Syphilis Health Check™ Frequently Asked Questions
About Syphilis Health Check™
What is Syphilis Health Check™?
Syphilis Health Check™ is a rapid treponemal test designed to detect antibodies to Treponema pallidum, the bacterium that causes syphilis, indicating either a current or past syphilis infection.
Who can perform Syphilis Health Check™ tests?
When using the Fingerstick Whole Blood Procedure, individuals in CLIA-waived settings can perform tests after reviewing the instructions for use. Additional requirements for non-license staff conducting CLIA-waived tests may be required in your state or at your facility.
When using venous whole blood, plasma, or serum samples, the testing needs to be performed in a moderate-complexity or high-complexity laboratory.
This test is intended for healthcare professionals and not for personal use by end-users.
Who can Syphilis Health Check™ tests be used on?
Syphilis Health Check is suitable for testing individuals aged 13 years and older.
Each kit includes;
20 tests in individual foil pouches
20 fixed volume pipettes
1 bottle of diluent (buffer)
Literature (package insert and quick reference guide)
All components are conveniently packaged in a compact box (approximately 5”x4”x4”), ensuring they require minimal storage space.
What sample types can be used?
Syphilis Health Check™ tests can be used with the following sample types: fingerstick whole blood, venous whole blood, serum, or plasma. Always refer to the package insert for full instructions on how to test with each sample type.
In what settings does Syphilis Health Check™ provide the most value?
Syphilis Health Check™ tests are ideal for use in sexual health clinics, emergency departments, prenatal clinics, pharmacies, mobile testing units, and community health outreach programs, especially those serving at-risk populations.
Test Procedure
How is Syphilis Health Check™ performed?
The fingerstick procedure is a popular method due to its simplicity and quick results. This process includes two simple steps:
Step 1. Collect the sample: Use a fingerstick to obtain the sample.
Step 2. Run the test: Add the sample and buffer drops into the sample well.
Results are ready to be read in just ten minutes – no readers required.
For more details on the fingerstick procedure, you can check out our training video or our Quick Reference Guide. For full details on procedures using all specimen types, view our Package Insert here.
How long does it take to run a test?
Syphilis Health Check™ tests deliver results in just 10 minutes. This rapid turnaround facilitates immediate counseling and enables prompt initiation of follow-up care or interventions promoting safe sexual health practices based on the test outcomes.
How does the test work?
Syphilis Health Check™ detects antibodies in the blood sample to a Treponema pallidum infection by using highly specific antigens coated on the strip that are bound by these antibodies. When bound, they accumulate on a test strip, producing a visible red/rose colored line produced by a protein-colloidal gold conjugate that binds to the antibodies as they migrate down the test strip.
How is the test read?
Syphilis Health Check™ tests offer a visual read feature, allowing providers to easily interpret the results by observing the presence or absence of a test line on the device strip. There’s no need for additional readers or digital devices. This straightforward approach allows for the test to be easily used in a wide range of settings, from clinical to field environments, providing immediate indication of a potential syphilis infection.
Performance and Result Interpretation
Syphilis Health Check tests offer a visual read feature, allowing providers to easily interpret the results by observing the presence or absence of lines on the test device.
Positive
If a line of any intensity appears next to the “T” in the results window and there is a second line next to the “C”, this indicates a reactive result that is interpreted as positive for syphilis antibodies.
Negative
If a line appears next to the “C” in the results window and there are no lines next to the “T”, this indicates a non-reactive result that is interpreted as negative for syphilis antibodies.
Invalid
If there is no line next to the “C” in the results window, whether or not there is a line in the “T” test area, the test is invalid and cannot be interpreted. In this case, repeat the test with a fresh specimen using a fresh device. Contact Diagnostic Direct Technical Services at 866-358-9282 if you cannot produce a valid result upon repeat testing.
IMPORTANT: The intensity of the lines does not matter. If there is any detection of a line, even faint, it should be recognized.
Syphilis Health Check has a sensitivity of 98.0% and a specificity 97.2%. The test detects both IgM and IgG antibodies to Treponemal antigens.
Syphilis Health Check can detect positive cases as early as 1–2 weeks post-exposure, depending on the antibody development of the individual.
Syphilis Health Check detects both IgM and IgG antibodies to Treponema pallidum, providing comprehensive detection capabilities.
