Strep B Antigen Rapid Test Cassette Kits 40 Tests/Kit CE ISO13485

Strep B Antigen Rapid Test Cassette Kits 40 Tests/Kit CE ISO13485

Products Description

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

Kit Components

Test Procedure - Strep B Test

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 Then press the swab against the side of the tube and squeeze the bottom of the tube as the swab is withdrawn.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

POSITIVE RESULT :

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 RESULT :

Only one colored band appears in the control region (C). No apparent colored band appears in the test region(T).

INVALID RESULT :

Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE :

1. The intensity of the color in test region(T)may vary depending on the concentration of

aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.

2. Insufficient specimen volume, incorrect operation procedure, or performing expired

tests are the most likely reasons for control band failure.

Q1: Are you a Manufacturer?
Yes, we are manufacturer based in Hangzhou, China with 165 workers, 8000 square meter non-dust workshop, advanced autonnate machines and professional R&D team ensure the high quality, speedy delivery and large production capacity.

Q2: Can we put our logoltext on the products or package?
Yes, we can do OEM or even ODM. All of our products can be customized.

Q3: Can you provide free samples?
Yes, free samples are provided. But you need to pay the freight.

Q4: How long is your delivery time?
Our delivery time is usually two to three weeks after receiving the deposit. For a container order quantity, the production time is four weeks. It depends on the specific situation.

Q5: What is the MOQ?
Small quantity like 1000pcs is available.

Q6: How to make the payment?
By T/T.

Shenzhen Wensidun Technology Co., Ltd. was established in 2018 and is located in Longgang District, Shenzhen, Guangdong Province, China. We have in-depth cooperation with Green Spring, which has 20 years of production and R&D experience.

We have more than 2000 square meters of GMP clean production workshop and more than 1000 square meters of R&D center in Shenzhen. Products cover over 100 varieties of food safety test kits, animal diseases diagnostic kits, in vitro diagnostic reagents, genetic antibody antigen preparation and form a complete set of testing instrument.Currently,our food safety test kit and animal disease diagnostic kit are widely used in many governments,enterprises and research institutes.Our products are sold to more than 40 countries and areas.

We have ISO9001, ISO13485 quality management system certification, GMP certificate. SARS-CoV-2 Antigen Rapid Test Kit has been awarded CE certification, German BfArM approved self-test and professional test, PEI certification, EU general and mutual recognition list, and multinational white list. Ranked No. 1 in German authoritative medical magazine Daz and No. 1 in Hong Kong sales.

Enterprise mission: Caring for health and benefiting the society. Focus on products and lead the industry.

Core values: Inheriting innovation, improving quality, honesty and law-abiding, and win-win cooperation.

Our vision is to become a leading company in the biodiagnostic reagent industry, providing high-quality, convenient and reliable services to the world.