A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum.
hyperthyroidism
hypothyroidism
point-of-care testing
thyrotropin
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 09 2022
27 09 2022
Historique:
received:
30
05
2022
accepted:
22
07
2022
pubmed:
12
8
2022
medline:
31
8
2022
entrez:
11
8
2022
Statut:
epublish
Résumé
Point-of-care (POC) measurement of thyrotropin (TSH) may facilitate prompt diagnosis of thyroid dysfunction. We evaluated the analytical performance of a new POC TSH assay (Wondfo). TSH measurements were made from 730 consecutive, unselected subjects in an outpatient setting, using Wondfo in whole blood, capillary blood and serum or automated reference equipment (serum only). TSH measurements were user-independent. Total intra-and inter-assay variation (CV%) was 12.1 and 16.2%, respectively. Total CV% was 10.6-22.6% and 14.5-21.6% in serum and whole blood, respectively. Linearity was very good. Recovery rate was 97-127%. Prolongation of incubation time increased TSH results of 12% (13%) and 33% (35%) after 2 and 5 additional minutes in serum (blood), respectively. When measured simultaneously in two Wondfo devices, the slope of the regression line was 1.03 (serum) and 1.02 (blood), with Spearman's correlation of 0.99 for both. TSH measurements between Wondfo and reference correlated strongly (r=0.93-0.96), though TSH measurements were lower with Wondfo (slopes of plots of measurements made using the two devices were 0.94 [serum vs. serum]; 0.83 [whole blood vs. serum] and 0.64 [capillary blood vs. serum]). Depending on sample material, TSH in capillary blood was lower vs. whole blood (slope: 0.82) and for whole blood vs. serum (Wondfo and reference method; slope: 0.69 and 0.83). Total haemolysis, but not elevated bilirubin or lipemia, disrupted TSH measurement. The Wondfo system was straightforward to use without need for specialist technicians and demonstrated analytic performance suitable for clinical use for the diagnosis of thyroid dysfunction.
Identifiants
pubmed: 35951769
pii: cclm-2022-0525
doi: 10.1515/cclm-2022-0525
doi:
Substances chimiques
Thyrotropin
9002-71-5
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1607-1616Informations de copyright
© 2022 Walter de Gruyter GmbH, Berlin/Boston.
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