CLIA COVID-19 NP IgM

Description

Coronaviruses belong to the family of enveloped RNA viruses. In humans, they cause diverse clinical pictures, from the common cold to severe respiratory syndromes (MERS, SARS, and COVID-19). SARS-CoV-2, the cause of COVID-19, is a respiratory virus discovered in 2019. It is primarily transmitted to an individual through close contact with an infected person, during which infectious droplets spread to the environment. Symptoms of COVID-19 are highly variable, ranging from none to life-threatening illness.

The SARS-CoV-2 virus contains four structural proteins: spike (S), nucleocapsid (N), envelope (E), and membrane (M) protein. Responding to the infection, the human immune system raises specific antibodies, starting with IgA and IgM. The IgG antibodies represent a later matured response. Serological tests play only a supporting role in COVID-19 diagnosis. However, they are effective in assessing the immune response of an individuum or population.

Nucleocapsid protein (NP) encapsulates viral genomic RNA and forms a major component of the viral structure. NP is a highly antigenic epitope, which is highly conserved and does not change when the virus is mutated. In patients who have had COVID-19 infection, the anti-NP antibodies are usually measured at higher levels than antibodies to other SARS-CoV-2 proteins.

Technical data

• Assay time: 40 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum, Plasma
• Sample volume: 10 μL
• Sample stability: 7 days at 2-8 °C, 24 months at -20 °C
• Measuring range: 5 – 100 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use. Date of delivery on request.

Specifications

• Catalog Number: CL-CoNM100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: COVID-19
• Diagnostic panel: COVID-19 Respiratory Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

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• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators