Lepu Medical – Test Sierologico Rapido 2019-nCoV Neutralization Antibody Kit – Colloidal Gold (CE IVD)

Il test 2019-nCoV Neutralization Antibody viene utilizzato per rilevare qualitativamente la presenza degli Anticorpi di neutralizzazione 2019-nCoV in ambito clinico su campioni di siero, plasma e sangue intero.

Confezione da 20 test.

Questo prodotto rileva qualitativamente gli anticorpi di neutralizzazione 2019-nCoV in campioni in ambito clinico (siero / plasma / sangue intero)

IVA 5% ai sensi dell’art. 124 D.L. 19 maggio 2020, n. 34 Parte II-bis 1-ter.1.

Il risultato positivo indica la presenza di anticorpi neutralizzanti contro la proteina RBD di SARS-CoV-2. Ciò suggerisce il livello di immunità al COVID-19

Neutralizing Antibody Rapid Test Intended Use

The 2019 novel coronavirus (SARS-CoV-2) has several structural proteins, including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S-protein contains a receptor binding domain (RBD), which can recognize the cell surface receptor, angiotensin-converting enzyme-2 (ACE2). In a recent study, neutralizing antibody (NAb) can block the interaction between the receptor-binding domain (RBD) of the novel coronavirus spike protein with the ACE2 cell surface receptor. The level of NAb, therefore, can be used to analyze a patient’s immunity against future SARS-CoV-2 infection. This COVID-19 neutralizing antibody lateral flow assay rapidly detects any antibodies that can neutralize the RBD-ACE2 interaction.

Researchers have been using traditional viral neutralization assay for testing SARS-CoV-2 neutralizing antibodies and there are several ELISA based neutralizing antibody test kits available in the market since May 2020. However, performing COVID-19 neutralization assays or ELISA requires complex laboratory settings, and it is time-consuming, despite a higher sensitivity and specificity. This neutralizing antibody rapid test cassette provides an easy way for the preliminary screening of NAb to estimate patients’ immunity to novel coronavirus infection.

COVID-19 NAb Rapid Test Principle

COVID-19 neutralizing antibody test kit is a lateral flow assay for rapid NAb screening, which can mimics the virus neutralization process. This lateral flow assay contains two key components: the recombinant SARS-CoV-2 RBD fragment and chicken IgY, labeled by colloidal gold are as tracers; and the human ACE2 receptor protein (hACE2) and goat anti-chicken IgY antibody, coated with cellulose nitrate membrane. The protein-protein interaction between RBD and hACE2 can be blocked if the test samples contains a certain level of neutralizing antibody against SARS-CoV-2.

(Immagine puramente indicativa)

When specimens are added to the sample pad, neutralizing antibodies present in the specimen will bind to the RBD labeled colloidal gold and block the protein-protein interaction between RBD and hACE2. The unbound RBD labeled colloidal gold as well as any RBD labeled colloidal gold bound to non-neutralizing antibody will be captured on the test line. The colloidal gold labeled chicken IgY antibody is bound to the goat anti-chicken IgY antibody coated with a colored band (C line), which acts as a procedural quality control line.

2019-nCoV Neutralization Antibody Test Kit – Result Interpretation

• POSITIVO: Purple red band appears in quality control area (C) and M/G test area
• NEGATIVO: Purple red band only appears in quality control area (C)
• INVALIDO: No purple stripe appears in the quality control area (C)

A positive result indicates you are likely to have had COVID-19 and have neutralizing antibodies against the RBD protein of SARS-CoV-2. This suggests you may have a level of immunity to COVID-19 (Vaccine Effect)