The COVID-19 pandemic has created a need to rapidly scale-up testing services and provide diagnoses to implement test-trace-isolate strategies which are essential to effectively treat, and care for patients and to control the spread of the virus. Hundreds of diagnostic products are now available on the market, targeting detection of viral RNA, viral antigens and host antibodies against SARS-CoV-2. Tests vary in their complexity and speed and countries have faced challenges in selection and effective deployment of the reference standard, nucleic acid amplification testing (NAAT). Services for SARS-CoV-2 NAAT testing have often been unavailable, or backlogged for several days, precluding the clinical utility of the results.
Lateral flow antigen-detecting rapid diagnostic tests (Ag-RDTs) which are easy to perform and provide results within 15-30 minutes have recently been commercialized and have the potential to fill at least a portion of the ‘testing gap’. Under certain conditions Ag-RDTs that meet minimum performance requirements are recommended for use and some have WHO Emergency Use Listing authorization. These simple-to-use tests offer the possibility of rapid case detection, especially of the most infectious patients, at or near the point of care.
In view of this WHO designed a protocol for monitored implementation of SARS-CoV-2 Ag-RDT and called for proposals in December 2020. Allergy Immunology and Cell Biology Unit under the leadership of Dr Chandima Jeewandara and Prof Neelika Malavige submitted an application with the partnership of the Ministry of Health as a collaborator.
After a competitive application process AICBU secured funding for the Sri Lankan protocol. AICBU secured funding for this proposal and became a one of the five countries selected by WHO under this scheme.
WHO will fund maximum of $199,999 USD and additionally will provide up to 200,000 WHO EUL approved Ag-RDTs for Sri Lanka. The proposed conditions and settings for Ag-RDT use are aligned with WHO interim guidance on the use of antigen detection for COVID-19 using rapid immunoassays.
Data collected using this protocol will be crucial for optimizing the delivery and use of Ag-RDTs and maximizing public health impact in programmatic settings.
