A multi-site validation in India of the line probe assay for the rapid diagnosis of multi-drug resistant tuberculosis directly from sputum specimens.
A multi-site validation in India of the line probe assay for the rapid diagnosis of multi-drug resistant tuberculosis directly from sputum specimens.
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DOI：
10.1371/journal.pone.0088626
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Dewan PK
中科院分区：
文献类型：
--
作者：
Raizada N;Sachdeva KS;Chauhan DS;Malhotra B;Reddy K;Dave PV;Mundade Y;Patel P;Ramachandran R;Das R;Solanki R;Wares DF;Sahu S;O'Brien R;Paramasivan CN;Dewan PK
利福平（R）和异烟肼（H）是主要的一线抗结核药物。未能及早检测到这两种药物的耐药性会导致治疗失败和临床结果不佳。该研究的目的是验证使用 GenoType MTBDRplus 线性探针测定 (LPA) 直接从印度涂片阳性痰样本中检测结核分枝杆菌菌株对 R 和 H 的耐药性。对 320 名患者的涂片阳性痰标本进行了 LPA，并将结果与传统 Lowenstein Jensen (LJ) 培养和药物敏感性测试 (C&DST) 的结果进行了比较。所有 R DST 结果不一致的样本均在国家参考实验室进行 rpoB 基因测序和/或在液体培养物 (MGIT 960) 上重复 DST。与 LJ C&DST 相比，LPA 观察到的可解释结果的比例显着更高（94% vs. 80%，p 值 <0.01）。共有 248 名患者同时获得了 LJ 和 LPA DST 结果； 232 名 (93.5%) 的 R DST 结果一致。在 16 个不一致的 R DST 结果中，有 13 个 (81%) 得到了与 LPA 结果一致的解决。最终 LPA 性能特征为敏感性 96%（CI：90%–98%）、特异性 99%（CI：95%–99%）、阳性预测值 99%（CI：95%–99%）和阴性预测值 95%（CI：89%–98%）。 LPA 的中位周转测试时间（包括样本运输时间）为 11 天，而 LJ C&DST 为 89 天。事实证明，LPA 在快速检测 R 抗性方面非常准确。诊断时间的缩短可能有助于更早开始适当的药物治疗，从而在一定程度上减少耐药菌株的传播。
Rifampicin (R) and isoniazid (H) are key first-line anti-tuberculosis drugs. Failure to detect resistance to these two drugs early results in treatment failure and poor clinical outcomes. The study purpose was to validate the use of the GenoType MTBDRplus line probe assay (LPA) to detect resistance to R and H in Mycobacterium tuberculosis strains directly from smear-positive sputum samples in India. Smear positive sputum specimens from 320 patients were subjected to LPA and results compared against those from conventional Lowenstein Jensen (LJ) culture and drug susceptibility testing (C&DST). All specimens with discordant R DST results were subjected to either sequencing of the rpoB gene and/or repeat DST on liquid culture (MGIT 960) at a National Reference Laboratory. Significantly higher proportion of interpretable results were observed with LPA compared to LJ C&DST (94% vs. 80%, p-value <0.01). A total of 248 patients had both LJ and LPA DST results available; 232 (93.5%) had concordant R DST results. Among the 16 discordant R DST results, 13 (81%) were resolved in agreement with LPA results. Final LPA performance characteristics were sensitivity 96% (CI: 90%–98%), specificity 99% (CI: 95%–99%), positive predictive value 99% (CI: 95%–99%), and negative predictive value 95% (CI: 89%–98%). The median turnaround testing time, including specimen transportation time, on LPA was 11 days as compared with 89 days for LJ C&DST. LPA proved highly accurate in the rapid detection of R resistance. The reduction in time to diagnosis may potentially enable earlier commencement of the appropriate drug therapy, leading to some reduction of transmission of drug-resistant strains.
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影响因子：
9.4
作者：
Brossier, Florence;Veziris, Nicolas;Sougakoff, Wladimir
通讯作者：
Sougakoff, Wladimir
影响因子：
3.7
作者：
Albert H;Bwanga F;Mukkada S;Nyesiga B;Ademun JP;Lukyamuzi G;Haile M;Hoffner S;Joloba M;O'Brien R
通讯作者：
O'Brien R
影响因子：
3.7
作者：
Johnston JC;Shahidi NC;Sadatsafavi M;Fitzgerald JM
通讯作者：
Fitzgerald JM
影响因子：
168.9
作者：
TELENTI, A;IMBODEN, P;BODMER, T
通讯作者：
BODMER, T
DOI：
10.1164/rccm.200709-1436oc
发表时间：
2008-04-01
影响因子：
24.7
作者：
Barnard, Marinus;Allbert, Heidi;Bosiman, Marlein E.
通讯作者：
Bosiman, Marlein E.