COVID-19 Antibody Test Kit
EUA Approved COVID-19 Rapid IgM/IgG Antibody Test Kit (Not For Home Use)
Please call 1-800-803-7854 or click here to request for quote for your COVID-19 Rapid Antibody Test Kit
Test kit Overview
The SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate).
The SARS-CoV-2 IgM/IgG Antibody Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.
Antibody Test Kit Features:
- Uses 10uL of sample volume
- Dual differential detection of IgG and IgM antibodies of SARS-CoV-2
- Results seen in 15 minutes
- Visual interpretation of results, including an internal control
- No special additional equipment needed
- Room temperature storage or refrigeration (2-30⁰C / 35.6-86⁰F)
Test Principle
The SARS-CoV-2 IgM/IgG Antibody Test is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N-protein antigen and mouse anti human IgM/IgG antibody. SARS-CoV-2 IgM/IgG in the sample reacts with SARS-CoV-2 recombinant N-protein antigen bound to gold particles. This complex migrates along the membrane and reaches the IgM/IgG test line (T) which contains mouse anti human IgM/IgG antibody against SARS-CoV-2 IgM/IgG complex. The sample diluent is supplied for the lateral chromatography process, to provide a suitable environment for the reaction of antigen and antibody.
The COVID-19 Rapid Antibody IgM/IgG Test Kit contains the following:
- Instructions for Use
- Test Cards
- Sample Diluent (Phosphate buffer containing casein)
- Dropper
COVID-19 Rapid Antibody Test Kit Result Judgement
- IgM(-) & IgG(-): Negative
- IgM(+) & IgG(-): Positive; Indication of an acute infection
- IgM(+) & IgG(+): Positive; Indication of an ongoing infection
- IgM(-) & IgG(+): Positive; Indication of a past infection
Performance Characteristics of the Antibody Test
SARS-CoV-2 IgM/IgG Antibody Test Kit Clinical Data
SARS-CoV-2 IgM/IgG Antibody Test Kit Sensitivity
SARS-CoV-2 IgM/IgG Antibody Test Kit Specificity
SARS-CoV-2 IgM/IgG Antibody Test Kit Different Stages
Sample Source: Samples were collected from 197 serum samples of 40 patients with COVID-19 on 1-7 days, 8-14 days, and at least 15 days after the onset of the disease to evaluate the coincidence rate of IgM / IgG over time.
Frequently Asked Questions
Is this a combined test?
Is this test approved by the FDA?
Yes. ThermoGenesis Corp. has entered into a supply agreement with BioHit Healthcare (Hefei) Co., Ltd. to market, under the ThermoGenesis brand, its SARS-CoV-2 IgM/IgG Antibody Test Kit, which has already received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
What is this test used for?
This test is only provided for use by clinical laboratories or to health care workers for point of care testing, and not for at home testing.
However, results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods, such as molecular testing.
How quickly can this test yield results?
Results are visible as little as 15 minutes after sample and diluent are placed in the test card.
Can I purchase this test for at home use?
How can I order these test kits?
You can request a quote on this page and we will send you a quote. Once you have reviewed the quote, you may submit your purchase order and we will process your order.
How can I stay informed about the availability of the COVID-19 IgG/IgM test?
Healthcare professionals, institutions, and other interested parties with questions about the Company’s recently licensed SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Test can send email inquiries to info@immunecyte.com
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