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The variability of immunologic laboratory tests.

P A Feigenbaum, T A Medsger, R G Kraines

The Journal of Rheumatology

|May 1, 1982

Summary

Immunologic tests for connective tissue diseases, including serum complement (C3), DNA binding (DNAB), and fluorescent antinuclear antibody (FANA), showed significant variability between laboratories. These objective tests are not reliable for defining disease or activity alone.

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Area of Science:

Immunology
Clinical Pathology
Rheumatology

Background:

Immunologic tests are crucial for diagnosing and monitoring connective tissue diseases.
Reliability of widely used tests like C3, DNAB, and FANA needs rigorous evaluation.

Purpose of the Study:

To assess the clinical reliability and inter-laboratory variability of serum complement (C3), DNA binding (DNAB), and fluorescent antinuclear antibody (FANA) tests.
To determine if these immunologic markers are sufficiently reliable for accurate disease classification and activity assessment.

Main Methods:

Blind measurement of C3, DNAB, and FANA on duplicate serum samples from 667 patients with connective tissue diseases.
Samples were analyzed at two independent university immunology laboratories.
Repeat assays were performed on a subset of 91 sera to assess reproducibility.

Main Results:

Significant inter-laboratory discrepancies were observed: 27% of patients were classified differently for C3, with a mean difference of 25 mg% and persistent variability.
DNA binding (DNAB) and fluorescent antinuclear antibody (FANA) tests also showed variability, with 15% and 11% of patients differently classified, respectively.
Repeat assays confirmed persistent variability in test results.

Conclusions:

The studied immunologic tests (C3, DNAB, FANA) exhibit substantial inter-laboratory variability.
These "objective" laboratory markers, when used alone, are not sufficiently reliable for accurately defining connective tissue diseases or their activity.
Clinical interpretation must consider the inherent variability of these diagnostic tools.

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