INTENDED USE

The Strep A Rapid Test Device (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

INTRODUCTION

Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 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.3,4

The Strep A Rapid Test Device (Throat Swab) is a rapid test to qualitatively detect the presence of Strep A antigen 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 antigen in a throat swab specimen.

KIT COMPONENTS

Test devices Sterile swabs Strep A Reagent A	(1M Sodium Nitrite)	Strep A Positive control  (Non-viable  Strep A; 0.09% NaN3)
Workstation Test tubes Strep A Reagent B	(0.4M Acetic Acid)	Strep A Negative control  (Non-viable Strep C; 0.09% NaN3)
Dropper tips Package insert

PROCEDURE

Allow the test device, reagents, throat swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1.Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch. 

2.Hold the Reagent A bottle vertically and add 4 full drops (approximately 240 mL) of Reagent A to an extraction test tube. Reagent A is red in color. Hold the Reagent B bottle vertically and add 4 full drops (approximately 160 mL) to the tube. Reagent B is colorless. Mix the solution by gently swirling the extraction test tube. The addition of Reagent B to Reagent A changes the color of the solution from red to yellow. See illustration 1. 

3.Immediately add the throat swab to the extraction test tube of yellow solution. Agitate the swab 10 times in the tube. Leave the swab in the tube for 1 minute. Then press the swab against the side of the tube and squeeze the bottom of the tube as the swab is withdrawn. Discard the swab. See illustration 2.

4.Fit the dropper tip on top of the extraction test tube. Place the test device on a clean and level surface. Add 3 full drops of solution (approx. 100 µL) to the specimen well (S) and then start the timer. See illustration 3.

5.Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not read the result after 10 minutes.

INTERPRETATION OF ASSAY RESULT

 

PERFORMANCE CHARACTERISTICS

Table: Strep A Rapid Test vs. PCR Test

Method		Culture		Total Results
Strep A  Rapid Test	Results	Positive	Negative
	Positive	102	7	109
	Negative	6	377	383
Total Results		108	384	492

Relative Sensitivity: 94% (88%-98%)*              Relative Specificity: 98% (96%-99%)*

Accuracy: 97% (96%-98%)*                              * 95% Confidence Intervals  

 

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.