DI Respiratory Viruses Multiplex (DIRESPI)
DI Respiratory Viruses Multiplex (DIRESPI) is an in vitro diagnostic medical device intended for the qualitative detection of RNA and/or DNA from viruses responsible for respiratory infections in human patients, whether or not they present clinical signs consistent with such infections, without restriction on age or associated conditions.
This device is based on real-time PCR technology combined with the patented Multiplex Probe Melting (MPM) technology. It enables the detection, in a single well, of the following viruses: SARS-CoV-2, Metapneumovirus A and B (MPV), Influenza B (Flu B), Adenovirus 3, 4, 7, 14, 55 (AdV), Respiratory Syncytial Virus A and B (RSV), Coronavirus 229E, NL63, OC43, HKU1 (CoV), Rhinovirus A, B, C (RV), Enterovirus A, B, C, D (EV), Bocavirus 1 (BoV), and Influenza A H1, H3, H5 (Flu A), without differentiation of subspecies. It also detects the GAPDH gene, used as an endogenous internal control to validate sample quality as well as the efficiency of extraction and amplification. In addition, it detects a sequence that hybridizes at the beginning of the PCR, allowing verification of proper PCR hybridization and the identification of potential PCR inhibition.
The device is designed for use with saliva samples, bronchoalveolar lavage samples, and nasopharyngeal swabs or aspirates. A prior extraction of nucleic acids (NA) must be performed using validated methods before PCR amplification.
| Samples | Nasopharyngeal swab or aspirate, saliva, bronchoalveolar lavage |
| Targets | SARS-CoV-2, MPV, Influenza A and B, AdV, EV, RV, CoV, BoV, RSV |
| Controls | Positive Amplification Control (PAC) and endogenous non-target control |
| Duration | ~ 1 hour |
| Equipment | Nucleic acid extraction kit, QuantStudio 5 thermocycler (Thermo Fisher Scientific) |
| Storage temperature | -16°C to -26°C |
| Reference | DIRESPI-25 |