COVID-19 Test Update

Covid-19-test_Druglizer

Alcolizer Technology continues the development of a COVID-19 test for the Druglizer LE5 device in the ongoing fight against the virus. This will mean greater supply security for Australia and control of test availability for Australians.

The current COVID-19 pandemic was initially discovered in the Hubei province of Wuhan city, China in December 2019. (Zhou, P. et al. Nature 2020, 579, 270) and found to be caused by a novel coronavirus which was named SARS-CoV-2. A recent study looking at aerosol and surface stability of the virus showed that it may be found in aerosols (<5mm) for at least up to 3h and may be more stable on plastic and stainless steel than on copper and cardboard (van Doremalen, N. et al N.Engl.J.Med. 2020, DOI: 10.1056/NEJMc2004973).

Diagnostics play an important role in the containment of COVID-19, enabling the rapid implementation of control measures that limit the spread of the virus. The main assays used for COVID-19 employ real-time reverse transcriptase polymerase chain reaction (RT-PCR) that takes a few hours and requires specialised laboratories. These assays measure the viral load. The existing RT-PCR assays are unable to detect COVID-19 in the early stages of the infection, and there are reports where it has given false negatives in subjects for up to two weeks (Rothe, C. et al. N. Engl. J. Med. 2020, 382, 970-971). The main reasons for false negative results are improper extraction of RNA from clinical samples, insufficient material for testing, and poor sample collection. According of the WHO, the immediate priority for COVID-19 diagnostics is the development of nucleic acid and protein tests and detection at the point of care (Report of the WHO-China Joint Mission on Coronavirus Disease 2019 ; Geneva, Switzerland, 2020). Other technologies need to be adapted to address the current deficiencies.

Serological assays measure antibodies generated in response to viral proteins , they are particularly useful for surveillance of the disease. The test measures antibodies, IgG and IgM, in serum or plasma. These are produced in suspects from the 2nd week of viral infection. IgM can be detected in patient samples from 10 to 30 days after viral infection, while IgG can be detected from 20 days onwards (Tan, W. et al medRxiv 2020). One potential challenge when developing accurate serological tests includes cross-reactivity of antibodies against other types of coronavirus. Alcolizer is currently developing serological assays for COVID-19.

Alcolizer is currently developing an antigen assay in collaboration with Australian universities. The antigen assay allows direct measurement of the viral load in a subjects saliva within 10 minutes.

An issue with RT-PCR assays is that a result can take from hours to days to get a result back to the subject. This is unacceptable for a screening assay at either a company or country border control site. Alcolizer is currently developing an antigen assay in collaboration with Australian universities. The antigen assay allows direct measurement of the viral load in a subjects saliva within 10 minutes. The test uses similar technology to our current Druglizer system except has much enhanced sensitivity due to a novel optical system and also the use of high emitting reporter molecules. This will allow low cost rapid mass testing to be achievable and allow manufacturing at our Balcatta facility and more updates will follow next quarter.

Recent outbreak events in Australia have reinforced this virus will be with us for some time and the importance of an accurate, quick and easy test. This test will be vital for Australia to get back to work while maintaining the safety of its workforce.

Alcolizer Technology will continue to update you on progress with this exciting project as new milestones are achieved.

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