TY - JOUR
T1 - Comparison of an industry-derived LCx Chlamydia pneumoniae PCR research kit to in-house assays performed in five laboratories
AU - Chernesky, Max
AU - Smieja, Marek
AU - Schachter, Julius
AU - Summersgill, James
AU - Schindler, Laura
AU - Solomon, Natalie
AU - Campbell, Karen
AU - Campbell, Lee Ann
AU - Cappuccio, Alison
AU - Gaydos, Charlotte
AU - Chong, Sylvia
AU - Moncada, Jeanne
AU - Phillips, Jack
AU - Jang, Dan
AU - Wood, Billie Jo
AU - Petrich, Astrid
AU - Hammerschla, Margaret
AU - Cerney, Mike
AU - Mahony, James
PY - 2002
Y1 - 2002
N2 - 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.
AB - 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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U2 - 10.1128/JCM.40.7.2357-2362.2002
DO - 10.1128/JCM.40.7.2357-2362.2002
M3 - Article
C2 - 12089248
AN - SCOPUS:0036308236
SN - 0095-1137
VL - 40
SP - 2357
EP - 2362
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 7
ER -