SARS CoV 2 IgG/IgM Rapid Antibody Test

SARS CoV 2 IgG/IgM Rapid Antibody Test is brought to you by Noviral Sweden AB

Size: 25 Test Cassettes
Run Time: <15 min
Sample Type: Serum, Plasma or Whole Blood
Species Sample: Human
Sample Size: 10 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
IVD, CE-Marked

Lancets and Buffer included

Assay Principle

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunochromato-graphic assay. The test uses anti-human IgM antibody (test line IgM) , anti-human IgG (test line IgG) and rabbit IgG  (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugat-ed with colloid gold (COVID-19 conjugates). When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID- 19 conjugates making antigen antibodies com-plex. This complex migrates through nitrocellulose mem-brane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-hu-man IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non reactive test result.
To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicat-ing that the proper volume of specimen has been added and membrane wicking has occurred.

Information for US Customers

During this crisis, steps are being taken to ensure that we can provide access to quality products for diagnostic testing. The Food and Drug Administration (FDA) has issued guidance which allows for distribution of the serological tests. At this time, the kits are released for sale in the United States under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

The kits are registered under product code QKO, the submission number is TBD

Per the aforementioned guidance, the following statements are required:

• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
• Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

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