ISO/TS 16099:2025 — requirements for PCR methods detecting microorganisms and viruses in water
On 23 July 2025 ISO published the Technical Specification ISO/TS 16099:2025 (edition 1, 71 pages, committee ISO/TC 147/SC 4), “Water quality — Polymerase chain reaction (PCR) for the detection and quantification of microorganisms and viruses — General requirements, quality assurance and validation”. It covers quantitative, qualitative, reverse transcription and digital PCR.
- It applies, among others, to drinking water, groundwater, pool water, process water, surface water and wastewater, and to bacteria, yeasts, fungi, parasites (Cryptosporidium, Giardia), amoebas, multicellular organisms and viruses; it also covers on-site PCR-based methods.
- The minimum requirements are intended to ensure comparable and reproducible results in different organizations; the document covers quality assurance as well as validation and verification of PCR-based methods.
- Separate clauses address sample preparation and concentration, samples containing heavy metal particles, removal or inactivation of nucleic acids from damaged microorganisms, the layout of laboratory areas and environmental monitoring for PCR.
- The procedure lists the controls: negative and positive process controls, internal process control, amplification control, positive and negative PCR controls and the controls required for dPCR, as well as evaluation of positive controls using control charts and evaluation of the standard curve.