Syphilis test

Information about the Syphilis test Syph-Check-1®

Syphilis test is a certified diagnostic medical device for testing at home.

Syphilis test enables to screen the infection with bacteria Treponema pallidum by detecting the presence of specific antibodies against the bacteria T. pallidum in whole blood.

Testing with this syphilis test is straightforward and discreet. You carry out the analysis in three steps:

1. withdraw blood from a fingertip,
2. add the blood and buffer to the testing device,
3. wait 10 minutes for the result.

Individuals usually need 5-10 minutes to complete the syphilis test at home. Above that, there is an additional 10-minute waiting time for the result to appear.

The test is manufactured in France and is ISO 13485 compliant and CE certified by Notification body 0483¹. The test is very accurate. In clinical trials, it showed a correct result in 97.6% cases.

In 2014 the test became the first and only rapid home test for the detection of Treponema pallidum antibodies certified by the U.S Food and Drug Administration.

The syphilis testing kit includes all required accessories to carry out the analysis at home, discreetly, and it comes with easy-to-follow instructions for use.

Syphilis test also comes with the Sanotest Quality Guarantee and will be replaced to you free of charge in case you were not able to obtain the result.

About syphilis, a sexually transmitted disease

Syphilis is a sexually transmitted disease with bacteria Treponema pallidum. Untreated disease can cause severe health complications and even death.

The infection is commonly transmitted through vaginal, oral or anal intercourse (acquired syphilis) and from a pregnant women to a child (congenital syphilis). A syphilis disease progresses through four stages of the disease – primary, secondary, latent and tertiary syphilis.

Primary syphilis

Within the first few hours or days after an infection, bacteria Treponema pallidum enter the bloodstream and spread throughout the body. In pregnant women, bacteria also infect the fetus.²

A markable sign of a primary syphilis is chancre. A chancre is an ulceration that occurs at the site where Treponema pallidum entered the body. A chancre is painless and can be easily left unnoticed.³

In men, a chancre most commonly occurs on the penis and in women on the labia, fourchette or cervix. It can also appear on the lips, mouth, anus or any other parts of the body.²

Primary syphilis is mostly diagnosed with men. Because chancre is not seen and often painless, syphilis in women is usually not diagnosed until the second stage of syphilis.²

Secondary syphilis

Within a few weeks or months after an infection, a secondary syphilis develops.

Secondary syphilis is typically a systemic disease, with the patient often presenting with a variety of symptoms, such as malaise, sore throat, headache, weight loss, low-grade fever, pruritus, and muscle aches, in addition to the dermatologic manifestations.⁴

Symptoms of secondary syphilis repeat in approximately 25% of patients. After two years after an infection, syphilis progresses into a latent phase.⁵

Latent syphilis

In the latent phase of syphilis, there are usually no signs or symptoms. Syphilis is asymptomatic.

Once in the latent state, the Treponema pallidum can survive for years in untreated individuals, establishing niduses of inflammation in skin, bones, the thoracic aorta, the posterior uveal tract and the central nervous system, that set the stage for recrudescent disease — collectively referred to as tertiary syphilis.⁶

Tertiary syphilis

Tertiary syphilis is rare nowadays. It can develop in untreated individuals long time after an initial infection.

Signs and symptoms can occur 5 to 15 years after an infection.² The main manifestations of tertiary syphilis are neurological disease (neurosyphilis), cardiovascular disease (cardiosyphilis) and gummatous lesions (gumma).⁷

Testing for syphilis at home

During the infection with Treponema pallidum, the body’s immune system produces specific antibodies against bacteria.

Detection of antibodies against Treponema pallidum is the primary tool in the screening and diagnosis of syphilis.²

Most commonly, syphilis is diagnosed by testing the blood (syphilis serology test). Mainly, medical laboratories carry out such analysis. But preventively, you can check the syphilis infection also by yourself at home.

The main advantage of this syphilis test is that you can perform the analysis at home, discreetly. You obtain the result in 10 minutes, and nobody will know you did the syphilis test.

You can test yourself at home also for Chlamydia and Trichomonas.

When to get tested for syphilis?

Syphilis is often overlooked. Individuals with syphilis are often not even aware they are infected. Therefore they can spread the disease to others.

Experts recommend regular testing for syphilis, especially to individuals who are at higher risk of acquiring a sexually transmitted disease⁸:

• individuals who have sex with unknown people (condom is not 100 % protection),
• men who have sex with men,
• individuals already infected with any of the sexually transmitted infections,
• individuals who suspect that risky sexual behaviour could lead to an infection.

