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.
Product: | SARS-CoV-2 Neutralization Antibody Rapid Test , Whole
Blood/Serum/Plasma Specimen |
Brand: | Citest |
Format: | Cassette |
Certificate: | CE |
Pack: | 25T |
Shelf Life: | 2 Years |
Features 2: | High Accuracy |
Cat. No.: | ICN-402 |
Principle: | Chromatographic Immunoassay |
Specimen: | WB/S/P |
Reading Time: | 10 Minutes |
Storage Temperature: | 2-30°C |
Features 1: | Fast Results |
Features 3: | Easy Visually Interpretation |
【INTENDED USE】
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.
【PRINCIPLE】
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.
【REAGENTS】
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.