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ALINITY m RESP-4-PLEX ASSAY*

*For In Vitro Diagnostic Use.

ALINITY m RESP-4-PLEX ASSAY
ALINITY m RESP-4-PLEX ASSAY
ALINITY m RESP-4-PLEX ASSAY

Innovative multiplex SARS-CoV-2, flu A, flu B, and RSV assay to curb the COVID-19 outbreak during flu season.  The Alinity m Resp-4-Plex assay offers workflow efficiency and high throughput solution the laboratory requires today to meet the public health need for differentiation of all 4 viruses. (Learn about SARS-CoV-2 variant detection, click here)

  • Improved Operational Efficiencies
    • Streamlined workflow with primary sample loading provides operational efficiencies allowing laboratories to process increased test volumes with existing lab staff and limited resources
  • Leading Science - Providing Confidence in Results
    • Single test with multiplex assay design to differentiate between SARS-CoV-2, flu A, flu B, and RSV and help diagnose infection by one of the viruses
    • Assay design with highly conserved target sequences of SARS-CoV-2, flu A, flu B and RSV for robust detection and clear interpretation of results
    • High sensitive assay to detect individuals with low viral load
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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.

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.

INTENDED USER

The intended users for the Alinity m Resp-4-Plex assay are laboratory and healthcare professionals.

 

ABBOTT ALINITY m RESP-4-PLEX ASSAY SPECIFICATIONS1-4
TechnologyQualitative multiplex real-time reverse transcription PCR
Assay Run Time< 115 min time to first result
ThroughputUp to 1080 samples in 24 hours (number of actual samples per 24-hour period may vary based on laboratory practice and workflow)
Assay DesignMultiplex assay to detect Flu A virus, Flu B virus, RSV and SARS-CoV-2
Target RegionRdRp 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 
Limit of DetectionSARS-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
Specimen TypesNasopharyngeal swabs 
Result InterpretationCycle number/not detected
Minimum Sample Volume Depending on tube between 0.8 mL and 1.4 mL. Sample input volume: 500 uL
ControlsNegative and positive control
Internal ControlArmored RNA (Pumpkin), added to each specimen and control

1. Alinity m Resp-4-Plex AMP Kit Package Insert: 53-608209/R3  2. Alinity m Resp-4-Plex Control Kit Package Insert: 53-608212/R1.   3. Alinity m Operations Manual: 54-605001/R12.  4. Abbott Data on File

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