Can the usual validation standard series for quantitative methods, ISO 5725, be also applied for qualitative methods?

Validation of qualitative PCR methods on the basis of mathematical–statistical modelling of the probability of detection

“…Uhlig et al [8] demonstrate that the reproducibility variance as proposed by both Wilrich [4] and Wehling et al [3] depends only on the theoretical mean of the POD across the laboratory population. Indeed, on the basis of the formulas suggested by Wilrich [4] and Wehling et al [3] for the repeatability variance r r 2 and the between-laboratory variance r L 2 , and for a finite laboratory population with K laboratories, we have…”

“…An approach that, on the one hand, allows for independent repeatability and between-laboratory variances and, on the other, adopts and expands the general POD framework introduced by Wehling et al [3] was described in Uhlig et al [8] and Uhlig et al [9]. The basic idea for this approach is to introduce a latent variable.…”

Efficient estimation of the limit of detection and the relative limit of detection along with their reproducibility in the validation of qualitative microbiological methods by means of generalized linear mixed models

“…While the concept of reproducibility is easily interpreted for qualitative methods in terms of consistent test results across laboratories for samples with the same level of contamination, it is not clear at all how to describe or characterize a qualitative method's reproducibility in such a way as to make possible a comparison to criteria or other methods. In the last few years, however, novel validation approaches have been proposed for the characterization of the reproducibility of a qualitative method (Uhlig et al 2011(Uhlig et al , 2013Grohmann et al 2015).…”

Interlaboratory comparison of test results of an ordinal or nominal binary property: analysis of variation

“…These works are related to binary scales with qualitative values coded as 0 and 1, and interpreted based on classical analysis of variance (ANOVA) for quantitative methods [7,8]. It was shown that for qualitative methods, the reproducibility (between-laboratory) standard deviation is a function of the average POD throughout laboratories participated in the experiment and cannot be used for characterization of performance of a test method and its comparison with different methods [16]. An alternative concept proposed in [16] was also linked to the same standards [7,8] for quantitative methods.…”

“…Certification of reference materials with nominal properties is the topic under development of ISO REMCO [13]. Determination of precision as withinlaboratory and between-laboratory variations (repeatability and reproducibility) of qualitative measurement or test methods by interlaboratory experiments [14] and use of probability of detection (POD) as a statistical model for validation of qualitative methods [15] were discussed not long ago in the paper [16]. These works are related to binary scales with qualitative values coded as 0 and 1, and interpreted based on classical analysis of variance (ANOVA) for quantitative methods [7,8].…”