Check4® Syphilis

Check4® Syphilis (26084AG) is a quick, accurate and easy-to-use self test for the detection of a syphilis infection. Quick, accurate and easy-to-use self-test that can performed in the comfort of your own home.

Description

Quick, accurate and easy-to-use self-test that can performed in the comfort of your own home.

Syphilis is a venereal disease that progresses through distinct stages of infection: primary, secondary, tertiary and quaternary. These stages produce diverse clinical symptoms, typically producing initial sores known as chancres then syphilitic rash followed by long periods of dormancy. Untreated infection eventually leads to cardiovascular problems and neurosyphilis.

Caused by spirochaete Treponema pallidum (TP), the infection is usually acquired by sexual contact, although the disease may be transmitted by transfusion of infected blood. Intrauterine infection also occurs. The organism has proved virtually impossible to culture in artificial media, and diagnosis of the infection usually depends on the detection of antibodies in the blood, which appear soon after initial infection.

Check4® Syphilis is a highly specific immunological rapid test for the detection of anti-TP antibodies with a fingerprick whole blood sample.

The box contains the material necessary to perform a test:

  • 1 sealed aluminium pouch containing: 1 test device, 1 plastic pipette and 1 desiccant bag.
  • 1 sterile lancet for blood sampling.
  • 1 dropper bottle containing 1 ml of diluent.
  • 1 instruction leaflet.

All our Check4® range of self-test products are:

  • CE-Marked for home self-test use
  • Made and Evaluated in France
  • Easy-to-use and easy to read results
  • Accurate and trust worthy
  • Quick with results in a matter of minutes

Product Specification

Specification Type Specification Value
Product Range Self-Tests
Product Code 26084AG
Product Name Check4® Syphilis
Product Category Infection Health Tests
Product Analyte TP
Product Size 1 x 1 Test
Product Storage 2°C to 30°C

When present in the body, TP induce the production of specific antibodies by the immune system. These circulating antibodies are able to recognize the spirochaete and to stick on them. The TP antigens coated on the Check4® Syphilis strip specifically detect those antibodies by producing a coloured line under the T mark of the cassette when the level of anti-TP antibodies is greater than 0.1IU/mL (determined against W.H.O.* reference) indicating the presence of TP spirochaete. A control line capturing the reagent excess appears as a coloured line under the C mark of the cassette.

*World Health Organization

The Check4® Syphilis test should be performed in case of appearance of clinical symptoms, the main ones being chancres and specific rash. The test can be performed at anytime of the day.

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if the Check4® Syphilis test gets wet before test performing or if the quantity of blood added to the sample well is not correct. The pipette provided in the box allows making sure the collected blood volume is correct. Very early stage of the infection could also lead to negative results due to the low concentration of anti TP antibodies in blood.

The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the colour intensity of the test lines.

When this line appears, it only means that the test was performing well.

No. The test should be read within 10 minutes after adding the diluent. The result is reliable up to 15 minutes.

If the result is positive, it means that anti-TP antibodies are present in blood and that you should consult a doctor to show the test results. Then, the doctor will decide whether additional investigation should be performed.

If the result is negative, it means that the test could not detect anti-TP antibodies in blood sample. Meanwhile it is recommended to consult a doctor if symptoms persist.

The Check4® Syphilis test is accurate and has been used for more than 15 years by professionals in the field. Evaluation reports show an overall agreement higher than 97% [96.1 – 98.3 %**] with reference methods. Although this test is reliable, false positive or false negative results could be obtained. This is especially true for patients being sero positive for herpes simplex virus (HSV), cytomegalo viruses (CMV) and heterophilic antibodies which may show false positive results when using the Check4® Syphilis test.

** 95% confidence interval.

For more information on syphilis you can visit the below:

  • https://www.nhs.uk/conditions/syphilis/
  • https://www.shl.uk/about-stis/syphilis