Lab POL Guide - 2023 - 1B

Covid-19 Molecular Testing
Covid-19/Influenza
cobas®
the cobas®
SARS-CoV-2
& Influenza A/B Assay
The cobas®
Liat®
SARS-CoV-2 & Influenza A/B nucleic acid test for use on
System is a multiplex, real-time polymerase
chain reaction (PCR) test that detects and differentiates SARS-CoV-2,
influenza A and influenza B in 20 minutes from a single nasal sample
and in just one test.
* 1 sample, 1 test, 20 minutes: know if it's COVID-19 or flu
* Take the workload out of testing with simple, intuitive user handling
* Minimize cross contamination and risk of exposure during testing
with the closed-system design
#09211101190, cobas®
SARS-CoV-2 & Influenza A/B Assay Kit
(139-2180).........................................................................................20/box
#9211128190, cobas®
SARS-CoV-2 & Influenza A/B
Positive/Negative Control
(139-2294)...........................................................................................9/box
This test has not been FDA cleared or approved.
In the United States (US), testing wth Cobas®
SARS-CoV-2 & Influenza A/B is authorized under an EUA
for " Authorized Laboratories. " Authorized Laboratories are (1) laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high
complexity tests, and (2) when used with the cobas Liat System for use at Point of Care (POC), i.e., in patient
care settings operating under a CLIA Certificate Of Waiver, Certificate Of Compliance,
or Certificate Of Accreditation.
This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic
acid from SARS-CoV-2, Influenza A Virus and Influenza B Virus and not for any other viruses or pathogens.
This test is only authorized in the United States 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.
Covid-19/Influenza/RSV
#XP3COV2/FLU/RSV-10, Xpert®
Xpert®
Xpress CoV-2/Flu/RSV
plus Test Kit
* Rapidly detect SARS-CoV-2
* Diagnose respiratory tract infections to ensure
appropriate treatment
* Rapidly differentiate flu, RSV, and SARS-CoV-2
and potential co-infections during respiratory
season
* Robust design with 3 distinct gene targets for
SARS-CoV-2: N2, E, & RdRP
* Detection and differentiation of SARS-CoV-2,
Flu A, Flu B, and RSV in individuals suspected
of respiratory viral infection consistent with
COVID-19 by their healthcare provider
* Results for SARS-CoV-2 in as little as 25 minutes
* Actionable results from a single sample
* Standardization of results between the central lab
and near-patient testing sites
* 3-gene design supports clinicians with broader
coverage for SARS-CoV-2 variants
* Ensures that patients receive appropriate
treatment in a timely manner
* Single cartridge with an easy-to-use workflow,
enabling effective management of limited
resources
* CLIA waived
henryschein.com/medical
Xpress CoV-2/
Flu/RSV plus Test Kit
(141-0461).................................................... 10/box
#NATFRC-6C, ZeptoMetrix NATtrol Flu/RSV/
SARS-CoV-2 Positive Control Kit
(138-6483).......................................................6/vial
#NATCV9-6C, ZeptoMetrix NATtrol Flu/RSV/
SARS-CoV-2 Negative Control Kit
(138-6589).......................................................6/vial
Testing of nasopharyngeal swab, anterior nasal swab or nasal wash/
aspirate specimens run on the GeneXpert Dx and GeneXpert Infinity
Systems is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet
requirements to perform high or moderate complexity tests.
Testing of nasopharyngeal or anterior nasal swab specimens run on the
GeneXpert Xpress System (Table and Hub Configurations) is authorized
for use at the Point of Care (POC), i.e., in patient care settings operating
under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate
of Accreditation.
This product has been authorized only for the detection and differentiation
of nucleic acids from SARS-CoV-2, influenza A, influenza B, and
respiratory syncytial virus (RSV), not for any other viruses or pathogens;
and the emergency use of this product is only authorized for the duration
of the declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection and/or diagnosis
of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
1b
22MS9092

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Lab POL Guide - 2023

Table of Contents for the Digital Edition of Lab POL Guide - 2023