The clinical performance of Invader technology and SurePath when detecting the presence of high-risk HPV cervical infection.

BACKGROUND: Testing for high-risk genotypes of the human papillomavirus (HR HPV) has been fully integrated into the management algorithms for the prevention of cervical cancer. The literature is limited with regard to the evaluation of the clinical performance of laboratory-developed tests (LDT) utilizing Invader V2.0 assay (ThirdWave/Hologic, Madison, WI, USA) for the detection of HR HPV. OBJECTIVES: To evaluate the clinical performance of Invader V2.0 LDT by determining its sensitivity, negative predictive value (NPV), specificity and positive predictive value (PPV). STUDY DESIGN: This study evaluated Invader V2.0 assay results from 12,490 SurePath Pap specimens and 1,931 cervical biopsies in order to assess the clinical performance of the Invader V2.0 assay. The cervical biopsy results were correlated with Invader V2.0 results to determine clinical sensitivity, NPV, clinical specificity, and PPV. RESULTS: The clinical sensitivity and NPV of Invader V2.0 LDT for cervical intraepithelial neoplasia 3 (CIN 3) or higher were 97.4% and 99.1% respectively. The clinical specificity and PPV for CIN 3 were 10.3% and 3.7% respectively. CONCLUSIONS: The results support the use of the Invader V2.0 in identifying patients who are at low risk for CIN 3 or higher. The power of the assay implies that it could be used as a primary screening tool for prevention of cervical cancer if a paradigm shift in cervical screening ever occurs.

A comparison of two methods to determine the presence of high-risk HPV cervical infections.

Clinical tests for human papillomavirus (HPV) DNA require clinical validation before being offered for use by laboratories. To determine the clinical viability of a laboratory-developed test using the Invader HPV reagents (Third Wave Technologies, Madison, WI), a retrospective study was designed using 213 patient cervical cytologic samples. The results of the Invader assay were directly compared with the results obtained using the Hybrid Capture 2 High-Risk HPV assay (Digene, Gaithersburg, MD). The results of both assays were also compared with cytologic evaluation. In addition, clinical performance was evaluated using a standard-of-care approach in which colposcopically guided biopsies were done in cases where standard of care dictated, and the histologic features of the biopsy specimens were noted. The Invader-based test demonstrated a clinical sensitivity in atypical squamous cells of undetermined significance cases of 98% for cervical intraepithelial neoplasia (CIN) 2 or worse and 100% for CIN 3 or worse and a negative predictive value of 96.9% (confidence interval, 89.3%-99.6%) using data generated mostly from the use of an earlier version of reagents. These findings support the clinical and laboratory benefits of the Invader method.

Fulminant development of mega-aorta due to Takayasu's arteritis: case report and review of the literature.

Takayasu's arteritis is a rare inflammatory arteriopathy characterized by segmental involvement of the aorta, its major branches, and, occasionally, the pulmonary arteries. Arterial inflammation generally results in occlusion, but Takayasu's arteritis occasionally presents as aneurysm formation. Takayasu's arteritis generally afflicts young women and is most often characterized by an acute episode of systemic illness and neurologic symptoms secondary to stenoses of the carotid and vertebral circulation. We report an unusual case of Takayasu's arteritis in a 43-year-old man who presented with severe back pain and provide a brief review of the literature.

Posttransplantation disseminated coccidioidomycosis acquired from donor lungs.

A North Carolinian developed fatal coccidioidomycosis immediately after bilateral lung transplantation. The donor had previously traveled to Mexico, and the recipient had no travel history to an area where Coccidioides immitis is endemic. Immunosuppressive therapy of the transplant recipient likely reactivated latent Coccidioides infection in the donor lungs, leading to posttransplant coccidioidomycosis.