COVID-19 (Corona Virus Disease) is an infectious disease caused by the most recently discovered coronavirus. COVID-19 IgG/IgM Rapid Test ( Serum/Plasma/Whole Blood) is a rapid chromatographic immunoassay for the qualitative of IgG and IgM antibodies to COVID-19 in human serum, plasma or whole blood.
Easier: No special equipment needed, Intuitive visual interpretation.
Rapid: Quick sampling by fingertip blood, Result in 10 minutes.
Accurate: Results with IgG and IgM respectively, Validated using PCR and CT.
Application: For suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact of infected patients and people under quarantine control.
IgM POSITIVE: Two lines appear.
Colored lines should be in the control line region (C) and IgM test line region. No line appears in IgG test line region.
IgG and IgM POSITIVE: Three lines appear.
Colored lines should be in the control line region(C), IgG line test region and IgM test line region. The color intensities of the lines do not have to match.
IgG POSITIVE: Two lines appear.
Colored lines should be in the control line region(C) and IgG test line region. No line appears in IgM test line region.
NOTE: The intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the concentration of COVID-19 antibodies in the sample. Therefore, any shade of color in the IgG and/or IgM test line region(s) should be considered positive.
NEGATIVE: One colored line should be in the control line region (C). No line appears in IgG and IgM test line region(s).
INVALID: Control line fails to appear.
Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new cassette. If the problem persists, discontinue using the test kit and contact your local distributor.
The kit can be stored at room temperature or refrigerated (2-30℃). The test cassette is stable before the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
1.COVID-19 Rapid Test is for in vitro diagnostic use only. The test should be performed using serum, plasma or whole blood samples only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test.
2. In the early onset of fever, anti-COVID-19 IgM concentrations may be below detectable levels.
3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
4. Results from immunosuppressed patients should be interpreted with caution.
5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
6. If the test result is negative and clinical symptoms persist additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
UNscience (https://www.uni-science.com), a wholly owned subsidiary of Elabscience, specializes in the research and development, production and sale of in-vitro diagnostic reagents. Certified with ISO 13485 and other documents, UNscience sell its products all over the world.
The company has 100,000 grade GMP purification workshop and quality management system, three major technical platforms (Colloidal Gold Immunochromatographic Platform, Fluorescence Immunochromatographic Platform, and Pathological Diagnosis Antibody Platform). UNscience has the independent research and development and production capacity of core raw materials, and has successfully developed 27 POCT immunochromatographic quantitative detection products (colloidal gold and fluorescence), mainly covering cardiovascular and cerebrovascular diseases, kidney diseases, diabetes, infectious diseases, reproductive health, health examination and other.
A*********sSubmitted [ Jun 15 2021 ]
Asked: Does the COVID-19 IgG-IgM combined antibody test detect antibodies to COVID-19 Spike or Nucleocapsid protein (or both)? The previous response I received just directed me what type of antibody is targeted (IgG/IgM), not the target of the antibody itself (S/N). Thank you for the clarification!
adminSubmitted [ Jun 15 2021 ]
Answered: It mainly detects antibodies to COVID-19 Nucleocapsid protein.
A**aSubmitted [ Jun 12 2021 ]
Asked: Does the test target antibodies to Spike or Nucleocapsid or both?
adminSubmitted [ Jun 12 2021 ]
Answered: The test is target antibodies to Nucleocapsid