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Cassette COVID-19 IgG Rapid Test Kit RBD Antibody Test Chromatographic Immunoassay

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Cassette COVID-19 IgG Rapid Test Kit RBD Antibody Test Chromatographic Immunoassay

City & Province hangzhou zhejiang
Categories Dyestuff Intermediates
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Product Details

COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma),COVID-19 RBD IgG, Antibody Test

 

PrincipleChromatographic Immunoassay
FormatCassette
SpecimenWB/S/P
CertificateCE
Reading Time10 minutes
Pack25T
Storage Temperature2-30°C
Shelf Life2 Years

 

Application

 

A rapid test for the qualitative detection of IgG antibodies to SARS-CoV-2 S-RBD and/or Nucleocapsid protein in human whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.
 
INTENDED USE 
 
The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) and/or Nucleocapsid protein in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.
 
False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.
 
PRINCIPLE
 
The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Anti-human IgG is coated in test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region.
 
If the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in test line region as a result of this. If the specimen does not contain IgG antibodies to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking hasoccurred.
 
DIRECTIONS FOR USE
 
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
 
1. Remove the test from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
 
2. Place the test on a clean and level surface.
 
3. Add Specimen and Buffer to the test cassette and read results according to illustrations below.
Note: When adding specimen and buffer, add them to specific well only. Not to use the buffer beyond 6 months after opening the vial.
For Venous Whole Blood Specimen, Serum or Plasma Specimen
 
For Serum or Plasma specimen:
Use a dropper: Hold the dropper vertically, draw the specimen to the fill line (approximately 10uL), and transfer the specimen to the Specimen well (S), then add 2 drops of buffer (approximately 80 uL) to Buffer well (B), and start the timer.
 
To use a pipette: To transfer 10 uL of specimen to the Specimen well(S), then add 2 drops of buffer (approximately 80 uL) to Buffer well (B), and start the timer
 
For Venous Whole Blood specimen:
Use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20 μL) of specimen to the Specimen well (S). Then add 2 drops of buffer (approximately 80 uL) to Buffer well (B) and start the timer.
 
Use a pipette: To transfer 20uL of whole blood to the Specimen well (S), then add 2 drops of buffer (approximately 80 uL) to Buffer well (B), and start the timer Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
 
 
For Fingerstick Whole Blood
 
1. Use alcohol pad to clean the fingertip of the middle finger or ring finger as the puncture site.
 
2. Carefully rotate and pull off the lancet cap.
 
3. Push the sterile lancet firmly into the fingertip of the middle finger.
 
4. Wipe off the first drop of blood. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
 
5. Hold the dropper vertically, draw the blood to 1cm above the fill line and transfer 1 full drop of blood (approximately 20 uL) to the specimen well (S), then add 2 drops of buffer (approximately 80 uL) to the buffer well (B), and start the timer.
 
6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
 
 
Sensitivity and Specificity
 
The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) was compared with RT-PCR/CLIA result; the results were tabulated as below.
 
Clinical study for immune response to SARS-CoV-2 infection:

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