Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method)

Details for Product No. ABIN6952310
Antigen
Reactivity
SARS Coronavirus-2 (SARS-CoV-2)
4
4
Application
Lateral Flow (LF), Rapid Test (rapid)
Options
Purpose This kit is suitable for the qualitative detection of SARS-CoV-2 N-Protein IgG antibodies in human serum, plasma, and whole blood.
Sample Type Blood, Plasma, Serum
Characteristics
  • Lateral flow device for the qualitative detection of IgG antibodies to the Coronavirus N-protein in serum, plasma, and peripheral blood.
  • For in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020.
  • This test has not been reviewed by the FDA. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • For more information please contact our customer support.


Components Detection Cassette: 1 unit / bag, 20 bags per kit (Test card, dropper, desiccant)
Sample Diluent: 250 μl / tube, 20 tubes per kit (Sample diluent, liquid)

The components of the Detection Cassette are:
  1. Novel coronavirus N protein (fixed on porous capillary membrane)
  2. Goat anti-chicken IgY antibody (fixed on porous capillary membrane)
  3. Colloidal gold-labeled mouse anti-human IgG antibody (on the release pad)
  4. Colloidal gold-labeled chicken IgY antibody (on the release pad)

  5. Note: The components in different batches cannot be used interchangeably.
Target Name (Antigen)
Alternative Name SARS-CoV-2 N-Protein IgG
Application Notes The detection kit uses the principle of immunochromatography: the separation of components in a mixture through a medium using capillary force and the specific and rapid binding of an antibody to its antigen. Each cassette is a dry medium that has been coated separately with novel coronavirus N protein ("T" test line) and goat anti-chicken IgY antibody ("C" control line) (Figure 1). Two free colloidal gold-labeled antibodies, mouse anti-human IgG (mIgG) and chicken IgY, are in the release pad section (S). Once diluted serum, plasma, or whole blood is applied to the release pad section, the mIgG antibody will bind to coronavirus IgG antibodies if they are present, forming an IgG-IgG complex. The sample and antibodies will then move across the cassette's medium via capillary action. If coronavirus IgG antibody is present in the sample, the test line (T) will be bound by the IgG-IgG complex and develop color. If there is no coronavirus IgG antibody in the sample, free mIgG will not bind to the test line (T) and no color will develop. The free chicken IgY antibody will bind to the control line (C), this control line should be visible after the detection step as this confirms that the kit is working properly.
Comment

  • This product is for research use only.
  • The assay should be performed as outlined in this manual, and in accordance with all instructions.
  • Do not use expired or damaged products.
  • Only use the matching diluent in the kit package. Diluents from different kit lots cannot be mixed.
  • Do not use tap water, purified water or distilled water as negative controls.
  • The test should be used within 1 hour after opening. If the ambient temperature is higher than 30 °C, or the test environment is humid, the Detection Cassette should be used immediately.
  • If there is no movement of the liquid after 30 seconds of beginning the test, 1 additional drop of sample solution should be added.
  • Take care to prevent the possibility of virus infection when collecting samples. Wear disposable gloves, masks, etc., and wash your hands afterwards.
  • This test card is designed for a single, one-time use. After use, the test card and samples should be regarded as medical waste with risk of biological infection and properly disposed of in accordance with relevant national regulations.

Sample Collection Assay is suitable for human serum, plasma, or whole blood samples. Samples should be used as soon as possible after collection.
  • Whole blood collection: Collection of whole blood requires a tube with anticoagulant. After anticoagulated blood is collected, shake the tube well to mix.
  • Serum and plasma collection: Serum and plasma should be separated as soon as possible after blood collection to avoid hemolysis.
  • Samples should be collected via venous draw and should not be hemolyzed. During sample processing disposable pipettes or pipette tips are required, and care must be taken to prevent cross-contamination.
Sample Preparation

Samples should be run as soon as possible after collection and kept at or below 8 °C at all times. Samples can be stored at 2-8 °C for 7 days if not run immediately. If long-term storage is required, please store at -20 °C for periods less than 3 months, or store at -80 °C for periods longer than 3 months. Avoid repeated freezing and thawing.

Assay Procedure

Read the instructions carefully before use. Bring the Detection Cassette, Sample Diluent, and sample to room temperature before testing.

  • Add 25 μL of sample to the Sample Diluent and mix thoroughly. Add 2-3 drops to the release pad section (S) of the Detection Cassette.
  • The results can be interpreted is 8-10 minutes. Results measured after 20 minutes are invalid and should be discarded.

Calculation of Results
  • Positive for coronavirus: Both the test line (T) and the quality control line (C) are colored.
  • Negative for coronavirus: The test line (T) does not develop color, but the quality control line (C) is colored.
  • Invalid: There is no colored control line (C) band. The results are invalid regardless of whether a red band appears on the test line (T), additional testing is required.
Restrictions For Research Use only
Storage RT,4 °C,-20 °C
Storage Comment

Storage: -20°C

storageComment: Keep kits in a cool and dry place at 2 - 30°C. Do not freeze. The individual kits and/or box Correctly stored kits are valid for 18 months (see the kit box for expiration information).

Supplier Images
Image no. 1 for Novel Coronavirus (SARS-CoV-2) IgG Antibody Detection Kit (Colloidal Gold Method) (ABIN6952310) Representative schematic of possible lateral flow device results.
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