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Journal of Clinical Microbiology, July 2003, p. 3013-3016, Vol. 41, No. 7
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.7.3013-3016.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Reliability of Nucleic Acid Amplification Methods for Detection of Chlamydia trachomatis in Urine: Results of the First International Collaborative Quality Control Study among 96 Laboratories

Roel P. Verkooyen,1 Gerda T. Noordhoek,2* Paul E. Klapper,3 Jim Reid,4 Jurjen Schirm,5 Graham M. Cleator,6 Margareta Ieven,7 and Gunnar Hoddevik8

Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam,1 Public Health Laboratory Friesland, Leeuwarden,2 Regional Public Health Laboratory, Groningen, The Netherlands,5 Public Health Laboratory, Leeds,3 ChimaeraBio, Glasgow,4 University of Manchester, Manchester, United Kingdom,6 Department of Microbiology, University of Antwerp UIA, Antwerp, Belgium,7 National Institute of Public Health, Oslo, Norway8

Received 22 July 2002/ Returned for modification 2 October 2002/ Accepted 4 April 2003

The first European Quality Control Concerted Action study was organized to assess the ability of laboratories to detect Chlamydia trachomatis in a panel of urine samples by nucleic acid amplification tests (NATs). The panel consisted of lyophilized urine samples, including three negative, two strongly positive, and five weakly positive samples. Ninety-six laboratories in 22 countries participated with a total of 102 data sets. Of 204 strongly positive samples 199 (97.5%) were correctly reported, and of 506 weakly positive samples 466 (92.1%) were correctly reported. In 74 (72.5%) data sets correct results were reported on all samples, and 17 data sets (16.7%) showed either one false-negative or one false-positive result. In another 11 data sets, two or more incorrect results were reported, and two data sets reported a false-positive result on one negative sample. The Roche COBAS Amplicor test was performed in 44 (43%) data sets, the Abbott LCx assay was performed in 31 (30%) data sets, the Roche Amplicor manual assay was performed in 9 (9%) data sets, an in-house PCR was performed in 9 (9%) data sets, the Becton Dickinson ProbeTec ET assay was performed in 5 (4.9%) data sets, and the GenProbe TMA assay was performed in 4 (3.9%) data sets. The results of the Roche Amplicor manual (95.6% correct), COBAS Amplicor (97.0%), and Abbott LCx (94.8%) tests were comparable (P = 0.48). The results with the in-house PCR, BD ProbeTec ET, and GenProbe TMA tests were reported correctly in 88.6, 98, and 92.5% of the tests, respectively. Freeze-drying of clinical urine specimens proved to be a successful method for generating standardized, stable, and easy-to-transport samples for the detection of C. trachomatis by using NATs. Although the results, especially the specificity, for this proficiency panel were better than most quality control studies, sensitivity problems occurred frequently, underlining the need for good laboratory practice and reference reagents to monitor the performance of these assays.

* Corresponding author. Mailing address: Public Health Laboratory Friesland, Post Box 21020, 8900 JA Leeuwarden, The Netherlands. Phone: 31-58-2939495. Fax: 31-58-2939200. E-mail: gerda.noordhoek{at}lvf.nl.

Journal of Clinical Microbiology, July 2003, p. 3013-3016, Vol. 41, No. 7
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.7.3013-3016.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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