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Diagnostic Accuracy of Urinary Cytokeratin 19 Fragment for Endometriosis

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Abstract

Endometriosis affects up to 10% of women of reproductive age and 176 million women worldwide. The prevalence in women with infertility is between 30% and 50% but may be higher in women with pelvic pain, interstitial cystitis, or irritable bowel syndrome. Cytokeratin 19 has been suggested as a potential biomarker in urine for the diagnosis of this condition. The objective of this study was to prospectively determine the accuracy and the performance of a urinary cytokeratin 19 (uCYFRA 21-1) test for diagnosing endometriosis. Ninety-eight consecutive women who underwent laparoscopy had a urinary sample obtained before surgery and were included in the study. Endometriosis was diagnosed by laparoscopy and pathology in 64.3% (63 of 98 women). The estimates and 95% confidence intervals for sensitivity, specificity, positive and negative predictive values, and likelihood ratios were 11.1% (4.5%–21.5%), 94.3% (80.8%–99.3%), 77.7% (39.9–97.1), 37% (27–47.9), 1.94 (0.43–8.86), and 0.94 (0.84–1.06), respectively. Despite the high specificity, the uCYFRA 21-1 test has limited value for clinical practice to discriminate between women with and without endometriosis.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Greenville Health System, 890W Faris Rd, Suite 470, 29605, Greenville, SC, USA

    B. A. Lessey MD, PhD

  2. Departmento de Ginecologia e Obstetrícia, Universidade Federal do Rio Grande do Sul, Rio Grande do Sul, Brazil

    R. F. Savaris MD, MSc, PhD

  3. Diagnostics Discovery Research, Abbott Laboratories, Abbott Park, IL, USA

    S. Ali MS & S. Brophy PhD

  4. Research, Abbott Laboratories, North Chicago, IL, USA

    S. Tomazic-Allen PhD

  5. Research and Development, AbbVie Inc, North Chicago, IL, USA

    K. Chwalisz MD, PhD

Authors
  1. B. A. Lessey MD, PhD
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  2. R. F. Savaris MD, MSc, PhD
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  3. S. Ali MS
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  4. S. Brophy PhD
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  5. S. Tomazic-Allen PhD
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  6. K. Chwalisz MD, PhD
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Corresponding author

Correspondence to B. A. Lessey MD, PhD.

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Lessey, B.A., Savaris, R.F., Ali, S. et al. Diagnostic Accuracy of Urinary Cytokeratin 19 Fragment for Endometriosis. Reprod. Sci. 22, 551–555 (2015). https://doi.org/10.1177/1933719114553064

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  • DOI: https://doi.org/10.1177/1933719114553064

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