Alinity m Resp-4-Plex Assay
For more information, contact Abbott.
For more information, contact Abbott.
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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.
The Alinity m Resp-4-Plex assay is not intended to detect influenza C virus infections.
Negative results do not preclude flu A, flu B, RSV, or SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Alinity m Resp-4-Plex assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
To learn more about Alinity m Resp-4-Plex Assay please visit: https://www.molecular.abbott/int/en/alinity-m-resp-4-plex-assay
| ABBOTT ALINITY m RESP-4-PLEX ASSAY SPECIFICATIONS1-4 | |
| Technology | Qualitative Multiplex real-time reverse transcription PCR |
| Assay Run Time | < 115 min time to first results |
| Assay Design | Multiplex assay to detect Flu A, Flu B, RSV and SARS-CoV-2 |
| Target Region | RdRp and N-genes 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 |
| Specimen Types |
Nasopharyngeal swabs |
| Result | Not detected/Cycle number; Interpretation: Negative/Positive |
| Minimum Sample Volume | Depending on tube type between 0.8 mL and 1.4 mL, sample input volume is 0.5 mL |
| Controls | Negative and positive control |
| Internal Control | Armored RNA (pumpkin), added to each specimen and control |
| Throughput | Up to 1080 samples in 24 hours (Number of actual samples per 24-hour period may vary based on laboratory practice and workflow) |
| Limitation of Detection | 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* *Depending on strain |
1. Alinity m Resp-4-Plex AMP Kit Package Insert: 53-608209/R1. 2. Alinity m Resp-4-Plex Control Kit Package Insert: 53-608212/R1. 3. Alinity m Operations Manual: 54-605001/R8. 4. Abbott Data on File
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.