ISO 16578:2013 pdf free

ISO 16578:2013 pdf free.Molecular biomarker analysis – General definitions and requirements for microarray detection of specific nucleic acid sequences
By their very nature, qualitative tests result only in yes/no answers. However, the determination of the range of use of the method is always necessary in the validation study. The method will only be applicable in that range.
In the case of microarrays, it is not realistic to determine the limit of detection (LOD) of each target being probed. If LODs of individual targets are required, an external measurement standard (or reference material) could be used for experimental determination of the limit of a series of representative targets on a given platform.
The experimental LODP is related to the test portion, the quality/quantity of the analyte, and the absolute LODP of the method. These values should be established via a collaborative trial using appropriate reference and control samples, and the lowest level of the external measurement standard (or reference material) obtained experimentally should have a false negative rate of less than or equal to 5 %.
The range of reliable signal, i.e. the range of application of the method, should be given for a known (determined/estimated) number of copies and/or concentrations of the external measurement standard (or reference material) at a 95 % confidence level. The values should be established via an interlaboratory trial using appropriate certified reference materials or reference materials. Information may also be derived from intralaboratory studies, as a temporary measure.
A solution or an extract containing DNA/RNA molecules appropriate to the field of application is prepared such that there is no demonstrated hybridization inhibition or interference with the electrical,colorimetric, and/or fluorescence detection.
Instruments including thermal cycler, hybridization oven, or other hybridization apparatus, DNA microarray scanner, and apparatus or equipment for measuring DNA/RNA integrity and concentration should be calibrated in accordance with ISO/IEC 17025. This includes criteria for the choice ofinstrument settings (e.g. background setting, normalization setting).
Any calculations or models used to derive the analytical result should be validated.ISO 16578 pdf download.