, n=25) and H.2 protocol (direct expectorate, n=30). All controls were prepared using the H.2 protocol. Results revealed 100% concordance of MTB/RIF results for all except the low-positive group in the H.1 study arm (n=10; 88% concordance). OM-S-treated sputa were successful in both protocols; if the Xpert buffer is not added during the H.2 procedure, sample viscosity may require repeat testing. Using OM-S could offer users flexibility in clinical testing algorithms. Larger compatibility studies are warranted, particularly with respect to MTB/RIF results for low-positive samples.
OMNIgene®•痰液（OM-S）是一种痰液运输试剂，旨在与所有结核病诊断方法配合使用，无需冷链。这项初步研究的目的是评估经OM-S处理的痰液与Xpert® MTB/RIF检测的兼容性。使用了来自全球抗击结核病药物研发联盟（FIND）结核病样本库的55份特征明确的痰液样本。针对Xpert的两种样本制备方法评估了OM-S的兼容性：H.1方案（沉淀物，n = 25）和H.2方案（直接咳痰，n = 30）。所有对照均采用H.2方案制备。结果显示，除了H.1研究组中的低阳性组（n = 10；一致性为88%）外，所有MTB/RIF结果的一致性均为100%。经OM-S处理的痰液在两种方案中均成功；如果在H.2程序中未添加Xpert缓冲液，样本粘度可能需要重复检测。使用OM-S可为用户在临床检测算法方面提供灵活性。有必要进行更大规模的兼容性研究，特别是关于低阳性样本的MTB/RIF结果。
