Ortho Clinical Diagnostics Launches Quantitative COVID-19 IgG Antibody Test with CE Mark
- Ortho's VITROS® Anti-SARS-CoV-2 IgG Quantitative Antibody test is traceable to the
- The test gives clinicians and public health leaders a standard tool to evaluate immune response after infection or vaccination
Ortho's new VITROS® Anti-SARS-CoV-2 IgG Quantitative (QN) Antibody assay provides numerical values traceable to the
"Ortho's new quantitative IgG antibody test provides healthcare teams and researchers with a standardized data 'ruler,' to assess immune response, acquired through infection or from vaccines, over time, offering additional data to help manage and understand this devastating virus," said
With 100% specificity and excellent sensitivity,ii the VITROS® Anti-SARS-CoV-2 IgG QN Antibody assay is intended for the qualitative detection and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma and is processed on Ortho's trusted VITROS® system. Up to 6.8 million of Ortho's COVID-19 tests can be processed daily on Ortho's globally installed base of over 5,600 analyzers.
Ortho plans to manufacture up to eight million quantitative IgG antibody tests each month.
Ortho's quantitative IgG test is the latest addition to Ortho's COVID-19 solutions, which help clinicians diagnose and treat SARS CoV-2 infections and follow the patient's immune response.
About Ortho's VITROS® COVID-19 Testing Solutions
Ortho's VITROS® COVID-19 testing solutions help labs meet demands of the pandemic and take control of the spread of the coronavirus in their communities.
Ortho's COVID-19 Total Antibody Test, designed to indicate recent or prior SARS-CoV-2 infection, detects all COVID-19 related antibodies (IgA, IgM and IgG). The company's COVID-19 IgG antibody test detects the IgG antibody, which appears in a patient's blood in the later phase of infection and remains elevated even after recovery. Offering high sensitivity and specificity, both the Total and IgG tests – which have FDA EUA and CE Mark – provide public health leaders with an exceptional tool in tracking viral community spread, bolstering serological surveillance efforts, and managing patient treatment pathways.
Ortho's VITROS® SARS-CoV-2 Antigen Test, which achieved CE Mark in
Questions from laboratories, health care providers, or government officials regarding Ortho's COVID-19 solutions can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://www.orthoclinicaldiagnostics.com/global/covid19/.
ii 100% Specificity, 94% Sensitivity greater than 15 days after symptom onset
Elaine Colón, Ortho Media Relations, M: +1-908-295-1579, email@example.com