Group A Streptococcus Antigen Detection Kit (Immunochromatography)

[Packaging Size]

1 test/kit, 20 tests/kit

[Intended Use]

This product is used for in vitro qualitative detection of group A Streptococcus(GAS) pyogenes antigens in human throat swab samples.
Group A Streptococcus is the main pathogen causing upper respiratory tract infection. If no targeted treatment is given after infection with this pathogen, it may cause serious sequelae such as rheumatic fever and rheumatic heart disease [1-2]; Screening can help guide the rational use of antibiotics in clinical treatment and avoid antibiotic abuse [3-4].

[Test principle]

This kit uses the double antibody sandwich method of immunochromatography. Goat anti-mouse IgG is coated on the quality control line “C”, Group A Streptococcus monoclonal antibody is coated on nitrocellulose at the test region (T). Another group A Streptococcus monoclonal antibody labeled with a red tracer was coated on the glass cellulose membrane.

During the assay, the processed specimen is added into the sample well and allowed to migrates chromatographically on the membrane by the capillary action. When the sample contains the group A streptococcus antigen, the group A streptococcus antigen will specifically bind to the anti-group A streptococcus antibody on the binding pad and be captured by the group A streptococcus monoclonal antibody on the detection line. A red band appears at T line. When the sample does not contain the group A streptococcus antigen, no red band appears at T line. A red band always appears in the control region (C) serving as procedural control regardless of the specimen contains GAS or not, unless the test is invalid. (Refer to information below regarding invalid test results).

[Main Components]

The test cassette is mainly composed of PVC backing, glass cellulose, nitrocellulose membrane, absorbent paper, etc. The nitrocellulose membrane is coated with goat anti-mouse polyclonal antibody (quality control line) and mouse anti-A Group Streptococcus monoclonal antibody (test line).

[Storage Condition and Shelf-life]

Storage condition: 4-30 °C sealed dry storage. Shelf life: 12 months
See label for production and expiry dates.

[Requirements for Samples]

Use a disposable sampling swab completely inserted into the throat from the oral cavity, with the pharyngeal tonsils or the posterior wall of the throat as the center, wipe the bilateral pharyngeal tonsils and posterior wall of the throat with moderate force [5-6], and try to avoid touching the teeth and gums when collecting samples , tongue and the inner surface of the cheek [7], remove the swab. Swabs should be processed as soon as possible after specimen collection with the extraction solution provided by this kit.

It is recommended to test as soon as possible after collecting the sample. If the test is not performed immediately, the throat swab can be refrigerated at 2-8°C for up to 72 hours, and the swab should be returned to room temperature before the test.