Antibody development varies by individual, which can impact the detection timeline. Some individuals may produce antibodies at a faster or slower rate. The body produces two types of antibodies in response to Treponema pallidum:
• IgM antibodies: Typically produced around 2 weeks after exposure and can be detected by Syphilis Health Check.
• IgG antibodies: Generally produced about 4 weeks post-exposure and are also detectable by the test.
Can the test be used as a screening test and/or a confirmatory test?
Yes, Syphilis Health Check fits seamlessly into the CDC’s recommended testing algorithm and can be used to screen and confirm cases.
The algorithm advocates for a combination of both treponemal and non-treponemal tests to improve diagnostic accuracy. The CDC recommends that a positive result from a screening test (treponemal or non-treponemal) should be followed up with additional testing using the alternative type (non-treponemal if the initial test was treponemal and vice versa) to confirm a diagnosis of syphilis.
According to the CDC, treponemal tests like Syphilis Health Check can be utilized in two distinct capacities within the syphilis testing algorithm:
As a Screening Tool: As an initial screening device to identify individuals who have been exposed to syphilis. Screening with a treponemal test is particularly useful in settings where rapid, on-site testing is needed and can significantly enhance early detection rates.
As Part of a Confirmatory Strategy: In instances where a non-treponemal test (e.g., RPR) has already been conducted and returned positive, the Syphilis Health Check can be used to confirm the presence of treponemal antibodies, thereby supporting the initial findings.
What is the difference between Treponemal tests and RPR (non-treponemal) tests?
Treponemal tests, such as Syphilis Health Check, detect antibodies specific to the Treponema pallidum bacterium, the cause of syphilis. These tests can indicate a past or present infection but don’t differentiate between active and treated infections. Once positive, treponemal test results typically remain positive for life, even after successful treatment.
RPR (Rapid Plasma Reagin), or non-treponemal tests, measure antibodies produced in response to the cellular damage caused by syphilis. Non-treponemal tests are primarily used to screen for active infections and monitor treatment effectiveness, as the antibody levels tend to decrease with successful treatment. They can fluctuate over time and may return to non-reactive status post-treatment or in late-stage syphilis.
The Centers for Disease Control and Prevention recommends using a combination of both treponemal and non-treponemal tests as part of the testing algorithms to accurately diagnose syphilis.
Training and Implementation Support
Yes, we offer training options to ensure efficient use of Syphilis Health Check. Below are some of the ways you can receive training;
On-Demand Training Course: Complete our on-demand Syphilis Health Check Training Course here and receive a proficiency certificate once completed. Available 24/7, this option is a robust introduction or a great refresher.
Live Trainings: For interactive learning, we can arrange a live Zoom session with one of our experts for deeper insights into Syphilis Health Check™ and testing protocols, allowing for immediate feedback and discussions.
The Training Hub: We’ve launched a comprehensive resource center featuring guides, articles, and the latest in syphilis and STI management. Visit our Resource Center here.
Our training programs are tailored to equip healthcare providers with the knowledge and skills needed for effective syphilis screening and management.
Yes. A detailed Implementation Protocol is available and can be downloaded by clicking here. It’s a comprehensive template developed to support programs in integrating or expanding Syphilis Health Check™ point-of-care testing. Additional training materials, quick reference guides, and quality control templates are also available through our Resource Center here.
Once you’ve successfully completed your on-demand training and passed the final quiz, a pop-up will appear at the top right hand corner of your browser screen. You can click and view it then.
When that pop-up disappears, or you want to re-download your certificate, please follow these steps:
1. Hover over “Resources”
2. Hover over “Syphilis Health Check On-Demand Training”
3. Click “On-Demand Training Account and Certificate”
4. Enter your login details and click “Login”
5. Your “Dashboard” will now be visible
6. Click “My Certificates”
7. Click your on-demand training certificate
8. Click “Print”
9. Set your print destination to “Save as PDF” and save to your computer
*Please note you must be logged in to access your certificate.
To rewatch the Syphilis Health Check On-Demand Training video again, please follow these steps:
1. Hover over “Resources”
2. Hover over “Syphilis Health Check On-Demand Training”
3. Click “On-Demand Training Account and Certificate”
4. Enter your login details and click “Login”
5. Scroll to the bottom the page (under “My Memberships”) where you will see a line that reads “Rewatch the Syphilis Health Check On-Demand Training Video here!”
