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Table 3. Nucleic Acid Detection Based Tests | CDC

43 rows · Dec 23, 2019 · Table 3. FDA-cleared Nucleic Acid Detection Based Tests for Influenza Viruses1. Influenza Virus Types Detected. Influenza Virus Subtypes Detected. Other Respiratory Viruses Differentiated. Approved Specimens2. ID NOW Influenza A & B 2. ID NOW Platform. Influenza A and B. NPS, NS direct, or NPS and NS in VTM. FilmArray® Respiratory Panel EZ.Nucleic Acid Amplification for Detection of Influenza AMay 02, 2020 · The gold standard for detection and characterization of IFVA is nucleic acid amplification technology (e.g., reverse transcriptase PCR [RT-PCR]), which must contend with a constantly evolving , nucleic acid detection subtypeTesting for Human Metapneumovirus (hMPV) Using Nucleic , nucleic acid detection subtypeSPECIAL CONTROLS DOCUMENT. Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays - Guidance for

Nucleic Acid Amplification for Detection of Influenza A

Apr 26, 2020 · Rethinking Approaches to Improve the Utilization of Nucleic Acid Amplification Tests for Detection and Characterization of Influenza A in Diagnostic and Reference Laboratories , nucleic acid detection subtype and for subtype , nucleic acid detection subtype555 Identification of Microorganisms0115U Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detectedFirst Positive Detection of H9 Subtype of Avian Influenza , nucleic acid detection subtypeJun 05, 2016 · Our results first reported H9 subtype of AIV nucleic acid existing in aerosol sample from LPM of Guangxi, China, providing support for aerosol transmission of AIV in LPM. H5 subtype of AIV nucleic acid was not detected positive in aerosol while it was positive in

Visual detection of H3 subtype , nucleic acid detection subtype - PubMed Central (PMC)

Jul 05, 2011 · Visual detection of H3 subtype avian influenza viruses by reverse transcription loop-mediated isothermal amplification assay. , nucleic acid detection subtype is required. The loop-mediated isothermal amplification (LAMP) assay is a simple, rapid, sensitive and cost-effective nucleic acid amplification method that does not require any specialized equipment.Information on Rapid Molecular Assays, RT-PCR, and other , nucleic acid detection subtype0115u respiratory infectious agent detection by nucleic acid (dna and rna), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS,Visual and modular detection of pathogen nucleic acids , nucleic acid detection subtypeAug 13, 2018 · Rapid, visual detection of pathogens is important for point-of-care diagnostics. Here the authors present enVision, which uses enzyme-DNA complexes to detect

Nucleic acid sequence-based amplification methods to , nucleic acid detection subtype

A further NASBA assay, based on the matrix gene, was able to detect examples of all known subtypes (H1H15) of avian influenza virus. The entire nucleic acid isolation, amplification, and detection procedure was completed within 6 h. The dynamic range of the three AIV assays was five to Comparison of nucleic acid-based detection of avian , nucleic acid detection subtypeNucleic acid amplification and detection. The NASBA method has been described previously [9] , [10] , [15] . To 5 l of nucleic acid extract, 10 l of a mixture containing 80 mM Tris, pH 8.3, 24 mM MgCl 2 , 140 mM KCl, 10 mM DTT, 2 mM each dNTP, 4 mM each NTP, Research articles Nucleic acid-based detection of , nucleic acid detection subtypeNucleic acid-based detection of influenza A virus subtypes H7 and N9 with a special emphasis on the avian H7N9 virus D Kalthoff 1, J Bogs 1, T Harder (und.de), C Grund , A Pohlmann , M Beer , B Hoffmann1 1. Friedrich-Loeffler-Institute, Institute of Diagnostic Virology, Greifswald-Insel Riems, Germany Citation style for this , nucleic acid detection subtype

Visual detection of H3 subtype avian , nucleic acid detection subtype - Virology Journal

The loop-mediated isothermal amplification (LAMP) assay is a simple, rapid, sensitive and cost-effective nucleic acid amplification method that does not require any specialized equipment. Results. A reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay was developed to detect the H3 subtype AIVs visually.Product Classification - Food and Drug AdministrationA respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and , nucleic acid detection subtypeCFR - Code of Federal Regulations Title 21Apr 01, 2019 · (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled "Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays." See 866.1(e) for the availability of these guidance documents.

