Rapid Test Kit CoV-19 Nqeutralizing Antibody Rapid Test Kit Easy
For Use 20 Test / Kit
Intended Use
- The kit is intended for the semi-quantitative determination of
neutraliaing antibodies to SARS-Cov-2 in human serum, plasma,
fingerstick wholeblood or venous whole bood specimens. Results are for the detection of total neutralizing antibodies to
SARS-COV-2. Antibodies to SARS-COV-2 are generally detectable in
blood several days after initial infection, although the duration
of time neutralizing antibodies are present post-infection is not
well characterized.
- The test is intended use as an aid in identifying individuals with
an adaptive immune response to SARS-COV-2, indicating recent or
prior infection or assisting in evaluating the effectiveness of the
vaccine clinical trials and mass vaccination.
Specifications
Test Item | Neutralizing Antibody Test Kit |
Sample Volume | Whole blood 20µL, Serum/Plasma 10µL |
Package | 20 Test/Box |
Specificity | 98.00% |
Sensitivity | 97.67% |
nspection Method | Immunochromatography |
Shelf Life | 18 Months |
Type | IVD Antibody Rapid Test |
Main Components
- Test cassettes
- Disposable pipettes
- Sterile Safety Lancets
- Sample Buffer
- Colorimetric chart
- Instruction for use
Product Feature
- Fast results as soon as 10-15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- Little specimens, easy for use
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
Advantage
Accurate: the product has a high accurate serology test for
Neutralizing Antibodies detection
Easy to administer and read results: no need for instrument or
other equipment during the test
Fast detection: the result appears in 10 minutes, can be used for
testing on a massive scale.
No specific storage requirement: room temperature (2-30ºC)
Use Step
- Place the lanceton the test site.
- Push down the lancet.
- Collect the bloodby transfer pipette.
- Add one drop of blood into the sample well.
- Add 1-2 drops (30-60µL) of sample buffer into the sample well
innediately.
- Wait 15 minutes then read the result.
Interpretation of results
- POSITIVE: The T line and C line are both displayed within the
reaction window, indicates the neutralizing antibodies to
SARS-COV-2 are detected. The result is positive.
- NEGATIVE:The C line is displayed within the reaction window only,
indicates absence of neutralizing antibody to SARS-COV-2.The result
is negative..
- INVALID:1. If the control (C) line is not displayed in 15 min, regardless
of whether T line is present, the test result is invalid. It is
recommended that the specimen should be re-tested.
The test result is invalid after 20 min.
Other Information
- The test is for in vitro diagnostic use only.
- This test is designed for semi-quantitative detection of SARS-COV-2
neutralizing antibodies.
- It is unknown at this time if the presence of antibodies to
SARS-COV-2 confers immunity to re-infection. Consider other
information including clinical history and local disease
prevalence, in assessing the need for a second but different
serology test to confirm an immune response.
Applicaton
- Evaluation of Vaccination
- Diagnosis of Infection
- Assessment of Convalescent Plasama Therapy
- Epidemiology Research