Syphilis Rapid Test (1 pc/box)

Syphilis Rapid Test (1 test/box)

The Syphilis Rapid Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of antibodies against Treponema pallidum in human whole blood, serum, or plasma samples. This test serves as an aid in the presumptive diagnosis of syphilis infection. Results should be confirmed with additional complementary testing.

Syphilis, also known as lues or “the great imitator,” is a chronic, sexually transmitted infectious disease caused by the spirochete bacterium Treponema pallidum. Transmission occurs primarily through sexual contact, but vertical transmission from mother to fetus during pregnancy or childbirth is also possible. The disease progresses through four stages—primary, secondary, latent, and tertiary—each with distinct clinical manifestations. Latent syphilis may persist for years with minimal or no symptoms.

Syphilis is a notifiable disease in many countries, including Canada, the European Union, and the United States. Early diagnosis is critical to prevent complications affecting the heart, brain, and other organs. Clinical diagnosis in early stages can be challenging and usually requires serological and microscopic examinations. For professional use.

Syphilis Rapid Test Specifications

Product Name: Syphilis Rapid Test

Sample Type: Whole blood / serum / plasma

Packaging: 1 test/box

Test Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No. 1418, Moganshan Road, Hangzhou, Zhejiang, China

EC REP: Lotus NL B.V., Koningin Julianaplein 10, Le Verd, 2595AA, The Hague, Netherlands

Expiration Date: 2026.09

Syphilis Rapid Test Kit Contents

• 1 test cassette

• 1 disposable dropper

• 1 buffer solution

• 1 lancet for finger prick

• 1 instruction leaflet in English

Lancet Usage Instructions

1. Remove the yellow, single-use lancet from the packaging.

2. Take off the transparent protective cap.

3. Press firmly against the fingertip; the lancet will automatically deploy.

4. Dispose of the lancet in an appropriate sharps container.

Testing Procedure

Read the Instructions for Use carefully before performing the test. Allow the test device, buffer, and specimen to reach room temperature (15°C-30°C) before testing.

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with patient or control identification. Perform the test within one hour after opening for optimal results.
2. For venous whole blood: Using the dropper, add 2 drops of blood (~50 μl) into the sample well (S), then add 1 drop of buffer (~40 μl) and start the timer.
3. For capillary whole blood (finger prick): Add 2 drops of blood into the sample well (S), then add 1 drop of buffer and start the timer.
4. For serum or plasma: Add 3 drops (~75 μl) of serum or plasma into the sample well (S). Avoid air bubbles and do not add buffer.
5. Wait for the colored lines to appear. Read results after 10 minutes. Do not interpret results after 20 minutes.

Result Interpretation

• Positive: Two colored lines appear - one in the control region (C) and one in the test region (T).

• Negative: Only one colored line appears in the control region (C). No line appears in the test region (T).

• Invalid: No line appears in the control region (C). The test is invalid and should be repeated with a new test device.

Performance

Analytical sensitivity determined according to WHO International Standard for human syphilis plasma IgG and IgG+IgM:

• Relative sensitivity: 99.6%

• Relative specificity: 99.1%

• Overall agreement: 99.3%

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions