The landscape of COVID-19 testing has been rapidly evolving. 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. With the sudden global demand and governments loosening requirements during the crisis, there has been an unprecedented flood of products. It has attracted scores of companies, some of which have rushed or cut corners and produced tests with low accuracy. In many cases there have been recalls and the FDA has issued warning letters, revoked EUAs, and tightened some of its more lenient regulations, for example for Policy D antibody tests.
Along with labs procuring additional systems and increasing their staffing, there are other ongoing activities that are being undertaken to address the various challenges of COVID-19 testing. The growth is expected to continue, even with some areas seeing declining cases for example in the US. Most labs are using multiple suppliers’ COVID tests, as a way to hedge against shortages or other problems.
A significant but decreasing portion of countries still remains relatively unscathed with small numbers of cases. There are only about 40 countries with zero to one case per day, out of 210, mainly islands or less-travelled 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
This is partly dictated by the existing instrumentation but there is usually some flexibility. Pooling and other techniques are being incorporated to stretch supplies out for more tests.
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 (AMP), for example, has developed five key recommendations for testing labs to best respond to the pandemic, based on its recent survey –
- Reassess type and location of SARS-CoV-2 testing services needed – better match to the situation
- Reprioritize supply allocations based on clinical testing needs, which could change over time – e.g. as prevalence falls or climbs
- Increase transparency, communication, and real-time transmission of information between laboratories and suppliers (commercial manufacturers and government) – reagent, supply, resource availability and supply quantities, allocation strategies etc
- Real-time coordination amongst laboratories to leverage moments of excess capacity – share supplies to ensure rapid processing of samples
- Standardize agency reporting format and processes for reportable infectious diseases during a pandemic – reduce significant burden on labs, reduce delays, 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; and for the others, they will likely be among the key considerations to prepare for the next pandemic.