Overview
ISO/TS 5798:2022 specifies requirements and recommendations for the design, development, verification, validation and implementation of in vitro diagnostic tests that detect SARS‑CoV‑2 by nucleic acid amplification. It covers pre‑examination, examination and post‑examination process steps for human specimens and is intended for medical laboratories, in vitro diagnostic (IVD) developers and manufacturers, and institutions supporting SARS‑CoV‑2 research and diagnostics. This technical specification does not apply to environmental samples.
Key topics and requirements
- Test design & development: defining intended use, customer/patient needs, clinical strategy, and design risk management for analytical tests.
- Nucleic acid amplification methods: guidance for common methods such as RT‑qPCR, RT‑dPCR, and isothermal amplification techniques; selection of target sequences and primer design.
- Pre‑, during‑, and post‑examination processes: specimen handling, biosafety, laboratory setup, instrumentation and personnel qualifications.
- Verification & validation: confirmation of analytical performance characteristics including accuracy, limit of detection (LOD), inclusivity, specificity, and robustness, plus clinical evidence using real specimens.
- Quality assurance & monitoring: performance monitoring, interlaboratory comparison, design changes and design transfer to production.
- Biosafety & risk control: laboratory area requirements, PPE, and risk mitigation for handling infectious respiratory samples.
- Regulatory and operational pathways: considerations for laboratory developed tests (LDTs), IVD devices and emergency use authorization processes.
Applications and users
Who uses this standard:
- Clinical and hospital laboratories implementing or validating SARS‑CoV‑2 NAAT diagnostics.
- IVD manufacturers and developers designing kits and assays (RT‑qPCR, RT‑dPCR, isothermal).
- Public health laboratories and research institutions involved in diagnostic method development or interlaboratory studies.
Practical uses:
- Creating standardized assay design and validation plans for reliable SARS‑CoV‑2 detection.
- Establishing laboratory workflows (pre‑analytical to reporting) that meet quality and biosafety expectations.
- Supporting regulatory submissions, emergency use pathways, and routine quality assurance programs.
Related standards
- Work prepared by ISO/TC 212 (Clinical laboratory testing and IVD test systems).
- Complementary guidance may be found in ISO standards addressing medical laboratory competence and quality management (for example, ISO 15189) and IVD device requirements.
Keywords: ISO/TS 5798:2022, SARS‑CoV‑2, nucleic acid amplification, RT‑qPCR, RT‑dPCR, in vitro diagnostic, LOD, validation, laboratory biosafety, IVD developers.