Addressing the RAT controversy

  • Allegations of wide profit margins untrue: Dr. LakKumar

BY Cassendra Doole

As the number of Covid-19 cases and the death increase by the day, so do a number of allegations against private healthcare providers and importers of necessary items such as the rapid antigen test (RAT) kits, and overall accusations against the reigning Government and other parties.

One of the most recent accusations was made by Ven. Dr. Omalpe Sobitha Thera who said the company importing RAT kits to Sri Lanka makes a profit of approximately Rs. 24,000 per test kit sold to private hospitals in the country.

According to the Thera, the test kits, containing 10 testing samples each, were imported at a cost of Rs. 800 each. However, private hospitals are reportedly charging patients Rs. 2,500 per sample.

Meanwhile, in July 2021, a case filed by George Steuart Health (Pvt.) Ltd. against one media organisation was taken up before Colombo District Judge Anura Aluthge, where the court held that said media organisation is not to publish defamatory content only in connection with the importation of RAT kits to the country, along with its distribution and sale.

These allegations were also taken up on social media, with a number of heated debates cropping up. However, in response to one such accusation, Association of Medical Specialists (AMS) President Dr. LakKumar Fernando told The Morning Business that there is a price control set by the National Medicines Regulatory Authority (NMRA) and that the cost of a RAT kit ranges from $ 4 to $ 5.

“All these allegations where they say the antigen tests can be bought at Rs. 80 are untrue. They (the company in question) are getting it down at a C&F (cost and freight) price of $ 4. Abbott and SD BioSensor are the two RAT kits, and these were the only WHO (World Health Organisation)-approved kits when RAT kits were first imported to Sri Lanka. These are among the most trusted RAT test kits in the world today. Unfortunately, or coincidentally, George Steuart was the agent for both these RAT kits,” he said.

Dr. Fernando said that these RAT kits were given to the Ministry of Health at a rate of Rs. 1,096 per kit, while it’s given to other labs at a rate of Rs. 1,146.22 when given in packs of 25.

RAT kits in Sri Lanka

The RAT (frequently referred to as the rapid test) differs from the PCR test mainly due to the turnaround time of the results being just under 15 minutes. Dr. Fernando noted that one of the main obstacles of the time was the PCR test and the time taken for the virus to be diagnosed.

He explained: “You cannot identify a patient immediately. You have to take a patient and wait for a day or many hours in isolation before you know if the patient is ready to be released or not. But as with many diseases in the world, things changed when the rapid antigen testing came in. You could just go and identify a patient within a few minutes, then and there, with a great degree of accuracy.

“I wrote in my paper that soon a rapid antigen testing will come in, that it has to come, and that it will make a big difference in the entire detection of cases, as it will be a turning point. The entire world expected an antigen test and there were many people who were looking and checking on methods of procuring or developing an antigen test.”

According to Dr. LakKumar, the origin of the SD BioSensor RAT kit is a company in South Korea that has done a lot of pioneering work not only for Covid-19, but also for many other diseases such as HIV, ebola, and even dengue in making the RAT. He said it is their technology that some of the other countries have adopted.

To draw a connection between the two test kits and their companies, the diagnostic company SD had been sold to Alere Inc., now known as Abbott Rapid Diagnostics, and SD BioSensor was spun off.

“Coincidentally, when the RAT kits were submitted for WHO licensing, both Abbot of the US and SD BioSensor of Korea were the first two companies to manufacture rapid antigen tests recognised by the WHO,” Dr. Fernando said, adding that George Steuart Health happens to be Sri Lanka’s agent for both RAT kits.

Specifics of RAT kits in SL

Following these allegations, George Steuart Health issued a statement with regard to the matter.

The statement reads: “It is observed that numerous misconceptions have cropped up in the recent past regarding the import and sale of antigen rapid diagnostic tests. GSH (George Steuart Health), being a registered importer of the test kits, wishes to clarify that the products marketed bear WHO Emergency User Listing (EUL) and have been granted National Medicines Regulatory Authority (NMRA) approval for import and sale.

“When the product was initially introduced, several falsified allegations and misconceptions were meted out against the importer, i.e George Steuart Health and the products. Following a court order, these allegations were proved to be false and baseless, circulated by vested parties with malicious intent. An injunction has now been served against the parties involved, preventing the circulation of such falsified information.

“Since only few WHO EUL products were available in the market at the time, the NMRA imposed a maximum retail price of Rs. 1,146.22 per test for healthcare institutions, based on the exchange rate of Rs. 187 at the time. The tests are invoiced at a cost of Rs. 1,146.22 per test, to date, despite the dollar appreciation, with support from the stakeholders, based on the prevailing market conditions.

“In certain instances, for large procurement quantities, the tests are offered at lower prices to the Government of Sri Lanka. The import and prices of Covid-related products are 100% transparent, where shipment-wise data is provided to the Ministries of Health and Finance in advance. Rapid antigen tests have positively aided screening the population, at affordable costs. The tests will continue to be sold by GSH at the ceiling price of Rs. 1,146.22 per test, until changes are made by the Government of Sri Lanka.”

Meeting the needs and demand

Dr. Fernando said that even though the RAT kit was approved by WHO, more time was given to evaluate and approve the test kits locally prior to their utilisation, after which the NMRA had approved and the test kits were imported.

“Getting it (RAT kits) down was a blessing; that was the most acceptable, trusted rapid antigen to bring in. I cannot find fault in somebody bringing the only WHO-approved test kit to Sri Lanka at a time where we desperately needed a much less costly way of testing, at one-sixth of the cost of a PCR test,” he said

He said that the only obstacle in bringing this much-needed testing tool to the country was the fact that the owner is allegedly connected to the Government.

“This is not a good-enough reason. There was a need, and it was met. If there was any other WHO-approved manufacturer who applied and was rejected, and people were singled out by favoritism, then that is wrong. There is no evidence that it had happened like that. RAT kits are a turning point in the entire sector, as we can detect more cases and prevent community spread,” he said in conclusion.