Directions for use

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour. Place the cassette on a clean and level surface.

For Serum or Plasma specimen

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40µL) to the specimen area, then add 1 drop of buffer (approximately 40µL),and start the timer.

For Venipuncture Whole Bloodspecimen

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80µL) to the specimen area, then add 1 drop of buffer (approximately 40µL), and start the timer

For Fingerstick Whole Bloodspecimen

To use a capillary tube: Fill the capillary tube and transfer approximately 80µL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40µL) and start the timer.

Reading the results

Wait for the coloured line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.

Interpretation of results

POSITIVE:*Two lines appear. One coloured line should be in the control line region (C) and another apparent coloured line should be in the test line region (T). The intensity of the colour in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of colour in the test line region (T) should be considered positive. NEGATIVE: One coloured line appears in the control line region (C). No line appears in the test line region (T). INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test

About Syphilis

Syphilis is a systemic disease caused by Treponema Pallidum. 1

The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, and tertiary).2 Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.4

Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.

How many tests are in a box?

There are 40 tests in a box

Test Cassettes
Buffer
Dropper
IFU

Syphilis Rapid Test Cassette

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