ArticleBMC gastroenterology2026
Assay performance verification and reference interval establishment for PIVKA-II on the Roche cobas e 801.
Article in BMC gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
objectiveTo validate the analytical performance of the Roche cobas e 801 chemiluminescent immunoassay for Protein induced by vitamin K absence or antagonist-II (PIVKA-II), establish age-/gender-specific reference intervals for healthy adults in the Gansu population, and evaluate its concordance with the Abbott Alinity i system currently used in our laboratory.
methodsPrecision (intra-run/inter-run coefficients of variation [CVs]), linearity (0.50-12000 ng/mL), and clinical reportable range (via 10-fold dilution with 80%-120% recovery criteria) were verified following Clinical and Laboratory Standards Institute (CLSI) and Chinese health industry standards. Agreement between the cobas e 801 and Alinity i systems was assessed using Passing-Bablok regression and Bland-Altman analysis (n = 173). Reference intervals were established based on 2253 healthy participants (≥ 18 years, permanent residents of Lanzhou). The 2.5th-97.5th percentiles were calculated using a nonparametric method, and decision tree analysis was used to determine age stratification cutoffs.
resultsIntra-run coefficients of variation ranged from 1.36% to 1.57%, and inter-run CVs from 1.13% to 1.16%, all below CLIA'88 total allowable error and manufacturer claims (except for intra-run high-value quality control (QC), which was slightly higher than the manufacturer's specification). The linear regression equation was Y = 0.99X + 6.34 (R
conclusionThe PIVKA-II assay on the Roche cobas e 801 system meets laboratory quality requirements for analytical performance and is suitable for clinical application. Due to significant proportional bias compared with the Abbott Alinity i system, system-specific reference intervals are recommended, and the two systems should not be used interchangeably. For results approaching the upper reference limit, clinical follow-up is advised. The established local reference intervals can provide more targeted decision-making support for hepatocellular carcinoma screening.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.