Estrogen receptor (ER) and progesterone receptor (PR) status in breast carcinomas are considered validated predictive factors for selecting patients for antihormonal therapy. Published surveys have shown a significant rate of disagreement and lack of reproducibility of immunohistochemistry (IHC) results from laboratories around the world. To address these limitations IHC assays for ER and PR were developed using characterized reagents, after careful calibration of the sensitivity and specificity to match established assays previously validated in large clinical studies. The ER assay uses a cocktail of 2 mouse monoclonal antibodies (1D5 and ER-2-123) and the PR assay uses 1 mouse monoclonal antibody (PgR 1294); both are followed by a polymer-peroxidase-based detection system. All antibodies were tested for specificity by epitope mapping. The sensitivity of the new assays was calibrated to be equivalent to previously validated IHC assays followed by a comparison with the validated assays in a concordance study involving over 200 specimens. All slides were scored with the "Allred Score," also used for scoring of the original validated assays. The overall concordance between the new and the established IHC assays was nearly perfect (99%). The concordance study demonstrated greater than 98% positive agreement and 100% negative agreement of the new IHC assays with the previously validated IHC assays. This equivalence establishes the clinical validation of the assays and, as they are based on newer generation reagents and are produced and tested under stringent quality control conditions to ensure their consistency, they add additional advantages to the user and patients.
BackgroundNutrition support professionals are tasked with estimating energy requirements for critically ill patients. Estimating energy leads to suboptimal feeding practices and adverse outcomes. Indirect calorimetry (IC) is the gold standard for determining energy expenditure. However, access is limited, so clinicians must rely on predictive equations.MethodsA retrospective chart review of critically ill patients who underwent IC in 2019 was conducted. The Mifflin–St Jeor equation (MSJ), Penn State University equation (PSU), and weight‐based nomograms were calculated using admission weights. Demographic, anthropometric, and IC data were extracted from the medical record. Data were stratified by body mass index (BMI) classifications, and relationships between estimated energy requirements and IC were compared.ResultsParticipants (N = 326) were included. Median age was 59.2 years, and BMI was 30.1. The MSJ and PSU were positively correlated with IC in all BMI classes (all P < 0.001). Median measured energy expenditure was 2004 kcal/day, which was 1.1‐fold greater than PSU, 1.2‐fold greater than MSJ, and 1.3‐fold greater than weight‐based nomograms (all P < 0.001).ConclusionDespite the significant relationships between measured and estimated energy requirements, the significant fold‐differences suggest that using predictive equations leads to significant underfeeding, which may result in poor clinical outcomes. Clinicians should rely on IC when available, and increased training in the interpretation of IC is warranted. In the absence of IC, the use of admission weight in weight‐based nomograms could serve as a surrogate, as these calculations provided the closest estimate to IC in participants with normal weight and overweight, but not obesity.
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