Developed and manufactured by BioMedomics, the point-of-care rapid serology test identifies antibodies that are generated by the body as a result of Covid-19 infection.
The antibodies, which are normally present during the middle and final stages of infection, may remain in the body after the exposure.
It will help clinicians to determine past exposure to Covid-19 even if a patient no longer exhibits symptoms.
Data on past exposure is considered to be vital for researchers in understanding the possible occurrence of SARS-CoV-2 infection across a population. The information can aid future strategies for fighting the pandemic.
BD Integrated Diagnostic Solutions president Dave Hickey said: “Serology tests are important because they provide an additional piece of information to aid in characterising possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity.
“Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test along with molecular diagnostics could be helpful in ruling out Covid-19.”
The test can analyse blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies related to SARS-CoV-2.
IgM enables the first line of defence during viral infections, while high-affinity IgG is generated afterwards for long-term immunity and immunological memory.
The detection of Covid-19 IgM antibodies hints a recent exposure to the disease and the detection of Covid-19 IgG antibodies indicates a later stage of infection.
The combined antibody test could also help identify the stage of the disease in patients.
BioMedomics CEO Frank Wang said: “Our test has been clinically validated at several hospitals and clinical laboratories in both the US and China and our published clinical data in the Journal of Medical Virology was one of the world’s first for a Covid-19 serology test.
“It has been used widely in China during the Covid-19 outbreak and is now ready to help combat coronavirus in the US through our collaboration with BD.”
The companies also noted that additional testing may be required, depending on the clinical scenario, to further evaluate the possibility of SARS-CoV-2 infection.