Erroneous laboratory results: what clinicians need to know

Area of Science:

• Clinical Chemistry
• Immunology
• Laboratory Medicine

Background:

• Conventional biochemistry tests are robust, but immunoassays have inherent limitations.
• Immunoassays are susceptible to analytical interference, leading to inaccurate patient results.
• Interfering antibodies can affect common diagnostic tests, including thyroid function tests.

Purpose of the Study:

• To highlight the prevalence and impact of analytical interference in immunoassay testing.
• To underscore the limitations of current quality control in detecting sample-specific interferences.
• To advocate for increased clinician awareness regarding immunoassay limitations.

Main Methods:

• Review of existing literature on immunoassay interference.
• Analysis of the prevalence rates of interfering antibodies.
• Discussion of the implications for laboratory quality assurance and clinical practice.

Main Results:

• Interfering antibodies causing inaccurate immunoassay results occur in 0.4% to 4% of cases.
• This interference is sample-specific, unpredictable, and often undetectable by standard quality control.
• The widespread use of immunoassays (over 10 million/year in the UK) amplifies the clinical impact.

Conclusions:

• Analytical interference in immunoassays poses a significant risk to patient care.
• Current laboratory quality control measures are insufficient to detect this type of interference.
• Enhanced clinician awareness is crucial for appropriate interpretation of immunoassay results and patient management.