Important Information
Warnings & Precautions
• Syphilis must be treated by a doctor to be cured. Treatment for syphilis infection requires a prescription for antibiotics.
• Please check the expiration date before you use the kit. Do not use this kit after its expiration date to avoid the risk of incorrect result.
• To prevent contamination, leave the test device in pouch until you are ready to use it.
• If you have a condition that makes it difficult to use the test (e.g., problems with vision,handling the test components, or understanding test instructions or results), please contact a healthcare provider for testing.
• Do not use this test if it has been stored outside the acceptable temperature of 59°F-86°F (15°C-30°C). Do not freeze.
• Use only the components included in this single use kit for performing the test. Do not use the kit if any of the components are missing or damaged.
• Dispose of the used and leftover kit contents in household trash.
• This kit contains small parts as well as single-use lancets used to pierce the skin. Keep kit components out of reach of children.
• Please discuss any symptoms that you are experiencing with a healthcare provider.
• Do not read the result after 30 minutes. An incorrect result may be obtained from reading a result before 15 minutes or after 30 minutes.
Limitations
• Results of testing with the First To Know® Syphilis Test will likely be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. The First To Know® Syphilis Test cannot determine whether there has been re-infection with syphilis, and testing must be performed by a healthcare provider to detect syphilis re-infection.
• A positive test result does not preclude the possibility of co-infection with additional pathogens.
• A negative test result does not preclude the possibility of infection with syphilis or other bacteria or viruses.
• The First To Know® Syphilis Test is not intended to replace routine healthcare during pregnancy regardless of test results. Testing for syphilis should be performed by a healthcare provider for women who are known to be pregnant or if pregnancy is suspected.
• The test is not a substitute for visits to a healthcare provider. The result obtained with this test should not be used to start, stop, or change any course of treatment unless advised by a healthcare provider.
• The First To Know® Syphilis Test is for fingerstick capillary blood only.
• Anti-Epstein Barr Virus (EBV) and Rheumatoid Factor positive (RF+) showed cross reactivity with 1 out of 10 samples.
• Gamma-globulin may cause invalid results at concentrations at 60 mg/mL or greater.
• Accurate results are dependent on adequate product storage and adherence to the specimen collection and testing procedures. Failure to follow test procedures can lead to incorrect results.
• Anyone with recent sexual contact with a person known to have a sexually transmitted infection, should visit a healthcare provider for treatment and evaluation as soon as possible (https://www.cdc.gov/std/treatment-guidelines/syphilis.htm).
Common Questions & Answers
General Syphilis Questions & Answers
1. What’s syphilis?
Syphilis is a type of infection that spreads through sex. It starts with a small sore around private parts or in the mouth. Even if you don’t see any sores, you can still spread it to others. There are other infections like chlamydia and gonorrhea that can look like syphilis, but they are caused by different bacteria and may require other testing and/or treatment.
2. What are the symptoms of syphilis?
Infected people may experience painless ulcers, sores, vaginal discharge or wart-like growths on genitals, rectum or mouth. People may also experience rashes, small bumps or ulcers on their skin, palms or soles. Additional common symptoms include fatigue, itching, sore throat, swollen lymph nodes, weight loss, or rectal lining inflammation.
3. What puts me at risk for syphilis?
Risk of syphilis results from unprotected sexual contact with one or multiple partners who is/are currently infected with syphilis. It is possible for a person to be infected with syphilis without having symptoms (i.e.; “asymptomatic”) and still transmit the infection to another.
4. How can I protect myself from being infected with syphilis?
If you are sexually active, doing the following can lower your chances of getting syphilis: (1) being in a long-term, mutually monogamous relationship with a partner who has been tested and has negative STD test results, or (2) using latex condoms the right way every time you have sex.
5. When should I test for syphilis?
If you’re sexually active and have symptoms or have had unprotected sex, you should get tested.
First To Know® Test Questions & Answers
1. How soon after a risk event can I test myself?
Most people develop antibodies between 10 days and 3 weeks after symptoms appear.
2. What does the test do?
The test looks for specific antibodies in your blood. Those antibodies are created by your immune system in response to the bacteria that cause syphilis. People infected with syphilis and people who have recovered from past syphilis infections have those antibodies.
3. Who should use this test?
Anyone who thinks they might have syphilis due to symptoms or having unprotected sex with someone who has syphilis.
4. How many drops of blood will it take to fill the test?
Most tests fill with 1-3 drops of blood.
5. The drop of blood is still not enough to refill the test. What should I do?
If you still do not get enough blood to fill the Fill Zone, you can use the extra lancet that is provided to prick a second finger. A different finger is recommended.
6. Why do I need to tap the test twice?
Tapping the test twice ensures the blood flows into the test and removes any air bubbles.
First To Know® Results Questions & Answers
1. How quickly will I get my result?
Test results are available in 15 minutes and up to 30 minutes after taking the test.
2. What does a positive result mean?
It means the test detected antibodies to the syphilis bacteria in the blood sample. You might have syphilis now or had it before.
3. What should I do if I get a positive result?
See your doctor to confirm the result. If you can’t see a doctor, contact your local health department (https://www.naccho.org/membership/lhd-directory). Treatment for syphilis infection is available but requires a consultation with a healthcare provider. Avoid sexual contact with others until after you have consulted with a doctor. You should notify anyone you have had sex with in the last 60 days (2 months) before receiving a positive test result or before your symptoms started. If you haven’t had sex in the last 60 days, you should notify your most recent partner.
4. What does a negative result mean?
It means the test did not detect antibodies to syphilis bacteria in the blood sample. There are a number of reasons your test may be negative:
1. You are not infected with syphilis;
2. You have been recently exposed/infected and tested too early to detect the antibodies in your blood;
3. You have a different sexually transmitted infection that is not syphilis.
5. What should I do if I get a negative result?
See your healthcare provider if you still have symptoms. It is possible you tested too early or have a different sexually transmitted infection.
6. My test result is negative but I think I have been exposed. What should I do?
See your healthcare provider about your concern. Only a doctor can diagnose and treat syphilis or a sexually transmitted infection.
7. When should I retest?
If you still think you have syphilis after a negative result, you can test again 10 days after symptoms show or 90 days after you were sexually active with someone that you believe had syphilis.
8. What should I do if the result is invalid?
If you get an invalid result, please call our toll-free number at 1-844-207-3370.
9. How accurate is this test?
A multi-site clinical study was conducted from September 1, 2021, to October 17, 2023, at six geographically diverse sites across the US. In this study, the First To Know® Syphilis Test was used by 1270 people, with results compared to a combination of three FDA-cleared tests. The First To Know® Syphilis Test correctly identified 93.4% of positive specimens (99 out of 106) and 99.5% of negative specimens (1158 out of 1164). Visit www.firsttoknow.com for more information.
10. Other questions?
Contact us toll-free at 1-844-207-3370 or go to www.firsttoknow.com for more information.
Further Guidance
There is a possibility that you might have other infections such as chlamydia, gonorrhea, or HIV. These can be serious and need treatment, even if you feel okay. See your healthcare provider for further testing.