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Multiplex Testing Proposal

Molecular Biology Department

Objectives:

Welcome

1) To examine various methods of multiplex testing for SARS-CoV-2 and Influenza A & B

  • Principles
  • Interpretation of Results
  • Advantages
  • Limitations

2) To make recommendations for a suitable testing assay based on projections

Why Multiplex Testing ?

Why ?

  • An efficient way to differentiate between respiratory viruses

  • Assist physicians in accurately diagnosing and treating a SARS-CoV-2 negative patient who also presents symptomatic

Where will Multiplex Testing occur?

  • General Molecular Biology department area (open floor)

  • Testing will be conducted by trained Medical Technologists and Medical Lab Assistants

Where?

Contents

  • Option 1:

CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay

  • Option 2:

Xpert Xpress CoV-2/Flu/RSV plus

  • Option 3:

Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit

  • 4 : Recommendations

1

CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay

PRINCIPLE

  • An RT-PCR test that detects and differentiates RNA from SARS-CoV-2, influenza A virus and influenza B virus in upper or lower respiratory specimens.

  • The assay provides a sensitive, nucleic-acid based diagnostic tool for evaluation of specimens from patients in the acute phase of infection.

Principle

Table 1.0 Flu SC 2 Multiplex Assay Interpretation

Interpretation of Results

Advantages

  • Permits the running of three tests in a single reaction well

  • The Flu SC2 Multiplex is more efficient in its use of reagents which allows higher throughput

  • Gives accurate results about the presence of SARS-CoV-2, influenza A and influenza B nucleic acid in a patient specimen

  • Allows for ongoing flu surveillance while also testing for SARS-CoV-2

  • Information obtained enables health-care providers to identify co-infections and provide more targeted treatment for influenza and COVID-19

Advantages

Limitations

  • Performance of the CDC Flu SC2 Multiplex Assay has only been established in upper and lower respiratory specimens.

  • Lower RNA sensitivity in adult specimens as compared to children; Children shed Influenza A and B viruses for longer periods than adults

Limitations

Ordering Information

Contact:

International Reagent Resource (IRR)

Website:

InternationalReagentResource.org

Email: contact@internationalreagentresource.org

Ordering Info

2

Xpert Xpress CoV-2/Flu/RSV plus

Principle

  • An automated in vitro diagnostic test for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, Flu A, Flu B, and RSV using reverse transcription PCR (RT-PCR).

  • This test is performed on GeneXpert Instrument Systems (Dx and Infinity Systems).

  • The primers and probes in the test are designed to amplify and detect unique sequences

Principle

Materials in Xpert Xpress Kit

Materials Included

1) Xpert Xpress SARS-CoV-2/Flu/RSV cartridge – 10 per kit

2) Disposable transfer pipettes – 10-12 per kit

3) Flyer – 1 per kit

Table 2.0 Xpress SARS-CoV-2_Flu_RSV plus Possible Results and Interpretation

Interpretation of results

Advantages

• This test increases result output per sample

• Reduced processing time; 36 minutes

• Results are interpreted automatically by the GeneXpert System and are clearly shown in the View Results window

• The system is fully automated and requires minimal sample prep time

Limitations

  • This Xpert Xpress SARS-CoV-2/Flu/RSV plus test has only been established for nasopharyngeal specimens.

  • The performance of this test has not been validated among vaccinated individuals.

  • The results are qualitative and not quantitative

  • This test has not been FDA approved. For use under the Emergency Use Authorization (EUA) only.

Ordering Information

Ordering Info

Xpert Xpress SARS-CoV-2/Flu/RSV

Number of tests: 10

Catalog #: XPCOV2/FLU/RSV-10

Contact (Gene Xpert supplier):

Khalil Lucky

Ryvex

Email: khalil@ryvex.net

Website: www.ryvex.net

Address: 11571 Interchange Circle South, Miramar, FL 33025, USA

Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit

By Bio-Rad

3

Principles

  • The Reliance SARS-CoV-2, Flu A and Flu B RT-PCR assay kit is a molecular in vitro diagnostic test using real-time PCR to detect multiple RNA targets from SARS-CoV-2 virus, Influenza A and B.

  • The reagents contained in this kit are said to perform quick and sensitive RT-PCR tests. Upper respiratory tract specimen collection includes nasopharyngeal swabs and anterior nasal swabs.

Principle

Materials Included in the Assay

Materials Included

One assay kit (stored at -20 °C) contains required reagent components for 200 reactions.

  • SARS-CoV-2, Flu A, and Flu B oligonucleotides

  • Reliance One-Step Multiplex RT-qPCR Supermix

  • Exact Diagnostics SARS-CoV-2, Flu, and RSV Positive Run Control

  • Exact Diagnostics SARS-CoV-2, Flu, and RSV Negative Run Control

Table 3.0 Reliance SARS-CoV-2, Fu A, and Flu B

RT-PCR Assay Kit Results

Interpretation of Results

Advantages

• Highly sensitive, one-step RT-PCR test

• The Assay kit is unlikely to be impacted by mutations in the SARS-CoV-2

• Multiplexed assay panel with, 3 sets of highly specific primers detecting 3 different viruses simultaneously

• Compatible with most popular qPCR systems

Limitations

• This assay kit has not been FDA approved but is authorized for emergency use under the Emergency Use Authorization (EUA)

Ordering Information

Ordering Info

Suppliers for Bio-rad:

Cheri Langston

Sales Consultant

Caribbean Diagnostics

Grand Harbor Medical Suites

Grand Cayman, Cayman Islands

Phone: 1-345-328-0574

Email: cheri@caribbeandiagnostics.com

Recommendations

4

  • The Gene Xpert results are issued in 36 minutes. However only 3 samples can be processed simultaneously. Therefore, Gene Xpert should be used for urgent samples.

  • CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay performs approximately 1,000 reactions per kit compared to the Reliance kit which performs 200 reactions per kit. The costing of the kits will be given subsequently once quotes are received. Based on the costing, final recommendations can be made.

References

  • Bio-Rad. (n.d.). Reliance SARS-CoV-2 Flu A Flu B RT-PCR Assay Kit. Bio-Rad Laboratories. Retrieved March 11, 2022, from https://www.bio-rad.com/en-nl/product/reliance-sars-cov-2-flu-flu-b-rt-pcr-assay-kit?ID=QKWS6LTU86LJ

  • Centers for Disease Control and Prevention. (2020, February 11). CDC’s Influenza SARS-CoV-2 Multiplex Assay and Required Supplies. Retrieved March 11, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex.html

  • Centers for Disease Control and Prevention. (2021, August). CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. Centers for Disease Control and Prevention-Influenza Division. https://www.fda.gov/media/139743/download

  • Cepheid Innovation. (2021b, October). Xpert® Xpress CoV-2/Flu/RSV plus. Cepheid.file:///C:/Users/User/Documents/MSDS/Cepheid_Xpert%20Xpress.pdf

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