The World Health Organization (WHO) has stated on a number of occasions since March that the infected need to be identified and tested regularly to control the Covid-19 outbreak.
PCR test was widely used in Sri Lanka as well as in the world to identify the Covid-19 patients. As discussions are made in other countries about the rapid antigen tests (RDT), several health unions in Sri Lanka have also urged the Ministry of Health to look into the possibility of conducting rapid antigen tests in the country.
Although there was no talk of a rapid antigen test back then, it came back into the limelight when a Sri Lankan private company imported 200,000 test kits to Sri Lanka.
PCR and Rapid Antigen Tests
In the most commonly used Polymerase Chain Reaction (PCR) tests, a person’s mucous membranes are examined for respiratory tract infections.
Doctors estimate that up to 70% of those infected with this disease, who are generally more sensitive to the diagnosis of a Covid-19 infection, can be easily diagnosed using PCR tests. Doctors say that in some cases, the PCR result of an infected person is negative because the sample does not contain enough viruses. The PCR test takes approximately 15 minutes to about two days to deliver results.
A rapid antigen test, or rapid antibody test, is a test that is done quickly, that is, in about 15 minutes to identify Covid-19 infections. The rapid antigen tests do not possess the sensitivity of the PCR tests to detect Covid-19 infections.
Abbott Rapid Diagnostics, a manufacturer of the rapid antigen test kits, says that successful tests can be performed within one to seven days of being infected with the virus. That is, the success of the rapid antigen test performed seven days after infection is very low.
The Centers for Disease Control and Prevention under the U.S. Department of Health and Human Services, says a negative rapid antigen test does not mean the patient is not infected with Covid-19. If a person has symptoms, is associated with a Covid-19 infected person, or tested negative following a rapid antigen test, it is still most suitable to carry out a PCR test too on that person, the institute said in a statement.
However, the institute points out that if a rapid antigen test gives a positive outcome, it is safe to treat the tested person as a Covid-19 infected and carry out necessary procedures.
WHO equipment list
In 2014, the Ebola virus began to spread in many countries in West Africa. At the same time, the WHO developed a methodology for maintaining a list of devices that can diagnose the virus for immediate use.
The main purpose of introducing this special methodology was to provide some guidance to the procurement authorities and regulatory agencies of the WHO member countries. The WHO documents state that there is a procedure for inclusion in the list of emergencies and that that equipment or the institute included in the emergency list should not be considered as fully qualified.
Institutions applying for such a listing will be added to the list from time to time, and if any malpractice takes place it may be removed from the list.
It was in September 2020, the WHO first added the rapid antigen tests to its list of emergency uses to diagnose coronavirus. The manufacturer of the STANDARD Q COVID-19 Ag Test, which was introduced on September 22, was identified as an institute called SD Biosensor, Inc.
As mentioned earlier, this list is revised from time to time after the manufacturers have tested the products they offer. Accordingly, the list was revised again on October 2, and another agency was added for rapid antigen testing.
The Panbio COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) was developed by Abbott Rapid Diagnostics Jena GmbH. The mere inclusion of these two institutions in the WHO’s emergency list does not mean that they are the two best rapid antigen tests in the world.
National Medicines Regulatory Authority
Sri Lanka cannot arbitrarily import and distribute drugs or medical equipment from other countries. This is to reduce the threat to the health of Sri Lankans by importing substandard drugs or equipment. The state agency for this is the National Medicines Regulatory Authority (NMRA).
If any health equipment is imported to Sri Lanka, there is an approved procedure for it. The Medicines Regulatory Authority has issued a set of guidelines on how to register a medical device. The activities of this Authority are empowered by the Act as well as by the regulations issued by a Gazette from time to time.
Accordingly, when importing a test kit to Sri Lanka, the first step is to submit an application to the NMRA. For this, the business registration certificate of the relevant institution, the letter of the foreign manufacturer stating that the relevant Sri Lankan company will be appointed as the agent in the country (that letter should be a letter addressed to the CEO of the NMRA), the free trade license and several other documents should be presented.
After the submission of the documents, a study will be conducted and if the NMRA is satisfied, a sample license will be issued. The sample license is issued in three copies and is valid for one year from the date of issuance.
The local company can then import a sample from the foreign manufacturer and begin the evaluation process after the sample is handed over to the NMRA. It is a lengthy process and after a lengthy examination of the quality of the sample, its potential for use in Sri Lanka, it is submitted to a committee to decide.
NMRA announced on October 26 that it has decided to register rapid antigen test kits in Sri Lanka and to submit applications in this regard.
State Pharmaceutical Corporation calls for tenders
On October 29, three days after the NMRA called for applications for registration of rapid antigen test kits, the State Pharmaceutical Corporation published a tender notice to purchase 100,000 rapid antigen test kits.
When inquired by MediaLK in this regard, the Chairman of the State Pharmaceutical Corporation Dr. Prasanna Gunasena stated that the bidding was done on the instructions of the Ministry of Health. The Chairman stated that the call for tenders was made on October 26. However, as far as we know, the call for tenders was made on October 29.The tender advertisement bearing the tender number DHS / RL / 74WAC / 20 states that the tender will be closed on November 2 at 2.30 pm. The day after the tenders were called was October 29, which is a Poya Day, followed by Saturdays and Sundays respectively. When the tender was called on Monday, November 2, about 32 companies had submitted their bids.
