Evidence map›Paper›PMID 42433632›Full record

ArticlePractical laboratory medicine2026

Adaptation of a routine immunoassay analyser for TSH measurement in dried blood spot and volumetric microsampling (Capitainer B50): evaluation for thyroid function testing in adults.

Katarzyna Bornikowska, Anna Król, Magdalena Ostrowska, Konrad Kowalski, Wojciech Zgliczyński, Piotr Glinicki

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Article in Practical laboratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Katarzyna BornikowskaDepartment of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland.
Anna KrólMasdiag Laboratory, Masdiag Sp. z o.o., Warsaw, Poland.
Magdalena OstrowskaDepartment of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland.
Konrad KowalskiMasdiag Laboratory, Masdiag Sp. z o.o., Warsaw, Poland.
Wojciech ZgliczyńskiDepartment of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland.
Piotr GlinickiDepartment of Endocrinology, Centre of Postgraduate Medical Education, Warsaw, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Thyroid-stimulating hormone (TSH) is the primary biomarker for diagnosing and monitoring thyroid disorders. Although serum remains the reference matrix, microsampling approaches, including dried blood spots (DBS) and volumetric devices (CPT B50), may improve accessibility and compliance. This study evaluated the analytical and clinical performance of TSH measurement from DBS and CPT B50 compared with serum. Methods: Paired serum, DBS, and CPT B50 samples were collected from 246 adults undergoing thyroid evaluation. DBS and CPT B50 samples were eluted and analyzed using a chemiluminescence immunoassay (RUO, LIAISON® XL, DiaSorin). Analytical performance, recovery, repeatability, stability, and method agreement were assessed. Microsample results were converted to serum-equivalent concentrations using inverse Passing-Bablok regression equations. Performance was evaluated using Passing-Bablok regression and Bland-Altman analysis with predefined acceptance criteria (bias ≤ ±15%, CV ≤ 15%, recovery 85%-115%), guided by CLSI EP15-A3 and EP17-A2 guidelines. Results: Repeatability CVs ranged from 3.7% to 10.4%, and recovery was 97%-110%. DBS and CPT B50 showed strong agreement with serum, with mean bias of -0.10 mIU/L for CPT B50 and 0.24 mIU/L for DBS. Samples remained stable for up to 8 weeks at +4 °C and -20 °C. Thyroid status classification accuracy was 96% for DBS and 98% for CPT B50. Conclusions: TSH measurement from DBS and CPT B50 showed high analytical and clinical concordance with serum. Volumetric sampling improved reproducibility and stability, supporting its use in remote thyroid testing and therapy monitoring.

Indexed as

Capitainer B50DBSDried blood spotImmunoassayThyroid functionTSHVolumetric microsampling

Identifiers

PMID42433632
PMCPMC13351441

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.