19 p.
Authors
- Citation
- World Health Organization . (2024). SARS-CoV-2 nucleic acid tests: protocol for performance evaluation of in vitro diagnostics for WHO prequalification assessment. World Health Organization. https://iris.who.int/handle/10665/379550 . License: CC BY-NC-SA 3.0 IGO
- ISBN
- 9789240102668 (electronic version) 9789240102675 (print version)
- Pages
- 24
- Published in
- Switzerland
- Rights
- CC BY-NC-SA 3.0 IGO
- Rights Holder
- World Health Organization
- Rights URI
- https://creativecommons.org/licenses/by-nc-sa/3.0/igo
Table of Contents
- 1. Introduction 5
- 1.1 Prequalification of in vitro diagnostics 5
- 1.2 WHO performance evaluation of SARS-CoV-2 nucleic acid tests 5
- 2. Intended audience 6
- 3. Study objectives 6
- 3.1 Overall objectives 6
- 3.2 Specific objectives 6
- 4. Study implementation 6
- 4.1 Performance evaluation laboratory 6
- 4.2 Training, performance evaluation and supervision 7
- 4.3 Safety 7
- 4.4 Test under evaluation 8
- 4.4.1 Production lots 8
- 4.4.2 Storage 8
- 5. Specimens 8
- 5.1 General description of the panels 8
- 5.2 Specimen preparation 9
- 6. Laboratory testing 10
- 6.1 Review of the instructions for use 10
- 6.2 Nucleic acid extraction 10
- 6.3 Analytical performance 10
- 6.3.1 Limit of detection 10
- 6.3.2 Reproducibility 10
- 6.3.3 Additional variant detection 11
- 6.3.4 Cross-contamination 11
- 6.4 Interpretation and recording of test results 11
- 7. Quality control 11
- 7.1 Competency panels 11
- 7.2 Internal quality control 11
- 7.3 Test kit controls 12
- 7.4 External quality control specimen 12
- 7.5 Limits of acceptability 12
- 8. Analysis of data 12
- 8.1 Invalid runs and invalid individual results 12
- 8.2 Analytical performance 12
- 8.2.1 Limit of detection 12
- 8.2.2 Reproducibility 13
- 8.2.3 Additional variant detection 13
- 8.2.4 Cross-contamination or carry-over 13
- 9. Technician's appraisal 13
- 10. Ethical considerations 13
- 11. Report preparation and dissemination 13
- 12. Materials and supplies 14
- 13. Roles and responsibilities 15
- 13.1 Responsibilities of the Performance Evaluation Laboratory 15
- 13.2 Responsibilities of WHO- Prequalification of In Vitro Diagnostics Team 15
- 13.3 Responsibilities of the manufacturer 15
- 14. References 16
- 15. Other documents and tools required 16
- 16. Document revision history 16
- 17. Annex – Operational characteristics and ease of use 17
- 17.1 Annex 1 – Assessment of operational characteristics and ease of use 17
