Syphilis Rapid Test (1 pc/box)

• Every order is shipped carefully sealed, in 100% discreet packaging with a neutral sender name.

• The price includes 5% VAT.

• The product can be ordered for professional use.

Syphilis rapid test

The syphilis rapid test (whole blood/serum/plasma) is an in vitro diagnostic immunochromatographic rapid test for the qualitative detection of antibodies to Treponema pallidum in human whole blood, serum and plasma samples. The product can be used as an aid in the diagnosis of syphilis. The result obtained must be confirmed by other supplementary tests.

Syphilis is a chronic, infectious sexually transmitted disease. Its causative agent is the spirochete bacterium Treponema pallidum subspecies pallidum. The infection is spread primarily through sexual contact, but a mother can also infect the fetus during pregnancy or during childbirth. Syphilis is divided into four stages (primary, secondary, latent and tertiary), and its signs and symptoms vary depending on the stage. In latent syphilis, which can last for years, few symptoms occur, or the infected person may even be completely asymptomatic.

Syphilis is a notifiable disease in many countries, including Canada, the European Union and the United States. Syphilis is difficult to diagnose clinically in the early stage of the disease. Diagnosis is made by blood test, or by direct visual examination and microscopic examination. The product can be ordered for professional use.

Syphilis rapid test specification

Product name: Syphilis rapid test
Sample: whole blood/serum/plasma
Packaging: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
Expiry date: 31/03/2028

Contents of the Syphilis rapid test kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 instructions for use in Hungarian

How to use the fingertip lancet

1. Take the yellow single-use fingertip lancet out of the packaging. Remove the transparent cap.
   
   
2. Press it against your fingertip. The needle will be ejected automatically.
   
   
3. After use, dispose of the lancet in the waste bin.
   
   

The visual aid is intended for healthcare professionals only. The product is not intended for self-testing.

Test procedure

Read the instructions for use carefully before performing the test! Collect the sample as described in the instructions for use.

Before use, allow the test, the buffer and the sample to reach room temperature (15°C–30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, level surface! Label the test with the patient or control identifier! For best results, the assay should be performed within one hour of opening.
2. Place the test device on a clean, level surface! Label it with the sample identifier!
3. For venous whole blood samples: Hold the dropper vertically and dispense 2 drops of blood (approx. 50 μl) into the sample well (S) of the test device, then add 1 drop of buffer (approx. 40 μl) and start the timer!
4. For fingertip whole blood samples: Dispense 2 drops of fingertip blood into the sample well (S) of the test device, then add 1 drop of buffer (approx. 40 μl) and start the timer!
5. For serum or plasma samples: Hold the dropper vertically and dispense 3 drops of serum or plasma (approx. 75 μl) into the sample well (S) of the test device, then start the timer! Avoid trapping air bubbles in the sample well (S), and do not add any solution to the result area!
6. Wait for the colored line to appear. The result should be read at 10 minutes.

Interpretation of results

• Positive: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test region (T).
• Negative: Only one colored line appears in the control region (C). No visible colored line appears in the test region (T).
• Invalid: No line is visible in the control region. Any test result in which no line is visible in the control region within the specified reading time must be considered invalid. Please repeat the test with a new test! If the problem persists, contact your local distributor!

Performance of the Syphilis rapid test

The analytical sensitivity of the syphilis rapid test was determined based on the 1st WHO International Standard for human syphilis plasma IgG (NIBSC code 05/122) and IgG+IgM (NIBSC code 05/132).

• Relative sensitivity: 99.6%
• Relative specificity: 99.1%
• Overall agreement: 99.3%

The test may only be used by competent professional staff and healthcare professionals! Carbon Web Kft. accepts no liability for its use for self-testing purposes.

ATTENTION!
Under Hungarian Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in respect of e) a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's competence; its liability is limited solely to information on intended use and to the goods delivered.