Derivation and independent validation of kidneyintelX.dkd: A prognostic test for the assessment of diabetic kidney disease progression.

Aims: To develop and validate an updated version of KidneyIntelX (kidneyintelX.dkd) to stratify patients for risk of progression of diabetic kidney disease (DKD) stages 1 to 3, to simplify the test for clinical adoption and support an application to the US Food and Drug Administration regulatory pathway.

Methods: We used plasma biomarkers and clinical data from the Penn Medicine Biobank (PMBB) for training, and independent cohorts (BioMe and CANVAS) for validation.

Analytical Validation of a Novel 6-Gene Signature for Prediction of Distant Recurrence in Estrogen Receptor-Positive, HER2-Negative, Early-Stage Breast Cancer.

Background: OncoMasTR is a recently developed multigene prognostic test for early-stage breast cancer. The test has been developed in a kit-based format for decentralized deployment in molecular pathology laboratories. The analytical performance characteristics of the OncoMasTR test are described in this study.

Analytical validation of a multi-biomarker algorithmic test for prediction of progressive kidney function decline in patients with early-stage kidney disease.

Background: The KidneyIntelX™ test applies a machine learning algorithm that incorporates plasma biomarkers and clinical variables to produce a composite risk score to predict a progressive decline in kidney function in patients with type 2 diabetes (T2D) and early-stage chronic kidney disease (CKD). The following studies describe the analytical validation of the KidneyIntelX assay including impact of observed methodologic variability on the composite risk score.

Methods: Analytical performance studies of sensitivity, precision, and linearity were performed on three biomarkers assayed in multiplexed format: kidney injury molecule-1 (KIM-1), soluble tumor necrosis factor receptor-1 (sTNFR-1) and soluble tumor necrosis factor receptor-2 (sTNFR-2) based on Clinical Laboratory Standards Institute (CLSI) guidelines.

Bedpan washer disinfectors: an in-use evaluation of cleaning and disinfection.

Background: As part of a comprehensive approach to decreasing Clostridium difficile in our health authority, an evaluation of the in-use performance of 2 brands of bedpan decontaminators (BPDs) in 2 acute care facilities was performed.

Methods: A continuous quality improvement approach consisting of 5 BPD audits and 4 intervention phases was used over a 16-month evaluation period. Visible fecal soil on processed items was used as the progress indicator, and infection preventionists performed audits.

Development of a surface plasmon resonance-based assay for the detection of Corynebacterium pseudotuberculosis infection in sheep.

Caseous lymphadenitis (CLA), a disease affecting sheep and goats, is caused by Corynebacterium pseudotuberculosis and is difficult to detect, especially at early stages in its development. A surface plasmon resonance-based biosensor assay for the detection of antibodies to the phospholipase D (PLD) exotoxin of C. pseudotuberculosis in sheep serum was successfully generated.