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RespiFast RG Panel CE

For detection and differentiation of pathogens causing respiratory tract infections
  • Compliance with EU IVD Directive 98/79/EC
  • Detection and differentiation of 22 pathogens
  • Extraction validated on QIAsymphony platform
  • Multiple controls for full confidence in results
The RespiFast RG Panel is a qualitative multiplex PCR test to detect and differentiate 16 RNA viruses, 2 DNA viruses and 4 bacteria.

The RespiFast RG Panel CE is intended for in vitro diagnostic use in Europe.


1
Overview of the workflow with the RespiFast RG Panel
Performance
Principle
Acute respiratory tract infection is the most widespread type of acute infection in adults and children and is a significant cause of disease in immunocompromised patients. Respiratory tract infections (RTI) are commonly divided into upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI). The URTI include rhinorrhea, conjunctivitis, pharyngitis, otitis media, and sinusitis. LRTI include pneumonia, bronchiolitis, and bronchitis. Both viruses and bacteria can cause acute RTI, and the number of causative agents is large as well as diverse, providing a great challenge for diagnostics.
Nucleic acid amplification tests have proven to be rapid, sensitive, and specific alternatives in either singleplex or multiplex format. Multiplex assays allow the co-amplification of more than one target, providing insight into the significance of mixed infections and the prognosis and recrudescence of the respiratory disease.
The RespiFast RG Panel is a qualitative multiplex PCR test to detect and differentiate 16 RNA viruses, 2 DNA viruses, and 4 bacteria, all of which can cause respiratory tract infections in humans.
The RespiFast RG Panel is based on a complex analysis that enables the detection of 22 different pathogens (see Table "Target genes of the RespiFast RG Panel", also included in the handbook).

Target genes of the RespiFast RG Panel
Target Gene Pathogen code
Control
Internal control MS2 phage lysis protein gene IC
Amplification control 1 Unique artificial sequence AC1
Amplification control 2 Unique artificial sequence AC2
 Viruses    
 Adenovirus  Hexon (H) gene  Adeno
 Bocavirus  Noncapsid Protein (NP1) gene  Boca
 Corona 229E  Nucleocapsid protein (NP) gene  229E
 Corona HKU1  Nucleocapsid phosphoprotein (N) gene  HKU1
 Corona NL63  Nucleocapsid protein (NP) gene  NL63
 Corona OC43  Nucleocapsid protein (NP) gene  OC43
 Human metapneumovirus  Nucleocapsid protein (NP) gene  hMPV
 Influenza A virus  Matrix protein (M1) gene  InfA
 Influenza B virus  Matrix protein (M1) gene  InfB
 Influenza A virus subtype H1N1pdm09  Neuraminidase gene  H1N1v
 Parainfluenza virus type 1  Hemagglutinin-neuraminidase (HN) gene  PIV1
 Parainfluenza virus type 2  Hemagglutinin-neuraminidase (HN) gene  PIV2
 Parainfluenza virus type 3  Hemagglutinin-neuraminidase (HN) gene  PIV3
 Parainfluenza virus type 4  Major nucleocapsid protein (N) gene  PIV4
 Rhinovirus/Enterovirus  5' untranslated region polyprotein (PP) gene  Rhino/Entero
 Respiratory syncytial virus type A  Nonstructural protein gene  RSVA
 Respiratory syncytial virus type B  Nucleoprotein gene  RSVB
 Bacteria    
 Bordetella pertussis  Insertion sequence 481 (IS481)  B. pert
 Chlamydophila pneumoniae
 Major outer membrane (OmpA) gene
 C. pneu
 Legionella pneumophila  Macrophage inhibitor potentiator (Mip) gene  L. pneu
 Mycoplasma pneumoniae  Cytadhesin protein (P1) gene  M. pneu

The reaction starts with a pre-amplification that combines a reverse transcription step with a PCR step to amplify the target cDNA or DNA. Subsequently, a part of the pre-amplification reaction is transferred to two PCR tubes. Two separate Step 2 reactions are performed (see Figure "Overview of the workflow with the RespiFast RG Panel"). The detection is performed using a Melting Curve analysis.
An internal control (IC) is included in the assay to discriminate between true negative samples and false negative samples due to nucleic acid degradation, PCR inhibition, or test failure.
Procedure

The input sample is total nucleic acids extracted and purified from nasopharyngeal swabs.

Preparation of samples is a separate process from the scope of the panel. The QIAamp® MinElute® Virus Spin Kit and QIAsymphony® DSP Virus/Pathogen Mini Kit from QIAGEN are validated for DNA and RNA purification from the indicated human sample type for use with the RespiFast RG Panel.

Preamplification is carried out on a standard block-based thermal cycler, followed by PCR detection on the Rotor-Gene Q MDx or the Rotor-Gene Q instrument.

Applications
The RespiFast RG Panel is for in vitro diagnostic use for detection and differentiation of viruses and bacteria that can cause respiratory tract infections in humans.
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