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.
