Comparison of an industry-derived LCx Chlamydia pneumoniae PCR research kit to in-house assays performed in five laboratories

Max Chernesky, Marek Smieja, Julius Schachter, James Summersgill, Laura Schindler, Natalie Solomon, Karen Campbell, Lee Ann Campbell, Alison Cappuccio, Charlotte Gaydos, Sylvia Chong, Jeanne Moncada, Jack Phillips, Dan Jang, Billie Jo Wood, Astrid Petrich, Margaret Hammerschla, Mike Cerney, James Mahony

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2357-2362
Number of pages6
JournalJournal of clinical microbiology
Volume40
Issue number7
DOIs
StatePublished - 2002
Externally publishedYes

ASJC Scopus subject areas

  • Microbiology (medical)

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