nucleic acid detection subtype

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; Complexity 4 Manufacturer Product Platform/ Instrument Influenza Virus Types Detected Influenza Virus Subtypes Detected Other Respiratory Viruses Differentiated Approved Specimens 2 Test Time 3; CLIA waived: Abbott: ID NOW™ Influenza A & B 2: ID NOW™ Platform: Influenza A and …

COMPLEXITY4MANUFACTURERPRODUCTPLATFORM/ INSTRUM…CLIA waivedAbbottID NOW™ Influenza A & B 2ID NOW™ PlatformCLIA waivedBioFire, Inc. BioMerieuxFilmArray® Respiratory Panel EZFilmArray 2.0 EZCLIA waivedCepheidXpert Xpress FluGeneXpert XpressCLIA waivedCepheidXpert Xpress Flu/RSVGeneXpert XpressSee all 43 rows on cdc.gov

Current Procedural Terminology - Infectious agent ...

Preferred Name: 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, 12-25 targets

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Visual and modular detection of pathogen nucleic acids ...

Aug 13, 2018 · Visual and modular detection of pathogen nucleic acids. a The enVision system consists of a series of enzyme–DNA nanostructures to enable target recognition, target-independent signaling, and visual detection. The nanostructures are designed to decouple recognition from signaling.

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Test Detail - State Hygienic Laboratory

Nucleic acid amplification by PCR to detect Influenza virus RNA. Reflex Test(s) If Influenza A RNA is detected, reflexes to Influenza A Subtype, Polymerase Chain Reaction (PCR). If Influenza B RNA is detected, reflexes to Influenza B Subtype, Polymerase Chain Reaction (PCR).

Testing for Human Metapneumovirus (hMPV) Using Nucleic ...

Classification into class II (special controls) of a respiratory viral panel multiplex nucleic acid assay that includes detection and identification of hMPV.

MolDX: Multiplex Nucleic Acid Amplified Tests for ...

types or subtypes, 6-11 targets 87633 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

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Comparison of nucleic acid-based detection of avian ...

Nucleic acid amplification and detection. The NASBA method has been described previously [9] , [10] , [15] . To 5 μl of nucleic acid extract, 10 μl 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, …

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Rapid and sensitive detection of avian influenza virus ...

Jan 10, 2003 · Nucleic acid sequence-based amplification with electrochemiluminescent detection (NASBA/ECL) is an isothermal technique allowing rapid amplification and detection of specific regions of nucleic acid from a diverse range of sources. It is especially suitable for amplifying RNA.

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555 Identification of Microorganisms

The use of nucleic acid testing using amplified probe technique with or without quantification of viral load is considered MEDICALLY NECESSARY for the following microorganisms:1 • Babesiosis • Ehrlichiosis, unspecified • Tick-borne rickettsiosis, unspecified.

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MOLECULAR DIAGNOSTIC INFECTIOUS DISEASE TESTING

A standardized nucleic acid probe reacts directly with nucleic acids in the test sample. This format is termed a Nucleic Acid Test (NAT). If the test sample contains the organism of interest, the reaction (e.g., hybridization) of these elements will create a detectable endpoint.

SHERLOCK: nucleic acid detection with CRISPR nucleases ...

Nucleic acid detection is an important method for pathogen identification but can be expensive, have variable sensitivity and specificity, and require substantial infrastructure.

Local Coverage Article: Billing and Coding: MolDX ...

87631 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, 3-5 targets

Challenges of Diagnosing Acute HIV-1 Subtype C Infection ...

Challenges of Diagnosing Acute HIV-1 Subtype C Infection in African Women: Performance of a Clinical Algorithm and the Need for Point-of-Care Nucleic-Acid Based Testing. Koleka Mlisana, 1, 2, 3, * Magdalena Sobieszczyk, 4 Lise Werner, 1 Addi Feinstein, 4 Francois van Loggerenberg, 1 Nivashnee Naicker, 1 Carolyn Williamson, 1, 5 and Nigel Garrett 1.

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Nucleic acid amplification free biosensors for pathogen ...

Li et al. developed a one-step method for nucleic acid detection. As is showed in Fig. 1 A, a dual-thiol modified hairpin DNA (dSH-HSP) was constructed to detect targets by one step of modification. Target DNA bound to partial loop of capture dSH-HSP while report probe bound to another part of the loop, forming a Y-shaped DNA duplex without an extra backfilling process (Li et al., 2016a).

