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Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women's Attitudes Toward Point-Of-Care Testing

Widdice, Lea E., MD*; Hsieh, Yu-Hsiang, PhD; Silver, Barbara, BS, MBA; Barnes, Mathilda, MS; Barnes, Perry, MSPM; Gaydos, Charlotte A., MS, MPH, DrPH

doi: 10.1097/OLQ.0000000000000865
Original Studies

Purpose This study compared performance of the Atlas io polymerase chain reaction–based, point-of-care (POC) assay for Chlamydia trachomatis (CT), to Aptima Combo 2, a standard of care nucleic acid amplification assay, and evaluated patient attitudes toward POC testing.

Methods Women 14 years or older undergoing CT screening/testing were recruited from Teen Health Center and a sexually transmitted disease clinic. Participants provided self-obtained vaginal swabs for testing with the Atlas io and Aptima Combo 2, and completed questionnaires assessing attitudes toward POC testing.

Results Of 296 women recruited, 284 (192 from sexually transmitted disease clinic, 92 from Teen Health Center) had Aptima Combo 2 and Atlas io results available; 273 completed the questionnaire. Average age was 27.4 years (SD, 10.8 years). Sensitivity and specificity of the Atlas io test were 83.9% (26/31 specimens; 95% confidence interval [CI], 70.9–96.8%) and 98.8% (250/253 specimens; 95% CI, 97.5–100%), respectively. When specimens with discrepant results were included in the analyses, adjudicated sensitivity and specificity were 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and 98.8% (253/256 specimens; 95% CI, 97.5 to 100%), respectively.

A majority (70%) of women preferred to collect vaginal self-swab if a POC test were available. Most (61%) were willing to wait up to 20 minutes, and 26% were willing to wait up to 40 minutes for results, if they could be treated before leaving clinic.

Conclusions A POC polymerase chain reaction test detecting CT had high sensitivity and specificity when testing prospective, vaginal swab samples. Availability of CT results during patients' visits may decrease time to treatment.

Pilot study assessing attitudes toward point-of-care testing and performance of a point-of-care Chlamydia trachomatis diagnostic test using self-obtained vaginal swabs showed variability in attitudes and similar performance to laboratory-based testing.

From the *Department of Pediatrics, University of Cincinnati College of Medicine; Division of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; and

Johns Hopkins Medical Institutions, Baltimore, MD

Conflicts of Interest: C.A.G. reports possible conflicts of interest, because her institution is receiving funds for her participation in an ongoing clinical trial of an Atlas Genetics test cartridge for the detection of both chlamydia and gonorrhea. The remaining authors report no conflicts of interest.

Sources of Funding: This work was funded by the NIH grant NIBIB/2U54 EB007958 (Gaydos, PI), C.A.G. received support from U01-068613, NIAID, NIH, and L.E.W. received support from UL1 TR001425 (Heubi, PI). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1 TR001425. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

The device manufacturer supplied all testing supplies and trainings on the operation of the device, and the final article was reviewed by the manufacturer.

Correspondence: Lea E. Widdice, MD, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229. E-mail: Lea.widdice@cchmc.org.

Received for publication February 14, 2018, and accepted April 22, 2018.

© Copyright 2018 American Sexually Transmitted Diseases Association