ProterixBio has announced commercial availability of a serology assay for Covid-19 validated for dried blood spots (DBS) from a finger stick.
The new quantitative Covid-19 test is an update to the SARS-CoV-2 (RBD) IgG Antibody test that was introduced earlier.
Through the company’s high-complexity CLIA testing laboratory, the new assay is being offered as a testing service.
ProterixBio has one of the only Covid-19 serology tests that offer a quantitative measurement of antibody levels linked to neutralising activity. It also has been validated with DBS.
The SARS-COV-2 (RBD) IgG Antibody test identifies antibodies that bind to the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.
The assay’s output is a numerical value of the antibody levels present and has been linked to neutralisation titer. It enables the results to be interpreted on a standardised basis.
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ProterixBio noted that it has generated validation data in key population segments.
They include children under 18 years, the general adult population aged between 18 to 80 years, and older adults aged 50 to 80 years with multiple chronic conditions, including chronic respiratory disease.
In addition, the test is authorised in various sample types, including serum, EDTA-plasma, heparin-plasma, and lately, dried blood spots from a finger stick.
Quantitative serology tests can evaluate the response a few weeks after Covid-19 vaccination and the longer-term durability of antibody levels.
It will be especially significant for first responders, healthcare workers, other essential workers, and at-risk populations.
ProterixBio president and CEO Michael Miller said: “Measuring and tracking levels of antibodies associated with neutralising activity may help an individual, together with their physician, make better health decisions.
“The ability to perform this test on finger stick samples increases test accessibility by allowing easier, more convenient specimen collection by healthcare providers.”
The SARS-CoV-2 (RBD) IgG Antibody test is offered as a laboratory-developed test (LDT).