Validation of the Cut-points Recommended for ROMA Using the Roche Elecsys CA125 and HE4 Assays.

Assessing the risk of malignancy in patients with a pelvic mass helps triage women suspected of ovarian cancer to specialized gynecologic oncologists to improve treatment outcomes. To this end, several algorithms have been proposed; most notably, the Risk of Ovarian Malignancy Algorithm (ROMA) based on CA125, HE4, and menopausal status. However, appropriate decision cut-points for the ROMA score depends on the choice of analytical assays used. This study validates the use of the Roche Elecsys CA125 and HE4 assays for ROMA calculation in a cohort of 207 women who presented to Mayo Clinic with a pelvic mass. Results were compared to a definitive histologic diagnosis in each case. Clinical performance of ROMA scores derived using these assays was similar to stated claims and indicates that recommended cut-points are acceptable for clinical use.

Analytical and clinical validation of parathyroid hormone (PTH) measurement in fine-needle aspiration biopsy (FNAB) washings.

BACKGROUND: Parathyroid hormone (PTH) quantitation in fine needle aspirate biopsy (FNAB) saline washings complements current modalities for parathyroid tissue localization. OBJECTIVES: To establish the performance characteristics of the Roche Elecsys intact PTH immunoassay in FNAB needle washings and its diagnostic performance for the identification of parathyroid tissue. DESIGN AND METHODS: Accuracy, precision, reportable range, and analytical specificity and sensitivity for the intact PTH immunoassay in FNAB needle washings were established. For clinical validation, 93 specimens from 79 patients were evaluated. Diagnostic cut-offs were established via receiver operator characteristic (ROC) curve analysis. Performance of PTH in FNAB needle washings was compared to cytology. RESULTS: Measurement of the PTH in FNAB needle washings demonstrated a matrix interference that was overcome by supplementation of the samples with a protein based matrix prior to analysis. ROC area under the curve (AUC) was 0.96 for PTH in FNAB needle washings. A PTH concentration ≥100pg/mL showed 100% specificity and 82% sensitivity for identifying parathyroid tissue. On histology-confirmed parathyroid specimens, 21/38 (55%) were correctly identified by cytology; whereas 31/38 (82%) were identified by PTH. CONCLUSIONS: Measurement of PTH in FNAB washings complements cytology for identification of parathyroid tissue. Analytical validation to exclude interference in the PTH immunoassay and proper localization of the parathyroid tissue by ultrasound is necessary to ensure the robustness of the method.