Testing has a crucial role in fighting this unprecedented global COVID-19 pandemic. Immunodiagnostic Systems (IDS) is proud to empower you with a full suite of reliable, high quality COVID-19 testing solutions.
Reliable diagnostic tests targeting patients that are currently infected by the virus, as well as those that have an immune response against the virus, are valuable. However, it is important to understand which tests are most suitable to use depending on their intended purpose.
There are two different testing types available for COVID-19: a test for current infection (diagnostic test) and a test for recent or previous infection which is also known as antibody test.
A diagnostic test is used to detect presence of the virus, therefore is indicative of a current infection. This type of test usually involves the assessment of a nasal or throat swab. The technology for diagnostic test includes molecular and antigen method.
An antibody test detects the immune response if a person has been recently or previously infected. This test is usually administered through blood draw.
Understanding if a person has recently or previously been infected with SARS-CoV-2 and the level of antibodies in the body is an important next step, and may allow the determination of the effectiveness of vaccines and therapies.
These tests detect a current infection by identifying SARS-CoV-2 antigens, which are viral surface proteins that cause an immune response.
Antigen tests involve the assessment of a nasal or throat swab which can either be performed in a clinical laboratory, on specific equipment that typically provides the results in hours, or by using a simple, rapid test format, which typically requires no laboratory equipment, providing results within 15 minutes (assay dependent).
Rapid SARS-CoV-2 antigen testing is a simple but useful tool to support swift identification of individuals with current infection, allowing faster deployment of contact tracing measures to help limit the spread of the infection. These tests are simple to use, requiring no specialised training or equipment to run supporting their use in any setting such as near patient, workplace, school, etc.
IDS offers following rapid antigen tests to detect the presence of SARS-CoV-2 Nucleocapsid protein antigen using direct nasopharyngeal (NP) swab. These simple-to-use antigen tests deliver rapid result within 15 minutes, without any laboratory equipment.
Coronavirus Ag Rapid Test Cassette (Swab)ii
SARS-CoV-2 Antigen Rapid Test Kitii
Elevations in specific IgM antibody levels typically occur three to five days after the onset of symptoms in response to viral infections. The presence of these antibodies generally persists for thirty to sixty days. IgG levels typically become elevated after ten to fourteen days and may remain detectable for years.
Since each person’s seroconversion process is different, it is important to identify both IgG and IgM seperately. Together, the IgM and IgG assays can identify antibodies in symptomatic and asymptomatic individuals.
IDS offers following rapid antigen tests to detect the presence of antibodies (IgG and IgM) against SARS-CoV-2 using serum, plasma or whole blood. This simple-to-use antibody tests deliver rapid result within 15 minutes, without the need for any laboratory equipment.
TGS Velox Ab COVID-19 IgM/IgG POCTii
IDS offers the following antibody tests, for use in a laboratory setting:
IDS SARS-CoV-2 IgG is a fully automated qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma, using the IDS-iSYS Multi-Discipline Automated System. For use under the Emergency Use Authorization (EUA) only.
TGS COVID-19 IgGii is a fully automated QUANTITATIVE chemiluminescent test for identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
When effective SARS-CoV-2 vaccines becomes reality, the level of antibodies is an important indicator of a person’s immune response to the virus. Thus, the SARS-CoV-2 antibody response levels may help determine the effectiveness of vaccines and therapies.
TGS COVID-19 IgMii is a fully automated chemiluminescent test to qualitatively detect antibodies that emerge early in the course of infection.
The automated IgG and IgM tests can be used together on the IDS system, to provide the most accurate view of the patient’s immune response. A 95.8% positive sample agreement with RT-PCR after 7 days of diagnosis and 98.6% agreement with presumed negative samples when the IgM and IgG results are combined together.
iEuropean Commission (2020). Guidelines on COVID-19 in vitro diagnostic tests and their performance (published 15 April 2020). https://ec.europa.eu/info/sites/info/files/testing_kits_communication.pdf
ii Not Available in USA.
Portfolio | Certification | Clinical Area | Product Type | RUO/IVD |
---|---|---|---|---|
SARS-CoV-2 S1-RBD IgG | CE Marked |
Automated | IVD | |
Spike Protein Inhibition Assay (SPIA) | Research use only |
Manual | RUO | |
TGS Velox Ab COVID-19 IgM/IgG POCT | CE Marked |
Manual | IVD | |
IDS SARS-CoV-2 IgG | For In Vitro Diagnostic Use |
Automated | RUO | |
Coronavirus Ag Rapid Test Cassette (Swab) | CE Marked |
Manual | IVD | |
SARS-CoV-2 Antigen Rapid Test Kit | CE Marked |
Manual | IVD | |
TGS COVID-19 IgM | CE Marked |
Automated | IVD | |
TGS COVID-19 IgG | CE Marked |
Automated | IVD |