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.

Clinical manifestations of hemoglobin Chico at high altitude.

Hemoglobin Chico is a rare hemoglobinopathy characterized by low oxygen affinity and a right-shifted oxygen dissociation curve. Detailed clinical evaluations of affected individuals have not been previously reported. We therefore report on the clinical features of Hemoglobin Chico in a Latino male living at high altitude, who desired to participate in school sports. As a young boy with asthma, he had the unusual finding of growth delay and digital clubbing which improved with asthma control. At 16 years of age, he had mild anemia and a decreased pulse oximetry (83%) but sufficient pulmonary reserve to participate in physically demanding activities.

Peripheral T-cell lymphoma with extensive dendritic cell network mimicking follicular dendritic cell tumor: a case report with pathologic, immunophenotypic, and molecular findings.

Peripheral T-cell lymphoma (PTCL) with a nodular pattern of growth is uncommon and may be misdiagnosed initially as a B-cell lymphoma or reactive process. We report a case of a rapidly growing PTCL with a distinctly nodular pattern in an axillary lymph node from an 89-year-old man. Immunohistochemical stains for CD21, CD23, and CD35 highlighted an extensive dendritic cell network that imparted the nodular appearance and, in addition, was associated intimately with the neoplastic cells. The neoplastic cells otherwise had an immunophenotype similar to previously reported cases of PTCL with a nodular pattern and germinal center origin (CD3+, CD4+, CD5+, bcl-6+, CD31+, subset CD10+, subset CXCL13+, and subset CD79a+). Molecular studies confirm a clonal T-cell receptor g gene rearrangement. This case emphasizes unusual morphologic features in a PTCL that may be mistaken for follicular lymphoma or a tumor of follicular dendritic cell origin.

Nonsecretory variant of immunoproliferative small intestinal disease: a case report with pathologic, immunophenotypic, and molecular findings.

We report a case of the nonsecretory variant of immunoproliferative small intestinal disease involving the distal small bowel and the mesenteric and retroperitoneal lymph nodes in a 19-year-old woman from Mexico. This variant extranodal marginal zone B-cell lymphoma appeared similar in the different sites of involvement, with more interspersed large cells and greater plasmacytic differentiation present in intestinal specimens. Characteristic lymphoepithelial lesions and follicular colonization were seen in intestinal and lymph node sections, respectively. The neoplastic B cells were cytoplasmic immunoglobulin (Ig) A heavy-chain restricted and lacked surface and cytoplasmic light-chain expression by flow cytometric analysis. Serum and urine protein electrophoresis/immunofixation revealed hypogammaglobulinemia with no paraprotein. Molecular studies showed absence of immunoglobulin heavy-chain (IgH) gene rearrangement, with a nonfunctional clonotypic rearrangement of the kappa light-chain gene. This case highlights the role for kappa light-chain gene evaluation in immunoproliferative small intestinal disease, because IgH gene rearrangement analysis is often negative.