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Journal of Clinical Microbiology, February 2006, p. 400-405, Vol. 44, No. 2
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.2.400-405.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay

Max Chernesky,1* Dan Jang,1 Kathy Luinstra,1 Sylvia Chong,1 Marek Smieja,1 Wenjie Cai,1 Beth Hayhoe,2 Eder Portillo,1 Cindy MacRitchie,3 Cheryl Main,3 and Ruth Ewert2

McMaster University, Hamilton, Ontario, Canada,1 Evergreen Health Centre, Toronto, Ontario, Canada,2 Sexual Health Awareness Centre, Hamilton, Ontario, Canada3

Received 8 September 2005/ Returned for modification 12 October 2005/ Accepted 9 November 2005

The clinical sensitivity of nucleic acid amplification tests may be determined by analytical sensitivity and inhibitors in patient samples. We established endpoints for detection of propagated Chlamydia trachomatis L2 434, diluted according to swab and urine protocols for APTIMA Combo 2 (AC2), ProbeTec ET (PT), and Amplicor (AMP) assays. AC2 was 1,000-fold more sensitive than PT and 10-fold more sensitive than AMP on mock swab specimens. For urine, AC2 analytical sensitivity was 100-fold greater than those of the other assays. Spiking an aliquot of each clinical-trial sample from 298 women demonstrated inhibition rates in first-void urine (FVU), cervical swabs (CS), and vaginal swabs (VS) of 12.1%, 12.8%, and 10.4% for AMP; 27.2%, 2%, and 2%, for PT; and 0.3%, 1.7%, and 1.3% for AC2. Inhibition of our C. trachomatis spike and the PT or AMP amplification controls from the manufacturers showed less than 50% correlation. Using an infected-patient reference standard (a specimen positive in at least two tests or a single test positive in two of three samples) in AC2, the VS identified 68/69 (98.6%) infected women compared to CS (89.9%) or FVU (81.2%). Significantly fewer women were identified by PT (65.2%, 63.8%, and 66.7%) or AMP (65.2%, 59.4%, and 56.5%) with the three specimens. By individual specimen type, AC2 confirmed virtually all PT- and AMP-positive specimens, but rates of AC2 confirmation by AMP or PT ranged from 62.9 to 80.3%. The AC2 test identified significantly more women infected with C. trachomatis (P = 0.001). Vaginal swabs appear to be the specimen of choice for screening.

* Corresponding author. Mailing address: St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON L8N 4A6, Canada. Phone: (905) 521-6021. Fax: (905) 521-6083. E-mail: chernesk{at}mcmaster.ca.

Journal of Clinical Microbiology, February 2006, p. 400-405, Vol. 44, No. 2
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.2.400-405.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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