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Key Messages
This Horizon Scan summarizes the information available regarding the rapid testing at the point of care for detecting Treponema pallidum, the bacteria responsible for syphilis.
Point-of-care screening for potential syphilis cases allows healthcare providers to test individuals where they are. This method eliminates the dependency on access to conventional healthcare settings. Quick test results can facilitate immediate treatment decisions, which is crucial to minimize the number of currently infected individuals who may not return for follow-up.
Currently, no point-of-care syphilis tests are approved for use by Health Canada; however, there is a likelihood that at least one multiplex test for syphilis and HIV detection will be licensed for use in Canada soon.
Evidence indicates that rapid tests for syphilis detection show adequate sensitivity and specificity for screening purposes. The implementation of point-of-care testing, home-testing options, and virtual care systems should be considered as health systems work to overcome screening backlogs exacerbated by the COVID-19 pandemic and target historically underserved populations.
Point-of-Care Tests Can Facilitate a Faster Syphilis Diagnosis Than Standard Lab Tests
Standard laboratory tests for diagnosing syphilis can take weeks to return results. In contrast, point-of-care tests can deliver results in under 20 minutes and enhance testing accessibility by being conducted in non-traditional healthcare environments.
How It Works
Antibodies are detected to confirm syphilis infection. While treponemal antigens signify either a current or past infection, they cannot independently confirm a new infection. Generally, a positive treponemal test is validated with a non-treponemal test.
Point-of-care syphilis tests utilize quick vertical flow immunoassays and can be performed by healthcare professionals using a fingerstick or IV blood sample. They can either test solely for syphilis or include multiplex testing for both syphilis and HIV-1/HIV-2. Some rapid tests yield results in as little as one minute. Recent trials in Canada have employed rapid multiplex tests to manage outbreaks effectively and provide immediate treatment access. Currently, these point-of-care tests only detect treponemal antigens and are unable to identify non-treponemal antigens, meaning that while they serve as screening tools for potential current infections, further testing is required for a definitive diagnosis.
Who Might Benefit?
Syphilis, caused by the bacteria Treponema pallidum, is a treatable sexually transmitted infection (STI). It ranks as the third most reported notifiable STI in Canada, following chlamydia and gonorrhea. The infectious syphilis rate in Canada escalated from 5.1 cases per 100,000 people to 24.7 cases between two specified years. Infection rates surged in nearly all provinces, with significant increases observed particularly in the Prairie provinces, which have seen rises exceeding 400%. Although men statistically experience higher rates of infection, the rate for women increased dramatically as well.
Untreated syphilis can result in severe, lasting health problems, including damage to the heart, brain, and nerves. Pregnant individuals can transmit syphilis to their unborn child, leading to serious complications. Early-stage syphilis can be effectively treated with antibiotics, and the presence of syphilis can heighten an individual's risk for HIV infection. The prolonged latent phase of syphilis infection makes screening challenging, further complicating efforts to control its transmission.
Unfortunately, many individuals face multiple barriers to accessing STI screenings, including rapid syphilis tests. Such barriers can include lack of transportation, inability to schedule appointments, and insufficient access to healthcare providers. Traditional lab tests for syphilis typically require one week or longer, creating delays that contribute to ongoing transmission and loss to follow-up.
Availability in Canada
In recent clinical trials in Canada, tests such as the Medmira Multiplo TP/HIV and bioLytical INSTI multiplex tests have not secured regulatory approval from Health Canada but are expected to do so soon. The INSTI Multiplex test anticipates receiving class IV medical device licensing before the end of this year. While some of these tests have achieved CE marks in Europe, they remain unapproved by the FDA in the United States.
What Does It Cost?
The anticipated cost for the bioLytical INSTI Multiplex HIV-1/2 Syphilis Antibody Test is C$24.99. These point-of-care tests are projected to decrease healthcare expenditures by reducing the need for laboratory confirmatory tests, as lab resources will be focused on confirming positive results from point-of-care screenings.
Current Practice
Canada employs two blood test screening algorithms for diagnosing syphilis. The reverse algorithm primarily uses a treponemal test to identify treponemal antibodies, followed by a quantitative non-treponemal test for confirmation. Positive treponemal tests typically yield lifelong positive results, necessitating further non-treponemal testing to confirm active syphilis cases.
What Is the Evidence?
Extensive research has demonstrated that rapid tests for syphilis detection are sufficiently sensitive and specific for screening. Current commercially available tests only identify treponemal antibodies and do not differentiate between active and previously treated infections.
Safety
No significant safety concerns regarding the use of rapid, point-of-care syphilis tests have been identified.
Issues to Consider
Patients receiving positive results through point-of-care testing must follow up for confirmatory tests and complete treatment regimens. Implementing point-of-care testing can significantly reduce diagnostic timelines and diminish the number of patients lost to follow-up.
User Perspectives
Qualitative assessments reveal that users generally have positive experiences with rapid syphilis tests. The quick turn-around for results and the minimal amount of blood required for testing are especially favorable aspects. These rapid tests implemented in non-traditional healthcare settings, such as outreach programs, provide accessible and effective screening options.
Related Developments
Ongoing Canadian studies are focused on further testing of syphilis and HIV multiplex tests, expanding to include First Nations communities. Additionally, there are efforts underway to create a self-test version of the INSTI Multiplex test. International research is happening in China, exploring saliva-based molecular detection methods for syphilis, which could improve testing accessibility.
Looking Ahead
The COVID-19 pandemic has underscored the need for increased STI testing beyond conventional clinical settings. The potential for point-of-care testing, home sample collection, and virtual consultations is promising as health systems aim to catch up on missed screenings.
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