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  • About this test

  • The First To Know® Syphilis Test is a blood test for the detection of antibodies to the bacteria that cause syphilis.

    This test is for people who think they might have an illness called syphilis because they have symptoms or have been sexually active with someone who has syphilis. This test works by looking for your body’s response (antibodies) to fighting the bacteria that cause the syphilis illness. Pregnant women should also get checked for syphilis when they visit their doctor.

    If you had syphilis before, this test might detect the syphilis antibodies (test positive) even if you don’t have syphilis anymore. It’s a good idea to talk to your doctor before taking the test.

  • INTENDED USE:

  • The First To Know® Syphilis Test is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary). This test is intended for over the counter (OTC) consumer use in individuals suspected of syphilis. Positive test results with the First To Know® Syphilis Test alone are not sufficient to diagnose syphilis infection and must be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis.

    This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider.

    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.

  • Open the test kit

    Before you start, lay out everything you need for the test.

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  • Read Educational Guide

    Read the enclosed Syphilis - Be The First To Know Educational Guide before conducting the test.

  • Find watch or timer

    Make sure you have a watch or timer ready.
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  • Wear contacts or glasses if needed

    If you wear contacts or glasses, make sure that you are wearing them when you read the result.
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  • Hydrate

    Ensure you are hydrated by drinking a full glass of water prior to taking the test.
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  • Warm your hands

    It is essential to get your blood flowing before you collect. Massage your hands under warm water.
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  • Get your heart rate up

    Run in place, do some jumping jacks, or shake your hands.
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  • Open pouch

    Remove test from pouch. Do not open test pouch until you are ready to begin your test.
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  • Get familiar with the test

    Locate the Sample Application Zone.
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  • Remove cap from lancet

    Twist the gray cap of lancet 5-6 times, then pull it outward to remove. DO NOT PUSH THE RELEASE TAB YET.
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  • Sanitize finger

    Wipe the end of the selected finger with the alcohol swab provided.
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  • Prick fingertip

    Firmly press the lancet to the finger in an off-center position, then press the release tab. Try not to use the center or top of the finger, since these are the most sensitive areas.
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  • Fill test

    Massage the finger beginning at the base of the palm until a large, full drop of blood appears. 
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  • Fill test

    Touch one or more drops of blood to the Sample Application Zone until the Fill Zone is full. If you can, stand up and hang your hand below your arm for better blood flow.
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  • Apply bandage

    Quickly put on the adhesive bandage.
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  • Tap test twice

    Hold the Sample Application Zone facing up and tap the opposite end of the test twice on a hard surface. Then, lay the test on the flat surface. 
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  • Set a timer

    Set a timer for 15 minutes.
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  • Read test result

    Read the result after 15 minutes and before 30 minutes.
  • If you see two lines, the test result is positive. One line may be lighter; they do not have to match. 

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  • Throw away test

    All used test components should be disposed of in your household waste.
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  • 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.

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