Respiratory Panel 1.0

Respiratory Panel 1.0 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 (ADV), parainfluenza virus 1, 2 & 3 (PIV1, PIV2, PIV3), human rhinovirus/enterovirus (HRV/HEV) and/or mycoplasma pneumoniae (MP) 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 and/or mycoplasma pneumoniae 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 SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, adenovirus, parainfluenza virus, human rhinovirus/enterovirus and/or mycoplasma pneumoniae 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.

8 pathogens commonly seen in respiratory tract infection in one test: SARS-CoV-2, Flu A, Flu B, RSV, AdV, PIV 1/2/3, HRV/HEV, MP.
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 : Microarray-qPCR
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 Clinical Evaluation (Compared to an FDA EUA RT-PCR assay or an NMPA-approved RT-PCR assay): - Sensitivity 98.4% - Specificity 99.9% 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 - Parainfluenza virus 1/2/3 : HN/L/HN genes - Rhinovirus/Enterovirus : Polyprotein gene - Mycoplasma pneumonia : Toxin gene

CE marked ; Nasopharyngeal,nasal or throat swabs ; FlashDx-1000-E ; Test : SARS-CoV-2, FluA, FluB, RSVA,RSVB, MP, ADV, PIV1, PIV2, PIV3,HRV/HEV / +2° to +8° C. / IVDD-CE-UKCA

Product Insert.pdf