EXPLAINER: Are point-of-care tests the answer to managing COVID-19 without a vaccine?

By Athena Kolivos, Chief Scientific Officer CRC and Farmaforce

Imagine if you could be tested for SARS-CoV-2, the virus that causes the COVID-19 disease, at your local pharmacy, GP or in your own home, and receive results then and there.

Point-of-Care Testing (PoCT) provides patients the ability to receive accurate and reliable testing results outside a clinical laboratory environment, at the site of patient care. Rather than having blood or respiratory samples sent to a laboratory for analysis with no clear indication of the waiting period to receive the outcome, PoCT can show this outcome in real-time.

PoCT involves taking a sample of blood, urine, saliva or other bodily fluid and receiving the results where the person being tested or treated is, which could be any clinical setting (e.g. pharmacy, doctor rooms, ambulance, hospital). Taking PoCT one step further is self-testing at home, which already exists; the self-monitoring of blood glucose by people with diabetes and home pregnancy urine tests are two examples.

Screening and diagnostic tests are as much a part of managing disease, delivering patient care and improving health outcomes as treatments are. This is why new medical innovations that can reduce the turnaround time to confirm new cases of disease, or provide biochemical and other clinical data rapidly, are so important, especially where time is of the essence as with COVID-19.

With the growth of mobile biotechnology research and development, “lab-on-chip”, biochemical/chemical sensor detection, wearable devices and other screening, diagnostic and monitoring advances, PoCT has become a particularly important area of focus in healthcare delivery. This is because the test results obtained (versus laboratory testing) enables more timely clinical decision-making across a continuum of care. These range from the early screening or diagnosis of a specific disease, choice of treatment and referral through to patient monitoring and prognosis.

The Biosensor Platform technology, developed by The iQ Group Global, is a printable organic transistor ‘strip’ designed to put the power of accurate and timely diagnosis in the hands of patients and their primary health practitioners at point of care. The Biosensor Platform is currently being developed to test for up to 130 indications, including glucose monitoring for diabetes management, immunological conditions and communicable (infectious) diseases.

PoCT is designed to be convenient and user-friendly to help reduce, if not eliminate, various opportunities for testing errors pre-analysis (e.g. mishandling, mislabelling, contamination, degradation) and post-analysis (e.g. misreporting, delayed reporting, lost data) of a sample taken. Ultimately, this means earlier detection and treatment for people with either a communicable or non-communicable condition (e.g. cardiovascular disease).

PoCT is a relative ‘newcomer’ in pathology and while some concerns may exist, such as the potential for inaccuracy, quality control issues and misinterpreting results, these are expected to resolve with ongoing technological advances. Nevertheless, in resource-constrained healthcare settings where clinical or laboratory capacities are stretched, results are urgently needed or where large populations need to be tested and monitored, PoCT is an expedient, practical and accessible option.  

In relation to COVID-19, never has the need for a fast, reliable and readily accessible diagnostic test been so crucial than right now, as Australia and countries across the globe gradually progress out of lockdown.

With an increasing number of people returning to their normal workplace, governments and businesses are on high alert for potentially infected employees, customers and other visitors. Temperature checks are already the norm in some places, while other businesses want their employees tested before returning.

The logistics of testing up to millions of people in a country is no small feat, and the ideal PoCT for COVID-19 would have both high sensitivity (detects a person with the disease as positive) and specificity (detects a person without the disease as negative) so there are very few or nil false positives or negatives.   

However, COVID-19 PoCTs are in their infancy, being rapid diagnostic tests detecting either;

  1. Viral proteins (antigens) expressed by the COVID-19 virus in a sample of saliva or nasal secretion.
  2. Antibodies present in the blood sample (serologic test) of a person infected or exposed to COVID-19.

For this reason, the WHO encourages further research into the performance and potential diagnostic value of rapid testing based on antigen detection. They also support continued work on the utility of rapid testing based on antibody detection for epidemiological research and disease surveillance. However, the WHO does not endorse either rapid test for patient care and so laboratory-based immunodiagnostic tests remain the recommended method for identifying and confirming COVID-19 cases.

Alongside this, as well as major interest in rapid serology testing to increase Australia’s capacity to test, a Therapeutic Goods Administration post-market review of all approved serologic COVID-19 PoCTs (only allowed for healthcare professional use subject to certain restrictions and prohibitions) is currently underway to confirm their performance and understand best use.

As society commences a return to some form of normalcy, it’s clear that innovations to progress point of care healthcare delivery will be fundamental to control COVID-19 and future pandemics.

Athena Kolivos

Chief Scientific Officer, CRC & Farmaforce

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