Performance Characteristics of a Calculated Index Control Method for the phi Multianalyte Assay with Algorithmic Analysis.

Background: Multianalyte assays with algorithmic analysis (MAAAs), such as the Prostate Health Index (phi), are increasingly utilized for generating disease risk scores. Currently, imprecision and bias in phi are not directly monitored by quality control (QC) assessment of the index but rather by QC assessment of individual components. This may not be adequately controlling for imprecision and bias in the calculated multicomponent phi value itself.

Evaluation of sporadic bovine alkaline phosphatase interference in the Beckman Access unconjugated estriol (uE3) assay affecting maternal serum screening results.

Objectives: Bovine alkaline phosphatase (BALP) mediated interference is a potential issue in the Beckman Access unconjugated estriol (uE3) assay. As the uE3 assay is a component of second trimester maternal serum screening characterizing this interference is essential for delivering accurate trisomy 18 and trisomy 21 risks.

Design And Methods: Residual serum samples (n = 517) were measured by two different lots of uE3 assay.

Comparing the performance of CA 15-3 CSF to cytology in a cohort of patients with breast cancer leptomeningeal metastasis.

Background And Objective: Leptomeningeal metastasis (LM) can occur as a late manifestation of breast cancer and has traditionally been diagnosed by CSF cytology; however, cytology suffers from low sensitivity and it is believed that many cases of LM go undiagnosed. Some studies have suggested the use of CA 15-3 in CSF (CA 15-3 CSF) to aid in the detection of LM. The purpose of this study was to compare the performance of CA 15-3 CSF to cytology for the detection and treatment monitoring of breast cancer LM.