Fast check for nab in blood neutralizing Antibody Rapid 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%).

[SPECIMEN]

• Only whole blood (venipuncture blood or capillary finger prick blood) /serum /plasma specimens can be used.
• Samples should be collected by standard protocol.
• The specimen should avoid hemolysis.
• Specimen with high viscosity, high fat, bacteria growth or turbidity is not suitable.
• Test the specimen as soon as possible if collected. Store the specimen at 2-8℃ if not used immediately.
• The specimen can be store at 2-8℃ up to 3 days. Serum /plasma can be frozen at -20℃ for long term. Do not frozen whole blood.
• Avoid multiple freeze-thaw cycles.
• Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.