Strep A Rapid Test Cassette

Strep A Rapid Test Cassette

The Strep A Rapid Test Cassette (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Strep A antigens in specimens taken from vaginal or rectal swabs of pregnant women, or general swabs from newborn. This kit is intended for use as an aid in the diagnosis of Strep A infection.

Product Introduction

Intended Use

 

Strep A2

The Strep A Rapid Test Cassette (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Strep A antigens in specimens taken from vaginal or rectal swabs of pregnant women, or general swabs from newborn. This kit is intended for use as an aid in the diagnosis of Strep A infection.

Streptococcus pyogenes is non-motile gram-positive cocci, whichcontains the Lancefield group A antigens that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess. Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.

The Strep A Rapid Test Cassette is a rapid test to qualitatively detect the presence of Strep A antigens in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigens in a throat swab specimen.

The Strep A Rapid Test Cassette a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of thetest. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

 

Specification

 

Read time 5-10 min

Shelf life

36 months

Store temperature 2-30℃
Operation temperature 15-30℃

 

Why To Test

1.What is Strep A ?

Strep A Streptococcus (GAS), scientifically known as Streptococcus pyogenes, is a Gram-positive bacterium that forms chains. It is classified as a beta-hemolytic streptococcus due to its ability to completely lyse red blood cells on blood agar plates, forming a clear zone around colonies. Based on the Lancefield serotyping system, which distinguishes streptococci by specific carbohydrate antigens in the cell wall, it belongs to Strep A . GAS is a primary pathogen, meaning it is a common cause of disease in humans.

2.How does Strep A spread?

Group A spreads primarily through respiratory droplets when an infected person coughs or sneezes. It can also be transmitted through direct contact with skin lesions or fomites (contaminated objects).

3.What are the symptoms of Strep A and severe Strep A?

Group A causes a wide range of illnesses. Mild to moderate infections​ include pharyngitis (strep throat), tonsillitis, impetigo, and cellulitis. Symptoms often include sore throat, fever, pain, and localized skin redness and swelling. Severe invasive infections​ include necrotizing fasciitis (a "flesh-eating" infection) and streptococcal toxic shock syndrome, which are characterized by rapid onset, intense pain, fever, low blood pressure, and organ failure.

Furthermore, Group A infections can trigger post-infectious immune-mediated complications​ such as acute rheumatic fever (affecting the heart, joints, and brain) and post-streptococcal glomerulonephritis (affecting the kidneys), which occur weeks after the initial infection.

 

 

Test Method


Strep A

Strep A

POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Catalog

Product Name

Model

Catalog Number

Components

Sample Type

Strip Type

Strep A Rapid Test

FS19-101

FS19-101-3

Test Cassette

Extraction Tube

Swabs

Dropper

Product Insert

Extraction Reagent 1

Extraction Reagent 2

Swab

Cassette

 

 

 

 

 

 

 

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