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一项用于检测结核分枝杆菌DNA的聚合酶链反应的盲法研究。阿扎伊分枝杆菌研究小组。

A blind study of the polymerase chain reaction for the detection of Mycobacterium tuberculosis DNA. Azay Mycobacteria Study Group.

作者信息

Doucet-Populaire F, Lalande V, Carpentier E, Bourgoin A, Dailloux M, Bollet C, Vachée A, Moinard D, Texier-Maugein J, Carbonnelle B, Grosset J

机构信息

Hôpital Pitié-Salpétrière, Paris, France.

出版信息

Tuber Lung Dis. 1996 Aug;77(4):358-62. doi: 10.1016/s0962-8479(96)90102-1.

DOI:10.1016/s0962-8479(96)90102-1
PMID:8796253
Abstract

SETTING

Nine French laboratories routinely involved in mycobacterial work.

OBJECTIVE

To assess the detection of Mycobacterium tuberculosis in experimental samples by polymerase chain reaction (PCR) using the insertion sequence IS6110 as a target for deoxyribonucleic acid (DNA) amplification.

DESIGN

Nine laboratories participated in a blind study of the detection of M. tuberculosis by PCR in 20 coded samples containing either a definite number of M. tuberculosis complex (positive samples) or environmental mycobacteria (four samples) or no mycobacteria (five samples).

RESULTS

Five laboratories reported false-positive PCR results, with an average rate of 7%. All laboratories except one reported positive PCR results for samples containing 10(5) cfu/ml or more. M. tuberculosis DNA was detected in two thirds of samples containing 10(4) and 10(3) cfu/ml, and in one third of the samples containing 10(2) cfu/ml.

CONCLUSION

The results of the study suggest that PCR using IS6110 as a target for DNA amplication is neither very sensitive nor really specific for the detection of M. tuberculosis.

摘要

背景

九家法国实验室常规参与分枝杆菌相关工作。

目的

评估以插入序列IS6110作为脱氧核糖核酸(DNA)扩增靶点,通过聚合酶链反应(PCR)检测实验样本中结核分枝杆菌的情况。

设计

九家实验室参与了一项盲法研究,对20份编码样本进行结核分枝杆菌的PCR检测,这些样本中包含一定数量的结核分枝杆菌复合群(阳性样本)、环境分枝杆菌(4份样本)或不含分枝杆菌(5份样本)。

结果

五家实验室报告了假阳性PCR结果,平均发生率为7%。除一家实验室外,所有实验室均报告了含10⁵ cfu/ml及以上的样本PCR结果为阳性。在含10⁴和10³ cfu/ml的样本中,三分之二检测到结核分枝杆菌DNA,在含10² cfu/ml的样本中,三分之一检测到结核分枝杆菌DNA。

结论

研究结果表明,以IS6110作为DNA扩增靶点的PCR检测结核分枝杆菌既不太敏感也不太特异。

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