For several years, there has been a growing need for the use of quick analysis kits in the water analysis sector. In 2006, AFNOR Certification developed the application of the NF VALIDATION mark to the sector of the microbiological analysis of water.
There are 2 different forms of certification.
The first is specific to the detection/quantification of Legionella and Legionella pneumophila by PCR since it is based on the determination of the intrinsic performance of the kit to be validated on the basis of the innovative experimental standard XP T90-471, published by AFNOR in 2006. and updated standard NF T90-471 in 2010. This standard describes the requirements for Legionella PCR kits, in terms of context, performance and control.
With the help of specialist experts in the field, AFNOR Certification has developed a protocol based entirely on this standard and adapted to the requirements of third party certification.
The examination of the first certification application for a Legionella PCR kit commenced at the beginning of 2007. In December 2007, the first certificates were granted to BIO-RAD and PALL GENEDISC TECHNOLOGIES, respectively for the kits iQ-Check Legionella and GeneDisc® Legionella.
The second form of certification, which is continuing to be developed in 2008, focuses on the comparison of the method to be validated with the standardised reference method, thus adopting the same principle implemented in the validation of methods in the food industry. A general technical protocol, determining the criteria to be tested (selectivity, sensitivity, accuracy, linearity, repeatability, etc.) is being developed by a task force led by AFNOR Certification. This protocol will propose experiment plans and appropriate statistical processes.
Specific certification rules applicable to the NF VALIDATION mark for water analysis were published by AFNOR Certification in 2007.
How to obtain the NF VALIDATION mark for water quality
To obtain the mark, the manufacturer concerned contacts AFNOR Certification in advance to confirm that its application comes within the scope of application of the NF VALIDATION mark for water analysis.
Then, the application is formulated by the manufacturer of the kit and examined by AFNOR Certification. The manufacturer chooses an expert laboratory from the list of approved laboratories and its application is submitted to the technical board formed by AFNOR Certification.
The technical board consists of microbiology experts and represents users, technical organisations and kit manufacturers. During the different phases of the study (preliminary and inter-laboratory), it reviews the proposals and results for each kit and issues an opinion on validation.
After receiving the approval of the technical board, AFNOR Certification grants the certification. This takes the form of a certificate and the right to use the NF VALIDATION mark.