Progress on Diagnostic Testing
(i) Dr. Blick's team is setting up the Abbott IgG assay for COVID-19 in the core clinical laboratory on a high throughput Abbott automated i2000 Architect immunoassay analyzer. The system can generate 200 patient results per hour. The test is FDA / EUA-approved and is performed on EDTA-treated plasma. The measurement is semi-quantitative and generates a RLU (Relative Light Unit) photon count for each result, therefore allowing an estimate of the concentration of IgG present. This is expected be helpful in establishing whether there is immunity in individuals with a high level of potential occupational exposure. It is also anticipated that the assay will be useful in evaluating and selecting individuals wishing to donate convalescent plasma. Abbott is finalizing a semi-quantitative IgM assay which should also be FDA / EUA-approved in several weeks.
(ii) The core is also first on Abbott’s Oklahoma list for receiving the highly-publicized FDA/EUA-approved Abbott ID NOW platform for the two Emergency Departments. This point of care (POC) testing device can generate a positive result on a swab in 5 minutes. A negative result takes up to 15 minutes.
(iii) Dr. Blick is also investigating a point of care microfluidic cartridge-based lateral flow method from Vivera which has been shown to have excellent specificity and reasonable sensitivity and is FDA/EUA-approved. A two-drop whole blood sample at the POC allows antibody detection of IgG/IgM at the patient’s bedside. Results are qualitative and available within minutes.