Author: Yanju Chen, Cheng Qian, Chengzhi Liu, Hong Shen, Zhijian Wang, Jianfeng Ping, Jian Wu, Huan Chen

Nucleic Acid Amplification for Detection of Influenza A

Apr 10, 2020 · Nucleic acid amplification tests Most sensitive approach for direct detection of IFVA Primers and probes can be designed to identify all subtypes of IFVA or may be subtype specific

CFR - Code of Federal Regulations Title 21

Apr 01, 2019 · The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when...

Eurosurveillance | Nucleic acid-based detection of ...

Nucleic 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 1, C Grund 1, A Pohlmann 1, M Beer 1, B Hoffmann 1

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Product Classification - Food and Drug Administration

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 individuals exhibiting signs and ...

Diagnosis of HIV Infection in Infants and Children ...

Dec 24, 2019 · Virologic assays (i.e., HIV RNA and HIV DNA nucleic acid tests [NATs]) that directly detect HIV must be used to diagnose HIV in infants and children aged <18 months with perinatal and postnatal HIV exposure; HIV antibody tests should not be used (AII).

Class II Special Controls Guidance Document: Testing for ...

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...

Visual detection of H3 subtype avian ... - Virology Journal

Jul 05, 2011 · 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.

Cited by: 28

Nucleic Acid Amplification for Detection of Influenza A

Mar 18, 2020 · Nucleic acid amplification tests Most sensitive approach for direct detection of IFVA Primers and probes can be designed to identify all subtypes of IFVA or may be subtype specific

Identification of Microorganisms Using Nucleic Acid Probes

The use of nucleic acid testing with quantification of viral load is considered . investigational. for microorganisms that are not included in the list of microorganisms for which probes with or without quantification are considered medically necessary. The use of nucleic acid testing using a direct or amplified probe technique with or

Current Procedural Terminology - Infectious agent ...

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 ...

How is lateral flow technology used for rapid nucleic acid ...

Jun 12, 2017 · Rapid nucleic acid detection for multiple industries PCRD is used by customers globally from many different industry sectors in order to facilitate sensitive and rapid nucleic acid detection. The use of PCRD along with DNA amplification has been demonstrated with RPA TwistAmp ® R&D kits.

Product Classification - Food and Drug Administration

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 individuals exhibiting signs and ...

Massively multiplexed nucleic acid detection using Cas13 ...

Apr 29, 2020 · Scalable, highly-multiplexed CRISPR-based nucleic acid detection shifts diagnostic and surveillance efforts from targeted testing of high-priority samples to comprehensive testing of …

Eurosurveillance | Nucleic acid-based detection of ...

Nucleic 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 1, C Grund 1, A Pohlmann 1, M Beer 1, B Hoffmann 1

Current Procedural Terminology - Infectious agent ...

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 ...

Identification of Microorganisms Using Nucleic Acid …

The use of nucleic acid testing with quantification of viral load is considered . investigational. for microorganisms that are not included in the list of microorganisms for which probes with or without quantification are considered medically necessary. The use of nucleic acid testing using a direct or amplified probe technique with or

Research articles Nucleic acid-based detection of ...

Nucleic 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 ([email protected]), C Grund , A Pohlmann , M Beer , B Hoffmann1 1. Friedrich-Loeffler-Institute, Institute of Diagnostic Virology, Greifswald-Insel Riems, Germany Citation style for this ...

US8980561B1 - 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 testing and molecular characterization of HIV ...

Significant advances have been made in the molecular assays used for the detection of human immunodeficiency virus (HIV), which are crucial in preventing HIV transmission and monitoring disease progression. Molecular assays for HIV diagnosis have now reached a high degree of specificity, sensitivity and reproducibility, and have less operator involvement to minimize risk of contamination.

How is lateral flow technology used for rapid nucleic acid ...

Jun 12, 2017 · Rapid nucleic acid detection for multiple industries PCRD is used by customers globally from many different industry sectors in order to facilitate sensitive and rapid nucleic acid detection. The use of PCRD along with DNA amplification has been demonstrated with RPA TwistAmp ® R&D kits.

139650: Respiratory Pathogen Profile, PCR | LabCorp

Detection 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 ...

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 aspects

What is the nucleic acid test (NAT)? | Blood Basics ...

The nucleic acid test (NAT) system can detect the presence of bacteria and viruses (e.g. human immunodeficiency virus (HIV) and hepatitis C virus (HCV)) in blood using a semi-automated system and further ensures the safety of blood products, including fresh frozen plasma, red cells, and platelets by permitting earlier detection of infections in donors.

REVIEW ARTICLE The increasing application of multiplex ...

