The landscape of COVID-19 testing is evolving rapidly -- for better and worse.
Worldwide, COVID-19 testing volume was on target to grow 25%-30% from May to June. New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods.
As governments loosened requirements for authorization of tests, there was a sudden surge in global demand and an unprecedented flood of new products. Scores of companies entered the fray, some of which have rushed or cut corners and produced tests with low accuracy.
In response, the Food and Drug Administration has issued warning letters, revoked emergency use authorization, and tightened some of its most lenient regulations, notably those applying to antibody tests.
Abundance of questionable products
Dozens of COVID-19 testing products have been introduced by major vendors, spanning a range of techniques and systems. Most of the larger companies already participating in the IVD market have or will soon have products.
There has also been a huge influx of product introductions from small, obscure companies. These have mostly targeted the low end of the price range and often had poor performance, while a small number of high-end automated systems are mostly limited to certain segments of the market, such as independent reference laboratories and centralized hospital laboratories.
Low-quality products from fly-by-night companies are the predictable result of the shortages and the relatively basic resources needed to produce mediocre antibody test kits with a low level of quality control. However, according to most sources, the leading companies such as Abbott, Roche, Cepheid, DiaSorin, Hologic, Thermo Fisher Scientific, and Quidel currently account for the majority of the tests that are being run in the U.S., along with laboratory-developed tests, which likely account for 20% or more.
Unpredictable virus spread tied to many variables
Globally. the pattern of COVID-19's growth is unfolding in diverse ways, and aside from the timing of its arrival, the reasons for differences between regions remain somewhat unclear. In many places, testing increases have been pushed constantly to achieve maximum growth. Even after the initial surge from zero, the month-to-month growth in the spread of the virus has persisted at 50%-100% for two to three months in many places, but this will likely flatten.
The spread of the virus is related to a number of variables including environment (urban versus rural) and cultural practices, such as shaking hands and kissing cheeks. Social distancing, masks, handwashing, and other mitigation measures have become an extension of those cultural habits and can also vary widely even over small distances. It is possible that large variations in the contagiousness and susceptibility of individuals can cause the herd immunity threshold to be reduced, shortening the spikes.
Continuous regional ebbs and flows
As countries experience different issues and transmission rates with COVID-19, testing is being handled differently based on the circumstances. With early and aggressive efforts, many of the areas hit first have been able to squash the curve sufficiently to control the low numbers that persist. The U.S. had delays in testing and the numbers eventually rose beyond a level of possible containment, with most states still increasing or flat.
Meanwhile, new hot spots have appeared in recent days in the Middle East, Africa, and Latin America as well as again in Asia, where the major concentration of new cases has been occurring in India, Pakistan, and Bangladesh. Indonesia, Nepal, Singapore, and the Philippines are also seeing high growth.
With many areas having large populations and limited healthcare infrastructure or funding, the situation in much of the developing world appears to be escalating beyond the ability to control or keep pace with testing. The volume of tests in these countries will generally be five- to tenfold lower per capita compared to North America and Europe and will lean more toward rapid diagnostic tests and point-of-care devices.
The hot spots in Europe have largely shifted to Eastern Europe, although Sweden and the U.K. are still facing significant challenges with reducing the numbers. In the Southern Hemisphere, a few countries are still running high numbers of tests despite management of the pandemic, with very low numbers of cases. With the winter bringing flu and cold season, it is still necessary to distinguish between the pathogens in places where the virus has been essentially stopped, such as Australia and New Zealand. There has also been a shift toward serology testing as the demand continues to grow for testing the population to help determine how safe it is to return to normal activities.
A significant but decreasing number of countries remain relatively unscathed, with small numbers of cases. Out of 200-plus countries and territories globally, only about 40 have around zero cases per day, mainly islands or less traveled areas. Regions that are seeing their first spike in cases are now facing the issue of scaling up to the necessary volume. Due to the unknowns that remain about the virus, it is also still a challenge to determine the appropriate level of testing. Some lessons can be applied from the countries that were hit earlier.
Trends, recommendations, consensus taking shape
Growth in testing is expected to continue, even though some areas are seeing declining cases, for example in parts of the U.S. Most labs are using COVID-19 tests from multiple suppliers as a way to hedge against shortages or other problems. Choice is partly dictated by the existing instrumentation, but there is usually some flexibility. Pooling and other techniques are being incorporated to stretch supplies to allow more tests to be conducted.
Due to the supply situation as well as the nature of scientific collaboration, many professional organizations have taken the initiative to address the challenges. The Association for Molecular Pathology, for example, has developed five key recommendations for testing labs to best respond to the pandemic, based on a survey of labs it recently conducted:
- Reassess type and location of SARS-CoV-2 testing services needed.
- Reprioritize supply allocations based on clinical testing needs, which could change over time, for example as prevalence falls or climbs.
- Increase transparency, communication, and real-time transmission of information between laboratories and suppliers (commercial manufacturers and government) about resource availability, supply quantities, and allocation strategies.
- Coordinate laboratories in real-time to leverage moments of excess capacity; share supplies to ensure rapid processing of samples.
- Standardize agency reporting formats and processes for reportable infectious diseases during a pandemic. Reduce significant burden on labs, reduce delays, and establish electronic systems and formats.
For countries that are still at the beginning of the crisis, taking these steps could improve the chances of success, while for the others, they will likely be among the key considerations to prepare for the next surge.
Justin Saeks is an analyst with market research firm Kalorama Information, part of Science and Medicine Group.
Disclosure: LabPulse.com is a sister company of Kalorama Information.