George Steuart Health says COVID-19 Rapid Antigen Test kits brought with all necessary approvals

Handover of the first batch of Rapid Antigen Tests to the Sri Lanka Red Cross Society

 First Shipment of Rapid Antigen Tests to Sri Lanka Red Cross and private hospitals

George Steuart Health, responding to allegations of its involvement in importing COVID-19 Rapid Antigen Test kits, said the WHO-approved test kits by Abbott Diagnostics were brought down for the private sector and Red Cross with all necessary approvals.

In a media statement, the company said the WHO granted emergency use listing for the COVID-19 antigen-based rapid diagnostic tests developed by Abbott Diagnostics and Standard Diagnostics in September. The WHO ordered 120 million of the tests to be distributed amongst low and middle income countries, with funding from the Bill and Melinda Gates Foundation.

Both Standard Diagnostics and Abbott Diagnostics have been represented in Sri Lanka for over a decade by George Steuart Health.

Citing WHO pre-approval, George Steuart Health has sought National Medicines Regulatory Authority (NMRA) approval for product registration early in October (the NMRA had turned down a request to consider use in March).

NMRA granted Provisional Registration for the test kits under the conditions that they be made available only to healthcare institutions, at a regulated price of Rs. 1,146.22 per test.

George Steuart Health received the certificate of registration and import license on 22 October; orders were received thereafter 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. 

Orders were placed with the manufacturers on 25 October and considering the national emergency, the kits were imported through a special aircraft operated by SriLankan Airlines on 3 November, paying the necessary airfreight and handling charges. The goods were distributed among private hospitals and the Sri Lanka Red Cross Society on 6 November.

Following a similar routine, registration was also granted to the product from Standard Diagnostics shortly thereafter, to be marketed at the same price. A tender for the test kits was closed by the State Pharmaceuticals Corporation on 2 November. This tender is under evaluation and is yet to be awarded.

The COVID-19 Rapid Antigen Tests produce a result in 20 minutes and have a sensitivity of 91.4% and specificity of 99.8%, when tested within the first seven days of infection. While PCR testing remains the gold standard and is the essential tool, the rapid test allows for faster identification and isolation of patients, thereby aiding in effectively disrupting the chain of transmission.

GS Health facilitated virtual training for microbiologists, virologists, epidemiologists and officials from the Ministry of Health on 2 November by experts from Abbott Diagnostics. The screening process of targeted populations will commence as soon as guidelines for use are issued by the Ministry of Health, the company said.