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      Strengths and Weaknesses of FDA-Approved/Cleared Diagnostic Devices for the Molecular Detection of Respiratory Pathogens

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          Abstract

          The rapid, sensitive, and specific identification of the microbial etiological characteristics of respiratory tract infections enhances the appropriate use of both antibiotics and antiviral agents and reduces the risk of nosocomial transmission. This article reviews the current nucleic acid amplification tests approved by the U.S. Food and Drug Administration (FDA) for the detection of respiratory pathogens. In addition, Emergency Use Authorization tests for the detection of 2009 influenza A H1N1 are discussed. The advantages and limitations of the current FDA-approved/cleared tests are reviewed.

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          Development of a respiratory virus panel test for detection of twenty human respiratory viruses by use of multiplex PCR and a fluid microbead-based assay.

          J. Mahony, S. Chong, F Merante … (2007)
          Virology laboratories historically have used direct fluorescent-antibody assay (DFA) and culture to detect six or seven respiratory viruses. Following the discovery of five new human respiratory viruses since 2000, there is an increasing need for diagnostic tests to detect these emerging viruses. We have developed a new test that can detect 20 different respiratory virus types/subtypes in a single 5-h test. The assay employs multiplex PCR using 14 virus-specific primer pairs, followed by a multiplexed target-specific primer extension (TSPE) reaction using 21 primers for specific respiratory virus types and subtypes. TSPE products were sorted and identified by using a fluid microsphere-based array (Universal Array; TmBioscience Corporation, Toronto, Canada) and the Luminex x-MAP system. The assay detected influenza A and B viruses; influenza A virus subtypes H1, H3, and H5 (including subtype H5N1 of the Asian lineage); parainfluenza virus types 1, 2, 3, and 4; respiratory syncytial virus types A and B; adenovirus; metapneumovirus; rhinovirus; enterovirus; and coronaviruses OC43, 229E, severe acute respiratory syndrome coronavirus, NL63, and HKU1. In a prospective evaluation using 294 nasopharyngeal swab specimens, DFA/culture detected 119 positives and the respiratory virus panel (RVP) test detected 112 positives, for a sensitivity of 97%. The RVP test detected an additional 61 positive specimens that either were not detected by DFA/culture or were positive for viruses not tested for by DFA/culture. After resolution of discordant results by using a second unique PCR assay and by using a combined reference standard of positivity, the RVP test detected 180 of 183 true positives, for a sensitivity of 98.5%, whereas DFA and culture detected only 126 of 183 true positives, for a sensitivity of 68.8%. The RVP test should improve the capabilities of hospital and public health laboratories for diagnosing viral respiratory tract infections and should assist public health agencies in identifying etiologic agents in respiratory tract infection outbreaks.
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            Excessive antibiotic use for acute respiratory infections in the United States.

            Diego Maselli, L M Sande, Nicole R Gonzales … (2001)
            Estimating the amount and cost of excess antibiotic use in ambulatory practice and identifying the conditions that account for most excess use are necessary to guide intervention and policy decisions. Data from the 1998 National Ambulatory Medical Care Survey, a sample survey of United States ambulatory physician practices, was used to estimate primary care office visits and antibiotic prescription rates for acute respiratory infections. Weight-averaged antibiotic costs were calculated with use of 1996 prescription marketing data and adjusted for inflation. In 1998, an estimated 76 million primary care office visits for acute respiratory infections resulted in 41 million antibiotic prescriptions. Antibiotic prescriptions in excess of the number expected to treat bacterial infections amounted to 55% (22.6 million) of all antibiotics prescribed for acute respiratory infections, at a cost of approximately $726 million. Upper respiratory tract infections (not otherwise specified), pharyngitis, and bronchitis were the conditions associated with the greatest amount of excess use. This study documents that the amount and cost of excessive antibiotic use for acute respiratory infections by primary care physicians are substantial and establishes potential target rates for antibiotic treatment of selected conditions.
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              Outbreak of swine-origin influenza A (H1N1) virus infection - Mexico, March-April 2009.

              (2009)
              In March and early April 2009, Mexico experienced outbreaks of respiratory illness and increased reports of patients with influenza-like illness (ILI) in several areas of the country. On April 12, the General Directorate of Epidemiology (DGE) reported an outbreak of ILI in a small community in the state of Veracruz to the Pan American Health Organization (PAHO) in accordance with International Health Regulations. On April 17, a case of atypical pneumonia in Oaxaca State prompted enhanced surveillance throughout Mexico. On April 23, several cases of severe respiratory illness laboratory confirmed as swine-origin influenza A (H1N1) virus (S-OIV) infection were communicated to the PAHO. Sequence analysis revealed that the patients were infected with the same S-OIV strain detected in two children residing in California. This report describes the initial and ongoing investigation of the S-OIV outbreak in Mexico.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Infect Dis
                Journal ID (iso-abbrev): Clin. Infect. Dis
                Journal ID (hwp): cid
                Journal ID (publisher-id): cid
                Title: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Publisher: Oxford University Press
                ISSN (Print): 1058-4838
                ISSN (Electronic): 1537-6591
                Publication date (Print): 01 May 2011
                Publication date (Electronic): 01 May 2011
                Volume: 52
                Issue: Suppl 4 , Workshop on Molecular Diagnostics for Respiratory Tract Infections
                Pages: S312-S325
                Affiliations
                Division of Infectious Disease Diagnostics, Department of Pathology and Laboratory Medicine and Department of Molecular Medicine, North Shore-LIJ Health System Laboratories, Hofstra North Shore-LIJ School of Medicine, Lake Success, New York
                Author notes
                Correspondence: Christine C. Ginocchio, PhD, Division of Infectious Disease Diagnostics, Dept of Pathology and Laboratory Medicine, North Shore-LIJ Health System Laboratories, 10 Nevada Dr, Lake Success, NY 11041 ( cginocch@ 123456nshs.edu ).
                Article
                DOI: 10.1093/cid/cir046
                PMC ID: 7107808
                PubMed ID: 21460290
                SO-VID: 7b5da51a-df05-4cdc-9e17-9e2df8ecda95
                Copyright © © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
                License:

                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

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                Subject: Supplement Articles

                ScienceOpen disciplines: Infectious disease & Microbiology
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                ScienceOpen disciplines: Infectious disease & Microbiology

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