Biocredit COVID-19 IgG/IgM Combo antibody rapid test with post-vaccine neutralizing antibodies

ISO13485:2016 Certified

CE Marked

The prestigious Korean biotechnology laboratory RAPIGEN Inc. has developed an advanced immunoassay for the diagnosis of the latest covid-19 infection with optimal levels of sensitivity and specificity (98% sensitivity and 100% specificity).

The BIOCREDIT Combo COVID-19 IgG/IgM antibody rapid test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-COVID-19 in whole blood, serum or human plasma. It is intended to be used by professionals as a screening test and as a complement in the diagnosis of COVID-19 infection, as well as in the detection of post-vaccine neutralizing antibodies (Protein S1 – RBD SARS-CoV-2).

The BIOCREDIT COMBO IgG/IgM tests allow full coverage to detect immunity against COVID-19 with sensitivity to detect antibodies due to real infection  and neutralized antibodies Post  COVID-19 vaccination – (Protein S1 – RBD SARS-CoV-2). Technical Report: Analytical Performance Characteristics Report : Detection of neutralized antibody

The BIOCREDIT Combo tests are published and recommended by the EU with high sensitivity and specificity levels:

Biocredit. Comisión europea

BIOCREDIT COVID-19 IgG/IgM Combo:
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1716

SKU: BCR-25COMBO-TEI Category:

Description

Biocredit COVID-19 IgG/IgM Combo antibody rapid test with post-vaccine neutralizing antibodies

The prestigious Korean biotechnology laboratory RAPIGEN Inc. has developed an advanced immunoassay for the diagnosis of the latest covid-19 infection with optimal levels of sensitivity and specificity (98% sensitivity and 100% specificity).

The BIOCREDIT Combo COVID-19 IgG/IgM antibody rapid test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-COVID-19 in whole blood, serum or human plasma. It is intended to be used by professionals as a screening test and as a complement in the diagnosis of COVID-19 infection, as well as in the detection of post-vaccine neutralizing antibodies (Protein S1 – RBD SARS-CoV-2).

The BIOCREDIT COMBO IgG/IgM tests allow full coverage to detect immunity against COVID-19 with sensitivity to detect antibodies due to real infection  and neutralized antibodies Post  COVID-19 vaccination – (Protein S1 – RBD SARS-CoV-2). Technical Report: Analytical Performance Characteristics Report : Detection of neutralized antibody

The BIOCREDIT Combo tests are published and recommended by the EU with high sensitivity and specificity levels:

Biocredit. Comisión europea

BIOCREDIT COVID-19 IgG/IgM Combo:
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1716

  • A sample generates two IgM and IgG results in the same cassette
  • High sensitivity (100%) and specificity (97.3%) verified by the clinical trial institution
  • Quick test time (10 ~ 15 min)
  • Differentiated Black Gold Conjugate Technology: Easy-to-use dual color system (control line: red, test line for IgG/IgM: black)
  • Simple detection of SARS-CoV2-specific IgG and IgM antibodies

Description

BIOCREDIT COVID-19 IgG/IgM Combo rapid test kit – Pack 25

This test detects both the early marker and the late marker, IgM/IgG antibodies in vein blood samples or simply with a finger prick like glucose tests.

It can be used with symptomatic or asymptomatic patients.
Prueba rápida de anticuerpos IgG e IgM de SARS-CoV-2-Pack 25 test

Features and benefits of Coronavirus Test Kit COVID-19 antibodies IgG IgM

The IgM-IgG Biocredit Rapid Combined Antibody Test is used to qualitatively detect IgG and IgM antibodies from the new coronavirus in human blood or plasma in vitro.

  • One sample generates two IgM and IgG results in the same Cassette
  • High sensitivity (100%) and specificity (97.3%) verified by the clinical trial institution
  • Quick test time (10 ~ 15 min)
  • Easy-to-use dual color system (control line: red, test line for IgG/IgM: black)
  • Simple detection of SARS-CoV2-specific IgG and IgM antibodies

Prueba rápida de anticuerpos IgG e IgM de SARS-CoV-2-Pack 25 test

Applications of the Antibodies rapid test BIOCREDIT COVID-19 IgG/IgM Combo

    • Allows a rapid examination and diagnosis where the test is taken
    • Designed for healthcare professionals: Hospitals, medical offices, pharmacies, laboratories
    • Can detect carriers who are asymptomatic
    • It can determine if the patient was recently infected by the virus, even if the virus is no longer present
    • See document: GUIDE TO USE QUICK ANTIBODIES TESTS FOR COVID-19

    According to the SEIMC Expert Group for the Analysis of Microbiological Diagnosis of COVID-19, the main applications of antibody detection during COVID-19 would be:

    • Patients who go to the ER more than five days after the onset of symptoms.
    • In cases with repeatedly negative PCR where symptoms have clearly started several days before. That is, to confirm the infection when there is a suspicion of a PCR false negative.
    • Detection of antibodies in health workers that would help identify those who are already immune (presence of IgGs) and can return to work to care for infected patients, minimizing the risk of spreading the virus to colleagues and other patients.
    • To understand the epidemiology of COVID-19, recognizing the role of asymptomatic infections.
    • Define prior exposure and identify highly reactive human donors for hyperimmune serum generation as a therapeutic approach.
    • For research (such as possible plasma clinical trials with immunized patients.)
    • For vaccine evaluation.

     

Prueba rápida de anticuerpos IgG e IgM de SARS-CoV-2-Pack 25 testPrueba rápida de anticuerpos IgG e IgM de SARS-CoV-2-Pack 25 test

Documents

PDF -> Prueba rápida de anticuerpos IgG e IgM de SARS-CoV-2-Pack 25 test
PDF -> Report Detection of neutralized antibody 2021.06.01.pdf