ISO13485 Rapid Neutralizing Antibody Test Kit 95.00% Acuracy

Rapid Test Kit Neutralizing Antibody Rapid Test Kit High Quality Detection Rapid Antibody Test Kit

Intended Use

• The Labnovation's SARS-CoV-2 neutralizing antibody rapid test kit is intended for the semi-quantitative determination of neutralizing antibodies to SARS-CoV-2 in human serum, plasma, fingersitick whole blood or venous whole blood specimens.
• 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

Main Components

• 20 Test cassettes
• 20 Disposable pipettes
• 20 Sterile Safety Lancets
• 1 Sample Buffer
• 1 Colorimetric chart
• 1 Instruction for use

Product Feature

• Fast Test, get antigen test result within 10-15 minutes.
• High sensitivity and specificity
• Easy to operate, no need equipment, convenient and fast
• Require little Specimens

Advantage

• It can not only screen in the window period of infection oneset but also indicate the previous infection and reduce the rate of missed diagnosis
• Blood sample detection , simple samplig, simple operation
• Combined with nucleic acid kit to improve the screening rate of suspected patients
• Rapid screening within 10-15minutes, resukts effective for 15minutes
• Single detection, visual interpretation, no equipment, to adapt to the community
• Easy operation, compatible with different samples
• Room temperature storage

Notic

• Sample should be human serum, plasma and whole blood only, other body fluid samples are not tested and may cause incorrect or inaccurate results.
• All reagents have to be brought to room temperature (18 to 25 °C) before performing the test.

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.

LIMITATIONS

• 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.

Application

• Hospitals
• Enterprise
• School
• Community
• Family

FAQ

• MOQ:

We have the MOQ limit,which is 10000 pieces.

• Delivery date:

After order confirmed,we will arrange your order immediately,and offer you an
estimated delivery date.

• Payment Method:

Business to business account.

• Shipment:

We choose Air cargo or Ocean cargo.

• Trade Company or Manufacturer:

Manufacturer

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.