Hormone Immunoassay Interference: A 2021 Update

Abstract

Immunoassays are powerful qualitative and quantitative analytical techniques. Since the first description of an immunoassay method in 1959, advances have been made in assay designs and analytical characteristics, opening the door for their widespread implementation in clinical laboratories. Clinical endocrinology is closely linked to laboratory medicine because hormone quantification is important for the diagnosis, treatment, and prognosis of endocrine disorders. Several interferences in immunoassays have been identified through the years; although some are no longer encountered in daily practice, cross-reaction, heterophile antibodies, biotin, and anti-analyte antibodies still cause problems. Newer interferences are also emerging with the development of new therapies. The interfering substance may be exogenous (e.g., a drug or substance absorbed by the patient) or endogenous (e.g., antibodies produced by the patient), and the bias caused by interference can be positive or negative. The consequences of interference can be deleterious when clinicians consider erroneous results to establish a diagnosis, leading to unnecessary explorations or inappropriate treatments. Clinical laboratories and manufacturers continue to investigate methods for the detection, elimination, and prevention of interferences. However, no system is completely devoid of such incidents. In this review, we focus on the analytical interferences encountered in daily practice and possible solutions for their detection or elimination.

Fulvestrant May Falsely Increase 17β-Estradiol Levels in Immunoassays: A Case Report of a 57-Year-Old Postmenopausal Patient With Recurrent Estrogen Receptor-Positive Breast Cancer

“…A known limitation of gonadal hormone immunoassays is cross-reactivity caused by structural similar compounds to the target hormone of the assay. It is reported that fulvestrant possesses the basic structure of 17β-estradiol, which may result in false positive results in the immunoassay ( 11 , 18 , 19 , 20 ).…”

Clinical and Technical Aspects in Free Cortisol Measurement

“…However, the organic extract must be removed because the antibodyimmobilized in immunoassay is denatured and this step requires technical expertise. Immunoassays are susceptible to interference because of the complexities of the antigen-antibody interaction occurring in a complex matrix [62]. The lack of specificity is also derived from different properties of various antibodies used in immunoassays, which leads to variability between different commercially available platforms [63,64].…”

Lateral flow assays for viruses diagnosis: Up-to-date technology and future prospects

“…CRISPR-based diagnostics tool can identify the attomolar levels of viral nucleic acids. They are more sensitive than RT-PCR-based approaches that only detect femtomolar concentrations [ 186 ]. LF CRISPR-based biosensing allows fast and sensitive identification of nucleic acids extracted from these diverse samples.…”

“…This feature prevents antibody testing from being used to diagnose COVID-19 promptly. However, detecting IgG and IgM is useful for studying the course of the disease post-illness or after vaccination [ 49 ]. Considering the advantages and disadvantages of antibody and antigen tests, there are many different studies for antibody detection and antigen detection.…”