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

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

• 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.