American journal of clinical pathology
-
Am. J. Clin. Pathol. · Sep 2019
ReviewThe Utility of Thromboelastography to Guide Blood Product Transfusion.
To provide an overview of the clot viscoelastic testing technology and to describe its utility in guiding blood product transfusions. ⋯ TEG/ROTEM can be helpful in guiding resuscitation and blood product transfusion. Several studies have demonstrated a reduction in transfusion of blood components with TEG/ROTEM; however, other studies have suggested that TEG/ROTEM is not clinically effective in guiding transfusion.
-
Am. J. Clin. Pathol. · Aug 2019
Analytical Performance and Clinicopathologic Correlation of Four Fecal Calprotectin Methods.
Calprotectin is a noninvasive biomarker that can distinguish inflammatory bowel disease from irritable bowel syndrome. We investigated four automated fecal calprotectin methods on five different platforms for their preanalytical process, analytical performance, and clinicopathologic correlation. ⋯ The automated calprotectin methods showed a good performance and comparable clinicopathologic correlation. Due to lack of standardization, the numerical values differ for the various methods.
-
To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of conventional IVDs and laboratory-developed tests (LDTs). ⋯ It is imperative that a clinical laboratory perspective on LDTs is understood and incorporated prior to advancement of future legislative proposals.
-
Am. J. Clin. Pathol. · Jan 2019
ReviewBenefits and Pitfalls of Point-of-Care Coagulation Testing for Anticoagulation Management: An ACLPS Critical Review.
Point-of-care (POC) testing is generally less precise and has higher reagent costs per test than laboratory-based assays. However, POC hemostasis testing can offer significant advantages in particular situations: patient-managed warfarin therapy as well as rapid turnaround time heparin management for intraoperative patients. Of note, POC hemostasis testing is generally approved for the purposes of anticoagulation monitoring and is inferior to laboratory coagulation testing for the diagnosis of congenital or acquired coagulopathy. ⋯ POC coagulation testing for anticoagulation monitoring offers advantages in particular situations. Clear policies and protocols must be developed to guide proper use of POC versus central laboratory hemostasis testing.
-
Am. J. Clin. Pathol. · Apr 2018
Facing the Inevitable: Being 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). ⋯ Respondents agree that a regulatory quality management system is needed in laboratories that develop LDTs, but the translation and method for design control to a clinical laboratory do not exist. As a result, laboratories are taking the wait-and-see approach.