Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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One Step Ncov-19 Neutralizing Antibody Test Kits For Vaccination Evaluation
For professional and in vitro diagnostic use only.
| Product Name | SARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6% |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25T/Box |
| Storage | 2℃-30℃ |
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 cPassTM 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:
| cPassTM | Total | |||
| Positive | Negative | |||
| Test reagent | Positive | 96 | 2 | 98 |
| Negative | 9 | 221 | 230 | |
| Total | 105 | 223 | 328 | |
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%).
[LIMITATIONS]
The device is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood.
Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
If symptoms persist and the result from the device is negative, it is recommended to collect a new sample from the patient a few days later and test it again.
A negative result can occur if the titer of antibodies against the SARS-CoV-2 virus present in the specimen is below the sensitivity of the assay.
Improper sample collection, improper sample storage or repeated freezing and thawing of samples can lead to inaccurate results.
[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.
