Diagnostics Direct
Fighting the Syphilis Epidemic with Cutting-Edge Rapid Testing

Traditional syphilis testing follows the Centers for Disease Control and Prevention’s (CDC’s) two-step algorithm, combining non-treponemal and treponemal tests. Historically, screening began with a non-treponemal test, followed by confirmation with a treponemal test. However, these lab-based methods were time-consuming and sometimes less accurate. The delay in results was a major concern, as studies showed that many individuals never returned for their STI results, hampering timely treatment, increasing the risk of transmission, and worsening health outcomes. Pregnant women face even higher risks—without quick diagnosis and treatment, syphilis can pass to the fetus, leading to preterm birth, severe lifelong complications, or even stillbirth. Given these dangers, there is an urgent need for faster, more accessible testing to ensure immediate treatment and prevent transmission.

Addressing this gap, Diagnostics Direct has been at the forefront of public health efforts to combat the syphilis epidemic with its flagship product, Syphilis Health Check^™. The CLIA-waived diagnostic test is FDA 510(k)-cleared and offers distinct advantages over traditional lab-based methods by providing instantaneous results at the point of care. Unlike standard procedures that involve blood draws and lab processing times, this test enables healthcare practitioners to diagnose and treat patients in a single visit. Positive patients can receive treatment immediately, reducing the chances of losing patients to follow-up. The test is also more sensitive and can detect syphilis as early as 10 days after exposure—compared to 30 days or more with other tests. It plays a critical role in birthing hospitals screening for congenital syphilis, ensuring early intervention for both mothers and newborns.

“Our mission is to empower healthcare professionals and organizations by delivering high-quality diagnostic solutions that meet their evolving needs. We strive to offer cutting-edge products that contribute to the improvement of healthcare outcomes globally,” says Jeff Tobias, co-founder and chief operating officer of Diagnostics Direct.

A Critical Tool in Syphilis Prevention

The Syphilis Health Check test is a fast, reliable, and user-friendly rapid test designed for the detection of Treponema pallidum (syphilis) antibodies. Offering both convenience and precision, this test delivers results in just 10 minutes, allowing for prompt diagnosis and timely medical intervention. Using a simple whole-blood fingerstick procedure, the test requires just a single drop of blood, which is placed into the cassette along with four drops of a specialized buffer solution. This solution facilitates the lateral flow process, providing an immediate and accurate result.

Our mission is to empower healthcare professionals and organizations by delivering high-quality diagnostic solutions that meet their evolving needs. We strive to offer cutting-edge products that contribute to the improvement of healthcare outcomes globally

Validated for individuals aged 13 and older, the Syphilis Health Check test boasts an impressive 98 percent sensitivity and 97.2 percent specificity, ensuring high accuracy and reliability. Backed by over 8 million tests conducted worldwide with virtually no reported issues, this diagnostic tool has proven to be a trusted solution for healthcare professionals. With a 30-month shelf life, it offers long-term usability and convenience for clinics and laboratories.

The test is portable and does not require additional equipment. Its ability to detect both IgM and IgG antibodies provides an added advantage, allowing for earlier and more accurate detection. Early identification is critical for timely treatment and improved patient outcomes. The test is well-suited for diverse medical and community settings, making it ideal for field testing and outreach programs.

The Syphilis Health Check test is suitable for both point-of-care settings and laboratory use. While healthcare providers can use it for on-the-spot testing, labs can also process serum or plasma samples using a specific protocol. Regardless of the setting, the rapid test plays a crucial role in early detection, effective disease management, and syphilis prevention, making it an indispensable tool in the fight against infection.

Widespread Adoption and Impact

Syphilis Health Check has been widely adopted by state public health departments, hospitals and emergency departments, university health centers, prisons, and military healthcare facilities.

One health professional noted, “With Syphilis Health Check, we could implement a one-stop-shop model for testing, treatment, and counseling—immediately benefiting populations with limited opportunities for follow-up by providing same-day results and treatment.”

Another provider emphasized its life-saving impact: “Syphilis Health Check empowered patients to get treatment immediately. When a patient has to wait more than a day for results, that lag time affects their willingness to seek adequate treatment. One patient who had previously deferred treatment agreed to get treated on-site [at a community event] when they saw the rapid result was positive.”

Bridging Knowledge with Innovation

Diagnostics Direct empowers healthcare providers with comprehensive training and innovative diagnostic solutions. Training options include a 24/7 on-demand video with a quiz and certification, as well as live remote sessions via Zoom, Teams, or Google Meet. The company trained over 600 people in 2024 through the on-demand course, live in-person events, and remote training sessions, accommodating groups ranging from just a few individuals to larger teams.

Behind these efforts is a dedicated team of healthcare and diagnostics experts committed to excellence. They ensure that the products are high-quality, accurate, and user-friendly. The team takes pride in supporting public health initiatives, expanding testing access, and improving patient outcomes— making a lasting impact on healthcare.

Corporate Responsibility and Giving Back

Diagnostics Direct is dedicated to making a meaningful impact beyond profit, actively supporting underserved communities through strategic partnerships and donations. The company has donated over $550,000 worth of tests, including a major initiative with Indian Health Services, and collaborates with KFF annually to provide 10,000 tests for the Greater Than HIV/Walgreens National HIV Testing Day event, helping meet the growing need for syphilis screening.

While syphilis cases have been rising for over a decade, increased testing plays a crucial role in reversing this trend by enabling early detection and timely treatment. Diagnostics Direct is committed to making testing accessible and affordable, offering a cost-effective solution at just $10 per test, with reimbursement rates of $13.24 through Medicare and Medicaid for those covered by insurance. Many of its customers operate through grant funding, and while funding challenges exist, the company remains optimistic that increased investment in public health will drive expanded access to critical testing.

Advancing Diagnostics for a Healthier Future

Diagnostics Direct continues to innovate, with several new products in development to meet emerging needs in STI testing. These future offerings aim to expand access, support earlier detection, and streamline workflows in both clinical and community settings. The company is also exploring innovative approaches to improve testing for less commonly addressed infections—areas where current tools fall short and more effective solutions are still needed.

By merging cutting-edge technology with a deep commitment to public health, Diagnostics Direct is driving meaningful change. Its advancements in rapid testing are breaking barriers, enabling early treatment, and making quality diagnostics more accessible than ever.