SARS-CoV-2 Neutralization Antibody Rapid Test , Whole Blood/Serum/Plasma specimen
A rapid test for the qualitative detection of SARS-CoV-2 Neutralization Antibody in human whole blood, serum or plasma specimens.For professional in vitro diagnostic use only.
|SARS-CoV-2 Neutralization Antibody Rapid Test , Whole Blood/Serum/Plasma Specimen
|Easy Visually Interpretation
The SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the cell surface receptor ACE2 in human whole blood, serum or plasma. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. Results are for the detection of SARS-CoV-2 neutralization antibodies. Positive results indicate the presence of neutralization antibodies to SARS-CoV-2.
This test contains two key components: the recombinant SARS-CoV-2 RBD fragment , labeled by colloidal gold, as tracers; and the human ACE2 receptor protein (hACE2) , coated with cellulose nitrate membrane. When specimens are added to the sample pad, neutralizing antibodies, if present in the specimen, will bind to the RBD labeled colloidal gold and block the protein-protein interaction between RBD and hACE2. The unbound RBD labeled colloidal gold as well as any RBD labeled colloidal gold bound to non-neutralizing antibody will be captured on the test line. The control line acts as a procedural quality control.
The test contains recombinant SARS-CoV-2 RBD fragment coated particles as a detection reagent and human ACE2 receptor protein coated with cellulose nitrate membrane as a capture reagent.
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to equilibrate to room
temperature (15-30°C) prior to testing.
1. Take out the test from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a flat and clean surface. For Serum or Plasma specimen:
• Use a dropper: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50L) to the specimen well (S). Start the timer.
• Use a pipette: Transfer 50uL of serum or plasma to the specimen well(S), then start the timer. For Whole Blood specimen:
• Use a dropper: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75L) to the specimen well (S). Then add 1 drop of buffer (approximately 40uL) and start the timer.
• Use a pipette: Transfer 75uL of whole blood to the specimen well(S), then add 1 drop of buffer (approximately 40uL) and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
【SPECIMEN COLLECTION AND PREPARATION】
1. The SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) can be performed using whole blood, serum, or plasma specimen.
2. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 7 days. For long term storage, they should be kept below -20°C. Whole blood specimens should be stored at 2-8°C if the test is to be run within 2 days after collection. Do not freeze whole blood specimens.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
4. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
5. EDTA-K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the anticoagulant for collecting the specimen.