Streptococcus A Self-Test Antigen Rapid Test - IVDR
Product Description
The Streptococcus A Self-Test Antigen Rapid Test - IVDR is a point-of-care diagnostic device designed for the rapid detection of Streptococcus pyogenes group A (GAS) antigens directly from throat swab specimens. This test aids in the diagnosis of streptococcal pharyngitis (strep throat), a common bacterial infection of the throat and tonsils. The easy-to-use format allows for quick results, enabling healthcare providers to make timely treatment decisions and reduce the spread of infection. The test utilizes an immunochromatographic assay, providing a visual result based on the presence or absence of GAS antigens. This rapid diagnostic test is intended for use by healthcare professionals in clinical settings as well as self-testing with appropriate instruction and interpretation.
Features
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Rapid results in 5-10 minutes
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Easy-to-use cassette format; minimal training required
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High sensitivity and specificity for accurate detection of GAS antigens
Specifications
| Parameter | Specification |
|---|---|
| Detection Target | Streptococcus pyogenes Group A antigen |
| Sample Type | Throat swab |
| Methodology | Immunochromatography |
| Detection Range | Positive/Negative |
| Reaction Time | 5-10 minutes |
| Storage Conditions | 2-30°C |
| Shelf Life | 24 months |
Product Advantages
Early Screening Tool
Helps quickly identify infected individuals, implement timely isolation measures, and control the spread of the epidemic.
Suitable for Multiple Scenarios
Suitable for various scenarios such as home self-testing, corporate screening, schools, and clinics.
Reliable Quality
Strict quality control system ensures stable and reliable product performance.
Instructions for Use
- Read the instructions carefully.
- Prepare sample collection tools and the test kit.
- Collect the sample according to the instructions.
- Add the sample to the test cassette.
- Wait 15 minutes to read the results.
Certification Information
- CE Certified
- ISO13485
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