50µL Serum Whole Blood 25pcs/ Box Rapid Test Kit Check Neutralizing Antibody after Vaccination

COVID-19 Neutralizing Antibody Rapid Diagnostic Test Cassette One Month Check after Last Vaccination Dose

 ² Specimen: Serum/Plasma/Whole Blood or Fingertip Blood.

 ² Usage: Detection of Neutralizing (NAb) that blocks RBD-ACE2 interaction.

² Fast: 15 Minutes

² Cheap: Lower cost with high efficiency

【PRODUCT NAME】

COVID-19 (2019-nCoV) Neutralizing Antibody Test Kit (Colloidal Gold method)

【PRINCIPLE OF NEUTRALIZING ANIBODY】

This kit uses immunochromatography. The test card contains: 1)colloidal gold-labeled recombinant novel coronavirus S-RBD antigen and quality control antibody gold markers; 2) two detection lines (T1 line and T2 line) and one quality Control line (C line) of nitrocellulose membrane.The T line is immobilized with Human ACE2 protein for detecting novel coronavirus neutralizing antibody and the C line is immobilized with a quality control antibody.

When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains Novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The rest gold-labeled novel coronavirus antigen in immune complex will be captured by the human ACE2 protein immobilized on the membrane to form a purple-red T1 and/or T2 line,the intensity of T line Inversely proportional to the concentration of antibody.

The test card also contains a quality control line C .The fuchsia quality control line C should appear regardless of whether a test line appears.If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.

【STORAGE & SHELF LIFE OF NEUTRALIZING ANIBODY】

• Store at 2～30℃ in the sealed pouch for 12 months.
• Please use it within 1 hour after opening the inner package, the test cassette would be invalid due to moisture absorption.

【OPERATION PROCEDURE OF NEUTRALIZING ANIBODY TEST】

Step 1: Remove the sample to be tested and the reagent required from the storage condition and balance it to room temperature (15 ~ 30℃);

Step 2: To prepare for the test, tear the aluminum foil bag, .and take out test cassette, put it on the horizontal table;

Step 3: Label the sample number on the test cassette;

Step 4: Before the test, thoroughly mix the sample (serum, plasma or whole blood sample) and add 2 or 3 drops of the sample into the sample well on the test cassette;

• Serum or Plasma Specimens:

Use the Dropper to transfer 2 drops of serum/plasma (approximately 50µL) into the specimen well of the test cassette, then add 1 drop of buffer. And start the timer.

• Whole Blood (Venipuncture/Fingerstick) Specimens:

Use the Dropper to transfer 3 drops of whole blood (approximately 75µL) into the specimen well of the test cassette, then add 1 drop of buffer. And start the timer.

Step 5: Timing, 10-15 minutes to determine the test result.

Do not interpret the result after 15 minutes.

【PRECAUTIONS OF RAPID TEST】

1) Do not open pouches until ready to perform the test to protect the test cards from getting damp exposing in air for too long.

2) The test cards can be stored in room temperature with sealed pouches. And the test cards shored in low temperature should reach room temperature before testing.

3) There should be appropriate bio-safety assurance procedure for infectious sources or potential infectious sources. Some relevant precautions are showed below:

3.1 Wear disposable gloves to deal with samples, or sterilize reagents.

3.2 Sterilize spilled samples or reagents with sanitizer.

3.3 Sterilize and cope with all of samples, reagents and potential contaminant with relevant local regulations.

【LIMITATIONS OF RAPID TEST】

1) The test is for in vitro diagnostic use only.

2) The test results of this kit are for clinical reference only. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other

laboratory tests, and treatment response. 

Please note that rapid test diagnostics is not the gold standard of Neutralizing Antibody, there is limit of its sensitivity. 

It is only convenient for early diagnosis.