评估Gen-Probe PACE II检测法直接检测宫颈标本中淋病奈瑟菌的效果。

Evaluation of the Gen-Probe PACE II assay for the direct detection of Neisseria gonorrhoeae in endocervical specimens.

作者信息

Chapin-Robertson K, Reece E A, Edberg S C

机构信息

Department of Laboratory Medicine, Yale University School of Medicine, New Haven, Connecticut.

出版信息

Diagn Microbiol Infect Dis. 1992 Nov-Dec;15(8):645-9. doi: 10.1016/0732-8893(92)90065-2.

DOI:10.1016/0732-8893(92)90065-2

PMID:1282447

Abstract

Evaluation of a non-isotopic DNA-rRNA hybridization assay [Probe Assay-Chemiluminescence Enhanced System (PACE II, Gen-Probe, San Diego, CA)] for the direct detection of Neisseria gonorrhoeae from clinical specimens was compared with culture. Culture and probe tests were performed on 795 endocervical specimens. Results demonstrated that total positives by culture were 18 (2.3% of total); both culture and the DNA-rRNA assay agreed in all cases but four. The PACE II yielded four hybridization-positive results with negative companion cultures. The sensitivity, specificity, and positive and negative predictive values for PACE II were 100%, 99.5%, and 82%, and 100%, respectively. The four discrepant results were resolved using a competitive nucleic acid hybridization assay with recalculated sensitivity, specificity, and positive and negative predictive values of 100, 99.7, and 91.6 and 100%, respectively. Overall, the DNA-rRNA assay offered a number of advantages over culture. The assay was more rapid, able to be performed directly on clinical specimens, and provided superior transport stability.

摘要

对一种用于直接从临床标本中检测淋病奈瑟菌的非同位素DNA-rRNA杂交检测方法[探针检测-化学发光增强系统（PACE II，Gen-Probe，加利福尼亚州圣地亚哥）]与培养法进行了比较。对795份宫颈标本进行了培养和探针检测。结果表明，培养法检测出的总阳性数为18例（占总数的2.3%）；除4例外，培养法和DNA-rRNA检测法在所有病例中结果一致。PACE II检测出4例杂交阳性结果，但其配套培养结果为阴性。PACE II的敏感性、特异性、阳性预测值和阴性预测值分别为100%、99.5%、82%和100%。使用竞争性核酸杂交检测法解决了这4例结果不一致的情况，重新计算后的敏感性、特异性、阳性预测值和阴性预测值分别为100%、99.7%、91.6%和100%。总体而言，DNA-rRNA检测法相对于培养法具有许多优势。该检测方法速度更快，能够直接对临床标本进行检测，并且具有更好的运输稳定性。