Analytical and Clinical Performance Evaluation of the Abbott Architect PIVKA Assay.

Abstract:

:Protein induced by vitamin K absence (PIVKA) is measured using various assays and is used to help diagnose hepatocellular carcinoma. The present study evaluated the analytical and clinical performances of the recently released Abbott Architect PIVKA assay. Precision, linearity, and correlation tests were performed in accordance with the Clinical Laboratory Standardization Institute guidelines. Sample type suitability was assessed using serum and plasma samples from the same patients, and the reference interval was established using sera from 204 healthy individuals. The assay had coefficients of variation of 3.2-3.5% and intra-laboratory variation of 3.6-5.5%. Linearity was confirmed across the entire measurable range. The Architect PIVKA assay was comparable to the Lumipulse PIVKA assay, and the plasma and serum samples provided similar results. The lower reference limit was 13.0 mAU/mL and the upper reference limit was 37.4 mAU/mL. The ability of the Architect PIVKA assay to detect hepatocellular carcinoma was comparable to that of the alpha-fetoprotein test and the Lumipulse PIVKA assay. The Architect PIVKA assay provides excellent analytical and clinical performance, is simple for clinical laboratories to adopt, and has improved sample type suitability that could broaden the assay's utility.

journal_name

Ann Clin Lab Sci

authors

Ko DH,Hyun J,Kim HS,Park MJ,Kim JS,Park JY,Shin DH,Cho HC

subject

Has Abstract

pub_date

2018-01-01 00:00:00

pages

75-80

issue

1

eissn

0091-7370

issn

1550-8080

pii

48/1/75

journal_volume

48

pub_type

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