CE Disposable Plastic Cassette for Rapid Strep a Test Kit

• Type: IVD Reagent
• Sample Type: Throat Swab
• Time to Results: 5 Minutes
• Kit Storage Conditions: Room Temperature (2- 30°c)
• Internal Controls: Positive and Negative
• Sensitivity: 92%
• Model NO.: STB-DS02
• Specificity: 98%
• Overall Accuracy: 95%
• Shelf Life: 24 Months From Date of Manufacture
• Transport Package: Carton
• Specification: 1/5/20/25/40tests/box
• Trademark: Dewei
• Origin: Foshan, China
• HS Code: 3822190090
• Production Capacity: 100, 000pieces/Week

Product Description

Product Description

Principle

The Dewei Strep A Rapid Test is a qualitative, sandwich lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. Strep A carbohydrate antigen present in the extracted throat swab sample reacts with the antibodies to Strep A that are pre-coupled onto particles. The antigen, antibody, and/or antigen-antibody complex migrate up the membrane and react with the antibodies pre-coated on the membrane in the test line and control regions of the cassette. The presence of a coloured line in the test line region indicates a positive result. To serve as a procedural control, a coloured line will always appear in the control region to show the test has been performed properly.

Test Attributes

• Throat swab samples to be used for testing
• Results available in 5 minutes
• Easy to use
• Results are read visually
• Cost effective method for assisting in the diagnosis of Strep A infections

Test Procedure

INTERPRETATION OF RESULTS
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.

Performance Characteristics

• Relative sensitivity: 95.1%,
• Relative specificity: 97.8%
• Accuracy: 97.1%

 

Company Profile

 

About Us

Dewei is devoted to R&D in the in-vitro diagnostic reagents area.

 

Dewei Medical Equipment Co.,Ltd. was founded in 2012, is jointly established by a number of experts engaged in in-vitro diagnosis industry for many years, set research & development, production, sales of rapid diagnostic reagents and biological raw materials in one of the bio-high-tech company.

Our products contain the following tests:Drug of Abuse Tests,alcohol test in urine and saliva, Infectious Disease Tests,Food Safety tests, Women Health tests, Infectious Diseases tests, Cardiac Markers tests and Tumor Markers tests.

 

Certifications

Packaging & Shipping

 

Exhibition

 

 

FAQ

1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.

2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.

3.Can you provide free samples?
Yes, free sample are available.

4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.

5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.