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Wednesday, March 12, 2008
P78

Performance of Two Nucleic Acid Amplification Tests (NAATs) for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae Using Self-collected Vaginal Swabs Obtained from an Internet-based Screening Program

Nicole Quinn1, Patricia Agreda1, Bulbul Aumakhan1, Mathilda Barnes1, Pamela Whittle2, Mary Terry Hogan1, and Charlotte A. Gaydos1. (1) Division of Infectious Diseases, Johns Hopkins University, 1159 Ross Bldg, 720 Rutland Ave, Baltimore, MD, USA, (2) Communical Diseses, Baltimore City Health Department, 210 Guilford Ave, Baltimore, MD, USA


Background:
An Internet-based screening program, www.iwantthekit.org, designed to educate and screen women for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), offered home self-sampling kits.

Objective:
To evaluate the performance of two NAATs used to detect CT and NG.

Method:
From July 2004 to October 2007, 995 self-collected vaginal swabs were tested for CT and NG by Becton-Dickinson ProbeTec™ SDA and Gen-Probe® APTIMA® Combo2 TMA. Vaginal swabs were self-obtained at home and mailed in a dry state to the laboratory for testing. Swabs were expressed in 800µl Tris-EDTA buffer; 200µl was placed into SDA diluent and 200µl was placed into TMA swab transport medium. All tests were conducted according to manufacturers' procedures. The gold standard for a CT or NG infected patient was defined as 2 positive NAATs. Discrepant samples were retested by the Gen-Probe® APTIMA® stand alone assay, ACT or AGC, or Roche PCR.

Result:
Of 995 swabs submitted, 91 were CT infected (9.1%), 14 NG infected (1.4%), and 7 of these were co-infected (0.7%). All CT and GC Combo2 positive/ProbeTec negative samples were confirmed as true positives by the alternative NAAT. CT: ProbeTec had a sensitivity and specificity of 81.3% (74/91) and 100% (904/904), respectively. Combo 2 had a sensitivity and specificity of 100% (91/91) and 100% (904/904), respectively. GC: ProbeTec had a sensitivity and specificity of 78.6% (11/14) and 100% (981/981), respectively. Combo 2 had a sensitivity and specificity of 100% (14/14) and 100% (981/981), respectively. Overall, ProbeTec had 17 CT false negative results (1.7%) and 3 NG false negative results (0.3%).

Conclusion:
Our results indicated APTIMA® Combo2 was more sensitive than Becton-Dickinson ProbeTec™ for self-obtained vaginal swabs collected at home and transported in a dry state.

Implications:
Self collected vaginal samples collected at home are suitable specimens for NAAT testing.