The WHO granted emergency use listing for the Covid 19 antigen-based rapid diagnostic tests developed by Abbott Diagnostics and Standard Diagnostics in September 2020. 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 sought NMRA approval for product registration early in October 2020 (the NMRA had turned down a request to consider use in March 2020). 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 22nd 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 25th October and considering the national emergency, the kits were imported through a special aircraft operated by Sri Lankan Airlines on 03rd November 2020, paying the necessary airfreight and handling charges. The goods were distributed among private hospitals and the Sri Lanka Red Cross Society on 06th 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 2nd November 2020. This tender is under evaluation and is yet to be awarded.
The Covid19 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 7 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 2nd 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.
George Steuart Health was established over three decades ago and represents over 60 major global pharmaceutical manufacturers. The company established its diagnostic division in 2008 and has since introduced several rapid diagnostics tests Dengue (Antigen), Influenza A/B/AH1N1 and HIV as well as hepatitis, cardiometabollics and drugs of abuse. These tests are widely used in Sri Lanka.