Abbott IMx evaluated for assay of prostate-specific antigen in serum

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 38; no. 10; pp. 2140 - 2142
• Main Authors: Dnistrian, AM, Schwartz, MK, Smith, CA, Nisselbaum, JS, Fair, WR
• Format: Journal Article
• Language: English
• Published: Washington, DC Am Assoc Clin Chem 01.10.1992; American Association for Clinical Chemistry
• Subjects: Autoanalysis; Biological and medical sciences; Humans; Immunoenzyme Techniques - standards; Immunoenzyme Techniques - statistics & numerical data; Male; Medical sciences; Nephrology. Urinary tract diseases; Prostate-Specific Antigen - blood; Reagent Kits, Diagnostic - standards; Reagent Kits, Diagnostic - statistics & numerical data; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Human; Urinary system disease; Tumor associated antigen; Radioimmunoassay; Exploration; Serum; Tumoral marker; Malignant tumor; Enzyme immunoassay; Prostatic disease; Comparative study; Quantitative analysis
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1093/clinchem/38.10.2140

We evaluated a new fully automated procedure for quantitative measurement of prostate-specific antigen (PSA) by the Microparticle Enzyme Immunoassay (MEIA) technology developed for the Abbott IMx automated immunoassay system. The performance characteristics of the Abbott IMx PSA assay (y) were evaluated and compared with those of the Hybritech Tandem-E PSA assay (x), a solid-phase two-site immunoenzymometric assay. PSA values for both assays were well correlated (r = 0.99); regression analysis yielded the equation y = 0.92x - 0.23 micrograms/L. The Abbott assay proved reliable and reproducible, as shown by the intra- and interassay coefficients of variation (2.0-3.4% and 3.1-4.7%, respectively). The assay gave a linear standard curve up to 100 micrograms/L and was very sensitive (detected PSA < 0.1 microgram/L). This analytical sensitivity was comparable with that of the Tandem-E PSA assay. Overall, the IMx PSA assay demonstrated the accuracy, precision, linearity, and intermethod correlation required for monitoring patients with prostate cancer.