Comparison Study of BD Onclarity HPV With digene HC2 High-Risk HPV DNA Test and Roche Cobas 4800 HPV for Detecting High-Risk Human Papillomavirus in Japan.

Objectives: To evaluate the clinical performance of novel detection kits for 14 high-risk human papillomavirus (hrHPV) types with the BD Onclarity HPV Assay (Onclarity; Becton Dickinson, Sparks, MD). Methods: Two cervical specimens from 144 women were obtained and placed in BD SurePath Collection Vials. The first specimen was used for cervical cytology and digene HC2 High-Risk HPV DNA Test (HC2; Qiagen, Germantown, MD), and the second specimen was used for Onclarity and Roche Cobas 4800 HPV (Cobas; Roche Molecular Systems, Pleasanton, CA). Other HPV genotyping kits were used for specimens identified as positive by Onclarity or Cobas. Results: Fifty-three of 144 specimens were positive by Onclarity. Overall agreement rates of Onclarity with HC2 and Cobas were 93.8% and 94.4%, respectively. The sensitivity and specificity for cervical intraepithelial neoplasia type 2 or higher of Onclarity were similar to HC2 and Cobas. Conclusion: The results showed that the clinical performance of Onclarity was equivalent to HC2 and Cobas.

Detection of circulating tumor cells in cervical cancer using a conditionally replicative adenovirus targeting telomerase-positive cells.

Circulating tumor cells (CTC) are newly discovered biomarkers of cancers. Although many systems detect CTC, a gold standard has not yet been established. We analyzed CTC in uterine cervical cancer patients using an advanced version of conditionally replicative adenovirus targeting telomerase-positive cells, which was enabled to infect coxsackievirus-adenovirus receptor-negative cells and to reduce false-positive signals in myeloid cells. Blood samples from cervical cancer patients were hemolyzed and infected with the virus and then labeled with fluorescent anti-CD45 and anti-pan cytokeratin antibodies. GFP (+)/CD45 (-) cells were isolated and subjected to whole-genome amplification followed by polymerase chain reaction analysis of human papillomavirus (HPV) DNA. CTC were detected in 6 of 23 patients with cervical cancers (26.0%). Expression of CTC did not correlate with the stage of cancer or other clinicopathological factors. In 5 of the 6 CTC-positive cases, the same subtype of HPV DNA as that of the corresponding primary lesion was detected, indicating that the CTC originated from HPV-infected cancer cells. These CTC were all negative for cytokeratins. The CTC detected by our system were genetically confirmed. CTC derived from uterine cervical cancers had lost epithelial characteristics, indicating that epithelial marker-dependent systems do not have the capacity to detect these cells in cervical cancer patients.

Successful detection of SRY gene via fine needle biopsy: A case of extragenital gestational choriocarcinoma in the kidney.

The current report describes a case of extragenital gestational choriocarcinoma in the kidney. A 36-year-old woman with a history of two deliveries of male babies visited the present hospital due to secondary amenorrhea following a positive urinary pregnancy test. Despite a high serum level of human chorionic gonadotropin, at 51,800 mIU/ml, diagnostic imaging methods and pathological examination did not detect any conceptus in the genital tract. Positron emission tomography-computed tomography detected 18F-FDG-positive tumors in the left kidney and right lung. A fine needle biopsy of the renal lesion pathologically revealed the presence of choriocarcinoma and a subsequent polymerase chain reaction analysis verified the presence of a Y-chromosome-specific the sex-determining region Y (SRY) gene, diagnosed as extragenital gestational choriocarcinoma. Clinically, 10 cycles of EMA/CO chemotherapy were administered and an optimal response was obtained. In conclusion, this is the first report of the diagnosis of extragenital gestational choriocarcinoma by the detection of the SRY gene with PCR using biopsy samples.