Cassette COVID-19 IgG Rapid Test Kit RBD Antibody Test Chromatographic Immunoassay
Brand Name:Citest
Certification:CE
Model Number:INCPG-402
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
Place of Origin:-
Contact Now
Add to Cart
Verified Supplier
Location:
Hangzhou Zhejiang
Address:
170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
Supplier`s last login times:
within 28 hours
Product Details
Company Profile
Product Details
COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma),COVID-19 RBD IgG, Antibody Test
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 25T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 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:
Cassette COVID-19 IgG Rapid Test Kit RBD Antibody Test Chromatographic Immunoassay
Inquiry Cart
0