Unilateral pleural effusion may result from a variety of diseases, including malignant, inflammatory, infectious and cardiovascular illnesses. Pleural fluid aspiration facilitates measurement of various disease biomarkers. If accurate, pleural fluid tests may obviate the need for pleural biopsy or other investigations and facilitate early treatment initiation, including early ICD in patients with complex PPE or empyema, so the next question asked:
- B4 What is the diagnostic accuracy of pleural fluid tests when diagnosing adult patients with unilateral pleural effusion?
To address this question, it was first necessary to define the disease states that are of clinical interest in adults presenting with unilateral effusion, and to define a relevant gold standard for each (Table 9). The index tests reviewed vary with the target disease resulting in five subquestions, each containing relevant index test gold standard pairs.
Table 9: Reviewed disease state subgroups and associated gold standards
|
Disease state
|
Gold standard
|
|
Secondary pleural malignancy
|
Malignant fluid cytology or pleural biopsy, or malignant pleural nodules/thickening on imaging and confirmed extra-pleural primary cancer
|
|
Tuberculous pleural effusion (TPE)
|
Clinical composite, including definite TPE (AAFB in pleural tissue or fluid culture, or sputum AAFB plus effusion) and probable TB (granulomatous histology or lymphocytic fluid, effusion resolved after TB therapy and other causes excluded)
|
|
Heart failure
|
Clinical composite including reduced LVEF on echo +/- MRI
|
|
Complex parapneumonic effusion or empyema
|
Clinical composite including evidence of infection plus purulent fluid, positive culture or Gram’s stain, fluid pH <7.2
|
|
Autoimmune pleuritis
|
Clinical compositive based on all available data
|
AAFB – acid alcohol fast bacilli; LVEF – left ventricular ejection fraction
A summary of the evidence review for each disease state (Table 9) is shown in subsections below, followed by the evidence statements, recommendation and GPPs. The full evidence review is available in online supplemental appendix B4.
Secondary pleural malignancy
A summary of the diagnostic accuracies of cytology and pleural biomarkers carcinoembryonic antigen (CEA), fragment of cytokeratin 19 (CYFRA21-1), carbohydrate antigen 19-9 (CA19-9), cancer antigen 15-3 (CA15-3) and cancer antigen 72-4 (CA72-4) for diagnosing secondary pleural malignancy are shown in Table 10.
Table 10: Summary of the diagnostic accuracies of secondary pleural malignancy pleural biomarkers
|
Biomarker
|
Contributing studies (n)
|
Sensitivity [95% CI]
|
Specificity [95% CI]
|
|
Cytology
|
7
|
0.46 [0.40, 0.52]
|
1.00 [0.00, 1.00]
|
|
CEA
|
8
|
0.54 [0.40, 0.68]
|
1.00 [0.96, 1.00]
|
|
CYFRA 21-1
|
3
|
0.58 [0.48, 0.67]
|
0.88 [0.78, 0.94]
|
|
CA19-9
|
3
|
0.22 [0.18 0.27]
|
1.00 [0.00,1.00]
|
|
CA15-3
|
6
|
0.44 [0.39, 0.50]
|
0.99 [0.97, 1.00]
|
|
CA72-4
|
3
|
0.38 [0.30, 0.46]
|
0.99 [0.97, 1.00]
|
CA15-3 – cancer antigen 15-3; CA19-9 – carbohydrate antigen 19-9; CA72-4 – cancer antigen 72-4; CEA – carcinoembryonic antigen; CYFRA 21-1 – fragment of cytokeratin 19
Tuberculous pleural effusion
The point estimate diagnostic accuracies of pleural biomarkers adenosine deaminase (ADA) and interferon gamma (IFN-gamma) for diagnosing tuberculous pleural effusion are shown in Table 11.
