American Journal of Clinical Pathology

List of Papers (Total 5,180)

HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal CytologyData From the Baseline Phase of the Onclarity Trial

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.

Analytical and Clinical Performance Evaluation of the Elecsys HIV combi PT Assay on the cobas e 602 Analyzer for the Diagnosis of Human Immunodeficiency Virus

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).

Breast Cancers With Magee Equation Score of Less Than 18, or 18-25 and Mitosis Score of 1, Do Not Require Oncotype DX TestingA Value Study

To investigate use of Magee equations (MEs) to determine which breast cancer cases can be excluded from Oncotype DX testing.

Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance PopulationResults of the Becton Dickinson Onclarity Trial

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.

Enhanced Detection of Cervical Cancer and Precancer Through Use of Imaged Liquid-Based Cytology in Routine Cytology and HPV Cotesting

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.

Bone Marrow as a Source of Cells for Paroxysmal Nocturnal Hemoglobinuria Detection

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.

Clinical Referral Laboratories in RwandaThe Status of Quality Improvement After 7 Years of the SLMTA Program

We investigated the quality system performance in Rwandan referral laboratories to determine their progress toward accreditation.

Interference of Therapeutic Monoclonal Antibodies With Routine Serum Protein Electrophoresis and Immunofixation in Patients With MyelomaFrequency and Duration of Detection of Daratumumab and Elotuzumab

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.

Quality Control Practices for Chemistry and Immunochemistry in a Cohort of 21 Large Academic Medical Centers

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.

Clinical Significance of Complex Glandular Patterns in Lung AdenocarcinomaClinicopathologic and Molecular Study in a Large Series of Cases

To explore whether complex glandular patterns (CGPs) have a potential role in the clinical management of patients with lung adenocarcinoma.

Variability of High-Sensitivity Troponin T Concentrations in Emergency SettingsImpact for the Diagnosis of Myocardial Infarction

To assess biological variation of troponin T in emergency settings and establish limits for interpretation of serial results.

Facing the InevitableBeing Prepared for Regulatory Requirements for Laboratory Developed Tests

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).

The American Society for Clinical Pathology’s 2016-2017 Vacancy Survey of Medical Laboratories in the United States

To determine the extent and distribution of workforce shortages within the nation’s medical laboratories.

Quality Improvement After Multiple Fatal Transfusion-Transmitted Bacterial Infections

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.

Delay to Formalin Fixation (Cold Ischemia Time) Effect on Breast Cancer Molecules

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...

Drone Transport of Chemistry and Hematology Samples Over Long Distances

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.

Epitope Preservation Methods for Tissue MicroarraysLongitudinal Prospective Study

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.

Ensuring the Quality of Point-of-Care Testing in a Large and Decentralized Ambulatory Care Setting

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.

Variability and Error in Cardiac Troponin TestingAn ACLPS Critical Review

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 in Neuroendocrine Neoplasms

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.