Clinical Chemistry
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Clinical Chemistry 45: 1944-1953, 1999;
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(Clinical Chemistry. 1999;45:1944-1953.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

New Electrochemiluminescent Immunoassay for the Determination of CYFRA 21-1: Analytical Evaluation and Clinical Diagnostic Performance in Urine Samples of Patients with Bladder Cancer

Marta Sánchez-Carbayo1,a, Antonia Espasa1, Virtudes Chinchilla1, Enrique Herrero2, Julián Megías2, Antonio Mira2 and Federico Soria1

1 Laboratorio de Marcadores Tumorales, Servicio de Análisis Clínicos, and
2 Servicio de Urología, Hospital General Universitario de Alicante, C/Maestro Alonso 109, 03010 Alicante, Spain.
a Author for correspondence. Fax 34-923222046.

Background: A new electrochemiluminescent immunoassay (ECLIA) has been developed for the determination of cytokeratin 19 (CYFRA 21-1) in the Elecsys 2010 immunoassay system. Urinary CYFRA 21-1 might have a role in the diagnosis of bladder cancer.

Methods: We performed an analytical evaluation of the CYFRA 21-1 ECLIA for serum and urine samples. The clinical value of urinary CYFRA 21-1 for the detection of bladder cancer was evaluated through its measurement in 226 urine samples from symptomatic and asymptomatic controls.

Results: At concentrations of 2–30 µg/L, within-assay imprecision (CV) was below 2.1% for sera and 3.3% for urines, with interassay CVs below 3.3% for sera and 4.9% for urines. The day-to-day CV was <20% at concentrations >0.2 µg/L (functional sensitivity). Measurement of diluted samples showed that the assay estimated CYFRA 21-1 between 98% and 103% for sera and 98% and 105% for urines. Recovery of added CYFRA 21-1 was 99–105% for sera and 96–115% for urines. We separately compared serum and urine CYFRA 21-1 ECLIA results with those obtained with an IRMA (CIS bio international). Regression analysis for sera was: CYFRA 21-1 (ECLIA) = 0.520 + 1.018 CYFRA 21-1 (IRMA); [95% confidence interval (CI) (y-intercept), -0.260 to 1.309]; 95% CI (slope), 0.978–1.060; n = 100; Sy|x = 3.242; r2 = 0.987. For urine samples it was: CYFRA 21-1 (ECLIA) = 0.716 + 0.966 CYFRA 21-1 (IRMA); 95% CI (y-intercept), 0.009–1.422; 95% CI (slope), 0.956–0.976; n = 100; Sy|x = 4.136; r2 = 0.986. In urine samples voided by patients with and without bladder cancer, the best ROC analysis discrimination provided 81.0% (95% CI, 72.7–87.7%) sensitivity and 97.2% (95% CI, 90.2–99.6%) specificity at a threshold value of 5.7 µg/L.

Conclusions: Our initial evaluation showed reliable analytical performance for urinary CYFRA 21-1, which might assist urologists in the detection of bladder cancer as a noninvasive adjunct to cystoscopy.




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