Therapeutic monoclonal antibodies and clinical laboratory tests: When, why, and what is expected?

Therapeutic monoclonal antibodies and clinical laboratory tests: When, why, and what is expected? BACKGROUNDMonoclonal antibodies (mAb) are antibodies that are made by identical immune cells derived from a unique parent B lymphocyte cell. During the past few decades, mAbs have become an integral and widely used technology for both laboratory diagnostics and clinical treatment. As it the case for many other prescription drugs, it is necessary to perform clinical laboratory tests before and after the treatment with therapeutic mAb to screen for potentially sensitive patients, check the patients’ background health status and to evaluate the response to treatment. It has also been reported that some mAbs may interfere with clinical laboratory tests, especially diagnostic kits that use mAb to detect a specific analyte. However, to the best of our knowledge, there have not been any systematic review about the clinical laboratory tests needed for and affected by therapeutic mAb based on the drug labels.Drug labels provide an excellent source of data for pharmacoepidemiological studies because they contain detailed information about the individual drugs. Therefore, we reviewed and analyzed all the labels of FDA‐approved therapeutic mAbs deposited in DailyMed, the official website for FDA‐approved drug labels (https://dailymed.nlm.nih.gov/dailymed/index.cfm), to provide a detailed profile of the clinical laboratory tests which should be performed before, during http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Clinical Laboratory Analysis Wiley

Therapeutic monoclonal antibodies and clinical laboratory tests: When, why, and what is expected?

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
Copyright © 2018 Wiley Periodicals, Inc.
ISSN
0887-8013
eISSN
1098-2825
D.O.I.
10.1002/jcla.22307
Publisher site
See Article on Publisher Site

Abstract

BACKGROUNDMonoclonal antibodies (mAb) are antibodies that are made by identical immune cells derived from a unique parent B lymphocyte cell. During the past few decades, mAbs have become an integral and widely used technology for both laboratory diagnostics and clinical treatment. As it the case for many other prescription drugs, it is necessary to perform clinical laboratory tests before and after the treatment with therapeutic mAb to screen for potentially sensitive patients, check the patients’ background health status and to evaluate the response to treatment. It has also been reported that some mAbs may interfere with clinical laboratory tests, especially diagnostic kits that use mAb to detect a specific analyte. However, to the best of our knowledge, there have not been any systematic review about the clinical laboratory tests needed for and affected by therapeutic mAb based on the drug labels.Drug labels provide an excellent source of data for pharmacoepidemiological studies because they contain detailed information about the individual drugs. Therefore, we reviewed and analyzed all the labels of FDA‐approved therapeutic mAbs deposited in DailyMed, the official website for FDA‐approved drug labels (https://dailymed.nlm.nih.gov/dailymed/index.cfm), to provide a detailed profile of the clinical laboratory tests which should be performed before, during

Journal

Journal of Clinical Laboratory AnalysisWiley

Published: Jan 1, 2018

Keywords: ; ; ; ;

References

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