The role of tumour marker assays in differentiating malignant from benign pleural effusions is not yet clear. This study was designed to prospectively assess the individual and combined diagnostic utility of three tumour markers in patients with pleural effusion.Pleural and serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 15-3 (CA 15-3) and cytokeratin 19 fragment (CYFRA 21-1) were determined in 115 patients with pleural effusions (42 malignant and 73 benign). The diagnostic utility of each tumour marker was assessed using accuracy to determine the optimal cut-off point, whilst a logistic regression model was used to obtain the optimal combined test.In serum, every marker showed an individual high specificity (over 97%) for malignancy. The sensitivity of CEA, CA 15-3 and CYFRA 21-1 was 36, 48 and 31%, respectively. In patients without renal failure, the sensitivity of CYFRA 21-1 rose to 53%, while those of CEA and CA 15-3 remained almost unchanged. In pleural fluid, CYFRA 21-1 showed low sensitivity (32%) and specificity (82%), while CEA showed the highest sensitivity (57%). Excluding patients with renal failure, the combined determination in serum of CEA, CA 15-3 and CYFRA 21-1 has a high accuracy (88%), similar to that for CEA plus CA 15-3 in pleural fluid (87%).We conclude that CYFRA 21-1 is useless in pleural fluid and should not be used in serum for patients with renal failure. The combined determination of CEA, CA 15-3 and CYFRA 21-1 in serum may obviate its determination in pleural fluid.

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Objectives: The first objective was to assess the diagnostic value of new biochemical criteria proposed to discriminate pleural transudates from exudates and to compare their efficiency with those of Light’s criteria. The second objective of the study was to assess the interstudy variability of the parameters repeatedly determinated in two different groups of patients with pleural effusion. Patients and Methods: We recorded clinical characteristics and final diagnoses and measured pleural fluid (PF) and serum levels of protein, LDH, cholesterol and cholinesterase of 243 patients with pleural effusion. Results: Sixty-one (25%) pleural effusions were transudates and 182 were exudates. The sensitivity (99%) and accuracy (96%) of Light’s criteria were higher than those of the other criteria tested, although the differences with those of the PF LDH-cholesterol combination (96 and 93%) did not show statistical significance. Pleural LDH concentration was the criterion with the highest specificity (95%), being significantly higher (p < 0.05) than that of Light’s criteria. The sensitivity, specificity and accuracy of most criteria tested did not vary when compared with those obtained in a study performed 5 years previously. Conclusions: Light’s criteria remain the criteria of choice for segregating exudates from transudates. Based on cost-efficiency reasons, the PF LDH-cholesterol combination appears as an alternative. Because both sets of criteria misdiagnose a substantial percentage of transudates, exceptions based on good clinical judgment and the complementary use of a more specific criterion, as the PF concentration of LDH, must be considered.

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 &lt;20% at concentrations &gt;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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