INTENDED USE:
The Alinity m Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection.
Results are for the identification and differentiation of RNA from flu A, flu B, RSV, and SARS-CoV-2. flu A, flu B, RSV, and SARS-CoV-2 RNA are generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of flu A, flu B, RSV, or SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
SPECIFICATIONS:
| ALINITY m RESP-4-PLEX ASSAY PERFORMANCE | |
| Target Region | RdRp and N-gene of the SARS-CoV-2 genome,
Matrix gene of the flu A genome, Nonstructural 1 gene of the flu B genome, Matrix gene of the RSV genome |
| Assay Design | Multiplex assay to detect Flu A virus, Flu B virus, RSV and SARS-CoV-2 |
| Specimen Type | Nasopharyngeal swabs |
| Limit of Detection (LoD | SARS-CoV-2: 0.005 TCID50/mL (30 GE/mL)
Flu A: 0.002 TCID50/mL; 0.015 TCID50/mL Flu B: 0.020 TCID50/mL; 0.050 TCID50/mL RSV: 0.300 TCID50/mL; 0.100 TCID50/mL |
| Result Reporting | Cycle number/not detected |
| Internal Control (IC) | Armored RNA® from pumpkin gene, added to each specimen and control |
