Main
Skip Navigation Links

User
Skip Navigation Links

Linkedin

Welcome

BIOplastics designs and manufactures products from polymer plastics, (Injection Moulded) for use in the molecular diagnostics (MDx) and molecular biology laboratory field. The products are of superior high-quality, state-of-the-art and offer great added value.

                        
Winter Action Winter Action

How good is your knowledge about (q)PCR and disposables….

Test your (q)PCR knowledge

SI-Traceable Calibration as a Prerequisite for Reliable IVD-(q)PCR
29-Aug-2025

Current IVD regulatory frameworks (FDA, IVDR, etc.) allow qPCR-based assays to be validated on
uncalibrated instruments, relying on internal reproducibility rather than SI-traceable
measurement. By contrast, clinical laboratories operating under ISO 17025 or ISO 15189 must
calibrate their PCR/qPCR instruments to SI standards. This mismatch creates a traceability gap
that undermines reproducibility, scientific defensibility, and clinical reliability.


Using population-based modeling, non-calibrated validation is shown to carry ~45% failure
probability across 10,000 instruments, versus ~1–2% when SI-traceable calibration is applied.
This document outlines the regulatory paradox, quantifies the risk, and defines how ISO 20836
calibration methods and ISO/IEC 17025 traceability close the compliance gap.

Read more



Optical lens (q)PCR cycler calibration at www.cyclertest.com
21-Aug-2018
Product introduction videos video icon
Catalog