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

1. What is/are the approved use case/s of RATs by selected regulatory agencies?
2. What are the validation testing requirements of selected regulatory agencies?
3. What are the performance standards used by selected regulatory agencies?

       Testing guidelines and evidence synthesis on use of RATs

1. Which country/countries have implemented testing strategies using RATs for diagnosis, determination of previous exposure, or epidemiologic surveillance of COVID-19?
2. 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

1. 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