COVID19Check-GEN
Antigenic Rapid Test
Multi-G's Covid19Check-GEN Antigenic Rapid Test for COVID-19 is used to qualitatively detect SARS-CoV-2 antigen in nasopharyngeal, oropharyngeal and nasal samples.
The test
There is a critical, global need for rapid antigen test that can complement nucleic acid (PCR) tests for diagnosing SARS-CoV-2 infection. Although critically important, PCR tests are not always available and can last too long in obtaining the result due to the large amount of people who need testing.
Covid19Check-GEN is an efficient and reliable solution to detect infection in cases where the viral load is significant (Ct <33) and the person is likely to be contagious.
This test kit is for healthcare professional use only.
COVID19Check-GEN has been validated by the Belgian Health authority (AFMPS/FAGG): https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx
Covid19Check-GEN is an efficient and reliable solution to detect infection in cases where the viral load is significant (Ct <33) and the person is likely to be contagious.
It is particularly useful in cases where frequent and or quick results are required.
The assay can be used as a bedside tool, in a laboratory or used in a general practitioner’s office.
Covid19Check-GEN detects the known variants of the Sars-Cov-2 virus: Lineage B.1.1.7 / 20I/501Y.V1 (UK variant), 484K.V2 (Brazilian variant), 501Y.V2 (South African variant).
Covid19Check-GEN detects the known variants of the Sars-Cov-2 virus: Lineage B.1.1.7 / 20I/501Y.V1 (UK variant), 484K.V2 (Brazilian variant), 501Y.V2 (South African variant).
This test kit is for healthcare professional use only.
COVID19Check-GEN has been validated by the Belgian Health authority (AFMPS/FAGG): https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx
Features & Benefits
Multi-G's Covid19Check-GEN Antigenic Rapid Test for COVID-19 is used to qualitatively detect SARS-CoV-2 virus in nasopharyngeal, oropharyngeal and nasal samples.
COVID19Check-GEN has been validated by the Belgian Health Agency: https://www.afmps.be/sites/default
/files/content/Belgian%20validation.xlsx
COVID19Check-GEN has been validated by the Belgian Health Agency: https://www.afmps.be/sites/default
/files/content/Belgian%20validation.xlsx
Precise results
- Global sensitivity : 93.18% (n=176)
- Sensitivity / PPA for Ct value <33 : 100% (n=125)
- Sensitivity / PPA 1 to 4 days after onset of symptoms: 100% (n=125)
- Specificity /NPA : 99.16% (n=441)
- Total coincidence rate : 97.7% (n=617)
Quick & intuitive feedback
- 20-30 minutes per test
- Intuitive visual interpretation
- No special equipment needed
- Portable reader device available on demand
How it works
The procedure is as follows.
Results
A total of two detection lines are possible: one test line, which shows a positive result, and the control (C) line acting as a quality control procedure, showing that the sample has flowed through the cassette and the test has worked properly.
Negative
Positive
Performance
Multi-G's Covid19Check-GEN was evaluated in a large base study with 617 492 samples, 176 positive and 441 negative. In that study, Multi-G's Covid19Check-GEN displayed a sensitivity of 93.18%, a sensitivity of 100% for Ct values ≤33, a sensitivity of 100% between days 1-4 after onset of symptoms, and a specificity of 99.32%.
Covid19Check-NGEN detects the known variants of the Sars-Cov-2 virus: Lineage B.1.1.7 / 20I/501Y.V1 (UK variant), 484K.V2 (Brazilian variant), 501Y.V2 (South African variant) and B.1.617 (Indian variant).
Covid19Check-GEN shows no cross reaction with a list of common pathogens such as H1N1 , H3N2, H5N1, H7N9, HKU1, MERS Cov, influenza B, respiratory syncytial virus, rhinovirus group, adenovirus 71, C1, Malaria, Dengue, human cytomegalovirus, No interference were found with common substances such as Whole Blood, Fluticasone Propionate, CVS Nasal Drops (Phenylephrine), Tamiflu(Oseltamivir Phosphate), Sucrets(Dyclonin/Menthol), Chloraseptic (Menthol/Benzocaine), Homeopathic(Alkalol), Ore Throat Phenol Spray, Tobramycin.
Covid19Check-NGEN detects the known variants of the Sars-Cov-2 virus: Lineage B.1.1.7 / 20I/501Y.V1 (UK variant), 484K.V2 (Brazilian variant), 501Y.V2 (South African variant) and B.1.617 (Indian variant).
Covid19Check-GEN shows no cross reaction with a list of common pathogens such as H1N1 , H3N2, H5N1, H7N9, HKU1, MERS Cov, influenza B, respiratory syncytial virus, rhinovirus group, adenovirus 71, C1, Malaria, Dengue, human cytomegalovirus, No interference were found with common substances such as Whole Blood, Fluticasone Propionate, CVS Nasal Drops (Phenylephrine), Tamiflu(Oseltamivir Phosphate), Sucrets(Dyclonin/Menthol), Chloraseptic (Menthol/Benzocaine), Homeopathic(Alkalol), Ore Throat Phenol Spray, Tobramycin.
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-GEN 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.
- Multi-G's Covid19Check-GEN has been validated by the Belgian Health Agency: https://www.afmps.be/sites/default/files/content/Belgian%20validation.xlsx
Applications
Multi-G's Covid19Check-GEN covers a range of applications. It allows you to speed up and scale up Covid-19 testing. It is suited for a variety of settings such as companies, pharmacies, airports, schools and universities etc. It is meant for health professionals only.
PCR labs
Reduce the workload of PCR labs, use PCR only to verify positive cases.
Cost reduction
Reduce the cost of testing : Ag Rapid test is on average 8 times cheaper than PCR.
Workplace security
Secure the workplace.
Public spaces
Secure public transports, schools, universities, events etc.
Private events
Screening participants to secure private events (weddings, conferences, exhibitions, etc).
Economic recovery
Accelerate economic recovery by allowing eligible businesses to reopen with screening measures.
