Lab Med Online.  2021 Oct;11(4):235-244. 10.47429/lmo.2021.11.4.235.

Comparison of Three Automated Calcitonin Immunoassays for Evaluating the Equivalence Near the Clinical Decision Point

• Song J
• Cho Y
• Lee SG

• KMID: 2526084
• DOI: http://doi.org/10.47429/lmo.2021.11.4.235

Abstract

Background
To date, only a few studies have focused on the standardization of the calcitonin assay, despite the fact that a lack of standardization of assays can lead to discrepancy in results. Here, we analyzed the concordance in serum calcitonin test results using three different assays.
Methods
The serum calcitonin levels in 104 residual specimens collected between January and February 2020 were measured using three different systems. The Spearman’s rank correlation coefficients and the slopes and y-intercepts were assessed to derive all possible pairs of analyzers. The agreement of classification according to a clinically relevant cut-off was also evaluated using Cohen’s kappa coefficient.
Results
The correlation coefficients for Cobas e801 versus LIAISON, Atellica IM-1600 versus LIAISON, and Cobas e801 versus Atellica IM-1600 were 0.77, 0.63, and 0.95, respectively. The kappa agreement of classification at a cut-off of 10 pg/mL was 0.81, 0.81, and 0.91, respectively. However, after excluding the data points for concentrations > 20 pg/mL, the correlation coefficients decreased to 0.39, 0.22, and 0.90, respectively.
Conclusions
Despite acceptable correlations for the full analytical measuring range, we observed limited correlations at low concentrations, especially around the clinical decision threshold. Therefore, continuous joint efforts by all stakeholders are essential for standardizing calcitonin assays.

Keyword

Calcitonin; Standardization; Method comparison; Immunoassay

Figure

• 

  Fig. 1 Passing–Bablok regression and bias plots for all data points. Results obtained using the Cobas e801 analyzer compared to those obtained using the LIAISON analyzer (upper left), results obtained using the Atellica IM1600 analyzer compared to those obtained using the LIAISON analyzer (middle left), and results obtained using the Atellica IM1600 analyzer compared with those obtained using the Cobas e801 analyzer (lower left) were plotted with the Passing–Bablok regression and identity lines. P-values for linearity test are also indicated. The corresponding relative bias plots are displayed on the right side.

• 

  Fig. 2 Passing–Bablok regression and bias plots excluding the data points for concentrations >20 pg/mL. Results obtained using the Cobas e801 analyzer compared to those obtained using the LIAISON analyzer (upper left), results obtained using the Atellica IM1600 compared to those using the LIAISON analyzer (middle left), and results obtained using the Atellica IM1600 analyzer compared to those obtained using the Cobas e801 analyzer (lower left) were plotted with the Passing–Bablok regression and identity lines. Only data points for concentrations <20 pg/mL were included in the regression analysis. P-values for linearity test are also indicated. The corresponding relative bias plots are displayed on the right side.

• 

  Fig. 3 Scatter plot showing calcitonin concentrations measured using all three analyzers. Data points for the calcitonin concentrations <50 pg/mL measured using the three analyzers were plotted in the order of increasing average concentrations. The discordance between the interpretive categories (concentration ≤10 pg/mL and concentration >10 pg/mL) is indicated by solid markers and all other results are indicated by hollow markers.

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