George Steuart Health imports COVID-19 antigen and antibody rapid kit tests

With the outbreak of COVID-19 in China, Abbott Diagnostics introduced the antigen and antibody rapid test kits earlier this year with George Steuart Health, part of the George Steuart Group, being its accredited agent in Sri Lanka. 

Highlighting the ‘Emergency Use Listing’ granted by the World Health Organization, George Steuart Health sought National Medicines Regulatory Authority (NMRA) approval for product registration early in October 2020. 

“Following expert evaluation, the NMRA granted Provisional Registration for the test kits, under the condition that the tests be made available to healthcare institutions alone, at a regulated price of Rs.1,146.22 per test. Samples of these tests have also been provided to the NMRA and the Ministry of Health for validation purposes,” the company said in a media release on Sunday.

The statement came amidst claims from the opposition and civil society groups that this company received ‘favourable’ treatment from the government in securing these test kits.

The statement said that the company having received the certificate of registration and import license on October 22, received orders from major private hospitals and the Sri Lanka Red Cross Society. Requests were also received from WHO affiliated agencies, for supplies to the Ministry of Health.

Subsequently, orders were placed with the manufacturers on October 25. Considering the national emergency, the kits were imported through a special aircraft operated by Sri Lankan Airlines on November 3, paying the necessary airfreight and handling charges.

A virtual training was conducted on Microsoft teams for microbiologists, virologists, epidemiologists and officials from the Ministry of Health on November 2, by experts from Abbott Diagnostics. Further trainings have been scheduled in the forthcoming weeks.

“The goods were distributed among private hospitals and the Sri Lanka Red Cross Society on November 6. The screening process of targeted populations will commence, no sooner the guidelines for use are issued by the Ministry of Health. These tests have a sensitivity of 91.4% and specificity of 99.8%, when tested within the first 7 days of infection, where antigen levels (viral load) and transmission rates are noted to be highest. Patients can be promptly identified within 20 minutes of conducting this test. The faster identification and isolation of patients, will aid in effectively disrupting the chain of transmission,” the statement added.

Here are extracts of the company statement:

“George Steuart Health has been at the forefront in the introduction of rapid diagnostic testing to Sri Lanka, following the establishment of the diagnostic division in 2008.
“We introduced rapid diagnostics through Standard Diagnostics (SD), Korea way back in 2009 with the launch of the first WHO prequalified Rapid Diagnostic Test (RDT) for HIV. In 2010, we introduced the first dengue antigen rapid diagnostic test to Sri Lanka, providing a breakthrough in the management of dengue, which was rampant in the island. Thus far, two local clinical studies have successfully been conducted and now, this test is considered by clinicians as the main tool in detecting dengue patients at an early stage, thus helping them save valuable lives.
“Today, these rapid diagnostic tests are the primary tests used for the detection of the Dengue. Subsequently, we introduced rapid diagnostic tests for influenza A/B/AH1N1. In 2013, Standard Diagnostics was subsequently bought over by Alere Medical; the world leader in rapid point of care tests and a conglomerate of 200+ rapid diagnostic and point of care test manufacturers. 
“We have further expanded the rapid diagnostic basket for infectious diseases including leptospirosis, hepatitis, cardiometabollics and drugs of abuse.
“Following the global acquisition of Alere Medical by Abbott Diagnostics in 2018, GSH has represented Abbott Rapid Diagnostic Products in Sri Lanka.
“With the outbreak of COVID-19 in China, Abbott Diagnostics introduced the antigen and antibody rapid test kits earlier this year. The use of these tests in Sri Lanka was however discouraged, due to concerns on the sensitivity and specificity of the tests at the time. Our requests to consider use was turned down by the NMRA in March 2020, as the WHO at that time had recommended the tests for research studies only.
“The rising infections have however, offered scientists a better understanding of how the virus operates. The efficacy of the test kits have since been scaled up by manufacturers.
“The world health organization has subsequently evaluated rapid test kits from many manufacturers worldwide. On September 28, Dr. Tedros Adhanom - Director General of the World Health Organization, stated that the WHO was pleased to announce that two such antigen test kits manufactured by Abbott Diagnostics and Standard Diagnostics, have proven to be effective in the identification of the virus, whilst promising to be a cost effective and faster method for screening.
Accordingly, the WHO, through funding received from the Bill and Melinda Gates foundation, placed orders for 120 million tests, to be distributed amongst low and middle income countries.”