Detailed Description
INTENDED USE
For qualitative detection of the neutralizing antibody against novel coronavirus in Serum, plasma and whole blood from the People who have been vaccinated to determine whether it has a protective effect.
About COVID-19
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.
The vaccine of COVID-19 generally needs two injections, and usually produces protective neutralizing antibodies about 7 days after the second injection. However, due to the difference of individual immunity, not everyone who has been vaccinated will produce neutralizing antibodies.
Some people who have been infected with the COVID-19 also produce protective neutralizing antibodies.
There are no definite evidence whether neutralizing antibodies can protect the mutated COVID-19. There are still lack of sufficient research on the protection period of neutralizing antibody.
A kit contains
Package specifications: 25 T/kit
1) Test device: 25 T/kit.
2) Transfer pipet: 25 pcs/kit.
3) Specimen diluent: 200 μL x 25 vials/kit.
4) IFU: 1 piece/kit.
5) Blood lancet: 25 pcs/kit.
6) Alcohol pad: 25 pcs or/kit.
Additional required material: clock/ timer/ stopwatch
Note: Do not mix or interchange different batches of kits.
Specifications
Test Item | Sample Type | Storage Condition |
Neutralizing Antibody | Whole Blood/Serum/Plasma or Fingertip blood | 2-30℃ |
Methodology | Test Time | Shelf Life |
Colloidal Gold | 15mins | 24 months |
Operation
Interpretation
POSITIVE: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test region (T).
NEGATIVE: Only one colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Results from any test which has not produced a control line at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem pers.