Overview
CEN ISO/TS 5798:2022 (adopted from ISO/TS 5798:2022) is a technical specification for in vitro diagnostic test systems used to detect SARS‑CoV‑2 by nucleic acid amplification methods. It provides requirements and recommendations covering the full lifecycle of molecular assays: design, development, verification, validation and implementation, and addresses pre‑examination, examination and post‑examination steps for human specimens. The document is intended for medical laboratories, in vitro diagnostic (IVD) developers and manufacturers, and institutions supporting SARS‑CoV‑2 research and diagnostics. It does not apply to environmental samples.
Key topics and technical requirements
- Scope and laboratory requirements: laboratory layout, biosafety, personal protective equipment (PPE), instrumentation and trained personnel for molecular SARS‑CoV‑2 testing.
- Assay design and development: defining intended use, customer and clinical needs, institutional guideline strategy (LDTs vs IVDs), emergency use considerations, design risk management, and reagent/method optimization.
- Nucleic acid amplification methods: guidance on commonly used techniques including RT‑qPCR, RT‑dPCR, and isothermal amplification methods; selection of target sequences and primer design; implications of viral variants.
- Analytical performance verification: confirmation of performance characteristics such as accuracy, limit of detection (LOD), inclusivity, specificity, and robustness.
- Clinical validation: use of clinical specimens to demonstrate performance consistent with the intended use.
- Implementation and reporting: procedures for assay transfer to production, laboratory implementation, result interpretation and reporting.
- Quality assurance: routine performance monitoring, design changes and optimization, and interlaboratory comparison programs.
- Annexes and support: informative annex on nucleic acid amplification techniques and bibliography for further reference.
Applications and who uses it
- Medical laboratories performing diagnostic SARS‑CoV‑2 testing to establish compliant workflows and demonstrate analytical and clinical performance.
- IVD developers and manufacturers designing and validating molecular assays (RT‑qPCR, RT‑dPCR, isothermal) for SARS‑CoV‑2.
- Clinical, public health and research institutions implementing laboratory‑developed tests (LDTs), preparing emergency use submissions, or harmonizing interlaboratory testing practices.
- Useful for quality managers, laboratory directors, regulatory affairs teams and assay validation specialists.
Related standards and context
- This Technical Specification originates from ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) and is published as CEN ISO/TS 5798:2022 for provisional application in Europe. It complements national and international IVD and laboratory quality standards and is intended for integration with existing laboratory quality management and biosafety frameworks.