Strep A Device – Immunochromatographic Method
Intended Use: An in vitro, immunochromatographic, medical diagnostic device for the rapid, qualitative determination ofstreptococcal antigen A in pharyngeal swabs in the diagnosis of infections sustained by group A Streptococcus strains.
Principle of the method:
It is a qualitative membrane-based, rapid, one-step analytical method based on the immunochromatographic principle “sandwich,” for the detection of group A Streptococcus carbohydrate antigen. In this analytical procedure, specific antibodies directed against the carbohydrate antigen of group A Streptococcus are immobilized in the region of the test line (T) on the membrane of the reaction support. When the sample extracted from the pharyngeal swab is inoculated into the sample well, it reacts with antibodies that coat the relevant particles dispersed in the membrane. These complexes migrate by chromatography across the membrane surface of the reaction media and react with the specific antibodies immobilized in the T region. If the sample contains group A antigen, a colored line develops at the test region (T), indicating a positive result. If the sample does not contain group A antigen, the colored line does not appear, indicating a negative result. As a procedural control, a colored line should always appear at the control region (C), indicating that the analytical procedure was carried out correctly.
- Disposable test cards: reaction media in individual sealed bag
- Disposable extraction tubes
- Disposable dropper tips
- Sterile swabs (in Dacron)
- Reagent 1 (2M sodium nitrite)
- Reagent 2 (0.027M Citric acid)
- Positive control (Gr. A non-vitalizing streptococcus strain in 0.09% NaN3)
- Negative control (Gr. C streptococcus strain non-vitals in 0.09% NaN3)
- Instructions for use.
Storage and stability of reagents:
The kit can be kept in a refrigerator or at T. A. (2-30°C.); do not freeze or use after the expiration date indicated on the sealed bag containing the reaction medium. Reaction media are stable only when stored in their sealed bags.
Preparation of reagents:
All reagents are ready to use.
- For professional in vitro diagnostic use. Do not use beyond the expiration date.
- Do not eat, drink or smoke in the sample and reagent handling area.
- Handle all samples as if they contained infectious agents. Observe current legal regulations established against biohazards throughout the procedure and follow standard procedures for proper disposal of samples.
- Wear protective clothing such as lab coats, disposable gloves and eye protection equipment when handling samples.
- Reagents/samples used must be disposed of according to Current Regulations.
- High humidity and temperature can alter the test results.
- Do not use the test card if the sealed bag is damaged.
- Reagent 2 contains acid in solution: if this solution comes in contact with the skin or eyes, wash thoroughly with water.
- POSITIVE and NEGATIVE controls contain sodium azide (NaN3,) as a preservative.
- Do not interchange the caps of each reagent with each other.
- Do not interchange the caps of each control with each other.
Produced by Nevia Biotech srl in the factory at 14/16- 00015 Monterotondo scalo (Rome) via Torricelli street