ISO13485 Group A Rapid Streptococcal Antigen Test 10-15 Minutes Read Time

Group A streptococcal Rapid Tests

Group A streptococcal Antigen Rapid Test Kit

Catalog No.: BG1501C

INTENDED USE

Bioneovan Group A Streptococcal Antigen Rapid Test Kit is an in vitro immunoassay for the qualitative determination of the detection of Group A Streptococcal in human throat swab specimens in one step. It is for diagnosis of early infection and epidemic survey. The kit is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as commercial anzyme immunoassay (ELISA) or RT-PCR.

TEST PROCEDURE

1. Preparation before inspection: The specimens to be tested are taken out from the refrigerated environment and allowed to equilibrate for 30 minutes at room temperature.
2. Add 5 drops (about 250 μl) of extract A and extract B to the tube for extraction. Mix well.
3. Place the cotton swab containing bacteria into the test tube with the extract, let stand for 3 to 5 minutes at room temperature, shake the cotton swab for a few seconds, and repeatedly squeeze and rotate on the tube wall; discard the liquid on the cotton swab and discard it. Throat swabs, tube extracts can be used for testing (tested within 60 minutes).
4. Inspection process: Remove the test card from the foil pouch and place it on a dry horizontal work surface. Add 100 μl of extract (about 2 drops, and then add a second drop after infiltration of the first drop) into the well and judge the results within 8 to 10 minutes.
5. Precautions during the inspection process: a. The test kit and the sample to be tested should be placed in a room temperature environment before being tested. b. The observation result is invalid after using the c.10 minutes within 30 minutes after the test card is opened.

INTERPRETATION OF RESULTS

Positive Two pink lines appear in both C and T position
Negative Only one pink line appears in C position
Invalid: The control line next to the test line does not become visible within 10 minutes after the addition of the sample.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world