Cov-19 nab neutralizing Antibody Rapid Test Kit blood test

For professional and in vitro diagnostic use only.

For professional and in vitro diagnostic use only.

[INTENDED USE]

The product is suitable for qualitative detection of neutralizing antibodies (NAbs) against SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the spike glycoprotein and the Angiotensin converting enzyme Ⅱ (ACE2) receptor. The device can be instrumental in vaccine and therapeutic development as it is suitable for all antibody isotypes. It may also help in current COVID-19 investigations of sero-prevalence, assessment of human immunity, longevity of protective immunity, efficacy of different vaccine candidates as well as tracking infection.

[PERFORMANCE CHARACTERISTICS]

Sensitivity

The sensitivity to S-mIgG1 neutralizing antibody can reach 2ug/mL.

Accuracy

A side-by-side comparison was conducted by the results of SARS-Cov-2 Neutralizing Antibody Test Device (Test Reagent) developed by Hangzhou Deangel Biological Engineering Co., Ltd. and cPass^TM from Genscript CO., Ltd. 328 clinical specimens from Professional Point of Care site were evaluated, 105 were positive and others negative. Base on the results from the clinical studies, the statistical analysis was made as follows:

For test reagent, the clinical sensitivity with the “Compared Reagent” was 91.4% (95% CI: 77.7%~100%), the clinical specificity was 99.1% (95% CI: 97.2%~100%), the coincidence rate was 96.6% (95% CI: 92.4%~100%).

[COMPOSITION]

The device is mainly composed of a nitrocellulose (NC) membrane strip assembled into a cassette. On the NC membrane, the T line is coated with ACE2, and the C line is goat anti mouse IgG polyclonal antibody. Dye conjugated with SP is embedded in the reagent pad.

The quantity of tests was printed on the labeling.

Materials Provided

·Test cassette ·Buffer ·Dropper · Package insert · Desiccant

Materials Required But Not Provided

·Timer

[STORAGE AND STABILITY]

• Store as packaged in the hermetic bag at the temperature (2-30℃ or 38-86℉) and avoid direct sunshine. The kit is stable within the expiration date printed on the labeling.

• Once open the hermetic bag, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.