Among the many stakeholders who are responsible for developing and implementing a national strategy for COVID-19 testing, government policymakers play a unique and important role. In addition to managing regulatory processes, they also have a strong influence over setting testing criteria and establishing the infrastructure necessary to handle rapid surges in demand.

While new testing modalities are increasingly being deployed in the fight against COVID-19, PCR testing remains the gold standard for identifying active cases. In this article, we look at some of the measures taken by policymakers in the Asia Pacific region to ensure that high-quality PCR tests are available, as well as the challenges that government may face in setting diagnostics policy.

Streamlining regulatory processes

Before any diagnostic tests can be performed on patients, regulators must evaluate and approve them for safety and efficacy. While regulatory processes are often cautious and deliberate, the COVID-19 pandemic forced policymakers in the Asia Pacific region to move quickly and clear a regulatory path for PCR tests (see this recent Dia:gram interview with Harjit Gill, CEO of the Asia Pacific Medical Technology Association, for more insight on how COVID-19 is reshaping regulatory processes in Asia).

Some regulators worked with blazing speed. By activating the emergency use authorization (EUA) system, South Korea’s Center for Disease Control and Prevention fast-tracked the approval of a PCR kit [1] in just three weeks after receiving the genome sequence of the virus. China likewise streamlined its regulatory processes [2] by conducting product inspection, quality management and application review of medical devices concurrently, enabling the approval of its first seven nucleic acid testing products in 11 days.

When fast-tracking approvals, regulators must walk a tightrope to ensure rapid access in times of need while continuing to protect patients. In some countries, lax oversight resulted in the widespread deployment of tests that lacked sufficient specificity and sensitivity, resulting in subsequent withdrawal of some tests from the market, as well as false positives and negatives that impeded containment efforts. Going forward, policymakers are likely to take greater caution and favour trusted equipment providers with a strong track record of quality.

Setting testing criteria

Beyond evaluating and approving new PCR tests, policymakers in the Asia Pacific region are working to establish testing criteria that are tailored to local needs. As the epidemiology and scientific understanding of the virus evolves, these criteria are changing constantly.

When the first COVID-19 cases showed up in Singapore in late January, for example, testing was primarily confined to patients with pneumonia or severe respiratory infection who had traveled recently to China. Over time, however, testing was applied to wider segments of the population, such as foreign workers living in the dorms that had become hotspots for the disease (see COVID-19 testing in Singapore: key updates from a public hospital lab for a detailed timeline on the country’s testing policies).

When setting testing criteria, policymakers need to consider more than just the epidemiological factors in their area of responsibility, but also the state of local health resources. Limiting factors include the availability of tests and the capabilities of the workforce. While well-resourced countries like South Korea have been able to conduct broad-based PCR testing, including for asymptomatic patients with minimal risk factors, other countries may need to have narrower criteria to preserve capacity.

Establishing new testing infrastructure and practices

As COVID-19 case counts rose in February and March, many healthcare systems in the Asia Pacific region had to adjust rapidly to surging demand for testing and isolation facilities. Some were forced to improvise. In late March, for example, Singapore General Hospital (SGH) turned its carpark into a sample collection zone (see The COVID-19 patient journey: a Singapore story for details on the experience of Hugh Mason, a university professor and former science filmmaker who was tested, diagnosed and isolated at SGH).

Due to the sheer volume of testing that needed to happen in Wuhan, the city that experienced the first large-scale outbreak, Chinese policymakers created special infrastructure to manage diagnostic workflows. By quickly mobilising architectural design, engineering and construction companies, the city built two temporary hospitals (Huoshenshan and Leishenshan) in just 12 days. Fully fitted with patient wards, consultation rooms and quarantine units, the makeshift hospitals also increased Wuhan’s capacity for PCR testing [3].

When setting their strategy for diagnostic infrastructure management, policymakers need to think carefully as to whether they have the incentives and the ability to consolidate their PCR testing operations in a few key locations or pursue a more decentralised approach. Countries that are compact or have strong logistics infrastructure might benefit from consolidation, but such an approach might be less effective in large countries that are less developed.  

Planning for the future

As new testing modalities become available in the coming months, policymakers will need to address new challenges, such as whether and how to manage highly sensitive data on lab operations and results. While some countries have allowed for connected PCR systems that enable the rapid pooling of data and remote support, for example, others have been more cautious due to concerns about data security.

Before the COVID-19 pandemic, many governments viewed laboratory capacity as a cost and not an investment for ensuring the safety and security of its people. That view is rapidly changing, and while every country has its own needs and should take its own unique approach to managing the crisis, most policymakers now have a new appreciation for the value of diagnostics.

[1] Ministry of Foreign Affairs, The Republic of Korea. Flattening the curve on COVID-19: How Korea responded to a pandemic using ICT.

[2] National Medical Products Administration, People’s Republic of China.

[3] ‘A closer look at nucleic acid testing at Huoshenshan Hospital‘, China Global Television Network