PlexPCR® Flu/RSV/SARS-CoV-2

This Class D IVDR Certified product detects clinically relevant seasonal respiratory viruses Influenza A, Influenza B, Respiratory Synctial Virus (A&B) and SARS-CoV-2 virus in a single-well multiplex qPCR test

 

Upfront Diagnosis

Triage seasonal respiratory testing with PlexPCR® Flu/RSV/SARS-CoV-2

Infections caused by Flu A, Flu B, RSV (A & B), and SARS-CoV-2 can all present with similar clinical symptoms. Adopt PlexPCR® Flu/RSV/SARS-CoV-2 to triage and diagnose these important seasonal respiratory viruses upfront.

  • Class D IVDR Certified
  • Stay ahead of seasonal influenza that results in substantial worldwide disease burden1
  • RSV is an important inclusion. It is a common cause of respiratory infections, and the main cause of severe cases of bronchiolitis and pneumonia in infants and young children2,3
  • Confidently detect SARS-CoV-2, including current known circulating variants4

 

With peaks in seasonal respiratory test numbers, sample workload for laboratories can push testing capacity. Prioritising detection of common respiratory viruses with a uniform testing approach can improve efficiency and productivity.

PlexPrep_Mastermix set up

PlexPCR® Flu/RSV/SARS-CoV-2 Workflow Solution

Combat seasonal testing surges with ease

Take advantage of our flexible workflow to achieve scalable throughput, easily adapting to seasonal test surges.

  • Maximise detection with this single-well multiplex test, simultaneously detecting by Flu A, Flu B, RSV (A & B), and SARS-CoV-2.
  • Obtain high sample throughput. Process up to 96 reactions per run and maintain clinically relevant turn-around times during peak testing season.
  • Enhance your productivity for rapid, routine diagnostics with PlexPrep® liquid handling automation.
  • Utilise provided analysis software to achieve automated result calling and simple data processing.

Affordable and Efficient

The COVID-19 pandemic and recent respiratory testing seasons have impacted laboratories with dramatic fluctuations in testing demands and staffing. Some laboratories are left with underused equipment and a drive to replace lost revenue, highlighting the need for affordable and efficient solutions.

 

PlexPCR® Flu/RSV/SARS-CoV-2 can help your laboratory work effectively and efficiently.

  • Upfront diagnosis, with a focussed multiplex and robust workflow, will streamline your routine testing
  • Test with your existing QuantStudio 5 instrument and avoid the expense of acquiring new systems and associated training, implementation and service contract costs.

PlexPCR® Flu/RSV/SARS-CoV-2 Performance Specifications

Demonstrated clinical performance – for more detail please see the PlexPCR® Flu/RSV/SARS-CoV-2 Instructions for Use.

Performance of PlexPCR® Flu/RSV/SARS-CoV-2
Flu A Flu B RSV SARS-CoV-2
Sensitivity 100.0% 94.60% 97.20% 99.00%
Specificity 99.00% 99.30% 98.90% 95.80%

Specifications

PlexPCR® Flu/RSV/SARS-CoV-2 is a single-well, multiplex qPCR assay, for the detection of Influenza A (Flu A), Influenza B (Flu B), Respiratory Syncytial Viruses A and B (RSV A and B) and SARS-CoV-2, plus an endogenous control.

Targets

Influenza A (Flu A), Influenza B (Flu B), Respiratory Syncytial Viruses (RSV) A and B, SARS-CoV-2, plus an endogenous Control

 

Sample types

Swabs: nasopharyngeal swabs only

 

Amplification instrument

  • QuantStudio 5

Shipping Conditions

Products are shipped on dry ice or ice gel packs.

 

Storage & stability

Expiry dates are stated on the labels. It is recommended that freeze/thaw cycles be limited to less than 12. Store protected from light at – 25°C to – 15°C.

 

Intended use

For in vitro diagnostic use. Not for sale in the USA.

 

Regulatory status

IVDR Certified

Resources

Please contact your local representative if you can’t find what you are looking for.

Information Brochures

 

Package Inserts

 

Related Products

Safety Data Sheets

For information contact [email protected]

 

Current Software Version

  • QuantStudio™ 5 Real-Time Detection System Analysis Software v1.5.2

Certificate of Analysis

For information contact [email protected]

 

Instructions for use

For information contact [email protected]

 

Software Download

For information contact [email protected]

Ordering Information

Please contact SpeeDx for information about offering SpeeDx diagnostics in your clinic or for a list of current pathology clinics where SpeeDx testing is available.

Product Compatible Size Catalogue
PlexPCR® Flu/RSV/SARS-CoV-2 QuantStudio 5 192 reactions† 1703192
Product Compatible Size Catalogue
Positive Control Flu/RSV/SARS QuantStudio 5 2 x 1 swabs

95006
PlexPrep® Liquid Handler Enquire 1 unit 6600200-01

†Additional volumes provided for use with liquid handling systems
PlexPCR® Flu/RSV/SARS-CoV-2 is only available for sale in the E.U.

1 Timothy M Uyeki, David S Hui, Maria Zambon, David E Wentworth, Arnold S Monto (August 2022) Influenza, The Lancet,Seminar Volume 400, Issue 10353, P693-706, August 27, 2022 https://doi.org/10.1016/S0140-6736(22)00982-5

2 Borchers AT, Chang C, Gershwin ME, Gershwin LJ (2013) Respiratory syncytial virus—a comprehensive review. Clin Rev Allergy Immunol 45: 331–379. 10.1007/s12016-013-8368-9

3 Jain H, Schweitzer JW, Justice NA. Respiratory Syncytial Virus Infection. [Updated 2023 Jun 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan https://www.ncbi.nlm.nih.gov/books/NBK459215/

4 https://www.who.int/activities/tracking-SARS-CoV-2-variants

Want PlexPCR® Flu/RSV/SARS-CoV-2 in your laboratory?