Implications of Monoclonal Antibody Therapeutics Use for Clinical Laboratory Testing

Abstract BACKGROUND Monoclonal antibody therapeutics (MATs) represent a rapidly expanding class of biological drugs used to treat a variety of diseases. The widespread use of MATs increasingly affects clinical laboratory medicine. CONTENT This review provides an overview of MATs currently approved for clinical use in the US, starting from basic biology of antibodies to the engineering, pharmacokinetic and pharmacodynamic properties, nomenclature, and production of MATs. Immunogenicity and the production of antidrug antibodies (ADAs) play a major role in loss of therapeutic response and the development of treatment failure to certain MATs. Laboratory-based monitoring for MATs and detection of ADAs represent emerging needs for optimizing the use of MATs to achieve the best outcomes at affordable cost. In addition, the increased use of MATs affects clinical laboratory testing by interference of MATs with clinical laboratory tests across different areas of laboratory medicine, including histocompatibility, blood bank, and monoclonal protein testing. SUMMARY The number of MATs is rapidly growing each year to address previously unmet clinical needs. Laboratory monitoring of MATs and detecting ADAs represent expanding areas of laboratory testing. Test-based strategies allow for treatment optimization at the level of the individual patient, thus providing a personalized medicine approach. In addition, clinical laboratories must be aware that the increasing use of MATs affects laboratory testing and be ready to implement methods to eliminate or mitigate interference with clinical tests.

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National Inventory of Clinical Laboratory Testing Services (NICLTS)

Archives of Pathology & Laboratory Medicine ◽

10.5858/2000-124-1201-nioclt ◽

2000 ◽

Vol 124 (8) ◽

pp. 1201-1208 ◽

Cited By ~ 4

Author(s):

Steven J. Steindel ◽

William J. Rauch ◽

Marianne K. Simon ◽

James Handsfield

Keyword(s):

Public Health ◽

United States ◽

Health Care ◽

Laboratory Testing ◽

Clinical Laboratory ◽

The United States ◽

High Complexity ◽

Specimen Type ◽

The Us ◽

Clinical Laboratory Testing

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

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