印度一家三级护理中心对固体培养法与 GenoType MTBDRplus 线探针分析检测法在早期诊断耐多药结核病（MDR-TB）中的比较评估。
Comparative evaluation of GenoType MTBDRplus line probe assay with solid culture method in early diagnosis of multidrug resistant tuberculosis (MDR-TB) at a tertiary care centre in India.
机构信息
Department of Internal Medicine (Division of Research for Pulmonary, Critical Care & Sleep Medicine), All India Institute of Medical Sciences, New Delhi, India.
出版信息
PLoS One. 2013 Sep 5;8(9):e72036. doi: 10.1371/journal.pone.0072036. eCollection 2013.
BACKGROUND
The objectives of the study were to compare the performance of line probe assay (GenoType MTBDRplus) with solid culture method for an early diagnosis of multidrug resistant tuberculosis (MDR-TB), and to study the mutation patterns associated with rpoB, katG and inhA genes at a tertiary care centre in north India.
METHODS
In this cross-sectional study, 269 previously treated sputum-smear acid-fast bacilli (AFB) positive MDR-TB suspects were enrolled from January to September 2012 at the All India Institute of Medical Sciences hospital, New Delhi. Line probe assay (LPA) was performed directly on the sputum specimens and the results were compared with that of conventional drug susceptibility testing (DST) on solid media [Lowenstein Jensen (LJ) method].
RESULTS
DST results by LPA and LJ methods were compared in 242 MDR-TB suspects. The LPA detected rifampicin (RIF) resistance in 70 of 71 cases, isoniazid (INH) resistance in 86 of 93 cases, and MDR-TB in 66 of 68 cases as compared to the conventional method. Overall (rifampicin, isoniazid and MDR-TB) concordance of the LPA with the conventional DST was 96%. Sensitivity and specificity were 98% and 99% respectively for detection of RIF resistance; 92% and 99% respectively for detection of INH resistance; 97% and 100% respectively for detection of MDR-TB. Frequencies of katG gene, inhA gene and combined katG and inhA gene mutations conferring all INH resistance were 72/87 (83%), 10/87 (11%) and 5/87 (6%) respectively. The turnaround time of the LPA test was 48 hours.
CONCLUSION
The LPA test provides an early diagnosis of monoresistance to isoniazid and rifampicin and is highly sensitive and specific for an early diagnosis of MDR-TB. Based on these findings, it is concluded that the LPA test can be useful in early diagnosis of drug resistant TB in high TB burden countries.
背景
本研究旨在比较线探针分析（GenoType MTBDRplus）与固体培养方法在早期诊断耐多药结核病（MDR-TB）方面的性能，并研究印度北部一家三级护理中心与 rpoB、katG 和 inhA 基因相关的突变模式。
方法
在这项横断面研究中，2012 年 1 月至 9 月期间，从新德里全印度医学科学研究所医院招募了 269 例先前治疗过的痰涂片抗酸杆菌（AFB）阳性 MDR-TB 疑似患者。直接在痰标本上进行线探针分析（LPA），并将结果与固体培养基上的常规药物敏感性试验（DST）[Lowenstein Jensen（LJ）法]进行比较。
结果
在 242 例 MDR-TB 疑似患者中比较了 LPA 和 LJ 方法的 DST 结果。LPA 检测到 71 例利福平（RIF）耐药、93 例异烟肼（INH）耐药和 68 例 MDR-TB 耐药，而传统方法分别为 70 例、86 例和 66 例。LPA 与传统 DST 的总体（利福平、异烟肼和 MDR-TB）一致性为 96%。检测 RIF 耐药的敏感性和特异性分别为 98%和 99%；检测 INH 耐药的敏感性和特异性分别为 92%和 99%；检测 MDR-TB 的敏感性和特异性分别为 97%和 100%。katG 基因、inhA 基因和同时存在 katG 和 inhA 基因突变导致的所有 INH 耐药的频率分别为 72/87（83%）、10/87（11%）和 5/87（6%）。LPA 检测的周转时间为 48 小时。
结论
LPA 检测可早期诊断异烟肼和利福平单耐药，并高度敏感和特异于早期诊断 MDR-TB。基于这些发现，我们得出结论，LPA 检测可用于高结核病负担国家早期诊断耐药结核病。
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