Syphilis Rapid Test

Intended Use

Syphilis Rapid Test (Whole blood/Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of antibodies to Treponema pallidum in human whole blood, serum and plasma specimens. Syphilis Rapid Test may be used as an aid in the diagnosis of syphilis. A reactive result should be confirmed by other supplemental assay(s).

Introduction

Treponema Pallidum(TP), a spirochete bacterium with an outer envelope and a cytoplasmic membrane, is the causative agent of the venereal disease syphilis. Although syphilis rates are declining in the United States after an epidemic between 1986 and 1990, but there are still the incidence of syphilis in Europe has increased since 1992.

The serological detection of specific antibodies to TP has been long recognized in the diagnosis of syphilis since the natural course of the infection is characterized by periods without clinical manifestations. The antibody response to TP can be detected within 4 to 7 days after the syphilis chancre appears, allowing early detection and diagnosis of syphilis infection.

Advantages

Product information

Test Procedure

Bring the test device, buffer and specimen to room temperature (15-30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID.

For venous whole blood specimens:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 µL) to the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For fingerstick whole blood specimens:

Dispense 2 drops of fingerstick whole blood onto the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For serum or plasma specimens:

Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 µL) to the sample well (S) of the test device, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

3. Wait for the colored band to appear. Read results at 10 minutes.

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