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GeneXpert® Platform

COVID-19 Diagnostic Tests Webinar Series

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GeneXpert® System*

• Thermal and optical module(s)

• Computer System and GeneXpert Dx Software

• ADF (Assay Definition File)

• Barcode scanner

The GeneXpert® system package

US-IVD, CE-IVD In vitro diagnostic medical device

Cartridge

• Self-Contained

• Disposable

Recommended Accessories

• UPS/ Power generator (Backup)

• Surge protector

Optional Accessories

• Printer

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MTB/XDR

Xpress CT/NG#

Xpress GBS#

Xpress Multiplex Vaginal Panel

HIV-1 Qualitative XC#

HIV-1 Viral Load XC #

BCR-ABL Minor (p190)

AML

MRSA NxGSA Nasal CompleteMRSA/SA BCMRSA/SA SSTIC. difficile BT vanA/vanB for VRE Carba-RNorovirus

Xpress Strep AXpress Flu/RSVSARS-CoV-2^*MTB/RIF Ultra EVEbola^

CT/NG CTTrichomonasHPVGBSResistancePlus MG**

HBV Viral LoadHCV Viral LoadHCV VL FingerstickHIV-1 Qualitative HIV-1 Viral Load

Bladder CA DetectionBladder CA Monitor Breast CA STRAT4BCR-ABL Ultra FII & FV

Critical Infectious Diseases

Virology

Women’s & Sexual Health

Targeted Test Menu subject to revision, particularly in the 2022 section.

*CE-IVD pending submission and approval by regulatory body.

# Tests are updates/upgrades, and not included in the test count.

** FleXible Cartridge program in partnership with selected Trusted Reagent Manufacturers and not included in product count.

^EUA (Emergency Use Authorization)

HealthcareAssociated

Infections

Oncology & Genetics

Expanding on the Best-in-Class MDx Menu – CE-IVDAvailable Now

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2020–21* 2022+*

Carba-R NextGen#

GI Panel

Candida auris

Respiratory Panel

TB Host Response

MTB/RIF/INH Ultra

Tropical Fever

Breast cancer

Prostate cancer

Lung cancer

AML

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The Cepheid Solution – Xpert® Xpress SARS-CoV-2*

• Detection of SARS-CoV-2 RNA

‒ E and N2 targets

• On-board internal controls for each sample

‒ Probe Check Control (PCC)

‒ Sample Processing Control (SPC)

• Closed cartridge system minimizes risk of contamination

‒ The test is complete in approximately 45

minutes

• On-demand results

• Random access

*EUA: Emergency Use Authorization from U.S. FDA

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GeneXpert® Systems

• GeneXpert® Dx software version 4.7b or higher

• Xpertise software version 6.4b or higher

Test Kits

• US-EUA^: XPRSARS-COV2-10

Materials Required but not Provided

• Nasopharyngeal (NP), nasal, or mid-turbinate swabs collected by a healthcare provider and/or nasal wash/aspirate specimens in 3mL of UTM/VTM

• Personal Protective Equipment (PPE)

• 1:10 Bleach

• 70% ethanol or denatured ethanol

Optional

• Uninterruptible Power Supply /Surge Protector

• Printer

Xpert® Xpress SARS-CoV-2 Requirements

^For Emergency Use Authorization Only

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Xpert® Xpress SARS-CoV-2 Kit Contents

Cartridges contain chemically hazardous substances-please see Instructions For Use and Safety Data Sheet for more detailed information.

Kit of 10 cartridges

Kit of 50 cartridges

Xpert® Xpress SARS-CoV-2

Catalog Number US-EUA^: XPRSARS-COV2-10

Tests Per Kit 10

Kit CD

Assay Definition File (ADF)

Assay Import Instructions

Flyer- instructions to access on-line reference

materials including Instructions For Use

Disposable Transfer

Pipettes12

Storage 2- 28 °C

^For Emergency Use Authorization Only

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Specimen Collection

Specimen Types*:

Nasopharyngeal (NP), nasal, or mid-turbinate swabs

and/or nasal wash/aspirate specimens

Place into a VTM/UTM tube containing 3mL transport medium

to preserve and transport respiratory virus specimens

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Nasopharyngeal swab

Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for

Coronavirus Disease 2019 (COVID-19)

https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

*See package insert for details; specimen types may vary by system

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1. Transfer 600 μL of the sample into the 3 mL Viral Transport Medium tube.

