Streptococcus A Rapid Test (1 pc/box)

Streptococcus A Rapid Test

The Streptococcus A Rapid Test provides a quick and simple solution for identifying scarlet fever and other upper respiratory infections caused by Streptococcus A, such as tonsillitis and pharyngitis, from throat swab samples. The test detects Group A Streptococcus antigens, which is a key step in diagnosing scarlet fever.

Scarlet fever is an infectious disease spread by droplet infection or direct contact, caused by toxins produced by Group A Streptococcus bacteria. It is most commonly accompanied by pharyngitis and characteristic skin rashes. Typical symptoms of scarlet fever include fever and sore throat, bright red rash often starting on the neck and face and spreading over the body, “strawberry tongue,” abdominal pain, headache, and fatigue. Scarlet fever mainly affects children but can also occur in adults.

Rapid diagnosis is crucial for treating scarlet fever, as untreated cases may lead to serious complications such as rheumatic fever or nephritis. The latest immunological techniques for direct detection of Group A Streptococcus antigen allow physicians to establish a diagnosis and start treatment immediately. This product is intended for professional use only.

Streptococcus A Rapid Test Specifications

Product name: Streptococcus A Rapid Test

Sample type: Human throat swab

Packaging: 1 test/box

Format: Cassette

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

Expiration date: 2026.05.

Contents of the Streptococcus A Rapid Test Kit

• 1 test cassette

• 1 reagent 1

• 1 reagent 2

• 1 positive control

• 1 negative control

• 1 sterile swab

• 1 extraction tube

• 1 tube holder

• 1 user manual in English

Testing Procedure

Before performing the test, carefully read the User Manual! Collect the sample as described in the instructions. Allow all devices, reagents, samples, and/or controls to reach room temperature (15°C-30°C) before use.

After sample collection:

1. Sample preparation:

• Add 4 drops of reagent 1 to the extraction tube, followed by 4 drops of reagent 2. Mix gently.

• Immediately insert the swab into the extraction tube after sample collection. Rotate the swab in circular motions, then press it against the tube wall to release the sample into the solution.

• Let stand at room temperature for 1–2 minutes, then firmly press the swab against the tube wall to extract as much liquid as possible. Dispose of the swab according to biohazard regulations.

2. Remove the test cassette from its sealed pouch and place it on a clean, flat surface. Mark the cassette with the patient’s name or control ID. For best results, perform the test within one hour.

3. Add 3 drops (approx. 120 μL) of the prepared sample solution into the sample well (S) of the test cassette. Avoid air bubbles in the well and ensure the solution does not touch the result window. Once the test starts, the color will migrate across the membrane.

4. Wait for the colored band(s) to appear. Read the result within 5 minutes. Results read after 10 minutes are invalid.

Result Interpretation

• Positive: Two distinct red lines appear. One line in the control region (C) and another in the test region (T). Any shade of pink to red line in the test region (T), even if faint, indicates a positive result.

• Negative: A single red line appears in the control region (C). No line appears in the test region (T).

• Invalid: Only a red line appears in the test region (T) without a control line (C), or no lines appear at all. Likely causes: insufficient sample volume or incorrect test procedure.

Performance of the Streptococcus A Rapid Test

• Relative sensitivity: 97.6%

• Relative specificity: 97.5%

• Overall agreement: 97.5%

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