Azam Khalide, Cadir Nureisha, Madeira Carla, Gillespie Stephen H, Sabiiti Wilber
Instituto Nacional de Saúde National Tuberculosis Reference Laboratory, Maputo, Mozambique.
FHI360 Challenge TB, Maputo, Mozambique.
ERJ Open Res. 2018 Feb 16;4(1). doi: 10.1183/23120541.00074-2017. eCollection 2018 Jan.
Tuberculosis (TB) diagnostics are centralised, requiring long-distance transportation of specimens in most resource-limited settings. We evaluated the ability of OMNIgene.SPUTUM (OM-S) to obviate cold-chain transport of TB specimens. A two-arm (same-day and after 5 days sample processing) study was conducted to assess contamination rates and viability in OM-S-treated samples against the standard decontamination procedure (SDP) in Mozambique, using Lowenstein Jensen (LJ) and mycobacterial growth indicator tube (MGIT) culture and molecular bacterial load assay. 270 specimens were processed using OM-S and SDP in same-day and 5-day arms. Contamination was lower in OM-S-treated than SDP-treated cultures: 12% 15% and 2% 27% in the same-day and 5-day arms, respectively. recovery in OM-S-treated LJ cultures was 10% and 56% higher in the same-day and 5-day arms, respectively, than SDP-treated cultures, but lower in MGIT (52% and 28% lower in the same-day and 5-day arms, respectively). viable count was 1log estimated CFU·mL lower in 5-day OM-S-treated sputa. OM-S was more effective at liquefying sputum with a shorter sample processing time: 22 min for culture. OM-S is simple to use and has demonstrated a high potency to suppress contaminants, maintenance of viability at ambient temperatures and higher recovery, particularly in the solid LJ cultures. Optimisation of OM-S to achieve higher MGIT culture positivity and shorter time to result will increase its application and utility in the clinical management of TB.
结核病（TB）诊断是集中化的，在大多数资源有限的环境中需要对标本进行长途运输。我们评估了OMNIgene.SPUTUM（OM-S）避免结核病标本冷链运输的能力。开展了一项双臂研究（同一天和样本处理5天后），以评估经OM-S处理的样本相对于莫桑比克标准去污程序（SDP）的污染率和活力，采用罗-琴（LJ）培养基和分枝杆菌生长指示管（MGIT）培养以及分子细菌载量测定法。在同一天和5天组中，分别使用OM-S和SDP处理了270份标本。经OM-S处理的培养物中的污染低于经SDP处理的培养物：同一天组和5天组分别为12%对15%和2%对27%。经OM-S处理的LJ培养物中的回收率在同一天组和5天组中分别比经SDP处理的培养物高10%和56%，但在MGIT中较低（同一天组和5天组分别低52%和28%）。在经OM-S处理5天的痰液中，活菌计数估计每毫升CFU低1个对数。OM-S在液化痰液方面更有效，样本处理时间更短：用于培养为22分钟。OM-S使用简单，已证明具有高效抑制污染物的能力，能在环境温度下维持活力且回收率更高，尤其是在固体LJ培养物中。优化OM-S以实现更高的MGIT培养阳性率和更短的出结果时间，将增加其在结核病临床管理中的应用和效用。
