COVID-19 rapid diagnostic test available in Australia by early April

By MiNDFOOD

COVID-19 rapid diagnostic test available in Australia by early April
Cellmid Limited, an ASX-listed biotechnology company, has signed an agreement to supply the COVID-19 rapid diagnostic tests (RDT) to Australia, with products expected to arrive in the country by early April.

The tests can be used in pathology labs, hospitals, nursing homes, schools, remote areas and by corporates when administered by healthcare professionals. The rapid COVID-19 test delivers results between three to 15 minutes, and requires no laboratory equipment. The small finger prick test does not require the use of PCR (Polymerase chain reaction) equipment, one of the limiting factors in widescale testing.

“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,” said Cellmid CEO Maria Halasz.

The COVID-19 rapid diagnostic test ordered by Cellmid and arriving in Australia in early April 2020, is approved by the NMPA in China and has received the CE mark on 5 March 2020 and was approved by the Therapeutic Good Administration (TGA) on 25 March 2020.The same rapid diagnostic test is already used in several countries including the UK, Belgium, Spain and Germany. It is produced in a TGA (Therapeutic Goods Administration) approved facility in China.

The COVID-19 rapid test is a small disposable kit that uses a lateral flow colloidal gold-based detection method against viral specific IgG/IgM. 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 rapid diagnostic test is stable at room temperature (2-30˚C) for up to one year.

The test consists of a small device that requires only 10 microliter of patient serum or plasma, or 20 microliter of whole blood, to be loaded into a receptacle, alongside an included buffer, which then migrate along the device to an area of immobilized 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 are typically seen within three to 15 minutes, depending on the quantity of IgG/IgM in the blood.

Clinical validation studies making use of over 500 clinical samples have shown specificity of 99.57% and a sensitivity of 86.43% on day 3 and 95% on day 5 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%.

SHARE THIS ARTICLE

Print Recipe

You may also like

BECOME A MiNDFOOD SUBSCRIBER TODAY

Let us keep you up to date with our weekly MiNDFOOD e-newsletters which include the weekly menu plan, health and news updates or tempt your taste buds with the MiNDFOOD Daily Recipe. 

Member Login