Diagnostic accuracy of human telomerase reverse transcriptase mRNA in malignant pleural effusions: A preliminary report for in situ hybridization detection.

Background: Detection of human telomerase reverse transcriptase (hTERT) mRNA by in situ hybridization (ISH) may be valuable in the diagnosis of cancer. We assessed the diagnostic performance of hTERT mRNA in cells from pleural fluid in malignant pleural effusions (PEs).

Methods: We used a 2-step ISH with digoxin-labelled oligonucleotide probes to detect hTERT mRNA in a blinded prospective study of cells from 103 unselected pleural fluid specimens. The reference standard for malignant PEs was clinical evaluation and pleural fluid cytology, combined with pleural biopsy, other examination and follow-up as needed.

Results: According to the final diagnoses, there were 41 malignant PEs, 55 benign PEs and 7 cases with uncertain etiology. When the 7 cryptogenic cases were excluded, the sensitivity and specificity of detectable hTERT mRNA for malignancy were 80% and 95%, respectively. When detection of hTERT mRNA was combined with clinical repeated pleural fluid cytology, the sensitivity and specificity were 90% and 95%, respectively.

Conclusions: Detection of hTERT mRNA in cells from pleural fluid by ISH could potentially be used in diagnosing malignant PEs as an aid. Further investigations with stricter controls and cross-validation tests will be warranted.