The U.S. Department of Health and Human Services (HHS) Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC: U.S. Department of Health and Human Services; 2020 cites the need for innovative solutions and approaches to address the ongoing and emerging challenges to Sexually Transmitted Infections (STI) prevention and control, including expanding the types of community and clinical sites that address STIs and developing vaccines, point-of-care diagnostic tools, and therapeutics. The plan is designed to facilitate a whole-of-nation response to the STI epidemic in the United States and to successfully prevent and reduce STI-associated morbidity and mortality.
Chlamydia and gonorrhea are the two most common sexually transmitted infections. They can spread through vaginal, anal, and oral sex, causing infections of the genitals, rectum, and throat. This test is designed to detect genital infections (affecting the penis or vagina)*.
Chlamydia:
Chlamydia is a bacterial infection caused by Chlamydia trachomatis. It can affect anyone who is sexually active. Chlamydia typically does not cause symptoms. Routine screening and early detection are essential as untreated chlamydia can spread easily to partners and have long-term health consequences.
Gonorrhea:
Gonorrhea is a bacterial infection caused by Neisseria gonorrhoeae. It can affect anyone who is sexually active. Gonorrhea typically does not cause symptoms. Routine screening and early detection are essential as untreated gonorrhea can spread easily to partners and have long-term health consequences.
A point-of-care (POC) test is a diagnostic tool that can detect the presence of gonorrhea or chlamydia bacteria in a patient sample. POC devices including lab-on-a-chip (LOC) devices, lab-on-a-disc (LOAD) devices, microfluidic paper-based analytical devices (μPADs), lateral flow devices, miniaturized PCR devices, and isothermal nucleic acid amplification devices (INAA) devices promoted the development of POC diagnostics. The seamless integration of those novel biosensors, advanced devices and recent artificial intelligence (AI) techniques would greatly accelerate the pace of progress in the development POC diagnostics toward labor-free and intelligent diagnosis. This paper “Point-of-care Diagnostics for Infectious Diseases: From Methods to Devices”systematically summarized recent progresses in the development of POC detection methods and correlated POC devices for the diagnostics of various pathogens caused infectious diseases including parasites, bacteria and viruses.
Some POC Tests Include:
The test, which uses female vaginal swabs and male urine specimens, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually transmitted infections chlamydia and gonorrhea, respectively.
The test is performed while the patient is present, providing an actionable result in approximately 30 minutes. The test’s performance was evaluated in females 16 years and older and in males 17 years and older and was demonstrated to be comparable to tests performed in a CLIA certified laboratory that meets the requirements for high or moderate complexity testing.
A rapid test that can be used in a variety of settings, including physician offices, urgent care, and community clinics. It can provide results in about 30 minutes and is comparable to tests performed in a CLIA-certified lab.
Let’s Get Checked Aptima Combo 2 Assay /Simple 2 Test by Hologic
The first at-home test for gonorrhea and chlamydia that can be purchased over-the-counter. It uses urine specimens or vaginal swabs and is intended for adults 18 and older.
90-minute real time PCR CT/NG testing for detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae from patient collected vaginal swabs, urine, pharyngeal or rectal swabs
Sexual Health Test by Visby Medical
A CLIA-waived device that can detect gonorrhea, chlamydia, and trichomoniasis in under 30 minutes. It has LED lights to indicate the status of the test, a sample collection port, and a test control to indicate if the results are valid.
Some challenges with POC gonorrhea and chlamydia testing include:
Detection Limits: The detection limit is (informally) the lowest concentration of the analyte that can be reliably detected and reflects the precision of the instrumental response obtained by the method when the concentration of the analyte is zero. Some infections may not be detected without greater sensitivity.
Cost: The cost of the test can be a major challenge.
Reporting: How to report notifiable diseases from POC tests performed in various locations, such as pharmacies, colleges, and emergency departments.
Workflow: If patients must wait for their results, a new workflow algorithm may need to be considered.