Specifications
Brand Name :
Citest
Model Number :
ICSG-CT402H
Certification :
CE1434
Place of Origin :
-
MOQ :
N/A
Packaging Details :
1T,2T,5T,7T,10T,20T/25T
Product :
SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood)
Cat. No. :
ICSG-CT402H
Specimen :
Fingerstick Whole Blood
Pack :
1T,2T,5T,7T,10T,20T/25T
Principle :
Chromatographic Immunoassay
Format :
Cassette
Certificate :
CE1434
Reading Time :
10 minutes
Storage Temperature :
2-30°C
Shelf Life :
2 Years
Sensitivity :
97.5%
Specificity :
99.4%
Accuracy :
98.2%
Features :
High accuracy
Description

SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood), CE1434,detection of SARS-CoV-2 S-RBD IgG

Product: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood),Cov/id-19 Antibody Test
Principle: Chromatographic Immunoassay
Certificate: CE1434
Pack: 1T,2T,5T,7T,10T,20T/25T
Shelf Life: 2 Years
Specificity: 99.40%
Format: Cassette
Specimen: Fingerstick Whole Blood
Reading Time: 10 Minutes
Storage Temperature: 2-30°C
Sensitivity: 97.50%
Accuracy: 98.20%

SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood)

INTENDED USE
The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human Fingerstick Whole Blood approximately 10 days after vaccination. 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 S-RBD IgG antibodies. Positive results indicate the presence of IgG antibodies to SARS-CoV-2.
STORAGE
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). DO NOT FREEZE.
Do not use the kit after expiration date printed on the test pouch.
Do not open the foil pouch until you are ready to use the test.
Test cassette should be used within 1 hour after opening.
TESTING
Before testing: Allow the test and buffer to room temperature (15-30°C) before testing.
Wash hands thoroughly in warm water and dry. Take out the test cassette from the foil pouch and use it within 1 hour. Do not touch the test reaction area (strip area beside to C, T, S) of the test strip. Best results will be obtained if the assay is performed immediately after opening. Place the test on a flat and clean surface.
1. Use alcohol pad to clean the fingertip of the middle finger or ring finger as the puncture site. Let it dry for 10 seconds.
2. Carefully rotate and pull off the lancet cap. Only open the lancet before testing.
3. Press the sterile lancet firmly against the fingertip of the middle finger or ring finger
4. To increase blood flow, use the thumb and forefinger to gently apply pressure around the puncture site.
5. Without squeezing the dropper, put it in contact with the blood.
Draw the blood to the line indicated on the dropper. You may massage again your finger to obtain more blood if the line is not reached.
Avoid air bubbles, discard the blood into a plastic bag (e.g., biosafety bag) if air bubbles happen, then repeat above collecting steps.
6. Put the end of the dropper in contact with the center of the specimen well(S) and release all the blood immediately after collection.
7. Add 2 drops of buffer to the Specimen well(S) and start the timer. Do not move the test during test developing.
8. Read results at 10 minutes. Do not interpret the result after 20 minutes.
CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood
Note: After test is completed, thoroughly clean the surface of testing. Do not reuse any used components of the kit.
Place all the used components of the test kit into the plastic bag (e.g., biosafety bag) and tightly seal it, then dispose according to local regulation.
READ RESULTS

CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood

POSITIVE:* Two colored lines appear. One colored line in the control region (C) and another colored line in the test region (T). Positive result
in the test region indicates there is SARS-CoV-2 S-RBD IgG detected in the sample.
CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood
NEGATIVE: One colored line appears in the control region (C). No colored line appears in the test line region (T).Negative result means SARS-CoV-2 S-RBD IgG Antibody is not detected in the sample.
CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact with your healthcare provider.
QUESTIONS & ANSWERS
1. How can I know my test is working well?
If your test is working well, you will see a line in the control line area(C) on the test cassette. If there is no line in the control line area, your test did not work and the test result is invalid.
2. When is the best time to run the test?
Test can be done at any time of the day.
3. How soon can I read my results?
You can read your results at 10 minutes after sample and buffer adding, do not read result after 20 minutes.
4. Can the result be wrong? Are there any factors that can affect the test result?
The results will only give accurate results as far as the fresh fingerstick whole blood used and followed the instructions carefully. Nevertheless, the result can be incorrect. Non-SARS-CoV-2 coronavirus strains or other interference factors may cause a preliminary Positive Result.
5. How to read the test if the color and the intensity of the lines are different?
The color and intensity of the lines have no importance for result interpretation. The test should be considered as Positive whatever the color intensity of the test line (T) is.
6. What should I do if the test result is positive but I was not vaccinated?
If your test result is positive but you were not vaccinated, you should isolate yourself and contact with your local healthcare provider to perform PCR test in case of COVID-19.
7. What should I do if the test result is negative but I was vaccinated?
If you were vaccinated and the test result is negative, it may because the antibody level is below the detection level or no SARS-CoV-2 S-RBD IgG antibody detected; it is recommended to run a new test several days later. If the test result is still negative, contact with your healthcare provider.
SUMMARY
Coronaviruses infect many species of animals including humans, causing acute and chronic diseases.1 The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source.
Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. All coronaviruses share similarities in the organization and expression of their genome, in which 16 nonstructural proteins (nsp1 through nsp16), encoded by open reading frame (ORF) 1a/b at the 5’ end, are followed by the structural proteins spike (S), envelope (E), membrane (M), and nucleocapsid (N), which are encoded by other
ORFs at the 3’ end.2 The virus gains entry to the host cell through binding of the S protein receptor-binding domain (RBD) to the angiotensin-converting enzyme 2 (ACE2) receptor on target cells, particularly respiratory epithelial cells of the host. Upon infection with SARS-CoV-2, the host usually mounts an immune response against the virus.
Order Information
Cat. No. Product Specimen Pack
ICSG-CT402H SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) Fingerstick Whole Blood 1T,2T,5T,7T,10T,20T/25T

CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood

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CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood

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Brand Name :
Citest
Model Number :
ICSG-CT402H
Certification :
CE1434
Place of Origin :
-
MOQ :
N/A
Packaging Details :
1T,2T,5T,7T,10T,20T/25T
Contact Supplier
CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood
CE1434 SARS-CoV-2 S-RBD IgG Antibody Rapid Test Fingerstick Whole Blood

CITEST DIAGNOSTICS INC.

Verified Supplier
3 Years
zhejiang, hangzhou
Business Type :
Manufacturer, Exporter, Trading Company
Total Annual :
80000000-100000000
Employee Number :
500~10000
Certification Level :
Verified Supplier
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