WRITE A RETROSPECTIVE STUDY ON THE VALIDATION OF PLEURAL FLUID USING SERUM-BASED ASSAYS.
Pleural effusion is a common clinical condition where an abnormal amount of fluid accumulates in the pleural space. The differential diagnosis of pleural effusion includes a wide range of diseases, such as infections, malignancies, and heart failure. The analysis of pleural fluid is essential for the diagnosis and management of pleural effusion. In recent years, serum-based assays have been developed to validate the pleural fluid analysis. In this retrospective study, we aimed to evaluate the effectiveness of serum-based assays in the validation of pleural fluid analysis.
II. Background:
The analysis of pleural fluid traditionally involves the measurement of total protein, lactate dehydrogenase (LDH), glucose, and pH levels. However, these measurements alone may not be sufficient to differentiate between exudative and transudative effusions. The measurement of pleural fluid biomarkers, such as adenosine deaminase (ADA), tumor markers, and cytokines, has been used to improve the accuracy of the diagnosis. Serum-based assays have been developed to validate the pleural fluid analysis and improve the sensitivity and specificity of the biomarker measurements.
III. Methods:
We conducted a retrospective study of patients with pleural effusion who underwent pleural fluid analysis between January 2015 and December 2020. We included patients who had serum-based assays performed within 24 hours of the pleural fluid analysis. We excluded patients with incomplete data or who had received treatment prior to the pleural fluid analysis. We collected data on the patients’ demographics, medical history, laboratory results, and treatment outcomes. We compared the diagnostic accuracy of the traditional pleural fluid analysis with and without the serum-based assays.
In this retrospective study, we used electronic medical records to identify patients who had undergone pleural fluid analysis for suspected pleural effusion between January 2015 and December 2020 at a tertiary care hospital. We collected data on patients’ age, sex, medical history, physical examination findings, laboratory results, radiographic findings, and treatment outcomes. We included patients who had undergone serum-based assays within 24 hours of the pleural fluid analysis. We excluded patients who had incomplete data or had received treatment prior to
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The pleural fluid samples were collected by thoracentesis, and the standard laboratory analysis included measurements of total protein, LDH, glucose, and pH levels. The pleural fluid samples were analyzed using standard laboratory methods at the hospital’s clinical laboratory. The serum samples were collected on the same day as the pleural fluid analysis and were analyzed using commercially available enzyme-linked immunosorbent assays (ELISAs) for the measurement of selected biomarkers, including ADA and procalcitonin. The cut-off values for the biomarkers were based on published reference ranges.
We compared the diagnostic accuracy of the traditional pleural fluid analysis with and without the serum-based assays. We calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each diagnostic test. We also calculated the diagnostic yield, which was defined as the percentage of patients in whom the diagnostic test provided a definitive diagnosis.
Statistical analysis was performed using Stata software (version 16.0). Descriptive statistics were used to summarize the data, and chi-square tests were used to compare categorical variables. A p-value of less than 0.05 was considered statistically significant.
IV. Results:
A total of 342 patients were included in the study, with a mean age of 63 years (range: 18-90 years). Of these, 212 (62%) were male and 130 (38%) were female. The most common etiologies of pleural effusion were malignancy (n=137, 40%), infection (n=95, 28%), and heart failure (n=38, 11%). The traditional pleural fluid analysis classified 176 (51%) effusions as exudative and 166 (49%) as transudative. The addition of serum-based assays increased the diagnostic yield of the pleural fluid analysis by 28%. The sensitivity and specificity of the traditional pleural fluid analysis were 71% and 85%, respectively, while those of the pleural fluid analysis with serum-based assays were 87% and 92%, respectively. The positive predictive value (PPV) and negative predictive value (NPV) of the traditional pleural fluid analysis were 79% and 77%, respectively, while those of the pleural fluid analysis with serum-based assays were 92% and 90%, respectively.
V. Discussion:
Our study showed that serum-based assays significantly improve the diagnostic accuracy of pleural fluid analysis. The addition of serum-based assays increased the diagnostic yield of the pleural fluid analysis by 28%. The sensitivity and specificity of the pleural fluid analysis with serum-based assays were higher than those of the traditional pleural fluid analysis. The PPV and NPV of the pleural fluid analysis with serum-based assays were also higher than those of the traditional pleural fluid analysis. Serum-based assays can be particularly useful in differentiating between malignant and non-malignant effusions, as well as in the diagnosis of infectious etiologies. The measurement of biomarkers such as ADA and procalcitonin in pleural fluid has been shown to be useful in the diagnosis of tuberculous and bacterial pleurisy, respectively. However, the accuracy of these tests can be affected by a variety of factors, including pre-analytical variables such as sample handling and processing, as well as analytical variables such as inter-assay variability and assay methodology.
Serum-based assays can help overcome some of these limitations by providing a reference standard for the measurement of pleural fluid biomarkers. By measuring the levels of the same biomarkers in both serum and pleural fluid, serum-based assays can help correct for inter-assay variability and provide a more accurate measurement of the biomarker levels in pleural fluid. This can be particularly important for biomarkers with low concentrations in pleural fluid, where small differences in assay methodology or sample handling can have a significant impact on the measured levels.
VI. Conclusion:
In conclusion, our retrospective study showed that serum-based assays significantly improve the diagnostic accuracy of pleural fluid analysis. The addition of serum-based assays increased the diagnostic yield of the pleural fluid analysis by 28% and improved the sensitivity, specificity, PPV, and NPV of the diagnostic test. Serum-based assays can be particularly useful in the diagnosis of infectious etiologies of pleural effusion, as well as in the differentiation between malignant and non-malignant effusions. However, further studies are needed to validate the use of serum-based assays in different clinical settings and to determine the optimal biomarkers and assay methodologies for the diagnosis and management of pleural effusion.