martes, 22 de diciembre de 2009

Laboratory Surge Response to Pandemic (H1N1) Outbreak | CDC EID




EID Journal Home > Volume 16, Number 1–January 2010

Volume 16, Number 1–January 2010
Synopsis
Laboratory Surge Response to Pandemic (H1N1) 2009 Outbreak, New York City Metropolitan Area, USA
James M. Crawford, Robert Stallone, Fan Zhang, Mary Gerolimatos, Diamanto D. Korologos, Carolyn Sweetapple, Marcella de Geronimo, Yosef Dlugacz, Donna M. Armellino, and Christine C. Ginocchio
Author affiliations: North Shore–Long Island Jewish Health System Laboratories, Manhasset, New York, USA (J.M. Crawford, R. Stallone, F. Zhang, M. Gerolimatos, D.D. Korologos, C.C. Ginocchio); Krasnoff Quality Management Institute of the North Shore–Long Island Jewish Health System, Manhasset (C. Sweetapple, M. de Geronimo, Y. Dlugacz); and North Shore University Hospital, Manhasset (D.M. Armellino)


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Abstract
The North Shore–Long Island Jewish Health System Laboratories serve 15 hospitals and affiliated regional physician practices in the New York City metropolitan area, with virus testing performed at a central reference laboratory. The influenza A pandemic (H1N1) 2009 outbreak began in this area on April 24, 2009, and within weeks respiratory virus testing increased 7.5 times. In response, laboratory and client service workforces were increased, physical plant build-out was completed, testing paradigms were converted from routine screening tests and viral culture to a high-capacity molecular assay for respiratory viruses, laboratory information system interfaces were built, and same-day epidemiologic reports were produced. Daily review by leadership of data from emergency rooms, hospital facilities, and the Health System Laboratories enabled real-time management of unfolding events. The ability of System laboratories to rapidly increase to high-volume comprehensive diagnostics, including influenza A subtyping, provided key epidemiologic information for local and state public health departments.

Local sentinel laboratories are a critical component of the Laboratory Response Network, providing frontline diagnostics and, in many instances, the initial reporting for infectious disease outbreaks. In the event of a major health crisis, the responses of a regional clinical laboratory can be central to the ability of civic authorities and healthcare systems to handle such emergencies. This report describes successful steps taken by a hospital-based regional reference laboratory in response to a 7.5× increase in respiratory virus testing during the first 3 weeks (April 27–May 15, 2009) of an outbreak of a novel influenza A (H1N1), now referred to as influenza A pandemic (H1N1) 2009, in the greater New York City metropolitan area.

The North Shore–Long Island Jewish Health System (NSLIJHS) is the third largest nonsectarian not-for-profit health system in the United States and serves Nassau and Suffolk Counties, New York, and the Queens and Staten Island boroughs of New York City. The NSLIJHS Central Laboratories serve 15 hospitals and affiliated regional physician practices; virus testing is performed at the Centralized Laboratories in the Clinical Virology Laboratory (CVL). In the aftermath of the anthrax event of September 2001, NSLIJHS developed an extensive system-wide emergency preparedness plan to deal with potential biothreat and bioterrorism events that could greatly affect a health system. This plan was tested, beginning Friday evening, April 24, 2009, when 20 students 14–17 years of age with symptoms of an influenza-like illness sought evaluation at the pediatric emergency room of Schneider Children's Hospital at Long Island Jewish Medical Center, one of the hospitals served by NSLIJHS. The students were among those attending a preparatory school in Queens, New York, who began experiencing influenza-like symptoms April 22–23, 2009 (1). Some students had recently traveled to Mexico, raising immediate concern about pandemic (H1N1) 2009 (2). The following day, Saturday, April 25, an additional 67 persons 11–18 years of age and 16 children <8 years of age were evaluated in NSLIJHS emergency rooms. Over the next 3 days, influenza-related cases at NSLIJHS emergency rooms increased rapidly. Specimens from index patients at Long Island Jewish Medical Center on April 24–25 were screened for influenza A/B antigen, using the 3M Rapid Detection Flu A+B test (3M Medical Diagnostics, St. Paul, MN , USA). In conjunction with the New York City Department of Health (DOH), the Medical Center shipped 35 specimens with test results positive for influenza A to the Centers for Disease Control and Prevention (CDC). Testing at CDC confirmed that 28 of the 35 influenza A–positive samples were influenza A pandemic (H1N1) 2009 (1). The remaining 68 samples from the Long Island Jewish Medical Center (i.e., those with negative rapid test results) were referred to CVL for direct fluorescent antibody (DFA) testing and viral culture, according to the usual protocol.

On Monday, April 27, 2009, an emergency operations status was declared for NSLIJHS. Herein, we detail the specific steps taken to increase the surge capacity at the NSLIJHS Central Laboratories, thereby enabling timely reporting of respiratory virus test results.

Standard Testing for Respiratory Viruses and Test Capacity
During the normal influenza season, the clinical laboratories of NSLIJHS hospitals perform rapid influenza A+B antigen testing, using either BinaxNOW A+B test (Inverness, Scarborough, MA, USA) or the 3M test. Nasopharyngeal swab samples in Universal Transport Media (Diagnostic Hybrids Inc., Athens, OH, USA) and nasopharyngeal wash and aspirate samples are tested. Specimens with test results positive for influenza A or B are not processed further unless warranted by underlying patient conditions. Due to the suboptimal sensitivity of rapid antigen tests, all samples with negative test results are forwarded to CVL for detection of adenovirus, human metapneumovirus, influenza A and B, parainfluenza viruses 1, 2, and 3, and respiratory syncytial virus by DFA testing, using D3 Ultra Respiratory Virus reagents (Diagnostic Hybrids Inc.) and by rapid respiratory virus culture, using R-Mix cells (Diagnostic Hybrids Inc.).

NSLIJHS laboratories routinely encounter a seasonal increase in respiratory virus testing, peaking in mid-to-late February and waning by May. The historic maximum test volume occurred in February 2008, when CVL tested 6,021 samples and clinical laboratories system-wide performed 2,901 rapid influenza tests, for a combined daily average of 308 tests. During April 1–23, 2009, CVL tested 1,955 samples and clinical laboratories system-wide performed 676 rapid influenza tests, for a combined daily average of 119 tests. These volumes were similar to those for preceding years.

Molecular Detection of Respiratory Viruses
During 2008, the central NSLIJHS Molecular Diagnostics Laboratory performed extensive validation studies of the Luminex xTAG Respiratory Virus Panel (RVP) assay (Luminex Molecular Diagnostics, Toronto, Canada) (3,4). The version of the RVP assay that has been cleared by the US Food and Drug Administration detects adenovirus, human metapneumovirus, parainfluenza viruses 1, 2, and 3, rhinovirus/enterovirus group, respiratory syncytial virus, and influenza A and B. This RVP assay can subtype influenza A as seasonal human H1 or H3 virus. The research-use-only version of the RVP assay also detects parainfluenza 4 and coronaviruses OC43, NL64, 229E, and HKU-1. Prior to the outbreak of pandemic (H1N1) 2009, the RVP assay was used for selected clinical cases and research studies, with the intention of converting to use of the RVP assay for all respiratory virus testing during the off-peak 2009 summer months.

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