| Respiratory Panel 1.1 is a rapid multiplexed nucleic acid microarray-qPCR test intended for in vitro qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), adenovirus (ADVB, ADVE), parainfluenza virus (PIV1, PIV2, PIV3), human rhinovirus/enterovirus (HRV/HEV), mycoplasma pneumoniae (MP), bordetella pertussis (BP) and/or human metapneumovirus (hMPV) in nasopharyngeal, nasal or throat swabs collected from individuals with or without symptoms, or other epidemiological reasons to suspect of respiratory viral infection. The test is run using FlashDx-1000-E or other compatible FlashDx systems.
Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, adenovirus, parainfluenza virus, human rhinovirus/enterovirus, mycoplasma pneumoniae, bordetella pertussis and/or human metapneumovirus RNA or DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co infection with other pathogens. The agent detected may not be the definite cause of disease. Negative results do not preclude SARSCoV-2, influenza A, influenza B, respiratory syncytial virus, adenovirus, parainfluenza virus, human rhinovirus/enterovirus, mycoplasma pneumoniae, bordetella pertussis and/or human metapneumovirus infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.
Respiratory Panel 1.1 is an in vitro diagnostic test for qualitative detection of nucleic acid from SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, adenovirus, parainfluenza virus, human rhinovirus/enterovirus, mycoplasma pneumoniae, bordetella pertussis and/or human metapneumovirus. The test is performed on FlashDx-1000-E Automatic Nucleic Acid Detection System. The test is a single-use disposable cartridge containing lyophilized and liquid reagents for sample processing, reverse transcription, cDNA amplification and detection. Once user closes the lid after sample is added, cartridge becomes self-contained and this can minimize cross-contamination between samples.
A microarray of specific probes is prepositioned on inner surface of amplification chamber to detect specific amplification products. When target cDNA is amplified, corresponding microarray spots can light up in an exponential manner similar to those during real-time qPCR such as TaqMan assay. This test targets specific conserved gene sequences in each pathogen. Within the cartridge, an Internal Control (IC) is also used to monitor the full process starting from sample processing to reverse transcription, amplification, microarray hybridization and signal detection. User first transfers sample from recommended sample transport medium, universal transport medium (UTM) or 0.9% saline, where sampling swab has been stored, into sample chamber of cartridge and close lid of chamber. The cartridge is loaded into the instrument loading bay according to on-screen instruction. Once user clicks to start the process, system automatically handles sample processing, RT-amplification/amplification and detection process. The instrument collects fluorescence signals of each microarray spot in real-time during amplification and automatically generates test result through analysis of amplification curves (fluorescence signal change). 10 pathogens commonly seen in respiratory tract infection in one test: FluA, FluB, RSVA,RSVB, SARS-CoV-2, MP,BP, AdV, hMPV, HRV/HEV, PIV1, PIV2, PIV3
Sample Types :
- Specimen: Nasopharyngeal, nasal or throat swabs
- Transport Media: UTM/VTM or saline (0.9%) ( Sample transport media with guanadine buffer is not compatible)
Instrument : FlashDx-1000-E
Technology : SPRT (semi-Solid Phase Real-Time PCR) technologies
Targets
- SARS-CoV-2 : N, E, and ORF1ab genes
- Influenza A : Matrix gene
- Influenza B : NEP/NS2 gene
- Adenovirus : E3 gene
- Respiratory Syncytial Virus : L gene
- Human Rhinovirus/Enterovirus : Polyprotein gene
- Bordetella pertussis : IS481 gene
- Human Metapneumovirus : N (nuclearprotein) gene
- Parainfluenza virus 1/2/3 : HN/L/HN genes
- Mycoplasma pneumoniae : Toxin gene
Batch or On-Demand : On-Demand
Minimum Batch Size : 1
Sample Extraction : Fully automated/integrated
Precision Pipetting : Not required
Turnaround Time : <1 hour
Hands-on Time : ~1 minute
Control : Internal Process Control Product Insert.pdf
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