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B-155 Easiness of Uncertainty Estimation and Use for Quantitative and

Qualitative Results According to ISO

Poster · July 2022

DOI: 10.13140/RG.2.2.27567.20647

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 Poster Number: B-155
Easiness of Uncertainty Estimation
and Use for Quantitative and
Qualitative Results According to ISO
Marco Pradella
Quality and Accreditation Commission, Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL), Via Ponchini
17/int.7 - 31033 Castelfranco Veneto (TV) Italy.
Background Results
The uncertainty component of the calibration, the prerogative of the manufacturers, is set to zero. The precision component
The revision of ISO 15189 retains the results for ALT σ 2.94 U/L (CV 8.3%), extended uncertainty (U) 5.88 U/L (16.6%), while for COVID-19 Ag the precision of the
requirement for uncertainty estimation, chosen level is fixed at POD 95%. Results of duplicate testing are presented. (Table 1)
referring to ISO/TS 20914 for implementation.
[1] With document Q16 [2], SIPMeL collects
Conclusions
In the medical laboratory, pressured by the amount of tests to be performed and turnaround times to be met,
the main ISO, literature, and CLSI guidance procedures for quality must be easily executable, simple, intuitively understandable, robust, and uncontroversial.
on the topic. Typical examples of application This is what ISO 20914 and a long list of ISO and CLSI documents, collected in SIPMeL Q16, are for. Knowledge of
of the Q16 Recommendations are presented uncertainty provides the laboratory with awareness of the reliability of results, information that is shared with users
here to demonstrate their ease of use. or third parties, for example, in accreditation visits.
"Precision" requires repetitions of the measurement on the same material at a set level. For qualitative results, it is
easy to determine how often observations differ from each other, rather than measuring by how much observations
Method differ from the mean.
The performance characteristics of an assay with
Table 1.Measurement uncertainty for numerical and nominal results following SIPMeL Recommendations Q16.
quantitative results ( ALT EC 2.6.1.2) are derived
from refs [3] and [4]. A test with "qualitative"
results, Abbott BinaxNOW-19 COVID-19 Ag card Numeric Quantitative Nominal qualitative *
[5] [6], is then described. 1 Result ALT U/L 35.2 (mean) Abbott BinaxNOW-19 Ag card:
The SIPMeL Q16 recommendations [2] provide Positive/Negative
for quantitative results, and for quantitative
phases of examinations with nominal results, the 2 Calibration Bias 7.6% (desirable 11.5%) LOD 4.04 x 104 - 8.06 x 104 viral
calculation of type deviation (σ) from the long- uncertainty Correction: no. Uncertainty: copies/swab (Perchetti 2021)
term IQC data and the repeatability limit from (calibrators) * zero. sensitivity 84.6% ***
type deviation (σ) in the series. For nominal Correction: no. Uncertainty: zero.
qualitative results, and for the weakly positive
result of a method that provides ordinal 3 Data source for Internal quality control* [3] Internal quality control**
qualitative values, the CQI for a material near the uncertainty
detection limit or C95 provides a frequency value
of positives (POD%), while the repeatability
4 Material for Biosystems level-1 (human) Close to detection limit or C95
check uses the equality criterion between two uncertainty quality control sera lot number
repeated results. 70A Level 35.2 U/L
5 Uncertainty Type deviation (σ): 2.94 Probability of positive outcome
References expression ** coefficient of variation (CV%): (POD): 95%
1. Pradella M. Alcune certezze dell'incertezza di
8.3%.
misura: nuova ISO 20914 e raccomandazioni expanded uncertainty (U): 5.88
SIPMeL. Riv Ital Med Lab 2021 Sep 15. DOI: (16.6%)
10.23736/S1825-859X.21.00112-2
2. SIPMeL Recommendations for estimating 6 Interpretation repeatability limit [4]: 2.22 Double test
measurement uncertainty in medical laboratories repeatability in audit duplicate test result 1: positive
(ISO 15189 and ISO 20914) *** result 1: 23 U/L result 2: positive
http://dx.doi.org/10.13140/RG.2.2.31013.63207/2
https://www.sipmel.it/en/lineeguida/approvate/118 result 2: 25 U/L
096 difference: 2 U/L
3. Biswas SS et al. Evaluation of imprecision, bias
and total error of clinical chemistry analysers.
Indian J Clin Biochem. 2015 Jan;30(1):104-8. * normally by * Long-term * also for weak positive of ordinal
4. Beckman Coulter. Alanine Aminotransferase manufacturer results
(ALT). https://bit.ly/BeckmanALT ** Do not combine ** Long-term
5. Perchetti GA et al. Analytical Sensitivity of the with result *** under study conditions
Abbott BinaxNOW COVID-19 Ag Card. J Clin *** Sample as point 4 LOD: limit of detection
Microbiol. 2021 Feb 18;59(3):e02880-20.
6. https://www.fda.gov/media/141570/download
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