Vazyme 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

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Background and Intended Use

This product is intended for the detection of COVID-19 / 2019-nCoV. It is an in vitro diagnostic test for the qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in human serum, plasma, and whole blood (venipuncture) samples collected by healthcare professionals at the point of care.

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). SARS-CoV-2 is a new strain that has not been previously identified in humans. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Detailed investigations found that SARS-CoV was transmitted from civet cats to humans and MERS-CoV from dromedary camels to humans. Several known coronaviruses are circulating in animals that have not infected humans yet.

2019 Novel Coronavirus (SARS-CoV-2) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. Patients reported with SARS-CoV-2 viral infections had mild to severe respiratory illness with symptoms of: fever, cough, shortness of breath. There is an urgent need for rapid tests to manage the ongoing pandemic.The qSARS-CoV-2 IgG/IgM Rapid Test is intended for rapid and qualitative detection of antibodies indicative of SARS-CoV-2 infection and used as an aid for diagnosis of SARS-CoV-2 infection.

Principle of Detection

This product is based on the capture and solid-phase immunochromatography methods for determination. The specimen (whole blood/serum/plasma) flows from the blood separator through to the conjugate release pad (which occurs when the conjugation reaction between IgG/IgM antibody in the specimen and the antigen colloidal gold of 2019-nCoV to form an immune complex of IgG/IgM and colloidal gold-labeled antigen) due to capillary action.

The sample then migrates to a capture zone of nitrocellulose membrane-immobilized antibody (mouse-anti-human IgM antibody) to form an immune complex of colloidal gold-labeled antigen, IgM antibody, and mouse-anti-human IgM antibody, thereby generating an IgM red line. The unreacted immune complex continues to flow upward, will be captured by the mouse-anti-human IgG antibodies to form an immune complex of colloidal gold-labeled antigen, IgG antibody, and mouse-anti-human IgG antibody, thereby generating an IgG red line.

The remaining uncaptured immune complex moves upward, combining with the C line (quality control line) to indicate the completion of this reaction.

Components Composition

Test Cassette

Aluminum foil pouch, desiccant, test strip and plastic card. Test strip composing blotting paper, nitrocellulose membrane, sepcimen separator, colloidal gold-labeled pad and PVC. IgM line (test line) coating 1.0 mg/mL mouse-anti-human IgM antibody. IgG line (test line) coating 1.0 mg/mL mouse-anti-human IgG antibody. C line (quality control line) coating 1.0 mg/mL actin protein C. Conjugate release pad containing 40 OD 2019-nCoV antigen-colloidal gold conjugate complex.

Specimen Dilution

HEPES Buffer containing casein (0.1 M), 5 mL/bottle


50 droppers/pack

Required but not supplied: Clock or timer.

Storage and Shelf-Life

This kit should be stored at 4C-30C for 18 months in a sealed condition. Once the imner packaging of the strip is opened (4 C - 30 C, humidity <65%), it must be used in 1 hour. The opened specimen dilution buffer should be stored at 4 C, and it is valid within 1 month. It is recommended to mark the opening date of the specimen dilution buffer.

Directions for Use

1. The test strips must be at room temperature before use, and the test must be opened at room temperature.

2. Remove the test strips from the foil pouch and place on a flat, dry table.

3. Using the dropper provided, add 1 drop (approx 20 uL) of the serum, plasma, or whole blood specimens to the oval sample slot. Then, add 3 drops of dilution buffer (about 60 uL) to the sample. Begin timing.

4. Read the results after 10 minutes.

Please see full instruction booklet for full information and technical specifications.

Samples and Handling Procedures

1. Suitable specimen types: serum, plasma, and whole blood.

2. Sediment and suspended matter in the specimen may affect the test result. It should be removed by centrifugation at 3000 g for 10 minutes.

3. Severe haemolytic, lipemic, and turbid specimens should not be used.

4. Whole blood/plasma specimens can be treated with heparin sodium or EDTA anticoagulant. After specimen collection, the test should be completed within the same day. If not, please store it using the following protocol. For whole blood specimens: store at 2-8 C for 3 days. For serum/plasma specimens, store at 2-8 C for 7 days, or at <-20 C for 12 months.

5. Specimens must be fully restored to room temperature (18-28 C) before testing. Freeze-preserved specimens should be completely melted, reheated, and mixed thoroughly before use.

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