Clinical Validation of the Vitro HPV Screening Assay for Its Use in Primary Cervical Cancer Screening.

Many scientific societies have issued guidelines to introduce population-based cervical cancer screening with HPV testing. The Vitro HPV Screening assay is a fully automatic multiplex real-time PCR test targeting the L1 GP5+/GP6+ region of HPV genome. The assay detects 14 high risk (HR) HPV genotypes, identifying individual HPV16 and HPV18 genotypes, and the HPV-positive samples for the other 12 HR HPV types are subsequently genotyped with the HPV Direct Flow Chip test. Following international guidelines, the aim of this study was to validate the clinical accuracy of the Vitro HPV Screening test on ThinPrep-collected samples for its use as primary cervical cancer screening, using as comparator the validated cobas® 4800 HPV test. The non-inferiority analysis showed that the clinical sensitivity and specificity of the Vitro HPV Screening assay for a diagnosis of cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) were not inferior to those of cobas® 4800 HPV (p = 0.0049 and p < 0.001 respectively). The assay has demonstrated a high intra- and inter-laboratory reproducibility, also among the individual genotypes. The Vitro HPV Screening assay is valid for cervical cancer screening and it provides genotyping information on HPV-positive samples without further sample processing in a fully automated workflow.

Atypical double colorectal metastasis: spleen and uterus.

Oligometastatic disease is a relatively new concept that refers to an intermediate stage between disseminated and localized cancer. Most frequent locations for colorectal metastasis are lung and liver. We present an a typical case of an 85-year-old woman who was diagnosed with a low-grade adenocarcinoma in left colon; she underwent a left laparoscopic hemicolectomy which resulted in a stage IIIb. After 24 months of follow-up, an increase of carcinoembryonic antigen (CEA) leads to the diagnosis of two metastatic lesions in two uncommon locations: spleen and myometrium. Stepwise surgical resection of both lesions was performed without complications. Spleen and uterus are organs that are rarely affected in colorectal cancer, the affection of both organs being even more infrequent. Despite the atypicality, surgical treatment is a valid strategy in this case of oligometastatic disease, which enables the disease-free survival of the patients.

Mammographic extent of microcalcifications and oestrogen receptor expression affect preoperative breast carcinoma in situ size estimation.

BACKGROUND: The aim of our study was to establish which clinical, radiologic and pathologic factors could predict the risk of under- and overestimation of the breast ductal carcinoma in situ (DCIS) size when preoperatively measuring the maximum mammographic extent of microcalcifications (MEM). METHODS: We made a retrospective review of patients with a DCIS treated in our Breast Unit between May 2005 and May 2012. Clinical, pathologic and radiologic data were evaluated as possible predictive factors for over- or underestimation of DCIS size when measuring MEM. RESULTS: We obtained precise measurements of MEM in 82 patients (84 DCIS lesions). Maximum MEM measurement correctly estimated maximum pathology size in 57 lesions (68.7 %). Patients with a correctly estimated DCIS, with an underestimated DCIS and with an overestimated DCIS significantly differed in DCIS ER expression (p = 0.022) and in maximum MEM measurement (p = 0.000). Constructing two ROC curves, we found that a maximum MEM measurement ≥25 mm and ER expression ≥90 % were both discrimination points for overestimation and ER ≤ 45 % was a discrimination point for underestimation. Using these cutoff points, we defined four groups of patients with different risks of over- and underestimation. CONCLUSIONS: Risk of over- or underestimation of DCIS size through MEM measurement depends on DCIS ER expression and MEM itself. Identifying which patients are at a significant risk of over- or underestimation could help the breast surgeon when discussing the surgical options with the patient.

Hybrid capture 2 high-risk human papillomavirus test: should "grey zone" results justify repeating the test?

OBJECTIVE: To determine the clinical importance of repeating the Hybrid Capture 2 (HC2) high-risk human papillomavirus (HPV) test when the result obtained falls between 2.7 and 0.8 pg/mL, the so-called "grey zone." STUDY DESIGN: Repeat testing was performed on 139 thin-layer liquid-based cytology cervicovaginal samples that were found to fall in the grey zone. The samples represented a variety of cytological diagnoses. The results of both HPV HC2 tests were analyzed related to the cytological diagnosis of both the previous and the follow-up cytological samples. RESULTS: The change of the HPV HC2 result from positive (2.7-1 pg/mL) to negative (< 1 pg/mL) when repeating the test is not related with the diagnosis obtained in the cytological follow-up of the patient. CONCLUSION: The HC2 test should not be repeated when the result falls between 2.7 and 0.8 pg/mL. In these cases the result of the cytology is more relevant and should be used in the clinical assessment of the patient.