REVIEW ARTICLE The increasing application of multiplex nucleic acid detection tests to the diagnosis of syndromic infections J. GRAY1,2 AND L.J. COUPLAND2* 1Norwich Medical School, University of East Anglia, NRP Innovation Centre, Norwich Research Park, Norwich, Norfolk, UK

MethylAction: detecting differentially methylated regions ...

INTRODUCTION. Differential DNA methylation distinguishes a broad range of biological subtypes including stages of mammalian embryonic development (), eusocial insect behavioral types (), immune cell activation and memory (3,4), human tissue types (), ages of human blood and brain tissue (6,7) and regions of the human brain ().There is also considerable utility to detecting differential DNA ...

87633 - ldh.la.gov

technique, multiple types or subtypes; 12-25 targets Synonyms RVP Brief Description of Test The eSensor® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the eSensor XT‐8™ system for the simultaneous detection and identification of multiple respiratory viral nucleic acids in

Diagnostic Influenza Tests: Reference Range ...

Jan 22, 2020 · Rapid antigen tests, immunofluorescent tests, and virus culture have been reported to often lack in assay sensitivity, specificity, testing time, and ability to subtype for influenza compared to molecular methods. [] In a study of the nucleic acid amplification tests ID Now (Abbott), Cobas Influenza A/B Assay (Roche Molecular Diagnostics), and Xpert Xpress Flu (Cepheid), Kanwar et al found the ...

Simple amplification-based assay: A nucleic acid-based ...

Amplification of the target nucleic acid sequence of HIV-1 in the SAMBA format is achieved by an isothermal amplification method [16], which is completed in 60 min. The amplified viral nucleic acid is further detected by the proprietary method for dipstick-based detection of nucleic acid, as described elsewhere [14, 17].

Proficiency of Nucleic Acid Tests for Avian Influenza ...

An 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.

US8835624B1 - Influenza A H1N1 subtype-specific aptamer ...

The present invention provides an Influenza A H1N1 subtype-specific aptamer. The aptamer was selected in vitro using SELEX and a microfluidic chip system. The aptamer is stable, establishing sensitivity about 100 times higher than antibody and high specificity to Influenza A H1N1 subtype. Thus, the aptamer can be effective in detection of H1N1 influenza virus.

Development and Verification of a New Coronavirus ...

High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems.

VERIGENE® Respiratory Pathogens Flex Test (RP Flex)

The VERIGENE® Respiratory Pathogens Flex Test (RP Flex) is an automated, multiplexed, flexible nucleic acid test for the identification of the viruses and bacteria that most commonly cause respiratory infections.. Respiratory testing needs vary by season, geography, and even from patient to patient. Yet currently, to meet diverse testing needs, labs must choose between running expensive mega ...

400 Medical Technology Assessment Investigational …

87532 Infectious agent detection by nucleic acid probe (DNA or RNA); Herpes virus-6, amplified probe technique - not covered for commercial products only 87533 Infectious agent detection by nucleic acid probe (DNA or RNA); Herpes virus-6, quantification 87540 Infectious agent detection by nucleic acid probe (DNA or RNA); Legionella pneumophila ...

New Coronavirus (2019-nCoV) Nucleic Acid Detection Kit ...

The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal and nasopharyngeal swab samples. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a ...

Amplification and Detection of HIV-1 Genomic RNA

Jul 07, 2015 · Nucleic acid sequences that can be used as primers and probes in the amplification and detection of all subtypes of HIV-1: 2005-04-19: Goudsmit et al. 6025124: Marker, method and an assay for detection and monitoring of latency and activation of human immunodeficiency virus: 2000-02-15: Adams et al. 6001558: Amplification and detection of HIV-1 ...

Rapid detection of equine influenza virus H3N8 subtype …

Rapid detection of equine influenza virus H3N8 subtype by insulated isothermal RT-PCR (iiRT-PCR) assay using the POCKIT™ Nucleic Acid Analyzer June 2014 Journal of Virological Methods 207

VERIGENE® Respiratory Pathogen Flex Test | Respiratory ...

The VERIGENE® Respiratory Pathogens Flex Test (RP Flex) is an automated, multiplexed, flexible nucleic acid test for the identification of the viruses and bacteria that most commonly cause respiratory infections.. Respiratory testing needs vary by season, geography, and even from patient to patient. Yet currently, to meet diverse testing needs, labs must choose between running expensive mega ...

Federal Register :: Guidances for Industry and Food and ...

Elsewhere in this issue of the Federal Register, FDA is publishing a final rule codifying the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)), and establishing these guidance documents ...

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