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
Institution
|
n
(Patients/Sample)
|
Sensitivity
|
Specificity
|
Pasteur
Institute,
Paris,
France
|
80
|
98%
|
98-100%
|
University Medical
Center Amsterdam, Netherlands Streeklab Haarlem,
Netherlands
|
368
|
100%
|
98.10%
|
Pro Health
Medical
Nederwart,
Netherlands
|
212
|
98.80%
|
99.20%
|
National Institute
for Public Health and the Environment, Ministry of
Health,
Netherlands.
|
489
|
95.30%
|
98.20%
|
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
- CE Certified
- ISO 13485 Certified
- Manufactured in Europe
- Highly Selective and Specific
- Actively used across healthcare settings in Europe and the Far East
- Pending Health Canada Authorization