On account of the increasing COVID-19 clusters in Sri Lanka, ramping up the country's testing capacity has become critical, along with its treatment capacity, international health authorities advised.

Sri Lanka has to date employed only Polymerase Chain Reaction (PCR) testing, which is a highly sensitive molecular test that typically delivers an accurate result with no need for repetition.

PCR testing requires complex machinery in a laboratory setting to obtain accurate results, a process which takes a minimum of six hours. Sri Lanka’s full PCR testing capacity currently lies between 9000 – 10,000 tests per day.

While PCR testing remains the gold standard, the rapid rise of infections globally has also necessitated the augmentation of PCR tests with other methods, such as rapid diagnostic tests to scale up testing capacity.

“High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission," Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organisation (WHO) said.

"The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods,” he added.

The WHO evaluated several rapid, point of care antigen tests and in September, granted Emergency Use Listing (EUL) to two such rapid tests developed by Abbott Diagnostics and SD Biosensor.

The WHO has noted these two tests are ‘highly portable, reliable, and easy to administer … faster and cheaper than laboratory-based tests, enabling countries to increase the pace of testing, tracing and treating people for COVID-19 at the point of care’.

Rapid tests enable countries to substantially increase testing without heavy investments in expanding laboratories and technical capacity.

The Rapid Diagnostic Test (RDT) works by detecting the presence of virus proteins on samples obtained through a nasal or throat swab.

These rapid tests produce results within 15 to 20 minutes. Importantly however, these tests are best used for screening purposes within 7 days of infection and PCR testing will still be required for confirmation.

Where accuracy is concerned, the tests from Abbott Diagnostic for example are reported to have a sensitivity of 91.4% and specificity of 99.8% during clinical evaluation.

In addition to WHO approval, the Rapid Tests manufactured by Abbott Diagnostics and SD Biosensor have received approval for use from the TGA Australia, Health Canada, Health Sciences Authority – Singapore and other regulated markets in Europe, including France, Germany and the UK. The tests are now in use and freely available in over 100 countries worldwide.

The registration process of these products in Sri Lanka commenced in March-April 2020 and was re-activated following the grant of the Emergency Use Listing by the WHO, with the local agents requesting the National Medicines Regulatory Authority (NMRA) to consider approval since the WHO evaluation was now in place.