By Rebecca Bowers

EXECUTIVE SUMMARY

Just-released research findings indicate that a potential rapid chlamydia test delivers accurate results in about 30 minutes, which could make it possible for patients to be treated right away. Such point-of-care testing could help eliminate the need for follow-up appointments because patients would receive treatment at the time of diagnosis, say researchers.

  • Chlamydia remains the most common condition reported to the Centers for Disease Control and Prevention. Statistics indicate that more than 1.7 million cases were diagnosed in 2017, with 45% reported in young women 15 to 24 years of age.
  • With current tests, patients usually receive results in 2-14 days. Research indicates that many patients may not return to receive results, counseling, and proper treatment.

When it comes to sexually transmitted infections (STIs), chlamydia remains the most common condition reported to the Centers for Disease Control and Prevention (CDC). Statistics indicate that more than 1.7 million cases were diagnosed in 2017, with 45% reported in young women 15 to 24 years of age.1

Just-released research findings indicate that a potential rapid chlamydia test delivers accurate results in about 30 minutes, which could allow patients to receive treatment right away.2 Such point-of-care testing could help eliminate the need for follow-up appointments because patients would receive their treatment at the time of diagnosis, say researchers.

With current tests, patients usually receive results in 2-14 days. Research indicates that many patients may not return to receive results, counseling, and proper treatment.3

Scientists are making “significant progress” toward developing point-of-care STI tests that are sensitive, specific, and easy to read with a short wait time, says Tiffani Bailey Lash, PhD, director of the National Institute of Biomedical Imaging and Bioengineering in the National Institutes of Health. The institute provided funding for the current research, which was conducted by scientists at the Johns Hopkins University Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases.

The goal is to provide test results quickly on a mobile platform, allowing patients increased options, states Charlotte Gaydos, DrPH, MPH, MS, professor of medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine. Gaydos serves as director of the university’s Center for the Development of Point of Care Tests for Sexually Transmitted Diseases.

“A patient should be able to choose if he/she comes into a clinic, goes to a pharmacy, or takes a test at home for STD diagnosis; the bottom line is to encourage people to get tested,” said Gaydos in a press statement.

Examine the Results

The test used in the study is under development by binx health (formerly Atlas Genetics) of Boston. Participants in the study included women 14 years of age and older undergoing chlamydia screening or testing at clinics in Maryland and Ohio. Women provided self-collected vaginal swabs for testing and completed questionnaires regarding participants’ attitudes about point-of-care testing. The analysis compared the performance of binx health’s polymerase chain reaction, point-of-care assay to the Aptima Combo 2, a nucleic acid amplification assay manufactured by Hologic Inc. of Marlborough, MA.

For the study, participants self-collected samples on swabs in the clinic. A lab technician then placed each swab into liquid. Once they were transported to a clinical lab, the swabs were loaded into a disposable, hand-held cartridge for processing. Of the 296 women recruited for the study, results from 284 were available for the study, with 273 completing the questionnaire.

Data indicate that the sensitivity of the test was 83.9% (26/31 specimens; 95% confidence interval [CI], 70.9-96.8%) and the specificity was 98.8% (250/253 specimens; 95% CI, 97.5-100%). To allow for specimens with discrepancies in results, the adjudicated sensitivity was 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and the adjudicated specificity was 98.8% (253/256 specimens; 95% CI, 97.5 to 100%).2

Women Asked About Self-Collection

Will women be amenable to a vaginal self-collected swab for testing? Most women (70%) in the current study said they preferred this practice if a point-of-care test were available. More than half (61%) indicated they would be willing to wait up to 20 minutes if they could receive treatment before leaving a clinic, while 26% said they would wait up to 40 minutes to receive test results.

Most study participants said they would be willing to pay $20 or less for a point-of-care test, and that they would be willing to share the test results with their partners.

“It was promising to see how well-received the test was among patients,” said Lash in a press statement. “I think the world has been waiting for a POC [point-of-care] STD test and I am eager to be a part of continuing to develop new POC technology.”

Johns Hopkins University researchers and binx health recently launched a clinical trial of the point-of-care test. Data from that study will be submitted as part of an application for Food and Drug Administration approval of the test.

REFERENCES

  1. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017. Atlanta: U.S. Department of Health and Human Services; 2018.
  2. Widdice LE, Hsieh YH, Silver B, et al. Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and women’s attitudes toward point-of-care testing. Sex Transm Dis 2018;45:723-727.
  3. Harding-Esch EM, Nori AV, Hegazi A, et al. Impact of deploying multiple point-of-care tests with a ‘sample first’ approach on a sexual health clinical care pathway. A service evaluation. Sex Transm Infect 2017;93:424-429.