TORONTO, Feb. 23, 2021
TORONTO, Feb. 23, 2021 /PRNewswire/ -- Saltex Pharma has today released performance results for a One Step Rapid Antibody Test for COVID-19; BIOZEK. Studies conducted at leading research centers, including The Pasteur Institute in Paris, France, in addition to extensive reviews conducted by the National Institute for Public Health and the Environment, Ministry of Health, Netherlands, found that BIOZEK detected antibodies at a much earlier stage post onset of symptoms.
Across the varying studies, 1149 patients had their blood tested for the presence of IgM and IgG, with results compared between traditional PCR tests, as recommended by WHO, and BIOZEK. All studies yielded an extremely high output and concordance, with sensitivity ranging from 95% to 100% and specificity ranging from 98% to 100%. All results surpass Health Canada's minimum performance requirements for serological testing (see figure 1).
BIOZEK tests are already used routinely in numerous care settings across Europe and the Far East and are currently pending approval from Health Canada. Saltex Pharma have secured 20 Million BIOZEK test kits ready to be made available to Healthcare Professionals and Healthcare Institutions across Canada once Health Canada give the go ahead.
Current methods for antibody testing are predominantly lab based, and can take up to 3 days to receive results back. Other Antibody tests require the use of additional apparatus, and processing is limited to only a few tests per hour in local settings. With BIOZEK testing requiring only a single finger-prick blood sample, and no special apparatus, results are available much faster within 15 minutes.
Samir Dhalla, Clinical Director, Saltex Pharma explains: "The opportunity to implement regular, safe and effective antibody testing in any population is key to ensuring that the economy is safeguarded where possible against further restrictive measures, and takes into account the general population's resistance to infection. The BIOZEK Test provides the ability to harness what the Canadian Healthcare system has already put in place as well as expand and build upon that."
Dhalla continues: "By helping to detect the immunity of an exposed population, monitor the spread of disease, test the infection status of a workforce segment and study the disease's progression, data can be used to make better informed decisions about quarantine and social distancing regionally or locally, as well as be used to risk stratify health care providers, police, firefighters, utility workers, and other essential workforce employees."
A further benefit of the BIOZEK Test, as confirmed by a joint study conducted by Public Health England and the University of Oxford, is its ability to actively detect antibodies at an acceptable level from day 10 onwards post symptom onset. When compared to existing antibody tests already approved by Health Canada, this significantly improves on the existing capabilities, where the current approved tests show acceptable detection rates at greater than 20 days post symptom onset.
Figure 1: Definitive results from selected study centers that compared the BIOZEK Rapid Antibody test performance vs traditional PCR testing methodologies
University Medical Center Amsterdam, Netherlands Streeklab Haarlem, Netherlands
Pro Health Medical
National Institute for Public Health and the Environment, Ministry of Health,
About Saltex Pharma
Saltex Pharma is a leading supplier of goods and services to government entities and healthcare providers around the world.
Saltex Pharma's mission is to expand the reach of niche pharmaceutical and medical device products to new markets, ensuring equal access to new and innovative technologies that support better health and care for patients.
Since their inception in 2009, Saltex Pharma has facilitated access to new markets for several pharmaceutical and biotechnology companies, and supported local governments and healthcare providers with the procurement of licensed medical goods and devices.
For more information about Saltex Pharma please visit www.saltexpharma.com
About BIOZEK One Step Rapid Antibody Test