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In vitro -diagnostiikka (IVD)

The Labmaster LUCIA™ SARS-CoV-2 IgG RBD -testipakkaus kokoverinäytteille

Labmaster LUCIA™ SARS-CoV-2 IgG RBD testi on in vitro diagnostinen vieritesti kvalitatiiviseen SARS-CoV-2 RBD IgG-vasta-aineiden tunnistamiseen kokoverestä.

RBD-testi on tarkoitettu rokotteen tai sairastetun koronataudin aiheuttaman immuunivasteen mittaamiseen.
RBD-testi on tarkoitettu terveydenhuollon ammattilaisten käytettäväksi puoliautomaattisen
Labmaster LUCIA™ -analysaattorin kanssa.

Näytetyyppi Kokoveri
Näytetilavuus 7 µL
Testiaika 6 minuuttia
Herkkyys 93 %
Spesifisyys 100 %
Säilytys +2 – +8 °C
  • Vieritesti voidaan suorittaa sormenpääverinäytteestä
  • Tulos valmistuu 6 minuutissa
  • Yksinkertainen testimenetelmä
  • Testipakkaus sisältää testin suorittamiseen tarvittavat reagenssit ja laimennuspuskurin
LM317 Labmaster LUCIA™ SARS-CoV-2 IgG RBD Kit for Whole Blood Samples CE-marked IVD Each kit contains 40 ready-to-use tests

Contents of the kit:

SARS-CoV-2 IgG RBD Cassette 40 pcs
SARS-CoV-2 IgG RBD Dilution Tube for Whole Blood sample 0.84 mL x 40 pcs
Li-Heparin coated capillaries (7 µL) 50 pcs
Plungers for capillaries 50 pcs
Transfer Pipette 40 pcs
SARS-CoV-2 IgG RBD NFC Card 1 pc
RBD Instructions for Use and Quick Guide 1 pc

The following components are required but not included in the kit: 

Labmaster LUCIA™ Analyzer LM26
Labmaster LUCIA™ Analyzer Instructions for Use LM28
Lancets for fingertip blood sample N/A

The Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike (S) protein is a major target for the antibody response, including Immunoglobulin G. Also, the recombinant SARS-CoV-2 RBD antigen was found to be highly sensitive (98%) and specific (100%) for antibodies induced by SARS-CoVs (i).

The presence of antibodies against a SARS-CoV-2 RBD pathogen in blood indicates an adaptive immune response to SARS-CoV-2 due to vaccination or prior infection. After exposure to pathogen, the anti-RBD IgG levels start gradually rising to reach their maximum within the period of 3–4 weeks (ii). As a result of vaccination, the antibodies can be detected from one week after the first dose of vaccination and start to decrease after 25 days (iii).

Current SARS-CoV-2 mRNA vaccines, such as Comirnaty (Pfizer-BioNTech) (iv) and Moderna (v) are based on SARS-CoV-2 S protein vector, which contains RBD. Thus, these vaccines trigger the immune system to produce antibodies against SARS-CoV-2 RBD. Antibodies against SARS-CoV-2 RBD are also formed as a result of native SARS-CoV-2 infection.

(i) Premkumar L. et al. 2020. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. 5: eabc8413.
(ii) Peng Z. et al. 2020. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature 579;270–273.
(iii) Pang, N.YL. et al. 2021. Understanding neutralising antibodies against SARS- CoV-2 and their implications in clinical practice. Military Medical Research 8.
(iv) WHO, World Health Organization. 2020.Transmission of SARS-CoV-2.
(v) (WHO, World Health Organization. 2021. COVID-19 vaccines.

Labmaster LUCIA MxA kit

Puh. +358 22 760 555
Rauhalinnantie 31, 20780 KAARINA, Finland

Legal disclaimer
Products designed, developed and manufactured by Labmaster Ltd. meet their specifications when stored, used and transported according to the instructions for use and product inserts. Labmaster LUCIA™ is a trademark designed and owned by Labmaster Ltd.

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