Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices
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Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices. / Dierks, Sascha; Andag, Reiner; Gauss, Friederike; Budde, Kathrin; Francke, Paul; Peschka, Manuela; Fischer, Andreas; Schanz, Julie; Petersmann, Astrid.
In: CLIN CHEM LAB MED, Vol. 60, No. 7, 25.04.2022, p. 1031-1038.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices
AU - Dierks, Sascha
AU - Andag, Reiner
AU - Gauss, Friederike
AU - Budde, Kathrin
AU - Francke, Paul
AU - Peschka, Manuela
AU - Fischer, Andreas
AU - Schanz, Julie
AU - Petersmann, Astrid
N1 - © 2022 Walter de Gruyter GmbH, Berlin/Boston.
PY - 2022/4/25
Y1 - 2022/4/25
N2 - OBJECTIVES: Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems.METHODS: Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied.RESULTS: Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927-1.013) to 1.276 (95% CI: 1.210-1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis.CONCLUSIONS: This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed.
AB - OBJECTIVES: Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems.METHODS: Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied.RESULTS: Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927-1.013) to 1.276 (95% CI: 1.210-1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis.CONCLUSIONS: This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed.
KW - Humans
KW - Point-of-Care Testing
KW - Reference Standards
KW - Thyrotropin
U2 - 10.1515/cclm-2022-0054
DO - 10.1515/cclm-2022-0054
M3 - SCORING: Journal article
C2 - 35451300
VL - 60
SP - 1031
EP - 1038
JO - CLIN CHEM LAB MED
JF - CLIN CHEM LAB MED
SN - 1434-6621
IS - 7
ER -
