RespiFast RG Panel CE
For detection and differentiation of pathogens causing respiratory tract infections
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.
See the online Performance Characteristics.
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).
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.
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.
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.