A fit-for-purpose approach to analytical sensitivity applied to a cardiac troponin assay: time to escape the 'highly-sensitive' trap.

Abstract:

BACKGROUND:Highly-sensitive cardiac troponin (cTn) assays are being introduced into the market. In this study we argue that the classification of cTn assays into sensitive and highly-sensitive is flawed and recommend a more appropriate way to characterize analytical sensitivity of cTn assays. STUDY:The raw data of 2252 cardiac troponin I (cTnI) tests done in duplicate with a 'sensitive' assay was extracted and used to calculate the cTnI levels in all, including those below the 'limit of detection' (LoD) that were censored. Duplicate results were used to determine analytical imprecision. RESULTS:We show that cTnI can be quantified in all samples including those with levels below the LoD and that the actual margins of error decrease as concentrations approach zero. CONCLUSIONS:The dichotomous classification of cTn assays into sensitive and highly-sensitive is theoretically flawed and characterizing analytical sensitivity as a continuous variable based on imprecision at 0 and the 99th percentile cut-off would be more appropriate.

journal_name

Clin Chem Lab Med

authors

Ungerer JP,Pretorius CJ

doi

10.1515/cclm-2013-0679

subject

Has Abstract

pub_date

2014-04-01 00:00:00

pages

553-6

issue

4

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2013-0679/cclm-2013-06

journal_volume

52

pub_type

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