Medical Devices - fda.gov

Oct 09, 2009 · Multiplex nucleic acid assays testing for detection and differentiation of Influenza A virus subtypes are intended to detect influenza A RNA and specific Influenza A subtype RNA extracted from , nucleic acid detection subtypeTest Detail - State Hygienic LaboratoryNucleic acid amplification by PCR to detect Influenza virus RNA: Panel Components: Influenza A Virus, Influenza B Virus: Reflex Test(s) If Influenza A RNA is detected, reflexes to Influenza A Subtype. If Influenza B RNA is detected, reflexes to Influenza B Subtype. Performed: Avg. Turnaround Time: Method: Coralville, 8 a.m. - 5 p.m., M-F: 1 - 3 , nucleic acid detection subtype139650: Respiratory Pathogen Profile, PCR | LabCorpDetection of organism target(s) does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms. The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation.

First Positive Detection of H9 Subtype of Avian Influenza , nucleic acid detection subtype

Free Online Library: First Positive Detection of H9 Subtype of Avian Influenza Virus Nucleic Acid in Aerosol Samples from Live Poultry Markets in Guangxi, South of China.(Short Communication, Report) by "Chinese Medical Journal"; Health, general Avian influenza Analysis Diagnosis Risk factors Nucleic acids Health aspectsMolDX: Multiplex Nucleic Acid Amplified Tests for , nucleic acid detection subtype87632 infectious agent detection by nucleic acid (dna or rna); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targetsNUCLEIC ACID AMPLIFICATION TECHNIQUES AND EVALUATION OF , nucleic acid detection subtypeQuantitative nucleic acid detection methods, like Q-NASBA, allow the monitoring of HIV-1 RNA during the course of infection which might have predictive value for disease development. View Show , nucleic acid detection subtype

Simple amplification-based assay: A nucleic acid-based , nucleic acid detection subtype

The sensitivity and viral subtype coverage of the SAMBA HIV-1 test were either comparable to or better than those of the commercially available nucleic acid-based HIV-1 diagnostic tests. Conclusions. The unique characteristics and competitive performance of the SAMBA HIV-1 test render it suitable for point-of-care and near-patient testing in , nucleic acid detection subtypeProficiency of Nucleic Acid Tests for Avian Influenza , nucleic acid detection subtypeAn avian influenza quality assurance program was used to provide information for laboratories on the sensitivity and specificity of their avian influenza nucleic acid testing. Most laboratories were able to correctly detect clinically relevant amounts of influenza virus (H5N1), and results improved as each subsequent panel was tested.MolDX: Multiplex Nucleic Acid Amplified Tests for , nucleic acid detection subtype87632 infectious agent detection by nucleic acid (dna or rna); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets

NUCLEIC ACID AMPLIFICATION TECHNIQUES AND EVALUATION OF , nucleic acid detection subtype

Quantitative nucleic acid detection methods, like Q-NASBA, allow the monitoring of HIV-1 RNA during the course of infection which might have predictive value for disease development. View Show , nucleic acid detection subtypeSimple amplification-based assay: A nucleic acid-based , nucleic acid detection subtypeThe sensitivity and viral subtype coverage of the SAMBA HIV-1 test were either comparable to or better than those of the commercially available nucleic acid-based HIV-1 diagnostic tests. Conclusions. The unique characteristics and competitive performance of the SAMBA HIV-1 test render it suitable for point-of-care and near-patient testing in , nucleic acid detection subtypeProficiency of Nucleic Acid Tests for Avian Influenza , nucleic acid detection subtypeAn avian influenza quality assurance program was used to provide information for laboratories on the sensitivity and specificity of their avian influenza nucleic acid testing. Most laboratories were able to correctly detect clinically relevant amounts of influenza virus (H5N1), and results improved as each subsequent panel was tested.

