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Establish pre-clinical diagnostic efficacy for parathyroid hormone as a point-of-surgery-testing-device (POST).

Abstract：

:Measuring the Parathyroid hormone (PTH) levels assists in the investigation and management of patients with parathyroid disorders. Rapid PTH monitoring is a valid tool for accurate assessment intraoperatively. Rapid Electro-Analytical Device (READ) is a point-of-care device that uses impedance change between target and capture probe to assess the PTH concentration in undiluted patient plasma samples. The aim of this work focuses on evaluating the analytical performance of READ platform to Roche analyzer as a prospective clinical validation method. The coefficient of variation (CV) for intra-assay imprecision was < 5% and inter-assay imprecision CV was < 10% for high (942 pg/mL) and low (38.2 pg/mL) PTH concentration. Functional sensitivity defined at 15% CV was 1.9 pg/mL. Results obtained from READ platform correlated well (r = 0.99) with commercially available clinical laboratory method (Roche Diagnostics) to measure PTH concentrations with a turn-around time of less than 15 min. Furthermore, the mean bias of 7.6 pg/mL determined by Bland-Altman analysis, showed good agreement between the two methods. We envision such a sensing system would allow medical practitioners to facilitate targeted interventions, thereby, offering an immediate prognostic approach as the cornerstone to delivering successful treatment for patients suffering from primary hyperparathyroidism.

journal_name

Sci Rep

journal_title

Scientific reports

authors

Tanak AS,Muthukumar S,Hashim IA,Prasad S

doi

10.1038/s41598-020-75856-2

subject

Has Abstract

pub_date

2020-11-02 00:00:00

pages

18804

issue

1

issn

2045-2322

pii

10.1038/s41598-020-75856-2

journal_volume

10

pub_type

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