KUALA LUMPUR, Feb 26 (Bernama) -- ADT Biotech Sdn Bhd has launched a device named “LyteStar 2019-nCoV RT-PCR Kit” for detection of SARS-CoV-2 (the virus which causes Covid-19) -- an easy-to-use and sensitive first-line screening assay for the routine diagnostic laboratory.
Based on the World Health Organisation interim guidelines, it said the test recommends a testing algorithm using a screening test for a broader detection of SARS-related coronaviruses followed by a highly specific confirmation test.
All previously available tests for the new coronavirus SARS-CoV-2 require the diagnostic labs to detect various target genes, sometimes in more than a single test.
“As much as these tests offer high specificity for SARS-CoV-2 and may be useful in academic institutions or reference centres, they also increase complexity, time-to-results, manpower and resource requirements in the routine diagnostics setting that is already stretched thin by the high number of suspected cases,” ADT Biotech said in a statement.
The kit adopts a dual-target strategy, targeting a gene sequence common to all SARS-related coronaviruses for the broader screening assay (E-gene) and a separate gene sequence for the SARS-CoV-2 specific confirmation test (RdRP-gene).
“The test is available as a complete dual-target kit, and also as individual kits for screening, for example, the LyteStar 2019-nCoV RT-PCR Kit – E-gene and for confirmation: the LyteStar 2019-nCoV RT-PCR Kit – RdRP-gene, hence, offering greatest flexibility in choosing the most appropriate testing algorithm and allowing high throughput screening in diagnostic routine labs under resource-stretched conditions,” it said.
ADT Biotech managing director Finn Zedler said from experience during the SARS pandemic in 2002/2003, a fast, reliable and sensitive first-line screening assay is a fundamental requirement for the management and eventual control of an outbreak.
“Our goal in ADT is to offer real value to the front line, for example, the hospital and pathology labs that struggle with increasing numbers of cases while time and resources are under pressure,” he said, adding that these labs need effective tools that simply do their job.
Following ADT’s approach of utilising a low complexity screening assay, large numbers of cases can be screened with a comparatively simple test procedure and only patients tested positive with the first-line screening assay will be followed up and results confirmed with a second confirmative test.
To date the test kits have been shipped to Korea, India and Thailand for evaluation by the national CDC’s or reference laboratories.
ADT Biotech is a Malaysian Bionexus status company, incorporated in 2010 with the vision of improving the standard of diagnostic tests and procedures by bringing advanced technologies, quality brands and innovative products to the healthcare markets in the Asia-Pacific region.
ADT Biotech, LyteStar 2019-nCoV RT-PCR Kit, SARS-CoV-2, coronavirus, Covid-19