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Journal of Clinical Microbiology, July 2002, p. 2357-2362, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2357-2362.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Comparison of an Industry-Derived LCx Chlamydia pneumoniae PCR Research Kit to In-House Assays Performed in Five Laboratories

Max Chernesky,^1* Marek Smieja,¹ Julius Schachter,² James Summersgill,³ Laura Schindler,³ Natalie Solomon,⁴ Karen Campbell,³ LeeAnn Campbell,⁵ Alison Cappuccio,⁵ Charlotte Gaydos,⁶ Sylvia Chong,¹ Jeanne Moncada,² Jack Phillips,⁴ Dan Jang,¹ Billie Jo Wood,⁶ Astrid Petrich,¹ Margaret Hammerschlag,⁷ Mike Cerney,⁴ and James Mahony¹

McMaster University, St. Joseph's Healthcare, Hamilton, Ontario, Canada,¹ University of California, San Franscisco, California,² University of Louisville, Louisville, Kentucky,³ Abbott Laboratories, Abbott Park, Illinois,⁴ University of Washington, Seattle, Washington,⁵ Johns Hopkins University, Baltimore, Maryland,⁶ State University of New York Health Sciences Center, Brooklyn, New York⁷

Received 7 December 2001/ Returned for modification 2 March 2002/ Accepted 15 April 2002

In a multicenter comparison of PCR assays utilizing 120 quantitated samples of 16 Chlamydia pneumoniae isolates, an LCx research-use-only (RUO) PCR developed by Abbott Laboratories demonstrated 100% sensitivity on 48 samples with >1 copy of DNA per µl of specimen. The sensitivities of five in-house PCR assays ranged from 54 to 94% for the same samples. All six assays showed decreased sensitivities as the DNA copy numbers of the samples decreased. Overall, sensitivities ranged from 68% for the LCx PCR assay to 29% for one of the in-house tests. The LCx RUO PCR and three of the five in-house PCR tests reported no false positives with the 24 negative samples. Increasing the number of replicates tested increased the sensitivities of all of the assays, including the LCx PCR. The LCx RUO assay showed high reproducibility for a single technologist and between technologists, with a kappa agreement of 0.77. The within-center agreements of the five in-house PCR tests varied from 0.19 to 0.74 on two challenges of 60 specimens 1 month apart. The LCx C. pneumoniae RUO PCR shows excellent potential for use in clinical studies, which could enable standardization of results in the field.

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* Corresponding author. Mailing address: McMaster University, St. Joseph's Healthcare, Hamilton, Ontario L8N 4A6, Canada. Phone: (905) 521-6021. Fax: (905) 521-6083. E-mail: chernesk{at}mcmaster.ca.

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Journal of Clinical Microbiology, July 2002, p. 2357-2362, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2357-2362.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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