METHODS: The labels of FDA-approved therapeutic mAbs were downloaded from DailyMed (the official website for drug labels) and were used as the sources of data for this review.
RESULTS: It was found that most of the labels provided information relevant to the clinical laboratory tests, including the tests needed before mAbs treatment to check the patients\' background status and to identify potentially sensitive patients, the tests needed during or after the treatment to evaluate the patients\' response, and the mAbs that may lead to false positive or negative results for clinical laboratory tests.
CONCLUSIONS: The present findings will be of interest to physicians, laboratory scientists, those involved in drug development and surveillance and individuals making health care policy.
方法:FDA批准的治疗性单克隆抗体的标签从DailyMed(药物标签的官方网站)下载,并用作本综述的数据来源。
结果:发现大多数标签提供了与临床实验室测试相关的信息,包括单克隆抗体治疗前需要的测试,以检查患者的背景状态并识别潜在的敏感患者,治疗期间或之后需要的测试,以评估患者的反应,以及可能导致临床实验室检查结果假阳性或阴性的单克隆抗体。
结论:目前的发现将引起医生的兴趣,实验室科学家,那些参与药物开发和监测的人和制定医疗保健政策的人。