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Mixed views on controversy surrounding rapid antigen test kits
Has there been an irregularity in the process of granting registration to the pharmaceutical importer, George Steuart Health (GSH), by the National Medicines Regulatory Authority (NMRA) for the importation of Rapid Antigen Test kits for COVID-19?
This is the question that needs to be answered amidst allegations and counter-allegations that have been swirling around in the past two weeks.
There were mixed reactions when the Sunday Times contacted a wide-range of experts.
Some sources were insistent that whether GSH, a subsidiary of George Steuart & Company Limited, has been importing other reliable rapid diagnostic test kits (for HIV, dengue influenza A/B/AH1N1), was not relevant to this issue.
“This does not and should not come into the equation when seeking an answer to this crucial question,” the sources pointed out.
Others reiterated that whether the two Rapid Antigen Test kits for COVID-19 imported by GSH are the best in the world is also not relevant. Were the registration protocols followed or were waivers granted to GSH?
However, others said that there was unnecessary controversy over the kits when GSH was the agent for both kits pre-validated by the World Health Organization (WHO).
They also suggested that in this unusual crisis created by COVID-19, the NMRA should adopt some procedures, in collaboration with the WHO, (with the stress on WHO collaboration), to fast-track the importation of emergency supplies for humanitarian reasons.
The kits in question are the Panbio COVID-19 Ag Rapid Test of Abbott Diagnostics and STANDARD Q COVID-19 Ag of Standard Diagnostics, both with manufacturing plants in South Korea. GSH is the agent for both kits.
When contacted by the Sunday Times, Executive Director of GSH, Eran Ranasinghe says that they initiated the registration process for the STANDARD Q kits by providing samples to the NMRA in March 2020. But the NMRA denied registration on the grounds that the WHO at that time had recommended the test for research studies only.
“However, by September 22, 2020 the WHO evaluated the kit of Standard Diagnostics and declared that it had proven to be effective in the identification of the virus, followed on October 2, 2020 for the kit of Abbott Diagnostics,” he points out, adding that the WHO put both kits under the ‘Emergency Use Listing’.
Here is thetimeline thereafter:
- October 6, 2020 – GSH states that the Board of Investment (BOI) and the Export Development Board approached them knowing that they were the agents for both the kits. The Health Ministry also called GSH.
- October 22 & 29, 2020 – The NMRA granted Provisional Registration for the Panbio kit and STANDARD Q COVID-19 Antigen kit respectively considering the WHO decision.
- October 25, 2020 – GSH placed orders with the manufacturers of these kits to bring in imports based on the Provisional Registration and import licence granted by the NMRA.
- October 28 & November 2, 2020 – GSH handed over the Abbott and Standard Diagnostic kit samples (75 tests each) respectively to the NMRA. They were sent for validation to the NIID (National Institute of Infectious Diseases). The evaluation reports are directly submitted to the NMRA by the evaluators and GSH states that they are yet to receive the outcome.
- November 2, 2020 – Abbott Diagnostics conducted a virtual training for microbiologists, virologists, epidemiologists and officials from the Health Ministry.
- November 3, 2020 – The first stock (200,000 kits) of Abbott Panbio COVID-19 Antigen Rapid Test Kit was imported in a special aircraft operated by SriLankan Airlines. GSH has orders and requests from 30 institutions including the private hospitals of Asiri, Nawaloka, Ninewells, Hemas and Kings; the Sri Lanka Red Cross Society; the Neville Fernando Hospital; the Kelaniya University and the Asian Development Bank (to donate them to the Health Ministry).
- November 6, 2020 – GSH distributed 175,000 kits among private hospitals and the Sri Lanka Red Cross Society, while Health Ministry guidelines are being awaited for their use.
When asked by the Sunday Times whether the registration of the two types of kits was fast-tracked by the NMRA, if so, why and usually, how long it takes if an application is fast-tracked, Mr. Ranasinghe of the GSH reiterated that the registration process was initiated in March 2020 and they requested Emergency Approval for the test kits on October 6, after the WHO granted Emergency Use Listing.
“Subsequently, the NMRA granted provisional registration in 2-3 weeks, considering the WHO pre-validation and the national need for the product. Priority Registrations are only entertained, depending on the absolute need for the medication/medical device,” he said.
According to him provisional registration was granted after ‘expert evaluation’ and with the condition that the kits be made available to healthcare institutions alone at a regulated price of Rs. 1,146.22 per test.
When asked about allegations that the expert evaluation was negative, he states that the first evaluation conducted in April 2020 proved low sensitivity to the virus. The NMRA turned down the GSH request for registration at that stage.
Mr. Ranasinghe says: “The scientists involved in the development of the tests have since learnt the disease and virus changing patterns due to large incidence of cases. As a result of this, they have been successful in modifying and scaling up the sensitivity and specificity of these tests, to successfully detect the presence of the COVID-19 antigen.
“Subsequent evaluation by the WHO proved significant sensitivity and specificity to the virus. Based on this outcome, the WHO entered into contracts with these two manufacturers only, to make the tests available to middle and low-income countries. The WHO is to procure 120 million such tests over a period of six months, to be distributed worldwide.
“Following our second request for registration, the NMRA originally requested that the kits be validated locally. However, considering the national emergency and the pre-validation by the WHO, we requested that the condition be waived off for the grant of the import licence.”
| WHO on Rapid Antigen Test Kits for COVID-19The Sunday Times asked the Country Office of the World Health Organization in Sri Lanka whether any Rapid Antigen Test Kits for COVID-19 have been pre-qualified by the WHO? Here is the answer: While PCR tests are reliable (especially when the sample collection and testing is done properly), they require considerable laboratory infrastructure and resources, which can be challenging in resource constrained settings. Antigen tests are a promising alternative as they are cheaper, faster and easier to administer. However, their reliability varies. WHO has issued guidance on their use, is currently evaluating some of these tests for Emergency Use Listing and has granted emergency use listing to two tests – Panbio COVID-19 Ag Rapid Test (product code 41FK10) manufactured by Abbott and STANDARD Q COVID-19 Ag (product code 09COV30D), manufactured by SD Biosensor, Inc
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| NMRA statementThe National Medicines Regulatory Authority (NMRA) states that it provides priority review for products that are used against COVID-19 and has done this for PCR kits, medical masks, sanitizers and other products to ensure timely and continued availability of these products in the country. “The NMRA has registered the two rapid antigen tests approved for procurement by the WHO after priority internal review considering the urgent need in the country. However, ONLY provisional registration has been granted on the condition that they will be used ONLY under expert review UNDER guidelines on their use that are developed by relevant experts in the Health Ministry. Until then, the two tests are not allowed to be used,” it states. The NMRA adds that as a further precaution samples of these kits were sent to IDH for local validation. All these steps have been taken by the CEO, NMRA, with an abundance of caution. |