Role of the laboratory in diagnosis of influenza during seasonal epidemics and potential pandemics.

Laboratory diagnosis of influenza is critical to its treatment and surveillance. With the emergence of novel and highly pathogenic avian influenza viruses, the role of the laboratory has been further extended to include isolation and subtyping of the virus to monitor its appearance and facilitate appropriate vaccine development. Recent progress in enhancing testing for influenza promises to both improve the management of patients with influenza and decrease associated health care costs.

Epidemiology of pandemic influenza: use of surveillance and modeling for pandemic preparedness.

Along with continual enhancement of current influenza surveillance programs, pandemic preparedness also involves application of current surveillance techniques to past pandemics to identify their viruses and patterns, as well as estimation of the potential burden of future pandemics. Although mortality surveillance has been in place in selected locations for more than a century, the recent development of molecular diagnostics has shed new light on the origin and structure of the viruses responsible for the past 3 pandemics, allowing for comparisons with new viruses identified through ongoing viral surveillance. Models previously used to estimate hospitalizations and mortality associated with past epidemics and pandemics have evolved to estimate the burden and required surge capacity of future pandemics of different severities.

Epidemiology of seasonal influenza: use of surveillance data and statistical models to estimate the burden of disease.

The US Centers for Disease Control and Prevention (CDC) uses a 7-component national surveillance system for influenza that includes virologic, influenza-like illness, hospitalization, and mortality data. In addition, some states and health organizations collect additional influenza surveillance data that complement the CDC's surveillance system. Current surveillance data from these programs, together with national hospitalization and mortality data, have been used in statistical models to estimate the annual burden of disease associated with influenza in the United States for many years.

Evaluation of the core antigen assay as a second-line supplemental test for diagnosis of active hepatitis C virus infection.

The British Columbia Center for Disease Control laboratory performs approximately 95% of all hepatitis C virus (HCV) antibody tests for the province's 4 million inhabitants. In 2002, the laboratory tested 96,000 specimens for anti-HCV antibodies, of which 4,800 (5%) were seroreactive and required confirmation of active infection. Although HCV RNA assays with a sensitivity of 50 IU/ml or less are recommended for the confirmation of active HCV infection, given the large number of seroreactive specimens tested annually, we evaluated the Ortho trak-C assay (OTCA) as a second-line confirmatory test and determined its limit of detection (LoD).

Improved detection of HCV Infection in hemodialysis patients using a new HCV RNA qualitative assay: experience of a transplant center.

Background: Hepatitis C virus (HCV) is frequently a silent infection in hemodialysis (HD) patients with a prevalence of 8-10%. Improving HCV detection in this population prior to transplantation is critical both for infection control and optimal patient care.

Objectives: To assess the current HCV testing practice of the National Institute for Transplantation (PCR testing of enzyme immunoassay (EIA) positive HD patients) by evaluating a subset of EIA positive and EIA negative samples with the VERSANT HCV RNA Qualitative Assay based on transcription mediated amplification (HCV Qual (TMA)) (sensitivity < or = 9.

Hepatitis C virus RNA tests: performance attributes and their impact on clinical utility.

The diagnostic market is driven by the burden of disease in the population and the ease or difficulty of disease diagnosis. The efficacy of available therapeutics determines the need for monitoring. Hepatitis C virus currently affects approximately 3% of the world's population, although the overall response rate to the best available therapies is 56%.

Successful HCV genotyping of previously failed and low viral load specimens using an HCV RNA qualitative assay based on transcription-mediated amplification in conjunction with the line probe assay.

Background: Hepatitis C virus (HCV) genotyping is a critical part of the diagnostic work-up for chronic hepatitis C. The VERSANT HCV line probe assay (LiPA) marketed by Bayer Corporation requires PCR-derived amplicons for genotyping usually obtained from commercial assays, including Amplicor HCV 2.0 (Amplicor 2.

Multicenter evaluation of the VERSANT HCV RNA qualitative assay for detection of hepatitis C virus RNA.

We report the results of a multicenter evaluation of a new assay for the detection of hepatitis C virus (HCV) RNA in human serum or plasma based on transcription-mediated amplification (HCV TMA). Analysis of combined data obtained from 15 independent sites, including 4 sites in the United States and 11 in Europe, by using preproduction kits showed a limit of detection of 9.8 IU/ml and an overall mean specificity of 97.

Performance evaluation of the VERSANT HCV RNA qualitative assay by using transcription-mediated amplification.

A preclinical evaluation of a qualitative assay for the detection of hepatitis C virus (HCV) RNA by transcription-mediated amplification (TMA) was conducted according to the guidelines of the National Committee for Clinical Laboratory Standards and the U.S. Food and Drug Administration.

Qualitative detection of hepatitis C virus RNA: comparison of analytical sensitivity, clinical performance, and workflow of the Cobas Amplicor HCV test version 2.0 and the HCV RNA transcription-mediated amplification qualitative assay.

The qualitative Cobas Amplicor hepatitis C virus (HCV) version 2.0 assay (HCV PCR) and the Bayer Reference Testing Laboratory HCV RNA transcription-mediated amplification assay (HCV TMA) were compared for analytical sensitivity, clinical performance, and workflow. Limits of detection were determined by testing dilutions of the World Health Organization HCV standard in replicates of 15 at concentrations of from 1.