However, only two companies were able to deliver samples at the time of bidding. They were George Stuarts and Dinasa Pvt. George Stuarts Health Company, chaired by Dilith Jayaweera, a well-known businessman and owner of Derana Media Network, who set the price of a test kit at US $ 6.19.
The price offered by Dinasa Pvt. Ltd. was also US $ 6.19. The antigen test kit presented by George Stuarts Health was manufactured by Abbott Diagnostics in Korea, while the kit presented by Dinasa Pvt. Ltd. was manufactured by SD Biosensor in Korea.
Both products are on the WHO’s emergency list. Some politicians have said that Dinasa is owned by George Stuarts Health.
As mentioned earlier, the advertisement for the registration of the Rapid Antigen Test Kits by the NMRA was published on October 26. This was a three days’ time span, from 26-29, and was not enough to submit the samples to the tender called by the State Pharmaceuticals Corporation or to receive the letter to import the samples. So, how did only two companies manage to get samples?
Privilege of registration
Investigations revealed that the NMRA had registered two products for the rapid antigen test kits with a date a few days before the advertisement for the rapid antigen test registration was published.
The license to import registered medical devices was issued by the CEO of the Medicines Regulatory Authority to George Stuarts Health on October 22. It is given until October 21, 2021.
There is a regulation that once a medical device is registered, it must be added to the list of registered medical devices on the Medicines Regulatory Authority’s website. However, this product, which is said to have been registered on the 22nd, was not included in the relevant list until the time of writing (Nov. 13).
Not only that, the Abbott Rapid Diagnostics Jena GmbH manufacturer is also not included in the list. Rapid antigen test kits have not yet been added to the list allowed to be imported from George Stuart Health.
Speaking to MediaLK, Ravi Kumudesh, Chairman of the Institute of Medical Laboratory Professionals, said that this methodology clearly shows how government institutions in Sri Lanka work. He added that the mere inclusion in the WHO’s list does not mean it is the best product out there and that there was “serious ambiguity in the way the NMRA allowed this company”.
“The Ministry of Health suddenly submits a tender and completes it in a few days. However, a similar tender was issued to import PCR test kits. There were prices also proposed for these rapid antigen tests. But it is not yet put into the field. It is unclear how government agencies work on rapid antigen testing. There is no transparency, ”he said.
The bitter truth
An official of the NMRA said that it is a practical fact that if a company is allowed to import this medical equipment to Sri Lanka, it will not be possible to do that within two to three days.
When contacted by MediaLK in this regard, Dr. Kamal Jayasinghe, CEO of the Medicines Regulatory Authority, said as follows;
“When you bring any equipment, you have to register its manufacturer here. Then his local agent has to register. We will accept the product file only when it is registered. All this is done online. But because of Covid-19 we do the first two procedures and then the file is taken over manually and done with quickly. We don’t care who owns it or where it is.
“Currently two types of rapid antigen testing kits have been registered. Both of those test kits have been through the real procedure. The WHO has listed emergency items related to Covid-19. It’s called pre-qualifying. We use that criteria.
“If one of those included in the WHO list comes up, we can give it a quick go. There are two products registered. The local agent for both the products is the same. In addition, another sample has been submitted. Its procedures are going on.”
However, George Stuarts Health has so far imported 200,000 rapid antigen test sets to Sri Lanka. In addition, a group of doctors from the Ministry of Health have been trained on how to perform rapid antigen testing. The trainee was a doctor who was an official with Abbott, the manufacturer of the Rapid antigen kits imported by George Stuarts.
When inquired by MediaLK whether the tender would be awarded to one of the two companies that submitted samples when the State Pharmaceutical Corporation called for bids, the Chairman of the State Pharmaceutical Corporation Dr. Prasanna Gunasena stated that the quality testing of the samples has not been completed yet.
“We closed the tender on the second day. We have never had this many people offering prices before. We have not completed the work yet. The tender committee has referred this to the technical committee. The work of the technical committee is not over yet. This should be done in a transparent manner so we emailed back to all those who came to the tender to hand over the samples.
We are waiting for more samples to arrive. This is very transparent. Even PCR kits were brought earlier. We didn’t get any such accusations at that time,” said the specialist doctor.
Who benefits from this deal with lives?
The WHO list is for emergency purchase only. Otherwise, any country has the opportunity to evaluate those products as well as other products. If so, Sri Lanka has a chance too.
We have to stay vigilant whether this tender will be awarded to a quality and affordable company that Sri Lanka needs. This is because both the quality and the price strongly affect the citizens of Sri Lanka.
This is a deal playing with the lives of the people. Changes in quality can weaken lifespan as well as cause side effects. Price change is bound with the overall quality of life. Higher prices will deprive people from another essential product or service.
The businessmen have the advantage here. An advantage gained by playing with the lives of the general public.