Lab POL Guide - 2023 - 1F

Covid-19 Antibody Testing
FREND™
COVID-19 Total
Premier Biotech COVID-19®
IgM-IgG Rapid Test Cassette
A rapid chromatographic immunoassay for the
qualitative detection and differentiation of IgG and
IgM antibodies to SARS-CoV-2 in human venous
Antibody Reagent Test
This test is a fluorescence immunoassay (FIA) for
the qualitative detection of total antibody to SARSCoV-2
in human dipotassium EDTA plasma. It is
intended for use as an aid in identifying individuals
with an adaptive immune response to SARSCoV-2,
indicating recent or prior infection.
Key features and benefits:
* U.S. FDA-authorized under an Emergency Use
Authorization
* Fast results: 3-4 minutes reaction and analysis
time
* Easy to use
* 96.7% and 98.8% combined sensitivity and
specificity, respectively
* LIS connectivity (data management)
* Moderately complex
#FRCOA-020, FREND™
COVID-19 Total Antibody
Reagent Cartridge
(139-2159).................................................... 20/box
#FRCOAC-012, Frend COVID-19 Total Antibody
Positive/Negative Level
(139-2295).................................................... 12/box
This test has not been FDA cleared or approved.
This test has been authorized by FDA under an EUA.
Testing is limited to 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 moderate or high
complexity tests. This test has been authorized only for the presence of
antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test 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 Food, Drug And Cosmetic Act, 21 U.S.C. § 360bbb-3(b)
(1), unless the authorization Is terminated or revoked sooner.
CovAb™
COVID-19 Test Kit
The test is the only 15-minute, rapid-result oral
swab test kit for qualitative detection of total
COVID-19 antibodies (including IgG, IgA, and
IgM). The test is intended for use as an aid in
identifying individuals with an adaptive immune
response to SARS-CoV-2, indicating recent or
prior infection. Samples should only be taken
from individuals that are 15 days or more post
symptom onset. Unlike other antibody tests
that require a blood draw, it is administered
with a simple mouth swab, making it easy and
painless for patients of all ages. Stores at room
temperature and is manufactured in the USA.
97.6% sensitivity, 98.8% specificity. CLIA waived.
#2046, CovAb COVID-19 Test Kit
(140-8049).................................................... 50/box
#2039, CovAb Positive/Negative Control
(140-8050)...........................................................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. Authorized laboratories are laboratories certified under
Clinical Lab Improvements Amendment Act of 1988 (CLIA), that meet the
requirements to perform high, moderate or waived complexity tests. This
test is authorized for use at the Point of Care, 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
detecting the presence of total antibodies to 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[1]3(b)(1),
unless the declaration is terminated or authorization is revoked sooner.
whole blood, serum or plasma, or fingerstick
whole blood. The test is intended for use as an
aid in identifying individuals with adaptive immune
response to SARS-CoV-2, indicating recent or
prior infection. CLIA waived.
#INGM-MC42, Premier Biotech COVID-19®
IgMIgG
Rapid Test
(139-7131).................................................... 20/box
Contains: 25 droppers, 1 buffer, 1 insert & 2 fact sheets.
#CD4000, Premier Biotech COVID-19 IgM-IgG
Positive/Negative Controls
(138-5357)...................................................... 2/pkg
*This test has not been FDA cleared or approved.
This test is authorized by FDA under an
Emergency Use Authorization (EUA) for use by
authorized laboratories only.
Authorized laboratories include laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a,
that meet requirements to perform moderate or high complexity test, when
the specimens used are serum, plasma, or venous whole blood. Testing
of fingerstick whole blood specimens is limited to 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. Testing of fingerstick whole blood 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 test has been authorized only for the presence of IgM and IgG Antibodies
against SARS-CoV-2, not for any other viruses or pathogens; and
This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.
henryschein.com/medical
1f
22MS9092

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Lab POL Guide - 2023

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