Detecting 2009 pandemic influenza A (H1N1) virus infection: availability of diagnostic testing led to rapid pandemic response.

Diagnostic tests for detecting emerging influenza virus strains with pandemic potential are critical for directing global influenza prevention and control activities. In 2008, the Centers for Disease Control and Prevention received US Food and Drug Administration approval for a highly sensitive influenza polymerase chain reaction (PCR) assay. Devices were deployed to public health laboratories in the United States and globally.

Proficiency testing performance in US laboratories: results reported to the Centers for Medicare & Medicaid Services, 1994 through 2006.

Context: Beginning in 1994, clinical laboratories performing nonwaived testing were required, under the regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to enroll and participate in a proficiency testing (PT) program approved by the Centers for Medicare & Medicaid Services. Successful PT performance is a requirement for maintaining CLIA certification to perform testing in certain specialties and subspecialties and for specific analytes.

Objective: To evaluate the PT performance from 1994 through 2006 of hospital and independent laboratories (HI) compared with all other testing sites (AOT) for selected commonly performed tests and analytes.

Development of genomic reference materials for Huntington disease genetic testing.

Purpose: Diagnostic and predictive testing for Huntington disease requires an accurate measurement of CAG repeats in the HD (IT15) gene. However, precise repeat sizing can be technically challenging, and is complicated by the lack of quality control and reference materials (RM). The aim of this study was to characterize genomic DNA from 14 Huntington cell lines available from the National Institute of General Medical Sciences Human Genetic Cell Repository at the Coriell Cell Repositories for use as reference materials for CAG repeat sizing.

Results of a survey of hospital coagulation laboratories in the United States, 2001.

Context: Coagulation and bleeding problems are associated with substantial morbidity and mortality, and inappropriate testing practices may lead to bleeding or thrombotic complications.

Objective: To evaluate practices reported by hospital coagulation laboratories in the United States and to determine if the number of beds in a hospital was associated with different practices.

Design: From a sampling frame of institutions listed in the 1999 directory of the American Hospital Association, stratified into hospitals with 200 or more beds ("large hospitals") and those with fewer than 200 beds ("small hospitals"), we randomly selected 425 large hospitals (sampling rate, 25.

Assessment of laboratory performance of nucleic acid amplification tests for detection of Mycobacterium tuberculosis.

During implementation of the Centers for Disease Control and Prevention's Mycobacterium tuberculosis nucleic acid amplification (NAA) evaluation program, 27.1% of participants used the same biological safety cabinet for NAA and specimen processing; 28.8% reported not using unidirectional workflow.