COVID-19 ANITBODY AND VIRUS TEST KITS
Zand Cell Covid 19 Test Kit
Since the outbreak of the Coronavirus end of 2019, it has been of utmost importance to detect as early as possible the virus in the human body. For this reason, a direct test has been developed on the basis of PCR technology, detecting specific genetic material of the virus. For this reason, this test was considered the golden standard until recently. Later also so-called antibody (immunoglobulin (Ig) tests became available, as the body’s innate immune system reacts to a virus by producing antibodies very rapidly within hours, the so- called IgM antibodies. A later reaction is an IgG which remains elevated up to several years. In this presentation the various methods and supplies of the antibody tests will be discussed.
COVID-19 RAPID TEST
Smart 8 Energy Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma, or whole bood in vitro.
This test has been widely used by medical staff around the world to combat COVID-19 infections globally. The test detects both early marker and late marker, IgM/IgG COVID-19 antibodies in human finger-prick or venous blood samples. The test can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic.
Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics, and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports, train stations, etc., giving it the potential to become a compelling force in the fight against this global threat.
FEATURES & BENEFITS
Smart 8 Energy Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma, or whole blood in vitro.
- Works with whole blood, serum, and plasma
- Test with both IgM & IgG antibodies
- Validated using PCR
- 2-10 minutes per test
- Intuitive visual interpretation
- No special equipment needed
HOW IT WORKS
- Collect blood/serum/plasma sample
- Add blood/serum/plasma sample to sample well
- Place 1 drop of buffer in sample well
- Read results after 2-10 minutes
Results are shown after 2-10 minutes and are valid 15 minutes after sample and buffer are combined in the cassette sample well.
Q & A
How does the COVID-19 Rapid Test work?
The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal anti-human IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.
How accurate is the COVID-19 Rapid Test?
In order to test the detection sensitivity and specificity of the COVID-19 IgG-IgM combined antibody test, blood samples were collected from COVID-19 patients from multiple hospitals and laboratories. The tests were done separately at each site. A total of 70 cases were tested: 20 (positive) and 50 (negative) clinically confirmed (including PCR test). Of the 70 blood samples, 21 tested positive and 49 tested negative, resulting in a sensitivity of 98.6%.
What do the results tell me?
A total of three detection lines are possible, with the control (C) line appearing when the sample has flowed through the cassette.
Note: The test is INVALID if the Control Line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are most likely reasons for control line failure. Review the procedure and repeat the process with a new test.
IgM Positive: This result indicates that you may have been infected and that your immune system is responding to the virus. If the test shows only IgM, you are likely in the early stage of the virus infection.
IgG Positive: This result indicates that you may have had COVID-19 in the recent past and have developed antibodies that may protect you from future infection. You are either over the infection or in its last stage. It is unknown at this point how much protection antibodies might provide against reinfection.
IgG and IgM Positive: This result indicates that you are likely in the middle stage of infection.
The COVID-19 IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of the test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.
The COVID-19 antibody rapid test kit is a rapid test that qualitatively detects severe acute respiratory syndrone coronavirus 2 (SARS-CoV-2). Using a rapid COVID-19 test provides an opportunity to identify more individuals who are infected or are unaware they have been previously infected.
Highest accuracy in the world: 99%
CE-certified for IVD use by POC (point of care)
Having an antibody test is helpful if:
- Your health care provider believes you may have been exposed to the coronavirus, which causes COVID-19, based on your current or previous signs and symptoms (e.g. fever, cough, difficulty breathing)
- You live in or have recently traveled to a place where transmission of COVID-19 is known to occur
- You have been in close contact with an individual suspected of or confirmed to have COVID-19
- You have recovered from COVID-19
Instructions for use
Please read the kit instructions carefully before use.
- Open the test sample and unpack the aluminum foil bag
- Remove the test cassette and place it on a horizontal table
- Add a drop of blood to the sample well of the test cassette
- Immediately add 2 drops of the sample dilution solution to the sample well
- Incubate for 2-10 minutes to achieve results (Note: reading beyond 30 minutes is invalid)
Antibody Test for IgG
This test detects IgG antibodies that develop in most patients within seven to ten days after symptoms of COVID-19 begin. IgG antibodies remain in the blood after an infection has passed. These antibodies indicate that you may have been infected and that your immune system is responding to the virus. If the test shows only IgG, you are either over the infection or in its last stage.
Antibody Test for IgM
This test detects IgM antibodies. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system is responding to the virus. If the test shows only IgM, you are likely in the early stage of the virus infection.