In vitro diagnostics (IVD)
The Labmaster LUCIA™ SARS-CoV-2 IgG RBD Kit for Whole Blood Samples
The Labmaster LUCIA™ SARS-CoV-2 IgG RBD test is meant for in vitro diagnostic qualitative detection of the presence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Receptor Binding Domain IgG antibodies from whole blood samples in near-patient testing by measuring the immunochemical interaction between the Anti-SARS-CoV-2 immunoglobulin G (IgG) and the SARS-CoV-2 Receptor Binding Domain (RBD).The test is designed for measuring immune response related to mRNA-based vaccinations or recovery from COVID-19 disease. The Labmaster LUCIA™ SARS-CoV-2 IgG RBD test Kit is to be used with semi-automated Labmaster LUCIA™ Analyzer by healthcare professionals.
|Sample Type||Whole Blood|
|Sample Volume||7 µL|
|Measuring Time||6 minutes|
|Storage||+2 – +8 °C|
- 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
|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. https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions.
(v) (WHO, World Health Organization. 2021. COVID-19 vaccines. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines.
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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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