A combined efficient design for biomarker data subject to a limit of detection due to measuring instrument sensitivity

DOI10.1214/11-AOAS490zbMATH Open1234.62149arXiv1202.6524WikidataQ58322499 ScholiaQ58322499MaRDI QIDQ766005FDOQ766005

Neil J. Perkins, Aijun Ye, Enrique F. Schisterman, Albert Vexler

Publication date: 22 March 2012

Published in: The Annals of Applied Statistics (Search for Journal in Brave)

Abstract: Pooling specimens, a well-accepted sampling strategy in biomedical research, can be applied to reduce the cost of studying biomarkers. Even if the cost of a single assay is not a major restriction in evaluating biomarkers, pooling can be a powerful design that increases the efficiency of estimation based on data that is censored due to an instrument's lower limit of detection (LLOD). However, there are situations when the pooling design strongly aggravates the detection limit problem. To combine the benefits of pooled assays and individual assays, hybrid designs that involve taking a sample of both pooled and individual specimens have been proposed. We examine the efficiency of these hybrid designs in estimating parameters of two systems subject to a LLOD: (1) normally distributed biomarker with normally distributed measurement error and pooling error; (2) Gamma distributed biomarker with double exponentially distributed measurement error and pooling error. Three-assay design and two-assay design with replicates are applied to estimate the measurement and pooling error. The Maximum likelihood method is used to estimate the parameters. We found that the simple one-pool design, where all assays but one are random individuals and a single pooled assay includes the remaining specimens, under plausible conditions, is very efficient and can be recommended for practical use.

Full work available at URL: https://arxiv.org/abs/1202.6524

zbMATH Keywords

measurement errorpoolinglimit of detectionduplicatecost-efficient designone-pool designthree-assay designtwo-assay design

Mathematics Subject Classification ID

Censored data models (62N01) Estimation in survival analysis and censored data (62N02) Applications of statistics to biology and medical sciences; meta analysis (62P10)

Cites Work

• Pooling biospecimens and limits of detection: effects on ROC curve analysis
• Maximum Likelihood Ratio Tests for Comparing the Discriminatory Ability of Biomarkers Subject to Limit of Detection
• ESTIMATION OF THE MEAN AND STANDARD DEVIATION OF A NORMAL POPULATION FROM A CENSORED SAMPLE
• Estimating the Parameters of a Truncated Gamma Distribution
• Using Pooled Exposure Assessment to Improve Efficiency in Case‐Control Studies
• Sample Size and Power Calculation in Comparing Diagnostic Accuracy of Biomarkers with Pooled Assessments
• A combined efficient design for biomarker data subject to a limit of detection due to measuring instrument sensitivity

Cited In (7)

• Regression for skewed biomarker outcomes subject to pooling
• Valid \(p\)-values and expectations of \(p\)-values revisited
• A nonlinear measurement error model and its application to describing the dependency of health outcomes on dietary intake
• A combined efficient design for biomarker data subject to a limit of detection due to measuring instrument sensitivity
• Single-index regression for pooled biomarker data
• Case-control data analysis for randomly pooled biomarkers
• A resample-replace lasso procedure for combining high-dimensional markers with limit of detection

Uses Software

• VGAM

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