Rapid Test Kit Neutralizing Antibody Detection 20 Tests For Professional Use
Intended Use
The SARS-CoV-2 Neutralizing Antibody Rapid Test Kit 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 |
| Number | LX-401701 |
| Specimen Type | Whole blood, Serum, Plasma |
| Sample Volume | Whole blood 20µL, Serum/Plasma 10µL |
| Package | 20 Test/Box |
| Specificity | 98.00% |
| Sensitivity | 97.67% |
| Accuracy | More than 95% |
| 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
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
Principle
The test employs the sandwich immunoassay to detect the total neutralizing antibodies. The color intensity of the T line is correlated with the level of the neutralizing Antibody in specimen. To determine the level of the neutralizing antibody in specimen, comparing the intensity of test line to the attached colorimetric chart.
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.
Application
Evaluation of Vaccination: An aid in theevaluation of individual immune response after vaccination
Diagnosis of infection: An aid in the diagnosis of individuals with suspected SARS-CoV-2 infection in conjunction with other tests and clinical lab.
Epidemiology Research: Immune surveillance of large populations or regions.
Assessment of Convalescent Plasma Therapy: Determine who may quality to donate blood for convalescent plasma therapy for sever COVID-19 patients.
FAQ
We have the MOQ limit,which is 10000 pieces.
After order confirmed,we will arrange your order immediately,and offer you an
estimated delivery date.
Business to business account.
We choose Air cargo or Ocean cargo.
- Trade Company or Manufacturer:
Manufacturer
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