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rRT-PCR Swine Flu Panel; influenza A H1N1 rRT-PCR

Indications: - swine flu Clinical significance: - for use with viral culture Specimen: nasopharyngeal &/or nasal swab specimens Procedure: - Swine Influenza Virus Real-time RT-PCR Detection Panel - panel of oligonucleotide primers & dual-labeled hydrolysis (Taqman) probes for use in the real-time RT-PCR assay on the ABI 7500 FastDx Real-Time PCR instrument - in vitro qualitative detection of swine influenza viral RNA in nasopharyngeal &/or nasal swab specimens - universal swine influenza swInfA (NP gene) & swH1 (HA gene) primer & probe sets are designed for detection of swine A/H1N1 influenza virus Includes the following primer & probe sets: - InfA detects universal influenza A strains - swInfA specifically detects swine influenza A strains (NP gene) - sw H1 is specific for swine influenza A, subtype H1 (HA gene) Includes control materials: - RNase P detects human RNase P; used as a positive control to indicate that adequate isolation of nucleic acid resulted from the extraction of the clinical specimen - Swine Influenza Positive Control (SIPC) is a positive control designed to react with all the primer & probe sets including RNase P

General

infectious agent nucleic acid microbiology panel

References

  1. Letter of Authorization: FDA: Food and Drug Administration Emergency Use of the Swine Influenza Virus Real-time RT-PCR Detection Panel http://www.fda.gov/cdrh/emergency/panel-authorization.html
  2. Fact Sheet for Healthcare Providers: Interpreting Swine Influenca RT-PCR Detection Panel Test Results FDA: Food and Drug Administration http://www.fda.gov/cdrh/emergency/panel-factsheet1.html
  3. Centers for Disease Control (CDC) Use of Rapid Influenza Diagnostic Tests for Patients with Influenza-like Illness during the Novel H1N1 Influenza Virus (Swine Flu) Outbreak Information for Health Care Professionals May 2, 2009 http://www.cdc.gov/h1n1flu/guidance/rapid_testing.htm
  4. H1N1 by PCR Laboratory Test Directory ARUP: 2004217