Table 11: Summary of the diagnostic accuracies of tuberculous pleural effusion pleural biomarkers
|
Biomarker
|
Contributing studies (n)
|
Sensitivity [95% CI]
|
Specificity [95% CI]
|
|
ADA
|
24
|
0.91 [0.87, 0.93]
|
0.88 [0.86, 0.93]
|
|
IFN-gamma
|
6
|
0.95 [0.85, 0.98]
|
0.96 [0.90, 0.98]
|
ADA – adenosine deaminase; CI – confidence intervals; IFN-gamma – interferon gamma
Heart failure
The point estimate diagnostic accuracy of pleural fluid N-terminal prohormone brain natriuretic peptide (NT-proBNP) for diagnosing heart failure pleural effusion is shown in Table 12.
Table 12: Summary of the diagnostic accuracy of heart failure pleural effusion pleural biomarkers
|
Biomarker
|
Contributing studies (n)
|
Sensitivity [95% CI]
|
Specificity [95% CI]
|
|
NT-proBNP
|
5
|
0.93 [0.88, 0.96]
|
0.93 [0.86, 0.97]
|
NT-proBNP – N-terminal pro hormone BNP
Pleural infection (complex parapneumonic effusion or empyema)
No studies directly investigated the diagnostic accuracy of pleural fluid tests for diagnosing pleural infection (complex parapneumonic effusion (CPPE) or empyema). This was primarily due to the use of inappropriate reference standards, failure to adequately describe reference standards used, discovery biomarker analyses without validation and the use of biomarkers for prognostic, not diagnostic, analyses.
Autoimmune pleuritis (lupus pleuritis)
The point estimate sensitivity and specificity of pleural fluid antinuclear antibody (ANA) for diagnosing lupus pleuritis are shown in Table 13.
Table 13: Summary of the diagnostic accuracy of lupus pleuritis pleural biomarkers
|
Biomarker
|
Contributing studies (n)
|
Sensitivity [95% CI]
|
Specificity [95% CI]
|
|
ANA
|
4
|
0.94 [0.72, 0.99]
|
0.87 [0.77, 0.93]
|
ANA – antinuclear antibody
Evidence statements
-
Pleural fluid biomarkers do not provide improved sensitivity, when compared with cytology, for diagnosing secondary pleural malignancy. (Low)
-
Pleural fluid ADA and IFN-gamma provide high sensitivity and specificity for diagnosing tuberculous pleural effusion. (Very low)
-
Pleural fluid NT-proBNP provides high sensitivity and specificity for diagnosing heart failure in patients with unilateral pleural effusion. (Very low)
-
Pleural fluid ANA provides high sensitivity and specificity for diagnosing lupus pleural effusion. (Low)
Recommendations
-
Pleural fluid cytology should be used as an initial diagnostic test in patients with suspected secondary pleural malignancy, accepting that a negative cytology should lead to consideration of further investigation. (Conditional)
-
Pleural fluid biomarkers should not be used for diagnosing secondary pleural malignancy. (Conditional)
-
In high prevalence populations, pleural fluid ADA and/or IFN-gamma test(s) can be considered for diagnosing tuberculous pleural effusion. (Conditional)
-
In low prevalence populations, pleural fluid ADA can be considered as an exclusion test for tuberculous pleural effusion. (Conditional)
-
Tissue sampling for culture and sensitivity should be the preferred option for all patients with suspected tuberculous pleural effusion. (Strong—by consensus)
-
Pleural fluid ANA should be considered to support a diagnosis of lupus pleuritis. (Conditional)
Good practice points
-
The clinical utility of pleural fluid cytology varies by tumour subtype, including diagnostic sensitivity and predictive value for response to subsequent cancer therapies. This should be taken into consideration when planning the most suitable diagnostic strategy (eg, direct biopsies in those with a likely low cytological yield can be considered).
-
Pleural fluid NT-proBNP is useful when considering heart failure as a cause in unilateral pleural effusions but not superior to serum NT-proBNP and therefore should not be ordered routinely.