安普瑞科沙眼衣原体聚合酶链反应检测方法的敏感性差异。

Differences in the sensitivity of the Amplicor Chlamydia trachomatis PCR assay.

作者信息

Ossewaarde J M, van Doornum G J, Buimer M, Choueiri B, Stary A

机构信息

Research Laboratory for Infectious Diseases, National Institute of Public Health and the Environment, Bilthoven, Netherlands.

出版信息

Genitourin Med. 1997 Jun;73(3):207-11. doi: 10.1136/sti.73.3.207.

DOI:10.1136/sti.73.3.207

PMID:9306903

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1195824/

Abstract

PURPOSE

To evaluate the use of the Amplicor PCR assay in two European centres (Amsterdam and Vienna) as a standard for amplification assays in comparative studies.

STUDY DESIGN

Both centres used the Amplicor PCR assay and their own standard diagnostic methods as the reference assay. Discrepant results were further analysed by an Omp1-PCR assay. In total 805 female patients and 614 male patients were included in the studies.

RESULTS

The prevalence of Chlamydia trachomatis infections in female patients was 10.0% in Amsterdam and 2.5% in Vienna and in male patients 13.7% and 10.8%, respectively. The mean sensitivity of the Amplicor PCR assay with cervical specimens from female patients was 92.5% and the mean specificity was 99.2%. For the reference assays the mean values were 87.5% and 100.0% respectively. The mean sensitivity of the Amplicor PCR assay with urine specimens from male patients was 70.3% and the mean specificity was 97.6%. For the reference assays these values were 64.9% and 100.0% respectively. The mean sensitivity of the Amplicor PCR assay with urethral specimens from male patients was 67.6% and the mean specificity was 98.5%. For the reference assays these values were 62.2% and 100.0% respectively. Of all specimens together, 1.0% showed an OD value between 0.25 and 0.5 in the Amplicor PCR assay and had to be retested. The sensitivity of the Amplicor PCR assay was less than could be expected from previous studies comparing amplification assays under similar conditions. Also, the sensitivity of the Amplicor PCR assay varied considerably between study centres using urine specimens from male patients-45.9% and 94.6%, respectively.

CONCLUSION

The Amplicor PCR assay cannot be considered as a standard for amplification assays in comparative studies.

摘要

目的

评估在两个欧洲中心（阿姆斯特丹和维也纳）使用Amplicor聚合酶链反应（PCR）检测法作为比较研究中扩增检测的标准。

研究设计

两个中心均使用Amplicor PCR检测法及其自身的标准诊断方法作为参考检测。对结果不一致的情况通过Omp1-PCR检测进行进一步分析。研究共纳入805例女性患者和614例男性患者。

结果

阿姆斯特丹女性患者沙眼衣原体感染率为10.0%，维也纳为2.5%；男性患者感染率分别为13.7%和10.8%。对于女性患者宫颈标本，Amplicor PCR检测法的平均灵敏度为92.5%，平均特异性为99.2%。参考检测的平均值分别为87.5%和100.0%。对于男性患者尿液标本，Amplicor PCR检测法的平均灵敏度为70.3%，平均特异性为97.6%。参考检测的这些值分别为64.9%和100.0%。对于男性患者尿道标本，Amplicor PCR检测法的平均灵敏度为67.6%，平均特异性为98.5%。参考检测的这些值分别为62.2%和100.0%。在所有标本中，1.0%在Amplicor PCR检测中OD值介于0.25至0.5之间，必须重新检测。Amplicor PCR检测法的灵敏度低于之前在类似条件下比较扩增检测的研究预期。此外，使用男性患者尿液标本的研究中心之间，Amplicor PCR检测法的灵敏度差异很大，分别为45.9%和94.6%。