How accurate is the syphilis test?

The syphilis test is very accurate and has been used for more than 15 years by professionals in the field. In clinical trials, the test showed a correct result in 97.6% cases.

The test is manufactured in France and is ISO 13485 compliant and CE certified in Germany by Notification body 0483¹.

In 2014 the test became the first and only rapid home test for the detection of Treponema pallidum antibodies certified by the U.S Food and Drug Administration.

How to perform the syphilis test?

Testing with this syphilis test is straightforward and completely discreet. You only need to follow step-by-step instructions for use that come with the testing kit, and you will complete the analysis instantly.

The syphilis test is a serology test. You need to collect a small sample of blood from a fingertip. Accessories for blood collection come with the kit.

You carry out the analysis in three steps:

1. withdraw blood from a fingertip,
2. add the blood and buffer to the testing device,
3. wait 10 minutes for the result.

Individuals usually need 5-10 minutes to complete the syphilis test. Above that, there is an additional 10-minute waiting time for the result to appear.

You should read instructions for use before you start the testing procedure. Individuals usually do not have difficulties using the test, but in case you find it difficult, we are here to help you. Contact our customer service.

The usefulness of the results obtained with the syphilis test

Results of the syphilis test are beneficial as information about the potential infection with bacteria Treponema pallidum, which is a cause of syphilis.

Results are interpreted visually as positive, negative or invalid.

In the case of a positive result: it is highly probable that you have syphilis. No panic. Syphilis is curable with antibiotics. You should consult your doctor immediately.

In the case of a negative result: it is highly probable that you do not have syphilis. Nevertheless, monitor signs and symptoms of syphilis. If you doubt the result, you should consult your doctor.

Important notice: in the very early stage of an infection, a negative result is possible due to the absence or low concentration of antibodies in the body. Although the effect is negative, there is still possible that you are infected. Experts recommend repeating testing for syphilis 1, 2 and 6 weeks after possible initial infection (European Guideline on the Management of Syphilis).

In case of an invalid result: the Sanotest Quality Guarantee applies. Please contact us.

Limitations of the syphilis test

With many advantages of this syphilis test, there are also some limitations you should consider before ordering the test.

You should not establish a diagnosis on your own and solely based on this syphilis test.

Although the test is highly accurate, you should not establish a diagnosis and conclusions about the treatment solely based on the result of this syphilis test.

This syphilis test is for screening purposes. You should always consult your doctor for further investigation, diagnosis, and potential treatment.

The syphilis test is for single use and one person only.

You should never combine blood samples or reuse the syphilis test. Only one person should use the test. Once the analysis is complete, you cannot reuse any parts of the testing kit.

Questions and answers about the syphilis test

In the following are summarized questions individuals frequently ask us about the syphilis test. Perhaps you find the answers useful.

If you have other questions, do not hesitate to contact us. Please send us your question by email to self-testing@sanotest.co.uk

Is a delivery of a syphilis test kit discreet?

Yes, a delivery is entirely discreet. We send out the tests packaged in unmarked packaging. Nobody except you will know what is inside the package.

Can the results of the syphilis test be incorrect?

Although this syphilis test is very reliable and accurate (97,6 %), false positive or false negative results could be obtained.

To minimize the probability of the wrong result, you should carefully follow instructions for use.

When is it best to use the syphilis test?

It is best to use the syphilis test in case of appearance of clinical symptoms, the main ones being chancres and specific rash. You can perform the analysis at any time of the day.

Literature:

¹ European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).
² King K. H. et al. Sexually Transmitted Diseases, 4th Edition. The McGraw-Hill Companies Inc., 2008.
³ Centers for Disease Control and Prevention. Syphilis – CDC Fact Sheet (Detailed). Accessible at: https://www.cdc.gov/std/syphilis/stdfact-syphilis-detailed.htm (28.02.2020).
⁴ Baughn, R. E., & Musher, D. M. (2005). Secondary syphilitic lesions. Clinical microbiology reviews, 18(1), 205–216.
⁵ French P. (2007). Syphilis. BMJ (Clinical research ed.), 334(7585), 143–147.
⁶ Peeling, R. W., Mabey, D., Kamb, M. L., Chen, X. S., Radolf, J. D., & Benzaken, A. S. (2017). Syphilis. Nature reviews. Disease primers, 3, 17073.
⁷ World Health Organization (2016). WHO Guidelines for the treatment of Treponema pallidum (syphilis).
⁸ Janier M. et al. (2014). European Guideline on the Management of Syphilis. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1248.