Can I use Fingerstick or Venous Whole blood, Serum or Plasma?
The test will work with all four. Please refer to the package insert for instructions on how to test with whichever medium is used.
Can Syphilis Health Check™ be used as a screening device and a confirmatory device?
Yes. As long as you are following the CDC algorithm for testing, you can use Syphilis Health Check as an initial screen OR to confirm against an already run Non-treponemal test.
Does temperature affect the test?
Yes – Extreme Heat and Extreme cold can affect the results of the test. Tests are to be run between 4-30 Celsius (39 – 86 Fahrenheit).
How accurate is the test?
The positive percent agreement was 94.9% for nontreponemal tests and 98.2% for treponemal tests. The positive percent agreement is the sensitivity of the test in detecting syphilis.
How long does it take to run the test?
Once the sample and diluent have been added to the sample well the results can be read after 10 minutes but not after 15 minutes.
How many steps are involved in running the test?
After acquiring the sample (e.g., fingerstick whole blood), the test can be run in 4 easy steps. Adding the sample to the sample well. Adding the diluent to the sample well. Setting a timer. And finally reading the result.
How many tests come in a box?
There are 20 tests in each box.
How should Syphilis Health Check™ be used?
CLIA waived settings should use finger stick whole blood. In Moderately Complex or High Complexity CLIA settings you can use use venous whole blood, serum or plasma samples.
How soon can Syphilis Health Check™ detect a positive post exposure?
Syphilis Health Check has been able to detect positives as early as 10 days post exposure. Best results for screening and confirming patients is between 30-60 days post exposure.
What are reporting requirements for Syphilis Health Check™ results?
If a patient tests positive using the Syphilis Health Check, additional blood draw may be required for further non-treponemal testing (e.g. RPR tests). All positive Syphilis Health Check results should be reported to the CDC and state health departments as required by each state.
What is the difference between Treponemal and RPR (Non-treponemal)?
In layman terms, testing using RPR looks to see if Syphilis is active in your system. Treponemal will determine if you have ever had Syphilis whether it is active or dormant.
What is the price?
$200.00 per box of 20 / $10.00 per test.
What settings should be targeted for use of Syphilis Health Check™?
CLIA waived facilities such as but not limited to clinical settings such as emergency departments or urgent care centers, sexually transmitted disease (STD) clinics, HIV clinics, family planning clinics, practices providing prenatal care, outreach settings, health fairs, etc.
Who can be tested with Syphilis Health Check™?
Any individual ages 13 years and older can be tested wit the Syphilis Health Check. It can be used as an initial screening test or in conjunction with a non-treponemal laboratory test (e.g., RPR) and clinical findings to aid the diagnosis of syphilis infection.
Who can perform Syphilis Health Check™?
This whole blood fingerstick test can be performed in CLIA waived facilities by individuals that have minimally reviewed 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 venous whole blood, plasma and serum samples are used for analysis, the testing needs to be performed in a moderate complexity or high complexity laboratory.
Who should NOT be tested with Syphilis Health Check™?
This test is not is not for individuals less than 13 years or old. A positive result using this device could be indicative of a past treated infection or a latent infection. A positive results is not diagnostic of syphilis without additional nontreponemal testing (e.g., RPR testing).