COVID-19 Serology Testing

SEROLOGY TESTING FOR COVID-19

Testing is a crucial step in controlling the novel COVID-19 pandemic. Testing the blood of a sample of the population to estimate just how widely the COVID-19 virus spread is important to collect data. It’s through these types of retrospective initiatives that the full number of cases can be approximated, which can help explain how common asymptomatic infections may be and calculate a better estimate for the mortality rate of a virus. The serology test will look for the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood and in other tissues of those who are tested after the infection.  The antibodies detected by this test indicate that a person had an immune response to SARS-CoV-2, whether symptoms developed from infection or the infection was asymptomatic.  Antibody test results are important in detecting infections with few or no symptoms.

Graph demonstrating the timetable of when the human body mounts an immune response to COVID-19

Information about Individual Test Kit Manufacturers

Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

• Immunoassay intended for qualitative detection of antibodies to SARS-CoV-2 in human serum and plasma.

• The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analysers. 

• The assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2.

• Systems - cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 801 module

• Testing time 18 minutes

• The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation)

ABBOTT’s COVID-19 Antibody Test

• Detects the IgG antibody to SARS-CoV-2.

• An antibody is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered.

• The test is a serology test, also called an antibody test

• The new Antibody test is to be used on Abbott's ARCHITECT i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests an hour.

Cellex qSARS-CoV-2 IgG/IgM Rapid Test

• Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens.

• Aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

• Results from the qSARS-CoV-2 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis.

• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.

VITROS® Total and IgG COVID-19 Antibody Tests

• Test Specimen used includes blood samples to check for IgG COVID-19 antibodies

• Ortho's IgG test demonstrated 100% specificity and can be used to support decisions for getting people back to work.

• Already installed in more than 1,000 hospital and reference labs throughout the United States.

• These tests can aid in diagnosing symptomatic or asymptomatic individuals of acute infection together with molecular tests or clinical information.

• It helps identify the immune response in individuals that are currently or recently infected with the COVID-19 virus.

• Aids in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent of prior infection. 

Autobio Anti-SARS-CoV-2 Rapid Test

DiaSorin fully automated serology test to detect antibodies against SARS-COV-2 in COVID-19 patients

• The test can be performed on the LIAISON® XL platform, which allows fully automated management of the diagnostic process, allowing laboratories to process up to 170 patient sera samples per hour, with a minimum level of intervention required by laboratory operators.

• The LIAISON® SARS-CoV-2 IgG kit will be made available in the next few days for clinical research and evaluation and will be launched in Europe CE marked and submitted to the FDA under the Emergency Use Authorization process in the following weeks.

Bio-Rad’s SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization, the First Total Antibody Test to Receive EUA from the FDA

• SARS-CoV-2 Total Ab test has demonstrated diagnostic specificity of more than 99 percent and diagnostic sensitivity of 98 percent.

• Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.

• Enables detection of antibodies in the majority of patients eight days after the onset of symptoms, versus an IgG only approach