Streptococcus A Rapid Test (1 pc/box)

• The product is available for professional use only.

• The product can be ordered for professional use.

Streptococcus A Rapid Test

The Streptococcus A Rapid Test is a quick and simple solution for identifying scarlet fever and other upper respiratory tract infections caused by Streptococcus A, such as tonsillitis and pharyngitis, from a throat swab. The test enables the detection of type A Streptococcus antigens, which is one of the key steps in diagnosing scarlet fever.

Scarlet fever is an infectious disease transmitted by respiratory droplets or direct contact, caused by toxins produced by group A Streptococcus bacteria. The disease is most commonly accompanied by a sore throat, together with a characteristic skin rash. Typical symptoms of scarlet fever include: fever and sore throat, bright red skin rash that often starts on the neck and face and may then spread over the entire body, strawberry tongue, abdominal pain, headache and fatigue. Scarlet fever mainly occurs in children, but adults can also contract it.

Rapid diagnosis is crucial in the treatment of scarlet fever, as untreated cases can lead to serious complications, such as rheumatic fever or kidney inflammation. The latest developments in immunological techniques for the direct detection of group A Streptococcus antigens enable physicians to establish a diagnosis and start therapy immediately. The product can be ordered for professional use.

Streptococcus A Rapid Test Specifications

Product name: Streptococcus A Rapid Test
Sample: human throat swab
Package: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA,
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry 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 specimen collection swab
• 1 extraction tube
• 1 test tube holder
• 1 Hungarian-language instructions for use

Test procedure

Read the Instructions for Use carefully before performing the test! Collect the sample according to the instructions provided in the Instructions for Use.

Before use, wait until the devices, reagents and samples and/or controls have reached room temperature (15°C–30°C).

After sample collection:

1. Sample preparation:

• Add 4 drops of reagent 1 to the extraction tube, followed by 4 drops of reagent 2. Gently mix the solution.
• Immediately after sample collection, place the swab into the extraction tube. Rotate the swab using circular movements, then press it against the side of the extraction tube so that the sample is released from the swab and mixes with the solution.
• Allow it to stand for 1–2 minutes at room temperature, then press the swab firmly against the tube to squeeze out as much liquid as possible from the collection swab. Dispose of the collection device in accordance with guidelines for infectious devices.

2. Remove the test cassette from the sealed pouch and place it on a clean, horizontal surface. Label the cassette with the patient's name or control identification number. For best results, the test should be performed within one hour.

3. Add 3 drops (approximately 120 μL) of the prepared solution in the extraction tube to the sample well of the test cassette. Make sure that no air bubbles enter the sample well (S) and that no solution reaches the result window. As the test begins to work, the color will migrate across the membrane.

4. Wait for the colored band(s) to appear. The result can be read within 5 minutes. The test result is considered invalid after 10 minutes.

Interpretation of results

Positive

Two separate red lines appear. One line appears in the control region (C), and the other line appears in the test region (T). A pink to red colored line (T) – regardless of how faint – indicates a positive result.

Negative

One red line appears in the control region (C). No line appears in the test region (T).

Invalid

Only one red line appears in the test region (T) and no red line appears in the control region (C). / No red line appears. The most likely causes are an insufficient sample volume or incorrect use of the device.

Performance of the Streptococcus A Rapid Test

• Relative sensitivity: 97.6%
• Relative specificity: 97.5%
• Overall agreement: 97.5%

The test may only be used by qualified professional personnel and healthcare professionals! Carbon Web Kft. accepts no responsibility for use of the test for self-testing purposes.

ATTENTION!
According to Government Decree 45/2014 (II. 26.), for products that cannot be returned after delivery for health protection or hygiene reasons, the 14-day right of withdrawal does not apply. Section 29 (1) e) states that the consumer may not exercise the right specified in Section 20 (the consumer's right of withdrawal) in respect of a sealed product which, for health protection or hygiene reasons, cannot be returned after opening following delivery.

Carbon Web Kft. is not responsible for fulfilling legal obligations related to the Buyer's procurement procedure, as these fall within the Buyer's responsibility. Its responsibility is limited exclusively to information concerning proper use and to the goods delivered.