The SARS-CoV-2 Antibody Test was developed by Sinocare.
This is a rapid blood test used to qualitatively detect the presence of antibodies (IgG &IgM)in serum, plasma or whole blood samples.
This blood test takes 15-20 minutes and does not require any refrigeration or instruments.
This test can be used in laboratories, emergency rooms, physician’s offices, nurses’ stations,medical clinics, pharmacies, drive through test stations, and other medical facilities toidentify if symptomatic patients may be infected with COVID19.
What is the SARSThis test has not been approved by the FDA.
What comes in the SARS-CoV-2 Antibody Test Kit?
Depending on your box specification, each test kit contains:
Test strip (s)
Sample diluent (dropping bottle)
Materials Required but Not Provided:
Sample collection containers
Personal protective equipment (protective gloves, surgical mask, goggles and lab coat).
To administer the test, a medical professional collects 10 μL of whole blood, serum, or plasma via venous draw collected in an EDTA or heparin tube. The collected sample is then transferred with the provided capillary tube and applied to the test strip’s sampling area. 2-3 drops of buffer solution are applied to the sampling area. Test time = 15-20 minutes.
The specimen migrates by capillary action along the test strip. During the test, specific SARS-CoV-2 antibodies in the blood sample conjugate with the colloidal gold marker recombinant antigen to form an immune complex. If the blood sample contains IgG and or IgM antibodies, these will be captured in the test area and a visible line will appear in the observation area.
Interpretation of Results for the SARS-CoV-2 Antibody Test
Positive Result Two red lines will appear. One should be in the Control region (C) and the other line with be in the Test zone (T).
Presence of antibody line in test area implies that the person has been exposed to the virus and has developed antibodies.
One line appears in the Control zone(C). No red line appears in Test zone (T). Person might have been exposed to the virus but has not yet produced antibodies against Covid-19 and is susceptible to infection.
Control line fails to appear. Repeat with new test strip and follow test method.
Performance Characteristics SARS-CoV-2 Antibody Test
1. Clinical Evaluation Total test on 140 subjects: 60 confirmed patients, 60 excluded and 20 cured patients
Negative reference coincidence rate(-/-)
Positive reference coincidence rate (+/+)
SARS-CoV-2Antibody Test Strip
(Colloidal Gold Method)
Facts Regarding SARS-CoV-2 Antibody Test
Antibody tests are NOT meant to diagnose active corona virus infections.
The presence of the antibodies may mean that the person hassome immunity but experts are unsure how long the antibodies will remain present.
Positive results can be indicative of acute or recent infection.
Negative results do NOT prevent SARS-CoV-2 infection.
The sensitivity of the test is unknown for early infection.
False positive results may occur due to pre-existing antibodies from other corona viruses or causes.