Special Design for N95 Face - Neutralizing Antibody – Binic

Pathogenesis:

The S protein is responsible for virus binding and entry into host cells , which consists two functional subunits, s1 and s2 and the receptor binding domain ( RBD ） is located within the s1 subunits. The RBD of the  SARS-CoV-2  S  protein  interacts  with  host angiotensin converting enzyme 2 ( AcE2 ）, triggering conformational changes in the s2 subunit that result

in virus fusion and entry into the target cell . Human secretory proteases, such as TMPRss2 and furin, localize to virally.target cells.

These proteases enhance viral entry into host cells through the proteolysis of both the s1, s2, and AcE2 proteins.

lntended use:

The Anti SARS-CoV-2 Neutralizing Antibody Rapid Test Kit is developed for in vitro qualitative detection of SARS-CoV-2 neutralizing antibodies in human blood samples. SARS-CoV-2 Neutralizing antibody is an important marker for assessing the effectiveness of the SARS-CoV-2 vaccines. The reagent is for neutralizing antibody detection in samples from individuals after vaccine injection or recovered from coV1D.19. The kit will also help in current coV1D.19 investigations of sero-prevalence, assessment of herd immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection in animals.

storage conditions and Validity:

All reagents are ready to use as supplied. Unopened reagent kits are stable at 4″c ～30″c for 24 months tentatively. 1t should be used within 1 hour once the pouch is opened. Do not freeze the kit or expose the kit above 37″c during storage.

Specification：

1 test / box; 5 tests/ box; 25 tests / box; 50 tests / box.

Test Procedure:

Do not open the pouch until you are ready to perform a test, and the single.use test is suggested to be used under low environment humidity (RHs70%） within 1 hour.

1.Allow all kit components and specimens to reach room temperature between 18″c～26″c prior to testing. 2.Remove the test card from the foil pouch and place on a clean dry surface.

3.1dentify the test card for each specimen.

4.Use dropper to deliver one drop (1） of serum, plasma or whole blood samples (40uL） into the sample well on the test card, followed by one drop of sample bufer.

5.start the timer and read result in 15 minutes.

lnterpretation of Test Result:

1nterpret test result according to the following color chart (As Below).

1.1f the color intensity is lower than G4, indicating the concentration of neutralizing antibody is larger than 200 PRNT50 2.1f the color intensity is between G4 and G6, indicating the concentration of neutralizing antibody is around 100 PRNT50 3.1f the color intensity is near G7, indicating a concentration is of neutralizing antibody is 50 PRNT50

4.The detection limit is 50 PRNT50

5.f the color intensity is stronger than G7, indicate a negative result.