High Acuracy Strep a Antigen Rapid Test Throat Swab Test

• Customization: Available
• Type: Detection Card
• Syringe: /
• Blood Sampling Needle: /
• Breathing Pattern: /
• Animal Anesthesia Machine Control Method: /
• Used for: Strep a Test
• Specimen: Throat Swab
• Assay Time: 10-15 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Support
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

INTENDED USE
The Strep A Antigen Rapid Test is arapid chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen in human throat swab specimen. This kit is intended for use as an aid in the diagnosis of Strep A infection.




STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2 - 30°C). The Test Strip is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
DO NOT FREEZE.
The stability of the kit under these storage conditions is 24 months.
 

 

Test Procedure

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (10 - 30°C) prior to testing.

 

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Reverse the assay buffer tube, extrude 3 drops (approx. 80μL) of the prepared specimen into the specimen well (S) of the test device and start the timer.
3. Wait for the colored band(s) to appear. Read the result at 10 minutes. A strong positive sample may show result earlier. Do not interpret the result after 15 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. 

PERFORMANCE

PERFORMANCE CHARACTERIST

Sensitivity and Specificity
To determine the analytical sensitivity of the test, Group A Streptococcus bacteria organisms were grown by standard culture techniques. The detection limit of the Strep A Antigen Rapid Test was determined to be 1.5×10⁵ organisms per test.
To determine the specificity of the test to Group A Streptococcal bacteria, the following Group A Streptococcal Strains were examined at different levels of organisms per test. Positive results obtained at a level of 1.5×10⁵ organisms/test for all strains indicate that the test is sensitive to Group A Streptococcal bacteria.
Group A Streptococcal Strains:
SS-091 SS-410 SS-492 SS-496
SS-633 SS-634 SS-635 SS-721
SS-754 SS-799 ATCC-19615
Correlation Study
Table: Strep A Antigen Rapid Test vs. Culture 

Method		Culture		Total Results
Strep A Antigen Rapid Test	Results	Positive	Negative
	Positive	131	9	140
	Negative	7	345	352
Total Result		138	354	492

Relative Sensitivity: 94.93% (95%CI: 89.72%~97.71%)  
Relative Specificity: 97.46% (95%CI:95.17%~98.73%) 
Accuracy: 96.75% (95%CI:94.74%~98.03%)
 
 

Company Profile

COMPANY PROFILE

Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the  human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
 

 

Certifications

 

Packaging & Shipping