I. Assessment
A. Policy and Research Question
Policy Question:
Which use case and for what population should the Philippine DOH consider the use of RATs?
Research Questions:
Regulatory Approval
- What is/are the approved use case/s of RATs by selected regulatory agencies?
- What are the validation testing requirements of selected regulatory agencies?
- What are the performance standards used by selected regulatory agencies?
Testing guidelines and evidence synthesis on use of RATs
- Which country/countries have implemented testing strategies using RATs for diagnosis, determination of previous exposure, or epidemiologic surveillance of COVID-19?
- What is the current position/ recommendation of HTA agencies regarding the use of RATs for diagnosis, determination of previous exposure, or epidemiologic surveillance of COVID-19?
Diagnostic Performance
- What is the accuracy of RATs in the following use cases?
a. Diagnosis of COVID-19 among asymptomatic patients
b. Determination of previous exposure to SARS-CoV-2
c. Epidemiologic surveillance of COVID-19
B. Protocol: Not available.
C. Reviewers: Health Technology Assessment Unit, DOH
D. Start of Review: May 29, 2020
E. End of Review: July 14, 2020
II. Recommendation
Evidence summary: Use of Rapid Antibody-based Test Kits (RATs) for Various Use Cases for COVID-19
Technical guidance: GUIDANCE DOCUMENT ON THE TECHNICAL REQUIREMENTS FOR SARS-COV-2 RAPID ANTIBODY TEST KITS AS AN ADJUNCT TEST FOR COVID-19
Rapid review: Use of Rapid Antibody- based Test Kits for Various Use Cases for COVID-19
III. Decision
Decision of the Secretary of Health: HTAC Recommendation on Rapid Antibody-Based Tests for COVID-19