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. 2015 Dec 23;2015(12):CD012019.
doi: 10.1002/14651858.CD012019.

Urinary biomarkers for the non-invasive diagnosis of endometriosis

Emily Liu  1 , Vicki Nisenblat, Cindy Farquhar, Ian Fraser, Patrick M M Bossuyt, Neil Johnson, M Louise Hull
Affiliations

Urinary biomarkers for the non-invasive diagnosis of endometriosis

Emily Liu et al. Cochrane Database Syst Rev. .

Abstract

Background: About 10% of reproductive-aged women suffer from endometriosis which is a costly chronic disease that causes pelvic pain and subfertility. Laparoscopy is the 'gold standard' diagnostic test for endometriosis, but it is expensive and carries surgical risks. Currently, there are no simple non-invasive or minimally-invasive tests available in clinical practice that accurately diagnoses endometriosis.

Objectives: 1. To provide summary estimates of the diagnostic accuracy of urinary biomarkers for the diagnosis of pelvic endometriosis compared to surgical diagnosis as a reference standard.2. To assess the diagnostic utility of biomarkers that could differentiate ovarian endometrioma from other ovarian masses.Urinary biomarkers were evaluated as replacement tests for surgical diagnosis and as triage tests to inform decisions to undertake surgery for endometriosis.

Search methods: The searches were not restricted to particular study design, language or publication dates. We searched the following databases to 20 April - 31 July 2015: CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP and ClinicalTrials.gov (trial register). MEDION, DARE, and PubMed were also searched to identify reviews and guidelines as reference sources of potentially relevant studies. Recently published papers not yet indexed in the major databases were also sought. The search strategy incorporated words in the title, abstract, text words across the record and the medical subject headings (MeSH) and was modified for each database.

Selection criteria: Published peer-reviewed, randomised controlled or cross-sectional studies of any size were considered, which included prospectively collected samples from any population of reproductive-aged women suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of one or more urinary biomarkers with surgical visualisation of endometriotic lesions.

Data collection and analysis: Two authors independently collected and performed a quality assessment of the data from each study. For each diagnostic test, the data were classified as positive or negative for the surgical detection of endometriosis and sensitivity and specificity estimates were calculated. If two or more tests were evaluated in the same cohort, each was considered as a separate data set. The bivariate model was used to obtain pooled estimates of sensitivity and specificity whenever sufficient data sets were available. The predetermined criteria for a clinically useful urine test to replace diagnostic surgery was one with a sensitivity of 94% and a specificity of 79% to detect endometriosis. The criteria for triage tests were set at sensitivity of equal or greater than 95% and specificity of equal or greater than 50%, which in case of negative result rules out the diagnosis (SnOUT test) or sensitivity of equal or greater than 50% with specificity of equal or greater than 95%, which in case of positive result rules the diagnosis in (SpIN test).

Main results: We included eight studies involving 646 participants, most of which were of poor methodological quality. The urinary biomarkers were evaluated either in a specific phase of menstrual cycle or irrespective of the cycle phase. Five studies evaluated the diagnostic performance of four urinary biomarkers for endometriosis, including three biomarkers distinguishing women with and without endometriosis (enolase 1 (NNE); vitamin D binding protein (VDBP); and urinary peptide profiling); and one biomarker (cytokeratin 19 (CK 19)) showing no significant difference between the two groups. All of these biomarkers were assessed in small individual studies and could not be statistically evaluated in a meaningful way. None of the biomarkers met the criteria for a replacement test or a triage test. Three studies evaluated three biomarkers that did not differentiate women with endometriosis from disease-free controls.

Authors' conclusions: There was insufficient evidence to recommend any urinary biomarker for use as a replacement or triage test in clinical practice for the diagnosis of endometriosis. Several urinary biomarkers may have diagnostic potential, but require further evaluation before being introduced into routine clinical practice. Laparoscopy remains the gold standard for the diagnosis of endometriosis, and diagnosis of endometriosis using urinary biomarkers should only be undertaken in a research setting.

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Conflict of interest statement

All authors declared no conflicts of interest.

Figures

1
1
Sequential approach to non‐invasive testing of endometriosis
2
2
Flow of the studies identified in literature search for systematic review on urinary biomarkers for a non‐invasive diagnosis of endometriosis.
3
3
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies
4
4
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study
5
5
Summary ROC Plot of NNE‐Cr for detection of endometriosis utilising a cut‐off > 0.96 ng/mgCr. Each point represents the pair of sensitivity and specificity for evaluation. The bars correspond to 95% CIs.
6
6
Summary ROC plot of VDBP‐Cr for detection of endometriosis utilising a cut‐off >87.83 ng/mgCr. Each point represents the pair of sensitivity and specificity for the evaluation. The bars correspond to 95% CIs.
7
7
Summary ROC plot of Proteome for detection of endometriosis. Each point represents the pair of sensitivity and specificity for each evaluation. The size of each point is proportional to the sample size and the shape designates the tests including different proteins. The bars correspond to 95% CIs of each individual evaluation. The data were not assessed by meta‐analysis.
8
8
Forest plot of proteome for detection of endometriosis. Plot shows study‐specific estimates of sensitivity and specificity (squares) with 95% CI (black line), country in which the study was conducted, menstrual cycle phase at which the test was performed and severity of the disease assessed by each study, reported as rASRM stage. FN: false negative; FP: false positive; TN: true negative; TP: true positive.
9
9
Summary ROC plot of CK 19 for detection of endometriosis utilising a cut‐off > 5.3 ng/ml. Each point represents the pair of sensitivity and specificity for the evaluation. The bars correspond to 95% CIs.
1
1. Test
NNE‐Cr (> 0.96 ng/mgCr).
2
2. Test
VDBP‐Cr (> 87.83 ng/mgCr).
3
3. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 1824.3 Da; ≥ 29.34 au).
4
4. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 1767.1 Da; ≥ 35.22 au).
5
5. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 2052.3 Da; cut‐off not reported).
6
6. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 3393.9 Da; cut‐off not reported).
7
7. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 1579.2 Da [collagen alpha 6(IV) chain precursor]; cut‐off not reported).
8
8. Test
Proteome by MALDI‐TOF‐MS (peptide m/z 891.6 Da [collagen alpha1 chain precursor];; cut‐off not reported).
9
9. Test
Proteome by MALDI‐TOF‐MS (5 peptides m/z 1433.9 +1599.4 + 2085.6 + 6798.0 + 3217.2 Da; cut‐off not reported).
10
10. Test
CK 19 [CYFRA 21‐1] (> 5.3 ng/ml).
See this image and copyright information in PMC

References

References to studies included in this review

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References to studies excluded from this review

Gjavotchanoff 2015 {published data only}
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