To determine the BD Onclarity human papillomavirus (HPV) assay performance and risk values for cervical intraepithelial neoplasia grade 2 (CIN2) or higher and cervical intraepithelial neoplasia grade 3 (CIN3) or higher during Papanicolaou/HPV cotesting in a negative for intraepithelial lesions or malignancies (NILM) population.
We evaluated the performance of the Elecsys HIV combi PT assay on the cobas e 602 analyzer for diagnosing human immunodeficiency virus (HIV; part of the US Food and Drug Administration [FDA] submission).
To investigate use of Magee equations (MEs) to determine which breast cancer cases can be excluded from Oncotype DX testing.
To determine clinical utility of Onclarity human papillomavirus (HPV) assay for atypical squamous cells-undetermined significance (ASC-US) triage, and the value of HPV genotyping within ASC-US.
To assess bone marrow (BM) sampling in academic medical centers.
Cervical screening strives to prevent cervical cancer (CxCa), minimizing morbidity and mortality. Most large US reports on cytology and human papillomavirus (HPV) cotesting of women aged 30 years and older are from one laboratory, which used conventional Papanicolaou (Pap) smears from 2003 to 2009.
To determine fluorescently labeled aerolysin (FLAER) binding and glycophosphatidylinositol–anchored protein expression in bone marrow (BM) cells of healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) detected in peripheral blood (PB); compare PNH clone size in BM and PB; and detect PNH in BM by commonly used antibodies.
We investigated the quality system performance in Rwandan referral laboratories to determine their progress toward accreditation.
We investigated the frequency and pattern of detection of therapeutic monoclonal antibodies (t-mAbs) daratumumab and elotuzumab by routine serum protein electrophoresis (SPE) and immunofixation (IF) in treated patients with myeloma.
In the United States, minimum standards for quality control (QC) are specified in federal law under the Clinical Laboratory Improvement Amendment and its revisions. Beyond meeting this required standard, laboratories have flexibility to determine their overall QC program.
To explore whether complex glandular patterns (CGPs) have a potential role in the clinical management of patients with lung adenocarcinoma.
To assess biological variation of troponin T in emergency settings and establish limits for interpretation of serial results.
We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and explore medical device requirements applicable to a laboratory environment to design, develop, and validate laboratory developed tests (LDTs).
To determine the extent and distribution of workforce shortages within the nation’s medical laboratories.
Transfusion-transmitted bacterial infection (TTBI) from platelet components is likely underrecognized and can be fatal. Twenty-four-hour prospective culture was felt to be insufficiently preventive after multiple TTBIs occurred and strategies to improve safety were sought.
The gold standard of examining breast biomarkers, including estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2)/Ki-67, is to perform these assays on formalin-fixed, paraffin-embedded tissue. However, preanalytical variables may confound these assays. One of these factors is delay to formalin fixation (DFF). The purpose of this review...
To determine the need and impact of repeating critical values in hematology and coagulation.
To evaluate the effectiveness of practices used to support appropriate clinical laboratory test utilization.
We addressed the stability of biological samples in prolonged drone flights by obtaining paired chemistry and hematology samples from 21 adult volunteers in a single phlebotomy event—84 samples total.
We sought to test recent guidelines for preserving immunoreactivity of precut slides, to quantify loss of immunoreactivity, and to determine potential for preservation by altering storage conditions.
In this project, we assessed the breadth, quality, trends, and outcomes of point-of-care (POC) testing and regulatory compliance in 200 University of California, Los Angeles (UCLA) Health system outpatient clinics.
To provide a comprehensive overview of the complexities associated with cardiac troponin (cTn) testing. An emphasis is placed on the sources of error, organized into the preanalytical, analytical, and postanalytical phases of the testing pathway. Controversial areas are also explored.
CD200 expression has been well studied in hematopoietic malignancies; however, CD200 expression has not been well-characterized in neuroendocrine neoplasms. We examined CD200 expression in 391 neuroendocrine neoplasms from various anatomic sites.