Assessment of eight nucleic acid amplification , nucleic acid detection subtype

Nucleic acid amplification technologies (NAATs) are high-performance tools for rapidly and accurately detecting infectious agents. They are widely used in high-income countries to diagnose disease and improve patient care. The complexities associated with test methods, reagents, equipment, quality control and assurance require dedicated laboratories with trained staff, which can exclude their , nucleic acid detection subtypeUS8980561B1 - Nucleic acid detection system and method The invention provides a rapid, sensitive and specific nucleic acid detection system which utilizes isothermal nucleic acid amplification in combination with a lateral flow chromatographic device, or DNA dipstick, for DNA-hybridization detection. The system of the invention requires no complex instrumentation or electronic hardware, and provides a low cost nucleic acid detection system , nucleic acid detection subtypeJournal of Virological MethodsNucleic acids were extracted from 50 l of each virus dilution with Ambion MagMAXTM Total Nucleic Acid Isolation Kit (Applied Biosystems, Foster City, CA, USA) as described in the user manual. Similarly, 50 l of nasal swab sample in VTM was used for the nucleic acid extraction from experimentally inoculated horses.

Nucleic acid-based detection of influenza A virus subtypes , nucleic acid detection subtype

Nucleic acid-based detection of influenza A virus subtypes H7 and N9 with a special emphasis on the avian H7N9 virus. [D Kalthoff, J Bogs, T Harder, C Grund, A Pohlmann, M Beer, B Hoffmann] PMID 24650867 . Abstract In 2013, a novel influenza A virus of subtype H7N9 was transmitted from avian sources to humans in China, causing severe illness , nucleic acid detection subtypeReviewChemical and Biological Sensors for Viral Detection , nucleic acid detection subtypeThe development of new nucleic acid biosensors that can accurately and sensitively detect specific sequences is quite encouraging, and many of the detection modalities provide potential ways to sense DNA and RNA. However, there several challenges remain for nucleic acid biosensors.Detection of influenza virus A/H1N1 using the NucleoMag , nucleic acid detection subtypeDetection of influenza virus A/H1N1 using the NucleoMag Virus kit The 2009 flu pandemic was a global outbreak of a new strain of influenza A virus subtype H1N1. The outbreak was first observed in Mexico, with evidence that there had been an ongoing epidemic

Current Procedural Terminology - Infectious agent , nucleic acid detection subtype

002: (For each specific organism nucleic acid detection from a primary source, see 87471-87660. For detection of specific infectious agents not otherwise specified, see 87797, 87798, or 87799 1 time for each agent) 001: (For assays that are used to type or subtype influenza viruses only, see 87501-87503) 003: (For infectious agent/antigen , nucleic acid detection subtypeSHERLOCK: nucleic acid detection with CRISPR nucleases , nucleic acid detection subtypeNucleic acid detection is an important method for pathogen identification but can be expensive, have variable sensitivity and specificity, and require substantial infrastructure. , nucleic acid detection subtype (subtype VI-B , nucleic acid detection subtypeNucleic Acid Dipstick Test for Molecular Diagnosis of , nucleic acid detection subtypeA new nucleic acid amplification-based rapid test for diagnosis of pandemic influenza (H1N1) 2009 virus was developed. The molecular test for pandemic H1N1, SAMBA ( s imple am plification- b ased a ssay), is based on isothermal amplification and visual detection on a dipstick characterized by high sensitivity, high specificity, a short turnaround time, and minimal technical requirements.

21 CFR § 866.3980 - Respiratory viral panel multiplex , nucleic acid detection subtype

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from , nucleic acid detection subtype Influenza A subtype H1 , nucleic acid detection subtype

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