Xpert® Xpress

Respiratory Product Comparison — EUA

In order to help in your transition from Xpert Xpress SARS-CoV-2 and/or Xpert Xpress SARS-CoV-2/Flu/RSV to
Xpert Xpress CoV-2 plus to Xpert Xpress CoV-2/Flu/RSV plus, we would like to highlight the differences in the
product configurations and attributes. This is a quick reference guide. Complete test resources can be found online:
cepheid.com/coronavirus-product-resources.

Xpert Xpress Xpert Xpress Xpert Xpress

CoV-2/Flu/RSV plus CoV-2 plus SARS-CoV-2

Xpert Xpress SARS-CoV-2/

Flu/RSV plus
Affiliated ADFs Xpert Xpress SARS-CoV-2/ Xpert Xpress CoV-2 plus SARS-CoV-2 only
Flu plus
Xpert Xpress SARS-CoV-2

Nasopharyngeal swab Nasopharyngeal swab

Nasopharyngeal swab
Specimen Types Anterior nasal swab
Nasal wash/aspirate1
Anterior nasal swab
Oropharyngeal swab 1
Mid-turbinate swab
Nasal wash/aspirate 1
Anterior nasal swab
Oropharyngeal swab1
Mid-turbinate swab
Nasal wash/aspirate1

UTM / VTM UTM / VTM

UTM / VTM
Transport Media eNAT2 eNAT
Saline
Saline Saline

N2 gene N2 gene
N2 gene
SARS CoV-2 Gene Targets E gene E gene
E gene
RdRP gene RdRP gene

Flu A: Genes encoding the

matrix protein, PB2 and PA
Flu A and B Gene Targets Flu B: Genes encoding -- --
the matrix protein and
non-structural protein

Nucleocapsid of RSV A and

RSV Gene Targets -- --
RSV B

Positive
Positive Positive
Presumptive Positive
Possible Reported Results Negative Negative
Negative
Invalid Invalid
Invalid

Approximately 36 minutes. Approximately Approximately

When running SARS-CoV-2 30 minutes. Positive 45 minutes. Positive
Time to Result only, positive results in as soon results in as soon results in as soon
as 25 minutes.3 as 20 minutes.3 as 30 minutes.3

1
 Xpert® Xpress
Respiratory Product Comparison — EUA

Xpert Xpress Xpert Xpress Xpert Xpress

CoV-2/Flu/RSV plus CoV-2 plus SARS-CoV-2

Sample Processing Control

Internal Controls
Probe Check Control

ZeptoMetrix Positive
ZeptoMetrix NATtrol Flu/
and Negative Control
RSV/SARS-CoV-2 Positive SeraCare AccuPlex Reference
Supported External and Negative Control kits,
kits, #NATSARS(COV2)-
Material Kit, catalog number
Controls ERC (Positive) and
#NATFRC-6C (Positive) and 0505-0126
#NATSARS(COV2)-NEG
#NATCV9-6C (Negative)
(Negative)

GeneXpert® II, IV, XVI

Supported Systems GeneXpert Infinity 48, 80
GeneXpert Xpress systems, hub and tablet

GeneXpert Dx Software 4.7b or later

Software Versions GeneXpert Xpertise Software 6.4 or later
Required
GeneXpert Xpress 5.0 and 5.1 for tablet and Xpress 6.1 or later for hub

ADF: CD in the kit

Located of ADF and ADF: Online4,5 ADF: Online4,5
and Online 5
Package Insert (PI) PI: Online 5 PI: Online 5
PI: Online 5

SARS-CoV-2-LOD6 138 copies/mL 403 copies/mL 0.02 PFU/mL

These tests have not been FDA cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. Xpert Xpress SARS-CoV-2
and Xpert Xpress CoV-2 plus have been authorized only for the detection of nucleic acids from SARS-CoV-2, and not for any other viruses or pathogens. Xpert Xpress
CoV-2/Flu/RSV plus has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B,
and respiratory syncytial virus (RSV), and not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

1 Specimen type not supported for use with GeneXpert Xpress systems (point of care)
2 For use with only Anterior Nasal Swabs or Nasopharyngeal Swabs
3 With Early Assay Termination (EAT)
4 If an ADF CD is required, please make a request by filling out a form at https://www.cepheid.com/en/contact/request-cd-international
5 Please visit cepheid.com/coronavirus
6 Claimed LOD is determined by the weakest of the three targets

Refer to most current package inserts for complete details.

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