Intended Use
The ELISA agile SARS-CoV-2 IgG test is qualitative and quantitative immunoassays for the detection of human antibodies in serum or plasma directed against SARS-CoV-2.
Contents of Kit
1. Break apart microtiter test strips each with eight antigen coated single wells (altogether 96), 1 frame. The coating material is inactivated. 12. Unopened / After opening: at 2-8°C in closed aluminum bag with desiccant. See expiry date 6 months
2. Standard serum (ready-to-use), Human serum in protein-containing phosphate buffer; negative for anti-HIV Ab, HBs-Ag (Hepatitis B-Virus surface Antigen) and anti HCV Ab; Preservative: <0.1% sodium azide; coloring: Amaranth O. 2 × 1 ml. Unopened / After opening: at 2-8°C. See expiry date 6 months
3. Negative control serum (ready-to-use), Human serum in protein-containing phosphate buffer; negative for anti-HIV Ab, HBs-Ag (Hepatitis B-Virus surface Antigen) and anti-HCV Ab; Preservative: <0.1% sodium azide; coloring: Lissamin Green V. 1 ml. Unopened / After opening: at 2-8°C. See expiry date 6 months
4. Anti-human IgG conjugate (ready-to-use), Anti-human IgG polyclonal antibody, conjugated to alkaline phosphatase, stabilized with protein stabilization solution; Preservative: <0.1% methylisothiazolone, <0.1% bromnitrodioxane.14ml. Unopened / After opening: at 2-8°C. See expiry date 6 months
5. Washing solution concentrate (sufficient for 1000ml), Sodium chloride solution with Tween 20 and 30mM Tris-HCl, pH
7.4; Preservative: <0.1% sodium azide. 33.3ml. Unopened / after opening at 2-8°C, See expiry date. Working dilution at 2-8°C, 2 weeks. Working dilution at room temperature, 1 week
6. Dilution buffer (ready-to-use), Protein-containing phosphate buffer with Tween 20; Preservative: <0.1% sodium azide; coloring: 0.01g/l Bromphenol blue. 2 × 55ml. Unopened / After opening at 2-8°C. See expiry date 6 months
7. Stopping solution (ready-to-use), <0.1N sodium hydroxide, 40mM EDTA. 15ml. Unopened / After opening at 2-8°C. See expiry date 6 months
8. Substrate (ready-to-use), Para-nitrophenylphosphate in solvent-free buffer; Preservative: <0.1% sodium azide. 14ml. Unopened / After opening at 2-8°C. See expiry date 6 months.
General Description
The beta coronavirus SARS-CoV-2, which causes the disease COVID-19, has been responsible for a global pandemic since early 2020. Common symptoms of COVID-19 are similar to those of a cold or flu, such as fever, cough, difficulty breathing or pneumonia in both lungs. In severe cases, the infection can lead to death.
During the first week after the onset of symptoms, qRT-PCR is used as a reliable method for detecting SARS-Cov-2 infection, and, as the infection progresses, the combination of qRT-PCT and antibody tests is often used. The use of antibody detection is useful in the later stages of infection when the virus is no longer detectable and can also be used to identify individuals who have developed immunity after infection and/or who may be potential plasma donors for therapeutic purposes.
For the ELISA agile SARS-CoV-2 IgG test, the whole spike protein is used exclusively for specific antibody detection and for correlation with protective antibodies that mainly target the spike protein.
Citations
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