Product Details
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
Company Profile
Labnovation Technologies, Inc. is an original manufacturer
established in Shenzhen, China since 2001. We are dedicated in
developing and manufacturing IVD instruments and reagents including
HbA1c analyzer and reagents, rapid test reader & reagents,
hematology reagents, clinical chemistry reagents, electrolyte
reagents, wash solution and urine test reagents.
Labnovation products are developed in house, tested extensively in
clinics and passed strict quality controls. All of our products are
CE marked and approved by SFDA. In the past 15 years, our products
have been exported to 110 different countries and used in 8000
hospitals worldwide. We provide both ready-to-use final products
and bulk OEM reagents, including ready-to-use reagents,
concentrated, and powder.
With an investment of 10% of our annual sales into R&D, we
release new products every years. We win more and more domestic and international cooperation by
company reputation and products quality while we actively take part
in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we
are well-known by the companies in this field.