The interference of monoclonal antibodies with laboratory diagnosis: clinical and diagnostic implications

Abstract

Diagnostic test interference is due to the presence of material that falsely changes an analytic test result. The development of monoclonal antibodies is discussed with focus on their extensive use as both therapeutic and diagnostic agents. In this review the interference of monoclonal antibodies with laboratory test methods and the potential impact on clinical care is addressed. Recognition of the types of interference, endogenous and exogenous, and the varied mechanisms by which monoclonal antibodies may cause interference are discussed in this report. Review of the literature identifies cases which exemplify the issues facing laboratorians and clinicians and describe the impact on patients. Approaches to reducing and eliminating sources of interference are also addressed. Education of ordering clinicians concerning the possibility of interference in at-risk patients is key in limiting the impact on care. Laboratorians and medical practitioners should be cognizant of the risk of interference to avoid incorrect management of patients.

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

“…Therapeutic mAbs can induce unexpected interference with laboratory tests via several mechanisms, including direct cross‐reactions with the test reagents, the suppression of physiological functions in the patient, activation of inflammatory processes after binding of the mAb to its target . Detecting or knowing about the interference and using an alternative method to run the laboratory test are critical to ensure the accuracy of results and safety of patients .…”

Immunotherapeutic Biologic Agents to Treat Autoinflammatory Diseases

“…Patients who developed anti-infliximab HACAs are also more likely to have infusion reactions and possibly reduced therapeutic benefit. Awareness of the risk of HACA formation and its consequences is crucial information for prescribing clinicians [69,70].…”

“…Autoantibody formation in patients receiving immunotherapeutic agents is well described [70]. Development of antinuclear antibodies (ANAs) is reported in patients in biologic trials.…”

“…Development of antinuclear antibodies (ANAs) is reported in patients in biologic trials. HACAs may produce false-positive autoantibody results due to interference in laboratory tests [70]. Autoimmune syndromes have been triggered by the use of immunotherapeutic in patients with RA and, in theory, also may develop in similarly treated patients with AutoIDx [51,71].…”

Letter from the Editor

“…Study of the relationships between IL-23R, IL-17, IL-21 polymorphisms and serum level of IL-17, IL-21 with acute graft rejection in Iranian liver transplant recipients, (Karimi et al, 2014), The interference of monoclonal antibodies with laboratory diagnosis: clinical and diagnostic implications (Ostrov & Amsterdam, 2013), Inhibition of accelerated rejection mediated by alloreactive CD4 + memory T cells and prolonged allograft survival by arsenic trioxide (Yan et al, 2013), Association between a TGFBR2 Gene Polymorphism (rs2228048, Asn389Asn) and Acute Rejection in Korean Kidney Transplantation Recipients (Kim et al, 2013), Reconstitution and Phenotype of Tregs in CMV Reactivating Patients Following Allogeneic Hematopoietic Stem Cell Transplantation (Velaga et al, 2013), Evaluation of a Cryopreservation Procedure to Set Up a New Bone Marrow Transplant Unit Using Lymphocyte Proliferation Test (Wong et al, 2012), HLA-C matching status does not affect rituximab-mediated antibody-dependent cellular cytotoxicity by allogeneic natural killer Cells. (Machino et al, 2012) Diversity of HLA-B 35 alleles and haplotypes among Croatians (Calusic et al, 2012) HLA class I and II polymorphisms in the Gujjar population from Pakistan (Raza et al, 2013) These papers have whet our appetite for understanding the current clinical state of the art for transplantation.…”