SARS-CoV-2 Neutralizing Antibody Rapid Test Kit

Intended Use

• The kit is intended for the semi-quantitative determination of neutraliaing antibodies to SARS-Cov-2 in human serum, plasma, fingerstick wholeblood or venous whole bood specimens.
• 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.
• False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

Specifications

TEST PRINCIPLE

The test employs the sandwich immunoassay to detect the total neutralizing antibodies. When the specimen is added into the sample well of the test cassette, the neutralizing antibodies in the specimen will bind to the gold labeled S-RBD, the antibody-antigen complex goes forward on the membrane. At the T line, the complex will be captured by another recombinant viral S-RBD protein and display as a red line, if neutralizing antibodies are present in the specimen. If no neutralizing antibodies in the specimen or the amount of them is too low, the gold labeled S-RBD will go through at the T line, and no visible red line will display. The color intensity of the T line is correlated with the level of the neutralizing Antibody in specimen.

Main Components

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

Product Feature

• Test the vaccine of the effectiveness
• Don't need complex operation required
• Read result within 15 min
• Sample and safe to use
• Fast recation
• High Accuracy, Sensitivity and Specificity

Advantage

• Accurate: the product has a high accurate serology test for Neutralizing Antibodies detection
• Easy to learn and use
• Less sample volume. Support sample type of fingertip blood
• Read test result visualli, no need of test equipment

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.
  2.The test result is invalid after 20 min.

Applicaton

• Evaluation of Vaccination
• Diagnosis of Infection
• Assessment of Convalescent Plasama Therapy
• Epidemiology Research

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.