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TGA Approved products include N95 rated Masks & COVID-19 IgG/IgM Rapid Test (ARTG No. 335081)

Independent Evaluation of Orient Gene COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2

Download independent study 1

This Independent Evaluation reviews the clinical sensitivity and specificity of three rapid SARS-CoV-2 Antibody (IgM/IgG) Tests on a hospitalized patient cohort: InTec, Cellex and OrientGene.

Download independent study 2

Covid Rapid test

COVID-19 lgG/lgM Rapid Test Cassette

In response to the Coronavirus epidemic, Scientists have developed a COVID-19 specific immunoassay. This test, specific to the virus antibody, can yield a result within 2-10 minutes.

The 2019 new coronavirus pneumonia (NCP) or COVID-19, was discovered for the 2019 Wuhan Viral Pneunomia case in China and was named by the World Health Organization on January 12, 2020. For confirmed coronavirus disease 2019 (COVID-19) cases, reported illnesses have ranged from mild symptoms to severe illness and deaths. Symptoms can include: loss of smell, fever, cough, and shortness of breath. The virus is thought to spread mainly from person-to-person.

According to the World Health Organization (WHO), “The best defense against any outbreak is a strong health system,” stressed WHO Director-General Tedros Adhanom Ghebreyesus. “COVID-19 is revealing how fragile many of the world’s health systems and services are, forcing countries to make difficult choices on how to best meet the needs of their people.”

The ALLIED health system needs support to fight the pandemic we face today and a combination of rapid testing and qPCR test are a fundamental diagnostic tool that enables the front line health professional to quickly and efficiently focus and allocate their valuable resources.

The Infectious Disease Investigation & Management Model (HAVE model) has a well-trodden and notable high success rate in unravelling both old and new infections.

In essence, the more data we hold on each of these parameters , Host Agent Vector & Environment, then the closer we are to resolving the issue.

At present we have a pandemic of a new disease and we need to get information as soon as is practicable and safe, so we can make better informed decisions on when to return to our daily activities of living.

Host Factors we need

  • Who is susceptible?
  • Who is incubating?
  • Who is infected?
  • Who is recovered and immune?
  • Who is an asymptomatic carrier?
  • What are the timelines for the stages of the infection?
  • Do all with infection exhibit an Immune response?

Rapid, point-of-care testing will assist greatly in filling in some of these blanks and yield a significant data-base fo both our clinicians and our policy makers.


Point of Care Tests (POCT)


  • POCT plays critical roles in diagnosis, treatment, and prevention of infectious diseases.
  • Simple, accurate, multiplex and widely accessible POC tests are needed for many major pathogens.
  • POCT technologies have advanced significantly in the past decade, including microfluidics and plasmonics.
  • POCT tests provide actionable results near the patient and thereby serve as a personal “radar”.
  • Biomarkers in COVID-19 provided by lateral flow POCT are the IgM & IgG qualitative detection

Expia Position

The Orient Gene Lateral Flow POCT does fulfill these comments noted above BUT our position, at this time, is that such a POCT should not be interpreted or used as a marker of acute diagnosis. Biologically this use  is implausible as it is a time-related marker of exposure and if used in this way it will be shown to be of enormous significance in staging and understanding the time-lines of :-
  1. The Incubation Period
  2. First development of IgM
  3. Disappearance of IgM
  4. Appearance of IgG
  5. Duration of IgG
  6. Significance of persisting IgG
The graph above allows stratification into 4 serological groups. The exact days are still not clarified for Covid-19 and are listed based on similar viral respiratory infectious agents.
  1. IgM -ve & IgG -ve
  2. IgM +ve & IgG -ve
  3. IgM +ve & IgG +ve
  4. IgM -ve & IgG +ve
Policy can be practicably directed for any individual if this data is known.
These timelines represent the present Covid-19 staging from the limited data. Hopefully, policy makers will identify this role of a POCT, in filling/confirming these data as they will be invaluable in the COVID-19 journey.