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Abstract Background Immunoglobulin E (IgE)-associated allergen conditions are increasing worldwide, affecting the quality of life of millions of individuals and are a burden on the health care system. The increasing availability of clinically relevant allergenic molecules has begun to change the way allergen-specific IgE antibody diagnostics are performed. Allergic diseases, respiratory infections, and autoimmune conditions have similar clinical presentations, and self-reported symptoms have low positive predictive…

Abstract Background The introduction of monoclonal antibody drugs has had major impact in medicine, leading to extraordinary progress in the treatment of a wide variety of diseases, particularly malignancies and chronic inflammatory and autoimmune diseases. Content This chapter provides a general overview of monoclonal antibody drugs approved for clinical use, including the basic biology of antibodies, production, pharmacologic characteristics, nomenclature, and various clinical indications. Because of…

Abstract Background Transplant compatibility testing is focused on developing an immune risk profile, which consists of three types of testing—human leukocyte antigen (HLA) typing, HLA antibody screening, and compatibility crossmatch. This immune risk profile is then put into clinical context by the transplant team to make clinical decisions. Content This chapter will begin by explaining the structure and clinically relevant properties of HLA. Typing methods for…

Abstract Background Since the first successful application of hematopoietic cell transplantation (HCT) in the 1950s there has been a consistent evolution in the practice of HCT, which has supported an increasing number of HCT survivors worldwide. HCT is a complex procedure which offers a curative option for many malignant and nonmalignant disorders. Content High-dose chemotherapy followed by autologous HCT is used as a therapeutic strategy for…

Abstract Background The development of transplantation for organ failure constituted a significant advance in the management of humans with solid organ failure, which progressed rapidly over the second half of the 20th century. The development of successful outcomes in different disciplines to achieve improved clinical and patient-centered outcomes has been a testament to dedicated clinicians and scientists worldwide. The changes in immunosuppression have improved outcomes but…

Abstract Background The systemic autoimmune diseases are a broad category of conditions characterized by chronic inflammation with a proven or suspected autoimmune etiology. Autoimmunity results from loss of immune system tolerance, leading to reactions against self-proteins. In many cases, autoantibodies are produced as part of this process. In some cases, these autoantibodies have well-defined antigen specificities and are clearly pathogenic, playing a major role in the…

Abstract Transfusion reactions remain a major issue particularly for patients with chronic transfusion requirements. The majority of reactions are mild, but some are severe and rarely fatal. In 2017, 44 fatal transfusion reactions occurred in the United States. Transfusion reactions and adverse events from transfusion can be divided between events that occur during or within several hours of the transfusion (acute) or events that occur over…

Abstract Background Blood transfusion practices should ultimately be driven by evidence-based decisions that integrate clinical observations, laboratory data, and a sound understanding of how patients can realistically benefit from blood products. In addition to acting as stewards of the local blood supply, the blood bank and transfusion medicine service are necessarily involved in ensuring that these concepts are understood and, consequently, that blood transfusions are appropriately…

Abstract Background Transfusion of blood requires multiple steps, including blood donation from nonremunerated healthy volunteers, manufacture, testing, and modifications of blood components, and finally administration of the product to a patient. While blood donation and transfusions have steadily decreased in the United States over the past decade, 16 million blood products were generated by collection and about 15 million transfused in 2019. Red cells, platelets, plasma,…

Abstract Background Specific knowledge of relevant blood group systems is essential for a thorough understanding of blood bank pretransfusion testing methodology and the potential practical applications of that information to clinical practice. In any given patient care setting, the blood bank and transfusion medicine service are tasked with integrating this information to improve the safety of blood transfusion and related activities. Content The first portion of…

Abstract Background Viral illness has a wide variety of clinical manifestations ranging from focal to systemic and affecting nearly every organ system. Infections may be asymptomatic, acute, or chronic in nature. The viruses causing these syndromes are diverse; however, unrelated viruses may cause clinically indistinguishable disease. Combined, these factors drive the importance of rapid and accurate laboratory diagnosis to enable effective patient management. Content In this…

Abstract Background Parasites are an important cause of human morbidity and mortality worldwide. They include a diverse array of single-celled eukaryotic organisms (protozoans), multicellular worms (helminths), and arthropods that live in or on the human body and can cause mild to severe life-threatening disease. While many parasites primarily infect impoverished individuals in tropical and subtropical regions of the world, others cause infection in the world’s temperate…

Abstract Background Ubiquitous in nature, fungi may be opportunistic organisms in compromised hosts or primary pathogens in immunocompetent individuals. Commensal fungi reside in the human body as part of the resident microbiota and cause opportunistic infections. Diagnosis of fungal infections relies on assessment of several factors, including geographical exposure, underlying host condition, clinical manifestations, and diagnostic accuracy of laboratory tests such as culture, anatomic pathology tests,…

Abstract Background There are currently approximately 200 recognized species of mycobacteria. Although some species are strictly environmental organisms, several are significant human pathogens, including Mycobacterium tuberculosis . M. tuberculosis is responsible for nearly 1.5 million deaths each year, and nontuberculous mycobacteria (NTM), such as Mycobacterium avium complex (MAC), are also responsible for significant morbidity and mortality. Content This chapter describes the laboratory methods used for the…

Abstract Background Antimicrobial susceptibility testing is one of the most important tasks of the clinical microbiology laboratory. Antimicrobial resistance is common, and early recognition of patients with resistant pathogens and appropriate optimization of their antimicrobial therapy significantly improves outcomes. Content This chapter reviews the key aspects of antimicrobial susceptibility testing (AST) of bacteria, mycobacteria, and yeast. In most circumstances, AST is performed by evaluating the effect…

Abstract The diagnosis of bacterial infection is one of the many important services provided by the clinical microbiology laboratory. The past decade has resulted in a dramatic shift in the manner in which clinical microbiologists identify bacteria. With the widespread adoption of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) and molecular methods such as 16S rDNA sequencing, clinical microbiologists are increasingly less reliant on traditional,…

Abstract Background The clinical laboratory occupies an important role in enabling effective infection prevention and control (IPC) and antimicrobial stewardship program (ASP) interventions. Indeed, the clinical laboratory generates the microbiologic data to guide clinical practice and recognize new trends that may signal nascent outbreaks and provides timely and accurate testing results that have the potential to impact patient care. In addition, the IPC and ASP groups…

Abstract Almost every portion of the human body can be infected in some manner by bacteria, viruses, fungi, or parasites. Symptoms of infection range widely from a mild or asymptomatic upper respiratory virus to severe and life-threatening infections such as meningitis. The variation in symptoms and disease severity is due to both differences in the pathogenic potential of the infecting organism and the response of the…

Abstract Background A subset of hemostatic disorders are due to an imbalance in coagulation or fibrinolysis. Disorders of coagulation or fibrinolysis can be either inherited (e.g., hemophilia A) or acquired (e.g., liver disease), and the clinical presentation is typically either bleeding or thrombosis. Laboratory testing is used to diagnose and to monitor the therapy of patients with these disorders. Additionally, a growing list of anticoagulant medications…

Abstract Primary hemostasis is characterized by vascular contraction, platelet adhesion, and formation of a platelet thrombus. It begins immediately after endothelial disruption with platelets and von Willebrand factor (VWF) being the key components in the initiation of hemostatic process. This chapter describes the laboratory testing of platelets and VWF and provides an overview of pathologic disorders. Test methods for evaluation of platelets Laboratory testing can assess…