ABSTRACT
Application of lean process management strategies to process improvement in clinical and anatomic pathology laboratories afford opportunities to enhance workflow process to lower costs and simultaneously to improve patient safety. Bar-codes are now employed in most modern anatomic pathology laboratories to track specimens from the clinicians' office or the operating room all through the continuum of service to specimen disposal. In order to enhance patient safety and workload optimization strategies, novel computer hardware and software assets are being developed to enable monitoring, analysis, and improvement of specimen workflow and diagnostic accuracy. More recently, data warehouse technologies from the retail industry have been optimized to permit high-throughput analysis of granular data in the laboratory arena. These optimize mass-data analysis in real time in the information technology space. In this review we describe the application of an in-house designed data warehouse to the anatomic pathology assets of a large regional reference laboratory.
Subject(s)
Data Warehousing/methods , Laboratories/organization & administration , Pathology, Clinical/organization & administration , Quality Assurance, Health Care , Workflow , Humans , Pathology, Clinical/methods , Patient SafetyABSTRACT
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.
Subject(s)
DNA, Viral/genetics , Molecular Diagnostic Techniques/methods , Papillomaviridae/isolation & purification , Papillomavirus Infections/diagnosis , Virology/methods , DNA, Viral/isolation & purification , Female , Humans , Papillomaviridae/classification , Papillomavirus Infections/virology , Predictive Value of Tests , Sensitivity and Specificity , United States , Uterine Cervical Neoplasms/prevention & controlABSTRACT
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.
