In vitro diagnostics (IVD)

The Labmaster LUCIA™ SARS-CoV-2 IgG NP test is meant for in vitro diagnostic qualitative detection of the presence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nucleocapsid Protein (NP) recognizing immunoglobulin G (IgG) antibodies from lithium-heparin whole blood samples in near-patient testing.

The SARS-CoV-2 IgG NP test kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The Labmaster LUCIA™ SARS-CoV-2 IgG NP test kit is to be used with semi-automated Labmaster LUCIA™ Analyzer by healthcare professionals.

• Point-of-care test based on fingertip blood sample
• Quick result in only 6 minutes
• Easy handling, only a few steps needed
• All-in-one kit, reagents and washing buffer included

The SARS-CoV-2 Nucleocapsid Protein (NP) is a multifunctional RNA-binding protein, which is not only responsible for packaging viral genomes but also regulates the innate immune response caused by viral infection. Compared with other potential SARS-CoV-2 antigens, the NP antigen has some distinct advantages, including the conservation of the NP sequence, the expanding knowledge of its genetics and biochemistry, and its strong immunogenicity (i).
The presence of antibodies against SARS-CoV-2 NP pathogen in blood indicates adaptive immune response to recent or prior infection. Antibody responses to SARS-CoV-2 can be detected in most individuals 10–15 days after the onset of COVID-19 symptoms (ii).

(i) Bai Z. et al. 2021. The SARS-CoV-2 Nucleocapsid Protein and Its Role in Viral Structure, Biological Functions, and a Potential Target for Drug or Vaccine Mitigation. Viruses 13.
(ii) Seow J. et al. 2020. Longitudinal observation and decline of neutralizing antibody responses in the three months following SARS-CoV-2 infection in humans. Nature Microbiology 5; 1598–1607.