COVID-19 IgG/IgM Rapid Test Kit

  • Cat.No.:UNCOV-40
  • Format:GICA
  • Reading Time:10 min
  • Sample Type:Serum/ Plasma/ Whole blood
  • Size:40T/kit
  • Lead Time:Order now, ship in 3 days
Filter:SARS-CoV-2

Product Introduction

COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in serum, plasma, or whole blood. This test consists of two test lines, an IgG line and an IgM line, which is pre-coated with two mouse anti-human monoclonal antibodies separately. During testing, the sample reacts with COVID-19 antigen-coated on conjugated pad. As the complex continues to travel up the strip, the anti-COVID-19 IgM antibodies are bound on the IgM line, and the anti-COVID-19 IgG antibodies are bound on the IgG line. The control(C)line appears when sample has flowed through the strip. The presence of anti-COVID-19 IgM and/or IgG will be indicated by a visible test line in the IgM and IgG region. To serve as a procedural control, the control line should always appear if the test procedure is performed properly and the reagents are working as intended.

Product Features

Sensitivity is 98.81% (95%CI: 97.25%, 99.61%) and specificity is 98.02% (95%CI: 97.05%, 98.74%).

Procedure is simple and time saving.

Obtain CE certification.

Suitable for large scale rapid screening.

No instrument needed.

Test Procedure

Bring the pouch to room temperature before opening. Take the cassette from the sealed pouch and use it within ONE hour.

Place the test cassette on a clean and flat surface.

For Serum or Plasma samples: add 20 μL of sample into sample well, then add 1 drops of buffer and start the timer. Avoid trapping air bubbles into the sample well.

For Whole Blood samples: add 20 μL of whole blood sample into sample well, then add 3 drops of buffer as soon as possible and start the timer. Avoid trapping air bubbles into the sample well. Note: It’s recommended to add 1 more drop of buffer if the liquid flows too slowly.

Wait for the colored line(s) to appear. The result shall be read at 10 minutes. The result is valid within 20 minutes.

Testing Results

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 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).

Kit Components & Storage

Components
1. Test cassette
2. Buffer
3. Desiccant
4.  Dropper
Storage
The kit can be stored at 2-30℃ for 18 months. Do not use after the expiration date.

About UNscience

UNscience, 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.