RAT and other tests were initially banned 

Trade union action to be taken if administrative issues remain unattended 

Rapid testing to be conducted as a control measure 

RAT products pre-validated by WHO

With the emergence of more COVID-19 positive cases Sri Lankan health services have decided to introduce Rapid Antigen Testing (RAT) to supplement the existing system of PCR testing. Although there are mixed views about this move, the Ministry of Health (MOH) is of the view that RAT is less expensive when compared to PCR tests. In addition to that, results could be delivered in 15 minutes and the process doesn’t require big machines like those used for PCR testing.

what is Rapid Antigen Testing?
According to the Centres for Disease Control and Prevention, a national public health institute in USA, Rapid Antigen Tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. Antigen tests are currently authorized to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent.

They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV). 

Antigen tests are relatively inexpensive and can be used at the point-of-care. The currently authorized devices return results in approximately 15 minutes. However, there are limited data to guide the use of rapid antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a previously confirmed case is still infectious.

RAT to be given to one company?

An antigen or antibody testing should happen in a laboratory but in the end we have to be answerable to all technical matters Ravi Kumudesh

“When the COVID outbreak took place, a PCR testing monopoly was created and Rapid Testing and other antibody tests were banned,” claimed Ravi Kumudesh, Sri Lanka Association of Government Medical Laboratory Technologists (SLAGMLT) President. “But now the Deputy Director General (DDG) for Laboratory Services at MOH says they are ready for Rapid Antigen Testing (RAT). They are allegedly going to give the tests to one company and we want to know what this company is, when the samples were brought in and other details,” said Kumudesh. 
While adding that 80% of RAT setups around the world have been a failure, Kumudesh further said that none of the professionals were consulted prior to taking this decision. “An antigen or antibody testing should happen in a laboratory but in the end we have to be answerable to all technical matters. Since the DDG (Laboratory Services) didn’t speak to us we instead have to speak to the President or the media and discuss our views,” he said. 

He further said that loopholes within the PCR testing capacity haven’t been rectified. “Even under a minimum capacity around 10,000 PCR tests could still be done. There are other administrative issues as well. Laboratory technicians aren’t given their overtime allowances, transport, the reagent supply chain isn’t functioning and the required workforce is only being recruited now. Therefore if no action is taken on these matters we will have to take trade union action within another 14 days,” he added. 

Although he agreed to the fact that the RAT is less costly than a PCR test, he said that a laboratory test should include a multiple approach. 

Technical committee consulted

Some of these products will be registered under the National Medicines Regulatory Authority (NMRA), they will also be given to other hospitals as well Ananda Jayalal

Airing his comments, DDG (Laboratory Services) Dr. Ananda Jayalal said that RAT will supplement PCR testing. “It was a decision taken after the technical committee agreed that we need to do rapid testing as a control measure. We need to find out people carrying the virus and therefore RAT will be a useful tool,” said Dr. Jayalal. 

When asked if there’s a company or entity that will overlook the process Dr. Jayalal said that the Ministry of Health will be getting the stocks. “Some of these products will be registered under the National Medicines Regulatory Authority (NMRA), they will also be given to other hospitals as well. The private sector will also be able to get involved in RAT later on while under the supervision of MOH,” he said. 

He further said that right now PCR tests are running at a maximum and around 9000 tests could be done in a single day.

Products pre-validated; local agent required
As the apex body that regulates all medical devices, the National Medicines Regulatory Authority (NMRA) has an important role to play in ensuring that any medical device is regulated including its price, prior to distributing to the market. When asked about the RAT, NMRA Chairman Prof. Asita De Silva said that there are only two products in the world to be used for RAT and that they have been pre-validated by the World Health Organisation (WHO). “When the WHO pre-validates a product it is for all countries,” he said.

When asked if there’s one company that will be involved in the process, he said that every product that is being brought down has to have an agent. “Our role is to ensure that these products are standardized while negotiating the prices. We need to ensure that these products are reasonably priced, that their sensitivity and specificity is checked, there after getting expert comments and conducting market authorization. It is only after that they could be brought into the country or else the customs will not allow entry,” said Prof. De Silva. 

He also said that the RAT is only a screening tool and not a confirmatory test. “This is because PCR tests take time and are expensive as well,” he added.

RAT will reduce ability to control virus

By turning to these tests, MOH is admitting its failure, which stems from its stubborn refusal since May to implement the guidance of the President and PM to build up PCR testing capacity Dr. Rannan-Eliya

According to Dr. Ravindra Rannan-Eliya, International Medical Researcher and Executive Director at Institute of Health Policy none of the countries successful in controlling COVID-19 are using RATs to substitute for PCR. “Their performance in detecting cases is not as good as PCR, especially when cases have no symptoms, which is usually the case in Sri Lanka. The scientific evidence is that this will reduce our ability to control the virus. WHO is primarily distributing these tests to countries in Africa, Latin America and elsewhere who have failed to control COVID-19. By turning to these tests, MOH is admitting its failure, which stems from its stubborn refusal since May to implement the guidance of the President and PM to build up PCR testing capacity. As a country we should be hanging our heads in shame that we have descended to this level. Whatever happens, building up PCR capacity and testing is still the best solution,” said Dr. Rannan-Eliya