BIOCREDIT COVID-19 lgG/lgM Manual
PDF-Document [437.1 KB]
CE Dokument COVID-19 lgG lgM
CE DoC_BIOCREDIT COVID-19 IgG+IgM Duo.pdf
PDF-Document [12.6 KB]
EU Produkt Zertifikat COVID-19 lgG/lgM Duo
RapiGEN Certificate of EU product notification.pdf
PDF-Document [382.0 KB]
RapiGEN, Inc., South Korea, has developed one of the first immunoassays for the diagnosis of COVID-19 infection.
The BIOCREDIT COVID-19 IgG+ IgM DUO One Step Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-COVID-19 in whole human blood, serum or plasma.
It is intended to be used by professionals as a screen test and as a supplement in the diagnosis of COVID-19 virus infection.
The BIOCREDIT COVID-19 IgG+IgM DUO One Step Rapid Test has been evaluated and compared to a gold standard test using clinical samples. Results show a degree of concordance of >90%.
BIOCREDIT Coronavirus Onme Step Rapid Test Kit COVID-19 antibody IgG + IgM DUO– Pack 25 test
Biocredit Covid-19 One Step Rapid Test lgG+LgM DUO has developed one of the first immunoassays for the diagnosis of COVID-19 infection.
This test detects both the early marker and the late marker, IgM/IgG antibodies in whole blood samples.
Can be used in symptomatic or asymptomatic patients.
Applications of Biocredit Coronavirus Test Kit COVID-19 antibody IgG+IgM DUO
Main applications of antibody detection during COVID-19:
Interpretation of Results
A total of three detection lines are possible, the control line © appears when the sample is correct.
1 | IgG and IgM Positive:
The colored line in the control line region © appears and two colored lines should appear in test line regions G and M (G and M). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary COVID-19 infection.
2 | IgG Positive:
The colored line in the control line region © appears and a colored line appears in test line region G (G). The result is positive for COVID-19 specific-IgG and is probably indicative of secondary COVID-19 infection.
3 | IgM Positive:
The colored line in the control line region © appears and a colored line appears in test line region M (M). The result is positive for COVID-19 virus specific-IgM antibodies and is indicative of primary COVID-19 infection.
4 | Negative result:
One red line „C“
IgM appears first after infection with the virus and then IgG in the middle and late stages of infection
IgM/IgG antibody test can determine if a patient is infected “recently 2019-nCoV”
It is widely known that IgM provides the first line of defense during viral infections, followed by adaption generation, high IgG affinity response for long-term immunity and immune memory.
Therefore, the test of COVID-19 IgM and IgG antibodies is an effective method for rapid diagnosis of COVID-19 infection.
In addition, detection of IgM antibodies against COVID-19 tends to indicate recent exposure to COVID-19, while detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection.
Manufacturer: RapiGEN Inc., 2F, 25, Heungan-daero, Gunpo-si, Gyeonggi-do 15809, Republic of Korea
European Representative: MT Promedt Consulting GmbH, Altenhofstrasse. 80, 66386 St. Ingbert, Germany
Distribution Pharmacies: Weko Pharma GmbH, Hochwaldblick 3–4, 54331 Pellingen