Lab POL Guide - 2023 - 1C

Covid-19 Antigen-Reader Testing
#256082, Veritor SARS-CoV-2 Test Kit
(138-4669).................................................... 30/box
#256088, Veritor SARS-CoV-2 & Flu A+B Test Kit
(140-5677).................................................... 30/box
#256087, BD Veritor SARS-CoV-2 Positive/Negative
Control Swab Set
(140-5674).................................................... 10/box
EUA Disclaimer:
BD Veritor™
Plus System
Point-of-care testing for SARS-CoV-2, Flu A+B,
RSV (respiratory syncytial virus), and Group
A Strep, providing rapid diagnostic testing in
a convenient, portable instrument. One-button
functionality and workflow flexibility allow the
health-care team to confidently use the device.
In addition, the system's fast and reliable results
may help improve the patient experience. The
system streamlines the point-of-care testing
experience, stores or downloads the lot number,
patient/specimen ID, operator ID, and test records
using the BD Veritor™
InfoWiFi module or via the
companion ImageMover application.
* Offers result printing capabilities via USB port
* Adapts easily to workflow by offering 2
operational modes
* Walk Away: the test device is inserted
immediately into the analyzer so staff can
multitask while the sample incubates
(15 minutes)
* Analyze Now: the test device is inserted after
the incubation time is complete, allowing
batches of samples to be tested at once
(results in seconds)
* CLIA waived
The system has not been FDA cleared or approved to detect SARS-CoV-2
or Flu A+B but it has been authorized for use by authorized laboratories
under an EUA to detect proteins associated with those viruses (but not
for any other viruses or pathogens) in anterior nasal swab samples taken
from individuals who are suspected of a viral respiratory infection consistent
with COVID-19 by a healthcare provider, within the first six days
of symptom onset. Authorized laboratories include those certified under
CLIA that meet the requirements to perform moderate, high, 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.
The emergency use of these products 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.
Sofia®
Sofia®
SARS Antigen Fluorescent
Immunoassay (FIA) for Sofia/Sofia 2/Sofia Q
Uses advanced immunofluorescence-based lateral-flow technology in a
sandwich design for qualitative detection of nucleocapsid protein from
SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia
analyzers, provides automated and objective results in 15 minutes,
allowing for COVID-19 testing of symptomatic patients within the first 5
days of symptoms and asymptomatic patients when tested serially (twice
over two or three days with at least 24 hours and no more than 36 hours
between tests).
* Nasal specimens
* Accurate detection with direct samples
* Results in 15 minutes
* Kit includes 25 sterile nasal swabs and a set of positive and negative
control swabs
#20374
(138-3310).........................................................................................25/box
This test has not been FDA cleared or approved. The test has been authorized by FDA under an Emergency Use
Authorization (EUA) for use by Authorized Laboratories. " Authorized Laboratories " include laboratories certified
under the Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42U.S.C. §263a, that meet
the requirements to perform Moderate, High or Waived Complexity Tests. This test is also 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. Emergency use of this test is limited to Authorized Laboratories
using the Sofia, Sofia 2, or Sofia Q instruments.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses
or pathogens. 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.
22MS9092
1c
2 Flu + SARS Antigen Fluorescent
Immunoassay (FIA)
Uses advanced immunofluorescence-based lateral-flow technology
in a sandwich design for qualitative detection of nucleocapsid protein
from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2
and Sofia analyzers, provides automated and objective results in
15 minutes, allowing for COVID-19 testing of patients within the first
5 days of symptoms.
* Accurate detection with direct samples
* Results in 15 minutes
* Kit includes 25 sterile nasal swabs and a set of
positive and negative control swabs
#20395, Sofia 2 Flu + SARS Antigen FIA Immunoassay With Analyzer &
1 Test Kit
(138-9832)............................................................................................... ea
#20377, Sofia 2 Flu + SARS Antigen FIA Immunoassay for Sofia 2 Analyzer
(138-9834).........................................................................................25/box
This
test has not been FDA cleared or approved. The test has been authorized by FDA under an
Emergency Use Authorization (EUA) for use by Authorized Laboratories. " Authorized Laboratories "
include laboratories certified under the Clinical Laboratory Improvement Amendments Of 1988 (CLIA),
42U.S.C. §263a, that meet the requirements to perform Moderate, High or Waived Complexity Tests.
This test is also 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. Emergency
use of this test is limited to Authorized Laboratories using the Sofia, Sofia 2, or Sofia Q instruments.
This product has been authorized only for the detection of proteins from SARS-CoV-2 and influenza,
not for any other viruses or pathogens. 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.
henryschein.com/medical

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Lab POL Guide - 2023

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