Evaluation of YD MolecuTech Real HPV Assay in Comparison with Roche Cobas HPV Assay and BD Onclarity HPV Assay for Detection of HPV Infection.

OBJECTIVE: Human papillomavirus (HPV) is a double-stranded DNA virus that belongs to the papillomavirus family. High-risk (HR) genotypes of HPV are associated with cervical cancer. The combination of molecular HPV testing and cytology results in an increased detection of high-grade cervical lesions. This study compares the performance of a newly developed MolecuTech Real HPV 16/18/HR assay to that of the cobas HPV assay and Onclarity HPV Assay in Korea. METHODS: A SurePath liquid-based cytology device (BD diagnostics, NC, USA) was used to prospectively collect cervical swab specimens. Onclarity HPV Assay (Onclarity; BD diagnostics), Cobas 4800 HPV Test (Cobas; Roche, Rotkreuz, Switzerland), and MolecuTech Real HPV 16/18/HR (MolecuTech; YD, Yongin, Korea) were performed to detect HPV genotypes. RESULTS: Of the 438 cervical specimens, 13.7% showed the HR-HPV genotype. The concordance rates between Onclarity and MolecuTech, cobas and MolecuTech, and Onclarity and Cobas were 94.9% (kappa=0.754), 95.7% (kappa=0.768), and 95.5% (kappa=0.791), respectively. Moreover, no statistically significant differences in HPV genotyping results were observed in the cytology-positive specimens. CONCLUSIONS: The MolecuTech Real HPV 16/18/HR assay showed good agreement in the detection of HR HPV genotypes, and similar analytical performance for the detection of HR HPV genotypes in samples with abnormal cytological findings.

Endobronchial Ultrasound Using Guide Sheath-Guided Transbronchial Lung Biopsy in Ground-Glass Opacity Pulmonary Lesions without Fluoroscopic Guidance.

Diagnosing ground-glass opacity (GGO) pulmonary lesions poses challenges. This study evaluates the utility of radial probe endobronchial ultrasound-guided transbronchial lung biopsy (RP-EBUS-TBLB) in diagnosing GGO pulmonary lesions. A total of 1651 RP-EBUS procedures were performed during the study period. This study analyzed 115 GGO lesions. The EBUS visualization yield was 80.1%. Of 115 lesions, 69 (60%) were successfully diagnosed. The average size of diagnosed lesions was significantly larger than that of undiagnosed lesions (21.9 ± 7.3 vs. 17.1 ± 6.6 mm, p < 0.001). Diagnostic yield varied by lesion size: 50.0% for lesions <20 mm, 65.1% for 20-30 mm lesions, and 85.7% for lesions >30 mm. The mixed blizzard sign on EBUS appeared in 60.6% of mixed GGO lesions, with no cases in pure GGO lesions. Multivariable analyses showed that lesion size (odds ratio [OR], 1.10; 95% confidence interval [CI], 1.00-1.16; p < 0.001) and mixed blizzard sign on EBUS (OR, 20.92; CI, 7.50-58.31; p < 0.001) were significantly associated with diagnostic success. Pneumothorax and hemoptysis occurred in 1.7% and 2.6% of patients, respectively. RP-EBUS-TBLB without fluoroscopic guidance is a viable diagnostic approach for GGO pulmonary lesions with acceptable complications.