SQI Diagnostics Inc.—a provider in the science of lung health—announced today that the New York State Department of Health (NYSDOH) has given conditional approval to its diagnostic testing partner, KSL Diagnostics, for the EXACT COVID-19 Antibody Test.
Access to the EXACT COVID-19 Antibody Test will now be available to physicians and their patients in the United States through AZOVA Inc, a telemedicine testing company.
“The EXACT COVID-19 Antibody Test is the next generation of tools in the fight against COVID-19,” says Andrew Morris, CEO of SQI Diagnostics. “It gives peace of mind because it can detect an immune response in both vaccinated and previously COVID-19 infected people. It also has the potential to give the health care system key insights and data into the relationship between antibody levels and breakthrough infections and reinfections. We’re bringing these tests to market now because we are determined to do our part to end the pandemic.”
NYSDOH, under the Clinical Laboratory Evaluation Program, evaluates and authorizes lab-developed tests for use in New York State certified clinical laboratories, which are subject to requirements equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The EXACT COVID-19 Antibody Test is a COVID-19 antibody test that provides semi-quantitative measurements of six distinct antibodies produced by the immune system in response to exposure to the SARS CoV-2 virus or to COVID-19 vaccination. The small volume blood sample can be collected in a home or office setting with a fingerstick. A positive test result could indicate the presence of antibodies arising from a prior COVID-19 infection or COVID-19 vaccination.
“The EXACT COVID-19 Antibody Test is a key part of SQI’s growing ability to offer unparalleled clinical insight through varied and improved COVID-19 testing,” says Morris. “We currently sell Health Canada-approved testing kits for SARS-CoV-2 RT-PCR molecular testing and point of care antigen testing products, which enable rapid serial testing of asymptomatic populations. We have also filed with Health Canada — for review under the Interim Order —SQI’s RALI-Dx IL-6 test, a hospital-based respiratory triage test for COVID-19 positive patients.”