Product Details
Rapid Test Kit Neutralizing Antibody Detection 20 Tests Rapid Test
Kit With Excellent Performance
Intended Use
The SARS-COV-2 Neutralizing Antibody Rapid Test Kit is a lateral
flow immunoassay intended for the semi-quantitative determination
of neutralizing antibodies (NAbs) .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.
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.
Specifications
Test Item | Neutralizing Antibody Test Kit |
Number | LX-401701 |
Sample Volume | Whole blood , Serum, Plasma |
Package | 20 Tests/Kit |
Specificity | 98.00% |
Sensitivity | 97.67% |
Accuracy | >95% |
nspection Method | Immunochromatography |
Shelf Life | 18 Months |
Type | IVD Antibody Rapid Test |
Humidity | 35%-60% |
Main Components
- Test cassettes
- Disposable pipettes
- Sterile Safety Lancets
- Sample Buffer
- Colorimetric chart
- Package Insert
Product Feature
- CE, ISO13485 Certificated
- No equipment required
- Easy to storage
- Instant result in 15 minutes
- Whole blood, serum and plasma can be detected
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 15 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.
- The test results of this kit are for clinical reference only, and
should not be used as the sole basis, and should be combined with
other test methods, as live virus and pseudovirus neutralizing
antibodies assay.
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.