ISO 17822:2020

Overview

ISO 17822:2020 - "In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide" - provides laboratory-focused quality requirements for nucleic acid amplification tests (NAAT). The standard covers the entire diagnostic workflow (pre‑analytical, analytical, post‑analytical) to ensure reliable detection, identification and quantification of microbial pathogens using NAAT technologies such as PCR, LAMP, TMA, SDA and other amplification methods. It is intended for laboratories that develop, implement or perform NAATs for medical, research or public‑health purposes. Note: it does not replace manufacturer requirements for IVD device development but does address verification and validation when those devices are used in the laboratory.

Key topics and technical requirements

• Laboratory risk management and biosafety: containment, biosafety and biosecurity considerations specific to high‑sensitivity nucleic acid assays.
• Laboratory setup and equipment: physical layout, segregation of workflow areas, and requirements for commercial equipment and software.
• Personnel competency: staff training, roles and responsibilities for molecular diagnostics.
• Quality control materials and reference material: selection, examination and use of QC and certified reference materials.
• Assay design and LDT development: defining intended use, target sequence considerations, design input criteria and diagnostic workflow analysis.
• Verification and validation: method comparison, predicate assay selection, analytical performance characteristics (range, accuracy, trueness, precision) and limit of detection (LoD) validation.
• Pre‑analytical to post‑analytical workflows: sample preparation, nucleic acid extraction, result interpretation and reporting practices.
• Quality assurance and performance monitoring: internal QC, inter‑laboratory comparisons and continuous optimization.

Practical applications and who should use it

ISO 17822:2020 is directly applicable to:

• Clinical and hospital molecular laboratories implementing NAATs.
• Public health and reference laboratories performing pathogen detection and surveillance.
• Research laboratories that perform NAATs with clinical or health‑related implications.
• Laboratory managers, quality managers, molecular assay developers (LDTs), and accreditation personnel responsible for verification, validation and ongoing QA of NAAT workflows.

It helps labs meet regulatory and accreditation expectations for reliable NAAT-based microbial testing and supports robust implementation of both commercial IVDs (as used by labs) and laboratory‑developed tests.

Related standards

• ISO 15189 - Medical laboratories - Requirements for quality and competence
• ISO 15190 - Medical laboratories - Requirements for safety
• ISO 17034 is referenced regarding certified reference materials

Using ISO 17822:2020 improves laboratory quality practice for NAAT, strengthens biosafety and supports consistent, traceable results in molecular pathogen detection.