COVID19Check-G
IgG Serologic Rapid Test
Multi-G's Covid19Check-G IgG Serologic Rapid Test for COVID-19 is used to qualitatively detect IgG antibodies against SARS-CoV-2 in human serum, plasma or whole blood in vitro.
The test
There is a critical, global need for serology assays that can complement nucleic acid (PCR) tests for diagnosing SARS-CoV-2 infection. Although critically important, PCR tests are only positive during the brief window of acute infection, after which they become negative.
And while serology tests are not meant to detect current infection, they are able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection as well as monitoring of the clinical evolution of a patient.
Knowledge of prior infection is important for epidemiological studies and represents a significant unmet need in the management of the COVID-19 pandemic.
And while serology tests are not meant to detect current infection, they are able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, which enables identification of prior infection as well as monitoring of the clinical evolution of a patient.
Knowledge of prior infection is important for epidemiological studies and represents a significant unmet need in the management of the COVID-19 pandemic.
This valuable serological assay could serve as a complementary diagnostic information to RT-PCR and chest imaging.
It may also be useful to monitor medical and non-medical workers during the ongoing pandemic or during subsequent waves, and to monitor the immunological status of the general population after social distancing measures have eased as well as a follow up after a vaccination campaign to assess its impact and efficiency.
The assay can be used as a bedside tool, in a laboratory or used in a general practitioner’s office.
This test kit is for healthcare professional use only.
This test kit is for healthcare professional use only.
Features & Benefits
Multi-G's Covid19Check-G IgG Serologic Rapid Test for COVID-19 is used to qualitatively detect SARS-CoV-2 IgG antibodies in human serum, plasma or whole blood in vitro. Detecting IgG antibodies on one single line provides essential information about the immune status of an individual, especially as IgG constitute a key element in the long term immune response against COVID-19, wheras IgA and IgM don't remain more than 2 weeks.
Quick & intuitive feedback
- 10-15 minutes per test
- Intuitive visual interpretation
- One single line
- No special equipment needed
- Portable reader device available on demand
How it works
Multi-G's Covid19Check-G is a lateral flow immunoassay used to qualitatively detect total IgG antibodies against SARS-CoV-2 in human serum, plasma or whole blood in vitro.
1
Collect a blood, serum or plasma sample.
2
Add the sample to the sample well.
3
Place 2 drops of buffer in the sample well.
4
Read the results after 10-15 minutes.
Results
A total of two detection lines are possible, with the control (C) line acting as a quality control procedure, appearing only when the sample has flowed through the cassette and the test has worked properly. Clinical significance of antibodies.
Negative
IgG Positive
Performance
Multi-G's Covid19Check-G was evaluated in a multi-center study in Belgium, leaded by the OostLimburg Hospital. In addition to its regional function, the Oost-Limburg Hospital fulfills a number of important expert functions within a Euregional context (MIC, NIC, cardiac surgery, neurosurgery, lithotripsy, NMR, fertility center, radiotherapy,…). The test was validated against a panel of samples previously confirmed with a RT-PCR test. Testing was performed by one operator using one lot of Multi-G's COVID-19 IgG Rapid Test. In that study, Multi-G's Covid19Check-G displayed high IgG sensitivity and specificity of 100%.
Quality standards
- In order to ensure the highest level of quality and reliability, Multi-G manufactures its test devices in Belgium, unlike most competitors who simple rebrand asian made tests.
- Multi-G's Covid19Check-G is compliant with CE-IVD regulations.
- Multi-G's production facility in Antwerp, Belgium, is LQRA ISO 13485:2016 approved.
- The production facility operates at the highest pharmaceutical standards.
Applications
Multi-G's Covid19Check-G covers a range of applications. It is meant for health professionals only. Clinical significance of antibodies.
Epidemiological
applications
Monitor the immunological status of the general population after social distancing measures have eased as a tool to fine tune COOVID-19 related policies.
Hospitals, physicians, laboratories & police force
Monitor the immune status of critical front line staff to better manage human ressources.
Mining &
oil companies
Monitor the immune status of staff in critical settings such as mines and oil rigs where social distancing is difficult to fully implement, in order to ensure staff safety and avoid infection outburst.
Seroconversion
Assess seroconversion and immune response of patients who have been vaccinated against COVID-19.
Herd immunity
Assess herd immunity to better manage COVID-19 restrictions policies.
