2019-nCov neutralizing Antibody Rapid Test Kit

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%).

[PRINCIPLE]

The Device uses the principle of the Surrogate Virus Neutralization Test method for detecting the neutralizing antibody against SARS-CoV-2 in human/animal specimens. The marker is composed of the recombinant spike glycoprotein (SP) labeled with Dye. When testing, the specimen was added into the sample well and migrated to the absorbent pad by the capillary effect. If there are enough NAbs contained in the specimen, it will react with the marker and block the marker captured by the ACE2 coated in the NC membrane. Then there is no colored line produced at the test area (T), indicating a positive result. If the NAbs not enough, the test region will show weak T line. If there are no NAbs, the T line will show and it means a negative result. Regardless of whether the Nab exists, as a procedural control, a colored line will always appear at the control area (C), indicating that proper volume of specimen has been added and the correct test procedure is conducted.