BACKGROUND: Our aim was to verify if procalcitonin (PCT) measurements using the new point-of-care testing i-CHROMATM are interchangeable with those of Liaison XL. METHODS: One hundred seventeen serum samples were processed sequentially on a Liaison XL and i-CHROMATM. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen's Kappa statistic. RESULTS: Proportional and constant differences were observed between i-CHROMATM and Liaison XL. The 95% CI of the mean bias% was very large, exceeding the maximum allowable TE% and the clinical reference change value. However, the concordance between methods at the clinical relevant cutoffs was strong, with the exception of the 0.25 ng/mL cutoff which was moderate. CONCLUSIONS: Our data suggest that i-CHROMATM is not interchangeable with Liaison XL. However, while the strong concordance at the clinical relevant cutoffs allows us to consider i-CHROMATM a suitable option to Liaison XL to support clinicians' decision-making; nevertheless, the moderate agreement at the 0.25 ng/mL cutoff recommends caution in interpreting the data around this cutoff.
Interchangeability of procalcitonin measurements using the point of care testing i-CHROMA™reader and the automated liaison XL
Stenner, Elisabetta
;Barbati, Giulia;West, Nicole;Ben, Fabia Del;
2018-01-01
Abstract
BACKGROUND: Our aim was to verify if procalcitonin (PCT) measurements using the new point-of-care testing i-CHROMATM are interchangeable with those of Liaison XL. METHODS: One hundred seventeen serum samples were processed sequentially on a Liaison XL and i-CHROMATM. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen's Kappa statistic. RESULTS: Proportional and constant differences were observed between i-CHROMATM and Liaison XL. The 95% CI of the mean bias% was very large, exceeding the maximum allowable TE% and the clinical reference change value. However, the concordance between methods at the clinical relevant cutoffs was strong, with the exception of the 0.25 ng/mL cutoff which was moderate. CONCLUSIONS: Our data suggest that i-CHROMATM is not interchangeable with Liaison XL. However, while the strong concordance at the clinical relevant cutoffs allows us to consider i-CHROMATM a suitable option to Liaison XL to support clinicians' decision-making; nevertheless, the moderate agreement at the 0.25 ng/mL cutoff recommends caution in interpreting the data around this cutoff.File | Dimensione | Formato | |
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Stenner_short_comm_2018.pdf
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