Assessment of clinical performance without adequate analytical validation: A prescription for confusion.

Objectives: Lp-PLA2 is a biomarker with promise for predicting cardiac risk. The lack of reproducible results has limited its use. In evaluating a new reagent kit, we investigated conditions for optimal reproducibility.

Insulin autoimmunity and hypoglycemia in seven white patients.

Objective: To report the clinical, biochemical, and immunologic characteristics of 7 white patients with the rare disorder of hyperinsulinemic hypoglycemia in association with spontaneously generated high titers of antibodies to human insulin.

Methods: We reviewed the clinical data, history, and symptoms of the 7 study patients and summarized the biochemical findings during a spontaneous episode of hypoglycemia. Insulin antibody binding was measured in all patients, and antibody affinity, capacity, and clonality were analyzed in 4.