Molecular
Molecular

Alinity m Resp-4-Plex Assay

Resp-4-Plex CE AMP Kit DSC_0295.jpg


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 efficency and high throughput solution the laboratory requires today to meet the public health need for differentiation of all 4 viruses:

  • 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 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

VIEW ORDERING INFORMATION

print-thumbnail.png
Product Details
 

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. 

specifications
 

 

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 result
Throughput Up to 1080 samples in 24 hours (number of actual samples per 24-hour period may vary based on laboratory practice and workflow)
Assay Design Multiplex assay to detect Flu A virus, Flu B virus, RSV and SARS-CoV-2
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 
Limit 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
Specimen Types

 

Nasopharyngeal swabs 
Result Interpretation Cycle number/not detected
Minimum Sample Volume  Depending on tube between 0.8 mL and 1.4 mL. Sample input volume: 0.5 mL
Controls Negative and positive control
Internal Control Armored RNA (Pumpkin), added to each specimen and control
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 
 
 
Helpful resources
 

Ordering Info

Related Product
 

Alinity m
alinity_m_right_no_shadow_edited2_thumbnail.png

 

Learn More
Back

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

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.

Do you wish to continue and enter this website?

Yes No

You are about to enter an Abbott country or region specific website.

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.

Do you wish to continue and enter this website?

Yes No