Easy to carry IVD Neutralizing Antibody Rapid test For Travel

For professional and in vitro diagnostic use only.

For professional and in vitro diagnostic use only.

[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%).

[TEST PROCEDURE]

Allow the test device and specimens to equilibrate to temperature (15-30℃or 59-86℉) prior to testing.

1. Remove the test device from the sealed pouch.

2. Hold the dropper vertically and transfer 1 drop of serum/plasma or 2 drops of whole blood to the sample well (S) of the test device. Make sure there are no bubbles. For better precision, we suggest transfer specimen by a pipette

3. Then add 2 drops of buffer and start the timer.

4. Wait for colored lines to appear. Interpret the test results after 15 minutes. Do not read results after 20 minutes.

[SUMMARY]

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.