SARS-CoV-2 antigen rapid diagnostic tests: protocol for performance evaluation of in vitro diagnostics for WHO prequalification assessment

Table of Contents

• 1. Introduction 5
• 1.1 Prequalification of in vitro diagnostics 5
• 1.2 WHO performance evaluation of SARS-CoV-2 antigen rapid diagnostic tests 5
• 2. Intended audience 6
• 3. Study objectives 6
• 3.1 Overall objectives 6
• 3.2 Specific objectives: 6
• 4. Study implementation 7
• 4.1 Performance Evaluation Laboratory 7
• 4.2 Training, performance evaluation and supervision 7
• 4.3 Safety 8
• 4.4 Test under evaluation 8
• 4.4.1 Production lots 8
• 4.4.2 Storage 8
• 5. Specimens 9
• 5.1 General description of the panels 9
• 5.2 LoD specimen preparation 9
• 5.3 VOC specimen preparation 10
• 6. Laboratory testing 10
• 6.1 Review of the instructions for use 10
• 6.2 Analytical performance 10
• 6.2.1 Limit of detection (LoD) 10
• 6.2.2 Variants of concern (VOC) detection 11
• 6.3 Lot-to-lot variation 11
• 6.4 Interpretation of results 11
• 6.5 Recording test results 12
• 7. Quality control 12
• 7.1 Competency panels 12
• 7.2 Internal control lines for rapid diagnostic tests 13
• 7.3 Test kit controls 13
• 7.4 External quality control specimen 13
• 7.5 QC acceptability 13
• 8. Analysis of data 13
• 8.1 Invalid runs and invalid individual results 13
• 8.2 Limit of detection 14
• 8.3 Detection of Variants of Concern 14
• 8.4 Lot-to-lot variation 14
• 9. Technician’s appraisal 14
• 10. Ethical considerations 14
• 11. Report preparation and dissemination 14
• 12. Materials and supplies 15
• 13. Roles and responsibilities 16
• 13.1 Responsibilities of the Performance Evaluation Laboratory 16
• 13.2 Responsibilities of WHO - Prequalification of In Vitro Diagnostics Team 16
• 13.3 Responsibilities of the manufacturer 16
• 14. References 17
• 15. Other documents and tools required 17
• 16. Document revision history 17
• 17. Annex – Operational characteristics and ease of use 18
• 17.1 Annex 1 – Assessment of operational characteristics and ease of use 18