KUALA LUMPUR: The Ministry of Health (MOH) Malaysia has awarded ADT Biotech to supply its LyteStar 2019-nCoV RT-PCR Kit to all centers under MOH jurisdiction authorized to test for SARS-CoV-2, the virus causing COVID-19. Preceding the award, the LyteStar 2019-nCoV RT-PCR Kit had been validated by the Institute for Medical Research (IMR) with concordant results against IMR’s reference test.
In line with WHO guidelines, the LyteStar 2019-nCoV RT-PCR Kit adopts a dual [ihc-hide-content ihc_mb_type=”show” ihc_mb_who=”2,3,5″ ihc_mb_template=”1″ ] target strategy, targeting the E-gene of SARS-related Coronaviruses for the broader screening assay and the RdRP-gene for the 2019-nCoV specific confirmation test.
ADT Biotech, a BioNexus Status company under Malaysian Bioeconomy Development Corporation (Bioeconomy Corporation), developed the test specifically for the need of having an easy-to-use and sensitive first-line screening assay for the routine diagnostic laboratory. 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 centers, 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.
The LyteStar 2019-nCoV RT-PCR 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 separately a kit is also available that only contains the screening components (LyteStar SARS-CoV-2 RT-PCR Kit S, S for Screen) to better manage workloads. All samples that are negative for the screening test don’t need to be tested for confirmation, hence facilitating high throughput screening in diagnostic routine labs under resource-stretched conditions.
Says Dr Finn Zedler, Managing Director of ADT Biotech: “We take pride in the knowledge that our product has met the requirements of the Institute for Medical Research and has been subsequently approved by the Ministry of Health. It gives all of us here at ADT Biotech a strong sense of purpose that we can take an active part in joining the fight against the pandemic. We are currently ramping up our manufacturing capacity and pledge our commitment to overachieve the agreed number of tests in a week from now.”
Finn added that part of this achievement was due to the various forms of support and assistance given by Bioeconomy Corporation, especially in terms of engaging with relevant parties to market the LyteStar 2019-nCoV RT-PCR Kit and other ADT products in Malaysia and regionally.
Following ADT’s approach of utilizing 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 1st-line screening assay will be followed up and results confirmed with a second confirmative test. To date test kits have also been shipped to various countries in Asia including Korea, India, and Thailand, and orders are lining up fast from countries as far as Europe.
The Technology utilized for the test is based on the specific detection of gene sequences unique to the target pathogen. These gene sequences are amplified in a process referred to as real-time PCR (Polymerase Chain Reaction) and detected by the use of complementary molecular probes labeled with fluorescent markers. [/ihc-hide-content]
