Antigen detection rapid diagnostic tests for coronavirus disease 2019 (COVID-19): master protocol for monitored implementation - Version 1.0 - Date 25 November2020

Sep 1, 2026

The COVID-19 pandemic requires rapid expansion of testing and diagnosis to support test-trace-isolate strategies and limit viral spread. While NAAT services are often unavailable or delayed in low- and middle-income settings, lateral flow antigen rapid diagnostic tests (Ag-RDTs) can deliver results in 15–30 minutes and help close testing gaps when minimum performance requirements are met. This monitored implementation protocol enables rapid, systematic data collection, aggregation, and analysis to evaluate impact across diverse health system settings.

LanguageEnglish

CategoryPresentations

FormatDOCX

Pages97

Reading Time34 min

AccessFree to download

Summary

Background

Introduction

Objectives

Methods

Design and duration

Case definition

Safety

Storage of assays

Recruitment of participants

Data collection

Testing procedures

Statistical analysis

Financing

References

Acknowledgments

Antigen detection rapid diagnostic tests for coronavirus disease 2019 (COVID-19): master protocol for monitored implementation Version: 1.0 Date: 25 November2020 Contents TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc56002440" 1 Summary PAGEREF _Toc56002440 \h 6 HYPERLINK \l "_Toc56002441" 2 Background PAGEREF _Toc56002441 \h 7 HYPERLINK \l "_Toc56002442" 2.1 Introduction PAGEREF _Toc56002442 \h 7 HYPERLINK \l "_Toc56002443" 2.2 Objectives PAGEREF _Toc56002443 \h 8 HYPERLINK \l "_Toc56002444" 3 Methods PAGEREF _Toc56002444 \h 9 HYPERLINK \l "_Toc56002445" 3.1 Design and duration PAGEREF _Toc56002445 \h 9 HYPERLINK \l "_Toc56002446" 3.1.1 Sites PAGEREF _Toc56002446 \h 9 HYPERLINK \l "_Toc56002447" 3.1.2 Scenarios PAGEREF _Toc56002447 \h 9 HYPERLINK \l "_Toc56002448" 3.1.3 Eligibility criteria for participation PAGEREF _Toc56002448 \h 10 HYPERLINK \l "_Toc56002449" 3.1.4 Endpoints PAGEREF _Toc56002449 \h 12 HYPERLINK \l "_Toc56002450" 3.2 Case definition PAGEREF _Toc56002450 \h 17 HYPERLINK \l "_Toc56002451" 3.3 Safety PAGEREF _Toc56002451 \h 18 HYPERLINK \l "_Toc56002452" 3.4 Storage of assays PAGEREF _Toc56002452 \h 19 HYPERLINK \l "_Toc56002453" 3.5 Recruitment of participants PAGEREF _Toc56002453 \h 19 HYPERLINK \l "_Toc56002454" 3.6 Data collection PAGEREF _Toc56002454 \h 20 HYPERLINK \l "_Toc56002455" 3.7 Testing procedures PAGEREF _Toc56002455 \h 22 HYPERLINK \l "_Toc56002456" 3.7.1 Use of Ag-RDTs PAGEREF _Toc56002456 \h 22 HYPERLINK \l "_Toc56002457" 3.7.2 Specimen collection PAGEREF _Toc56002457 \h 22 HYPERLINK \l "_Toc56002458" 3.7.3 Specimen transport and storage PAGEREF _Toc56002458 \h 22 HYPERLINK \l "_Toc56002459" 3.7.4 Confirmatory NAAT PAGEREF _Toc56002459 \h 22 HYPERLINK \l "_Toc56002460" 3.8 Ethical considerations PAGEREF _Toc56002460 \h 23 HYPERLINK \l "_Toc56002461" 3.8.1 Informed consent PAGEREF _Toc56002461 \h 23 HYPERLINK \l "_Toc56002462" 3.8.2 Treatment of subjects PAGEREF _Toc56002462 \h 23 HYPERLINK \l "_Toc56002463" 3.8.3 Data handling and record keeping PAGEREF _Toc56002463 \h 23 HYPERLINK \l "_Toc56002464" 3.8.4 Publication policy PAGEREF _Toc56002464 \h 24 HYPERLINK \l "_Toc56002465" 4 Statistical analysis PAGEREF _Toc56002465 \h 24 HYPERLINK \l "_Toc56002466" 4.1 Sample size PAGEREF _Toc56002466 \h 24 HYPERLINK \l "_Toc56002467" 4.1.1 Endpoints related to Ag-RDT performance PAGEREF _Toc56002467 \h 25 HYPERLINK \l "_Toc56002468" 4.1.2 Endpoints related to health worker competency and compliance PAGEREF _Toc56002468 \h 25 HYPERLINK \l "_Toc56002469" 4.1.3 Endpoints related to impact PAGEREF _Toc56002469 \h 25 HYPERLINK \l "_Toc56002470" 4.1.4 Cost effectiveness PAGEREF _Toc56002470 \h 26 HYPERLINK \l "_Toc56002471" 4.2 Statistical considerations PAGEREF _Toc56002471 \h 27 HYPERLINK \l "_Toc56002472" 5 Financing PAGEREF _Toc56002472 \h 27 HYPERLINK \l "_Toc56002473" 6 References PAGEREF _Toc56002473 \h 27 HYPERLINK \l "_Toc56002474" 7 Acknowledgments PAGEREF _Toc56002474 \h 27 HYPERLINK \l "_Toc56002475" 8 References PAGEREF _Toc56002475 \h 28 Summary Background Introduction 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 andcare 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. Services for SARS-CoV-2 NAAT assays have often been unavailable, especially outside of metropolitan areas in low- and middle- income countries (LMICs), or backlogged for several days to weeks, precluding the clinical utility of the results. Lateral flow a

FAQs

Why are SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) emphasized in this protocol?

Ag-RDTs are easy to perform and provide results within 15–30 minutes, helping address limited or delayed NAAT testing services and supporting rapid case detection when minimum performance requirements are met.

What is the purpose of the “monitored implementation” master protocol?

It enables rapid and systematic collection and sharing of data in a standardized format to support aggregation, tabulation, and analysis across different settings and levels of the health system.

How does the protocol align Ag-RDT use with existing guidance?

The proposed conditions and settings for Ag-RDT use are aligned with WHO interim guidance on antigen detection for COVID-19 using rapid immunoassays.

Sep 1, 2026

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