CovidCheck SARS-CoV-2 Rapid IgG/IgM Test Kit

CovidCheck™ SARS-CoV-2 Ropid IgG/IgMTest is a colloidal gold enhanced, rapid immunoassay far the qualitative detection of SARS-CoV-2 lgG and lgM antibody in serum, plasma and whole blood samples from patients with suspected SARS-CoV-2 infection

CovidCheck™ SARS-CoV-2 Rapid IgG/IgM Test

CovidCheck™ SARS-CoV-2 Ropid IgG/IgM Test is a colloidal gold enhanced, rapid immunoassay far the qualitative detection of SARS-CoV-2 lgG and lgM antibody in serum, plasma and whole blood samples from patients with suspected SARS-CoV-2 infection. This product is for in vitro emergency use only during the pneumonia epidemic of the SARS-CoV-2 infection since December 2019. The test kit should be complied with the relevant requirements of the “Pneumonitis Diagnosis and Treatment Scheme for SARS-CoV-2 “and “Pneumonitis Prevention and Control Scheme far SARS-CoV-2” in use. The SARS-CoV-2 is a new type of coronavirus belonging to the genus Beta- it has a capsule, and its particles are round or oval, eften polymorphous, with a diameter of 60-140 nm. lts genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Current research shows that it has more than 85% homology with bat 5AR5-like coronavirus (bat-SL-CoVZC45). in vitro isolation and culture, SARS­CoV-2 can be found in human respiratory epithelial cells in about 96 hours, while it takes about 6 days ta isolate and culture in Vera E6 and Huh-7 cell lines.

PRINCIPLE OF THE TEST

SARS-CoV-2 IgG/IgM Rapid Test Kit

The SARS-CoV-2 Rapid IgG/IgM Test is a Colloidal gold enhanced capture immunoassay far the qualitative determination of SARS-CoV-2 lgG and lgM antibody in human serum, plasma, and whole blood samples. The product is pre-embedded with recombinant SARS-CoV-2 antigen and rabbit antibody on the nitrocellulose membrane, and coated with anti-human lgM, anti-human lgG and goat anti-rabbit antibody respectively on the T1 line, T2 line and C line on the nitrocellulose membrane. When a positive sample is tested, the SARS-CoV-2 lgM and/or lgG antibody combines with the colloidal gold labeled SARS-CoV-2 antigen to form a complex. Under the action of chromatography, the complex flows along the membrane, when it passes T1 line and/or T2 line it combines with the anti-human lgM and/or lgG ta form a colloidal gold complex to show color, and the gold colloidal labeled rabbit antibody combines with Goat anti-rabbit antibody at C lint to show color. Negative samples only show color on C line.

STORAGE AND STABILITY

STORAGE AND STABILITY

Storage: Stere in a dry place at 2-30°C
Shelf life: 24 months.
• The test device should be used as soon as possible after being removed from the aluminum foil bag.
• MFD date and EXP dates are marked on aluminum foil bag.

SAMPLE REQUIREMENTS


1. Open the aluminum fail bag, take aut the test card, and lay it flat on a flat operating table and number it.
2. Add 1 drop (l0µL) of specimen (whole blood/serum/plasma) ta the sample well of the test card using the plastic dropper provided according ta the figure.
3. Then add 2 drops (80 µL) of sample diluent ta the sample well.

SPECIMEN REQUIEMENTS

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1. it is suitable far serum, plasma, ar whole blood samples. The commonly used anticoagulants (heparin, EDTA ar sodium citrate) have na effect on the results of this kit.
2. Samples should be collected according ta routine clinical methods and avoid hemolysis.

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3. lf serum ar plasma specimens are ta be tested in 5 days, they should be refrigerated at 2°C~8°C. Storage at -20°C should not exceed 3 months. Far long time storage, they should be 70°C cryopreservation and avoid repeated freezing and thawing (na more than 3 times).

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4. Whole blood samples can be stored at 2°C~8°Ckept in refrigerator far 3 days with na cryopreservation.
5. Restore the sample ta room temperature before test.
6. Obvious hemolysis, lipohemia and jaundice samples should not be used.
7. Transportation of the samples should be sealed ice cup with ice ar sealed foam box with ice.

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