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COVID-19 IgG/IgM Rapid Test

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Cat Number:  UNCOV-40
Lead Time:   7~10 days

Sample:  Serum/ Plasma/ Whole Blood

Format:  Cassette

Reading Time:  10 minutes

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COVID-19 IgG/IgM Rapid Testing Kit

COVID-19 (Corona Virus Disease) is an infectious disease caused by the most recently discovered coronavirus. COVID-19 IgG/IgM Rapid Test (Whole Blood/ Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma.

Product Features

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.

How Does the Coronavirus Rapid Test Kit Work?

Test Procedure

Testing Results

Test Procedure

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.

Kit Components & Storage

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.

Materials supplied:
*Test cassettes
*Droppers
*Package inserts
*Buffer bottle
Storage:
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.

FAQs

In order to test the detection relative sensitivity and specificity of the COVID-19 IgG-IgM combined antibody test, serum samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 1585 cases were tested: 421 (positive) clinically confirmed (including PCR test) COVID-19-infected patients and 1164 negative. The test results showed that the product has a relative sensitivity of 98.81% (95% CI: 97.25%, 99.61%) and a relative specificity of 98.02% (95% CI: 97.05%, 98.74%).
The coronavirus testing kit price is mainly related to the quantity you required. Buy COVID-19 igm/igg rapid test kits please feel free to contact us. We will feedback you ASAP. (Normally in less than 24h.)
Please make sure the kit is recovered into room temperature and perform the kit under the room temperature(15℃~30℃). The results will be affected by high or low temperature.
Serum and plasma specimens may be stored at 2-8℃ for up to 3 days. For long-term storage, specimens should be kept below -20℃. Whole blood collected by venipuncture should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingertip should be tested immediately.
The test strip consists of a sample pad and a chromatographic membrane (the detection area is coated with a mouse anti-human IgM monoclonal antibody and a mouse anti-human IgG monoclonal antibody and goat anti-mouse IgG antibody), colloidal gold binding pad (coated with colloidal gold-labeled recombinant novel coronavirus (COVID-19) antigen and mouse lgG antibody), liner and absorbent pad.
The COVID-19 IgM/IgG rapid testing kit can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of 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.

Limitations of COVID-19 IgM/IgG Rapid Test Kit

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.

About UNscience

UNscience (https://www.usciencecorp.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.

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