6. Click on that text and you’ll be brought back to the video to re-watch.
*Please note you must be logged in to access the video – otherwise it will just bring you to the sign-up page.
We offer in-person events at conferences and other meetings from time to time. To find out when and where we’ll be, subscribe to our mailing list here so you never miss an event.
To request live or hands-on training, please complete this Training Request form here or email info@diagnosticsdirect2u.com with your organization name, location, and training needs. A member of our team will follow up to coordinate scheduling and details.
Regulatory and Reporting Requirements
Yes, Diagnostics Direct, LLC, received 510(k) clearance for the Syphilis Health Check product from the FDA on August 11th, 2011.
Yes, the test is CLIA-Waived for use with fingerstick Whole Blood. For venous whole blood, serum, and plasma it is CLIA-Moderate Complexity.
Instructions for applying for a CLIA certificate are available on the Centers for Medicare & Medicaid Services (CMS) website. Please visit the official CLIA application page here for detailed guidance and forms.
Use LOINC code 47236-5 (T pallidum IgG+IgM SerPl Ql IA) to identify Syphilis Health Check tests.
As per The Centers for Disease Control and Prevention, “all 50 states require that syphilis cases be reported to the state or local public health agency so that it can take action to find and treat exposed persons.” For the most current testing requirements, refer directly to the CDC or other authoritative sources.
Storage Information
Syphilis Health Check tests have a shelf life of 30 months (2.5 years) from the date of manufacture.
For proper storage of Syphilis Health Check, please follow the below guidelines:
Storage temperature: 4°C to 30°C
Operating temperature: 15°C to 30°C
At no point should the tests be exposed to extreme heat or extreme cold. Extreme temperatures can compromise the test’s accuracy, potentially leading to unreliable results.
External controls should be stored refrigerated at 2°C to 8°C (36°F to 46°F).
Quality Controls
Two types of controls are used to ensure accuracy and reliability of test results: onboard controls and external controls.
Onboard controls are built into each Syphilis Health Check test. They confirm the test reagents are functioning correctly and that the test has been performed properly. When a test is completed correctly and is functioning properly, a line will appear next to the “C” (which stands for “Control”) in the results window.
External controls are used with a test device to verify the its ability to accurately identify the presence or absence of syphilis antibodies. Controls are sold as a set with one positive and one negative reagent. The positive control is designed to yield a positive result, the negative control will yield a negative result. Controls should be run as an unknown patient sample.
External controls should be run according to your organization’s standard quality control procedures. Some examples of when you should run an external control would be;
Each time you start using a new lot of tests
Each time you receive a new shipment (even if from the same lot previously received)
Each time someone new receives training, or if it has been at least 2 weeks since an individual has run a test
Monthly as a continued check on storage conditions
If problems are identified (storage, operator, or other)
These are only some examples of when you should run external controls, always refer to your operation’s QC procedure.
Yes, external controls have their own expiry date which can be found on the label of each control bottle.
Yes, temperatures can impact Syphilis Health Check external controls. Please follow the below guidelines:
Storage temperature: 2°C to 8°C (refrigerated)
Operating temperature: 15°C to 30°C.
Before using the controls, allow them to warm to room temperature, 15℃ – 30℃. Return to refrigeration after use.
View the Control Stability Study here.
You typically get about 7-10 uses out of one set of controls.
Reimbursement Information
Yes. Syphilis Health Check is a CLIA-waived test and may be eligible for reimbursement when billed with the appropriate CPT code (86780QW). Coverage and payment vary by payer, region, and setting. Please consult current coding and reimbursement guidance for your practice.
The appropriate CPT code is 86780QW.
No. External quality control runs are performed for internal quality assurance and are not billable to insurance.
Ordering and Samples
CLIA-Waived facilities can place an order by;
Phone: 866-358-9282
Online: Shop now
Have questions before ordering? Contact us, we’re here to help.
Controls are sold separately. CLIA-Waived facilities can place an order by;
Phone: 866-358-9282
Online: Shop now
Have questions before ordering? Contact us, we’re here to help.
To request samples for internal validation or evaluation purposes, please contact our team through our Sample Request Form here or by emailing info@diagnosticsdirect2u.com. A team member will follow up to confirm eligibility and next steps.