Cellmid Limited (ASX:CDY) is playing a role in Australia’s efforts to combat the COVID-19 pandemic through an agreement to supply rapid diagnostic tests (RDT), with products expected to arrive in the country by early April.
The test uses a virus-specific detection method that delivers results anywhere between three to 15 minutes and requires no laboratory equipment.
It also does not require the use of Polymerase chain reaction (PCR) equipment, which is one of the limiting factors in wide-scale testing.
Since the outbreak began Australia has conducted just over 190,000 tests, however, as well as being limited by the availability of PCR equipment, the pathology system is also limited by the lack of reagents.
Rapid tests are important to remove this bottleneck.
Benefit could be "enormous"
Cellmid CEO Maria Halasz said the benefit to the Australian health system could be enormous.
She said: “Social distancing is absolutely critical, as is learning from countries that managed the coronavirus infections well, such as Singapore and South Korea.
“These countries conducted widespread COVID-19 testing, isolated positives and provided early treatment. They not only controlled the spread of infection, they saved lives and medical resources.
“Our agreement allows for one of the fastest available COVID-19 tests to be made available for testing in Australia at scale.
“However, international demand for these tests is accelerating exponentially and to ensure ongoing supply over the next six months we need to act immediately.”
RDT tests have a critical role to play in flattening the infection curve and are economically competitive against other COVID-19 tests, which take much longer and require specialist laboratory equipment and medical skills.
Test is approved
The RDT ordered by Cellmid and arriving in Australia in early April, is produced by Guangzhou Wondfo Biotech Co Ltd with the company to pay a fixed price for each test it will purchase.
It is approved by the National Medical Products Administration (NMPA) in China, received the CE mark on March 5, 2020, and was approved by the Therapeutic Good Administration (TGA) on March 25, 2020.
This rapid diagnostic test, which is already used in several countries including the UK, Belgium, Spain and Germany, is produced in a TGA approved facility in China.
It is suitable as a bedside test, can be used in pathology labs, hospitals, nursing homes, schools, remote areas and by corporates when administered by healthcare professionals.
Small disposable kit
This RDT is a small disposable kit that uses a lateral flow colloidal gold-based detection method against viral-specific IgG/IgM, delivering results in as little as three minutes without laboratory equipment.
Most other available COVID-19 tests make use of PCR technology to detect viral RNA which requires skilled technicians, takes several hours to produce a result and is limited in throughput by the availability of specific laboratory equipment.
The RDT is stable at room temperature (2-30˚C) for up to one year which, combined with its ease of use, makes it an attractive option for regional testing or for mobile/rapid screening centres.
It consists of a small device that requires only 10 microlitres of patient serum or plasma, or 20 microlitres of whole blood, to be loaded into a receptacle, alongside an included buffer, which then migrates along the device to an area of immobilised viral S protein fragments.
If virus-specific IgG or IgM is present, conjugates are formed, which show up as a distinctive red band on the device.
Results in three to 15 minutes
Results are typically seen within three to 15 minutes, depending on the quantity of IgG/IgM in the blood.
Clinical validation studies making use of more than 500 clinical samples have shown specificity of 99.57% and a sensitivity of 86.43% on day 3 and 95% on day five from symptoms.
Cross comparison of PCR-based testing with the device showed a 93.41% coincidence.
Technical validation studies have shown no cross-reactivity with major respiratory pathogens, no interference from common biological confounders and a kit to kit and intrasample precision of 100%.