The Covid-19 pandemic has prompted a global rush to produce rapid tests that confirm the presence of the new virus, and separate antibody tests that show a person has had the disease.
Speed is critical because of the rapidity of disease spread, even by those showing no symptoms, but so is reliability.
The understandable race to make tests available quickly has led to tests coming into use – notably antibody tests using blood samples – that subsequently proved to be too inaccurate.
In terms of both speed and reliability, the rapid Covid-19 test developed by Irish diagnostics company HiberGene is significant in a global context.
With moderate to high “viral loads”, positive results from nose or throat swabs are returned within 30 minutes on average, enabling rapid diagnosis of the disease at the early and highly infectious stage of infection. Negative results are returned within 60 minutes.
Lab avoided
This contrasts with the cumbersome process of sending samples to a laboratory, deploying what’s known as a PCR test, which can be done in less than 24 hours but in most cases takes three days (and often more) with samples from the community – from the point of taking swabs to returning results. A quicker timeline exists in healthcare settings, especially acute hospitals treating Covid-19 patients.
For any diagnostic test, the key performance indicators are sensitivity and specificity: a highly sensitive test should capture all true positive results; a highly specific test should rule out all true negative results.
A clinical evaluation study at the Mater Private Hospital, Dublin, has demonstrated the efficacy of the HiberGene test on both fronts. This enabled it late last week to achieve CE approval (ie conformity with EU health and safety protection standards), allowing its use in Europe, while other countries will deploy it on that basis.
In too many instances, tests, including some developed by major pharma companies, have failed on these criteria. The US Food and Drug Administration has stiffened its rules to counteract what some have called a “wild west” of antibody testing for coronavirus – more than 250 developers have been bringing products to the market in the past few weeks.
Low standards elsewhere
In an effort to make antibody tests available as quickly as possible – which becomes increasing important as economies come out of lockdown to enable people go back to work – it had set a low standard for these tests.
The UK government had to abandon finger pinprick kits for use at home, after they proved to be unreliable in validation testing, in favour of more reliable lab-based testing.
HiberGene’s Covid-19 test is for use when the disease is becoming infective and involves broadly similar proven technology and reagent it has deployed in its tests for diagnosing flu, herpes, pneumonia and other viral conditions.
In this instance it can be effectively deployed remotely, in healthcare settings and in medical labs where it has matched the performance of PCR testing for samples from individuals at all stages of Covid-19 infection. Centralised labs are frequently required to undertake additional tests for confirmation or out-of-hours testing. Moreover, the HiberGene technology can carry out four tests concurrently.
Covid-19 has forced health services to scale back daycare procedures and elective surgery because of a high risk of Coronavirus transmission in circumstances where physical distancing of 2m is not possible. The HiberGene rapid test has obvious potential in enabling operations proceed in such circumstances, on the day they are scheduled – once test results are shown to be negative.
