Lab POL Guide - 2023 - 1A

Covid-19 Molecular Testing
Covid-19 Only
ID NOW™
COVID-19
2.0 Assay
ID NOW™
Xpert®
Xpress
SARS-CoV-2 plus
* Rapidly detect SARS-CoV-2 to provide timely, effective triage
* Increase workflow efficiencieswith minimal hands-on time
* 3 gene targets for SARS-CoV-2 as well as an optimization of N2
probes to enable more reliable virus detection
* Rapid sample-to-answer testing with actionable results from a
single sample
* " True PCR " technology
* For both symptomatic and asymptomatic. Anterior nasal swab
specimens must be used for patients that are asymptomatic
#XP3SARS-COV2
(142-1966).................................................................................10/box
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for
use by authorized laboratories. " Authorized Laboratories " means (i) for testing of nasopharyngeal swab,
anterior nasal swab, mid-turbinate nasal swab, oropharyngeal swab or nasal wash/aspirate specimens
using the Test Kits run on the GeneXpert Dx and GeneXpert Infinity systems, 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; and (ii) for testing of nasopharyngeal swab, anterior nasal
swab or mid-turbinate nasal swab specimens using the Xpert Xpress CoV-2 plus test run on the GeneXpert
Xpress System (Tablet and Hub Configurations), laboratories certified under CLIA that meet requirements to
perform high, moderate, or waived complexity tests. Testing of these specimens 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 of nucleic acid from SARS-CoV-2, 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. § 360bbb 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
COVID-19 2.0 is a nucleic acid
amplification test (NAAT), indicated for the
qualitative detection of nucleic acid from
SARS-CoV-2 in direct anterior nasal or
nasopharyngeal swab specimens from
individuals who are suspected of COVID-19 by their healthcare provider
within the first seven days of the onset of symptoms. This isothermal
molecular technology uses proprietary enzymes and constant temperature
to achieve rapid amplification, with results in a fraction of the time it takes
traditional molecular lab tests. Delivers reliable molecular results in just
minutes, providing real-time access to the information needed to make
actionable decisions right at the point of care. COVID-19 positive results in
as early as 6 minutes; COVID-19 negative results in 12 minutes.
PPA 93.3%, NPA 98.5%.
#192-000, Assay
(142-3598)..................................................................................... 24/box
Contains: 24 tests, 24 swabs, 24 patient fact sheets and 1 of each: positive
control swab, healthcare provider fact sheet, package insert & quick reference
instructions.
#192-080, Control Swab Kit
(142-3602)..................................................................................... 24/box
#190-010, Swab Transport Tube Accessory Pack
(140-3061).....................................................................................24/box
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA
under an EUA for use by authorized laboratories (i.e., laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high,
moderate or waived complexity tests. This test 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 of nucleic acid from SARS-CoV-2, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Solana®
SARS-CoV-2 Assay Lyophilized Kit
This isothermal Reverse Transcriptase-Helicase-Dependent Amplification
(RT-HDA) assay is intended for the qualitative detection of nucleic
acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab
specimens from individuals suspected of COVID-19 by their healthcare
provider or Silaris dock. Molecular identification of SARS-CoV-2 occurs
by the use of targeting highly conserved regions of the SARS-CoV-2
virus nonstructural Polyprotein (pp1ab). The assay consists of 2 major
steps: (1) specimen preparation, and (2) amplification and detection of
target sequences specific to SARS-CoV-2 using isothermal Reverse
Transcriptase-Helicase-Dependent Amplification (RT-HDA) in the presence
of target-specific fluorescence probes which are performed in the Solana
instrument. Results are displayed on the touchscreen, can be saved to the
instrument, printed, and are capable of being sent to the LIS and exported
through one of Solana's 5 USB ports.
22MS9092
#M312, Solana SARS-CoV-2 Assay Lyophilized Kit
(141-9768).......................................................................................... 48/box
Contains: 96 tests, controls.
#M5203, Solana Sars-CoV-2 Negative Control
Included with kit, additional may be ordered separately.
(139-6635).................................................................................................ea
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA
under an EUA for use by authorized laboratories (i.e., 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). This product has been authorized only for the detection of nucleic acid from
SARS-CoV-2, 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. § 360bbb-3(b)
(1), unless the declaration is terminated or authorization is revoked sooner.
1a
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Lab POL Guide - 2023

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