Pesce Michael A, Spitalnik Steven L
Department of Pathology, College of Physicians and Surgeons of Columbia University, New York, New York 10032, USA.
Ann N Y Acad Sci. 2007 Mar;1098:192-9. doi: 10.1196/annals.1384.032.
There have been increasing numbers of applications using oral fluids, saliva in particular, as the target substrate for performing clinical diagnostic tests. These have focused primarily on point-of-care (POC) testing. These POC testing approaches range from, for example, currently available, highly specialized screening tests for the presence of antibodies recognizing HIV to the potential development of "lab-on-a-chip" platforms. Broad claims have been made that the latter will revolutionize clinical laboratory testing. From the perspective of large centralized clinical laboratories, multiple issues must be considered before implementing individual tests using saliva as the target fluid in a POC format or using saliva as a universal test fluid for measuring multiple analytes in a centralized laboratory format. The current scope of laboratory testing is large and comprehensive, involving both POC and centralized testing. Current academic laboratory programs have the ability to qualitatively identify and/or quantitatively measure several thousand analytes in various target matrices including blood, plasma, serum, urine, joint fluid, pleural fluid, peritoneal fluid, cerebrospinal fluid, and tissue. These tests fall into multiple clinical pathology disciplines, including clinical chemistry, hematology, coagulation, transfusion medicine, microbiology, cytogenetics, molecular diagnosis, and immunology. In addition, before implementing a given test, multiple issues need to be evaluated to ensure the validity of the reported result; these include considerations involving the three major phases of testing: preanalytical (e.g., patient identification and specimen collection, stability, and transport), analytical (e.g., sensitivity, specificity, accuracy, and precision), and postanalytical (e.g., reporting results, quality improvement, and turn-around-time).
越来越多的应用将口腔液体，尤其是唾液，用作进行临床诊断测试的目标底物。这些应用主要集中在即时检验（POC）方面。这些POC检测方法范围广泛，例如，从目前可用的用于检测识别HIV抗体的高度专业化筛查测试，到“芯片实验室”平台的潜在开发。有人广泛宣称，后者将彻底改变临床实验室检测。从大型集中式临床实验室的角度来看，在以POC形式使用唾液作为目标液体进行个别检测，或以集中实验室形式将唾液用作测量多种分析物的通用测试液体之前，必须考虑多个问题。当前实验室检测的范围广泛且全面，涉及POC检测和集中检测。当前的学术实验室项目有能力定性识别和/或定量测量包括血液、血浆、血清、尿液、关节液、胸水、腹水、脑脊液和组织在内的各种目标基质中的数千种分析物。这些检测属于多个临床病理学科，包括临床化学、血液学、凝血、输血医学、微生物学、细胞遗传学、分子诊断和免疫学。此外，在实施特定检测之前，需要评估多个问题以确保报告结果的有效性；这些问题包括涉及检测三个主要阶段的考虑因素：分析前（例如，患者识别和标本采集、稳定性和运输）、分析（例如，灵敏度、特异性、准确性和精密度）和分析后（例如，报告结果、质量改进和周转时间）。