2. Cap the tube.

Specimen Collection - Nasal Wash/Aspirate

9 © Cepheid 301-3254, Rev A

Specimen Collection - Nasopharyngeal Swab

9

10 © Cepheid 301-3254, Rev A

Specimen Collection - Nasal Swab

10

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Specimen Collection – Mid-Turbinate Swab

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Cartridge Preparation

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SARS-CoV-2 POSITIVE

The 2019 novel coronavirus (SARS-CoV-2) target

nucleic acids are detected.

• The SARS-CoV-2 signal for the N2 nucleic acid

target or signals for both nucleic acid targets (N2

and E) have a Ct within the valid range and

endpoint above the minimum setting

• SPC: NA; SPC is ignored because coronavirus

target amplification occurred

• Probe Check: PASS; all probe check results pass

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SARS-CoV-2 NEGATIVE

The 2019 novel coronavirus (SARS-CoV-2) target

nucleic acids are not detected.

• The SARS-CoV-2 signals for two nucleic acid

targets (N2 and E) do not have a Ct within the valid

range and endpoint above the minimum setting

• SPC: PASS; SPC has a Ct within the valid range

and endpoint above the minimum setting

• Probe Check: PASS; all probe check results pass

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SARS-CoV-2 PRESUMPTIVE POS

The 2019 novel coronavirus (SARS-CoV-2) nucleic

acids may be present.

Sample should be retested. For samples with a

repeated Presumptive Positive result, additional

confirmatory testing may be conducted, if it is

necessary to differentiate between SARS-CoV-2 and

SARS-CoV-1 or other Sarbecovirus currently unknown

to infect humans, for epidemiological purposes or

clinical management.

• The SARS-CoV-2 signal for only the E nucleic acid

target has a Ct within the valid range and endpoint

above the minimum setting

• SPC: NA; SPC is ignored because a target

amplification has occurred.

• Probe Check: PASS; all probe check results pass

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Analytical Sensitivity

For detailed information, refer to 302-3562 rev B Package Insert EUA GX SARS-COV2

Sensitivity

‒ The analytical sensitivity (LoD) was was performed using AccuPlex

SARS-CoV-2 Reference Material with testing performed on one reagent

lot in replicates of 35 prepared in pooled NP swab clinical matrix. The

claimed LoD for the assay is 250 copies/mL

‒ The analytical sensitivity (LoD) was was performed using Live SARS-

CoV-2 Virus with testing performed on one reagent lot in replicates of 22

prepared in pooled NP swab clinical matrix. The claimed LoD for the

assay is 0.0100 PFU/mL

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Analytical Specificity

Specificity

‒ 7 Microorganisms from the same genetic family and 32 high priority

organisms were tested: Three replicates of each isolate were spiked

into buffer and tested at a concentration of ≥107 CFU/mL

‒ No potential unintended cross reactivity with other organisms is

expected based on the in silico analysis.

‒ E primers and probes are not specific for SARS-CoV-2 and will detect Human and Bat

SARS-coronavirus.

For detailed information, refer to 302-3562 rev B Package Insert EUA GX SARS-COV2

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Biosafety, PPE and Disposal guidance

• Biological specimens, transfer devices, and used cartridges should be

considered capable of transmitting infectious agents requiring standard

precautions

• The biological specimens and used cartridges

should be disposed of per WHO [World Health Organization] guidelines

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- Many other vendors for quality control material are also available in addition to the one outlined above.

- External controls should be used in accordance with local, state accrediting organizations, as applicable

Vendor Description Configuration Storage

SeraCareAccuPlex™ SARS-CoV-2 Reference Material Kit

Catalog # 0505-0126

Positive Control 1.5mL 2-8°C or -20°C

Negative Control 1.5mL 2-8°C or -20°C

1. Open the cartridge lid.

2. Rapidly invert the external control tube 5 times.

3. Using a clean transfer pipette, transfer one draw of the external control sample into the large opening (Sample

Chamber) in the cartridge.

4. Close cartridge lid.

To minimize degradation of the control material, return any unused sample to the recommended storage conditions immediately after use.

Commercially Available External Controls

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Training and online resources

• Training materials

‒ Videos

‒ Cartridge preparation card

‒ Sample collection guidance

‒ Technical training presentation

• Online resources

‒ https://www.cepheid.com/coronavirus

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