[核酸扩增检测在涂片阴性肺结核诊断中的局限性]

[Limits of nucleic acid amplification tests for diagnosis of smear negative pulmonary tuberculosis].

作者信息

Ito K, Yoshiyama T, Nakazono T, Ogata H, Wada M, Mizutani S

机构信息

Research Institute of Tuberculosis, Japan Anti-tuberculosis Association, Japan.

出版信息

Kekkaku. 2000 Dec;75(12):691-7.

PMID:11201136

Abstract

STUDY OBJECTIVES

To assess the usefulness of commercial kits of nucleic acid amplification test (NAAT) for diagnosis of smear negative (SN) pulmonary tuberculosis.

DESIGN AND PATIENTS

Retrospective study of patients who were diagnosed as, or suspected of pulmonary tuberculosis during 3 years from January 1996 to December 1998 in Fukujuji Hospital which has 100 beds for tuberculosis patients.

MEASUREMENTS AND RESULTS

145 smear-negative culture-positive pulmonary tuberculosis patients are entered to our analysis. The DNA-based amplification test kit (Amplicor Mycobacterium Tuberculosis Test (AMPL), Roche Diagnostic Systems, Basel, Switzerland) detected 39.2% (20/51, 95% confidence interval (CI): 25.8-52.6%) of smear-negative culture-positive (SNCP) pulmonary tuberculosis cases. The RNA-based amplification test kit (Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (AMTDT), Gen-Probe Inc., San Diego, Calif., USA) detected 40.5% (15/37, 95% CI: 24.7-56.3%) of SNCP pulmonary tuberculosis cases. For both NAATs (AMPL and AMTDT), between two groups with and without the NAAT at diagnosis of SNCP pulmonary tuberculosis, there was statistical difference in culture-positive rate (proportion of positivity in sputum culture tests at diagnosis), but no statistical difference in maximum number of colony of Mycobacterium tuberculosis (MTB). When stratified for the culture-positive rate, adjusted sensitivity for SNCP patients was 44.2% (AMPL) and 40.4% (AMTDT) respectively. On the other hand, among 245 patients with sputum AMPL positive results during the 3 years, 8 were smear-negative culture-negative (SNCN), only one out of these 8 cases was judged as true active tuberculosis without treatment. Among 89 patients with sputum AMTDT positive results, 7 were SNCN, and 3 out of them were judged as true active tuberculosis without treatment.

CONCLUSION

Usefulness of commercial NAAT kits (AMPL and AMTDT) to diagnosis SN pulmonary tuberculosis is limited in the point of sensitivity.

摘要

研究目的

评估核酸扩增检测（NAAT）商用试剂盒在诊断涂片阴性（SN）肺结核中的实用性。

设计与患者

对1996年1月至1998年12月这3年间在拥有100张肺结核病床的福住寺医院被诊断为或疑似患有肺结核的患者进行回顾性研究。

测量与结果

145例涂片阴性培养阳性的肺结核患者纳入我们的分析。基于DNA的扩增检测试剂盒（Amplicor结核分枝杆菌检测（AMPL），罗氏诊断系统公司，瑞士巴塞尔）检测出39.2%（20/51，95%置信区间（CI）：25.8 - 52.6%）的涂片阴性培养阳性（SNCP）肺结核病例。基于RNA的扩增检测试剂盒（Gen - Probe扩增结核分枝杆菌直接检测（AMTDT），Gen - Probe公司，美国加利福尼亚州圣地亚哥）检测出40.5%（15/37，95% CI：24.7 - 56.3%）的SNCP肺结核病例。对于两种NAAT（AMPL和AMTDT），在SNCP肺结核诊断时使用和未使用NAAT的两组之间，培养阳性率（诊断时痰培养检测的阳性比例）存在统计学差异，但结核分枝杆菌（MTB）菌落最大数量无统计学差异。当按培养阳性率分层时，SNCP患者的调整后敏感性分别为44.2%（AMPL）和40.4%（AMTDT）。另一方面，在这3年中245例痰AMPL检测结果为阳性的患者中，8例为涂片阴性培养阴性（SNCN），这8例中只有1例未经治疗被判定为真正的活动性肺结核。在89例痰AMTDT检测结果为阳性的患者中，7例为SNCN，其中3例未经治疗被判定为真正的活动性肺结核。