CLINITEST Rapid COVID-19 Antigen Test - Point of Care Testing Unrestricted
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CLINITEST Rapid
COVID-19 Antigen Test
Point of Care Testing
Restricted © Siemens Healthineers., 2021
Unrestricted
Siemens Healthineers COVID-19 patient pathway *To help indicate an immune response 2 This pathway is for illustration purposes only | Status: November 20, 2020 Restricted © Siemens Healthineers., 2021
Scalable COVID-19 antigen testing in minutes for any setting
Fast
Get ahead of the spread with accessible testing for all Only 15 minutes to result
Accessible
Does not require specialized laboratory personnel or equipment
Scalable
Deployable for high-volume testing where you need it most
CLINITEST® Rapid COVID-19 Antigen Test*
• Time to results: 15 minutes
• Targets the SARS-CoV-2 nucleocapsid protein
• Nasopharyngeal or nasal swab sample collection
• No instrumentation needed – lateral flow, visual read
• Distributed by Siemens Healthineers
3
*Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local
Restricted © Siemens Healthineers., 2021
representative for availability.
What types of COVID-19 testing are available?
Molecular Testing (NAAT, RT-PCR)
• Detects the genetic material (RNA) of the virus Serology test Likely negative Likely positive
• Sensitivity varies by manufacturer, but generally very high for antibodies
Likely Likely positive Likely negative
due to amplification of the genetic material Molecular
negative
• Sample types: nasopharyngeal, anterior nasal, and oral test for virus
Likely
swabs or wash Antigen test Likely positive Likely negative
negative
for virus
• Studies suggest that RT-PCR results may be positive while
patient is not contagious1
Antigen Testing
• Detects the presence of a specific viral antigen, most RNA
commonly the nucleocapsid protein Antigen
• Sample types: nasopharyngeal, anterior nasal, and
oropharyngeal swabs SARS-CoV-2 IgG antibodies
• Results are dependent on viral load and may not correlate exposure
with NAAT/RT-PCR results2
IgM antibodies
Antibody (IgG/IgM) Testing
• Detects the presence of antibodies to SARS-CoV-2 which can
help identify people who may have previously been infected Week -2 Week -1 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
• Sample types include whole blood, serum, and plasma Before symptom After symptom onset
• May not detect a current infection as antibodies start onset
developing 1-3 weeks after infection3 Estimated time intervals and rates of viral detection are based on data from several published reports. Because of variability in values among studies,
estimated time intervals should be considered approximations and the probability of detection of SARS-CoV-2 infection is presented qualitatively.
1. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
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2. https://www.mayoclinic.org/tests-procedures/covid-19-diagnostic-test/about/pac-20488900
3. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests.html Restricted © Siemens Healthineers., 2021
When should rapid antigen testing be used?
World Health Organization guidance How can CLINITEST Rapid COVID-19 Antigen Test help?
When specialized laboratory equipment or laboratory personnel Rapid results in only 15
Anterior nasal specimen
are not available to quickly respond to COVID-19 outbreaks: collection increases
minutes
accessibility
• Remote settings
• Institutions
• Closed and semi-closed communities (such as schools, care-
homes, prisons, workplaces)
Testing can be performed
Test can be performed by
outside of traditional clinical
trained healthcare provider
settings
When limited resources are available and RT-PCR testing must be
prioritized
Scalable deployment to help
Testing can be deployed with
To support outbreak investigations in closed or semi-closed limited resources
control community
settings or where there is widespread community transmission transmission
World Health Organization; Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays 5
Document number WHO/2019-nCoV/Antigen_Detection/2020.1 Restricted © Siemens Healthineers., 2021
What comes in the box?
20 Individually Wrapped Cassettes
20 Swabs
1 Box = 20 Tests
Note: these tests are ordered in cases 20 Extraction Tubes and Tips
Instructions
(1 case = 48 boxes = 960 tests) for Use
1 Package Insert 2 Extraction Buffer Vials
1 Workstation
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Restricted © Siemens Healthineers., 2021Simple-to-follow procedure for trained professionals
Specimen Collection Sample Preparation
Nasopharyngeal OR Nasal Swab
Nasopharyngeal Swab
• Insert the sterile swab into
patient’s nostril
• Gently rotate the swab
several times over the
surface of the posterior
nasopharynx, and gently
remove.
• Add 10 drops of • Roll the swab 6+ times • Safely remove • Lay cassette flat
Nasal Swab sample extraction inside tube and discard swab
• Label
buffer
• Squeeze against bottom • Insert dropper tip
• Carefully insert the sterile • Add 4 drops of test
and sides of tube into tube with
swab into patient’s nostril • Keep the tube sample to sample
upright using stand specimen.
(2-4cm) • Rest for 1 minute well
• Roll swab 5 times along the provided.
mucosa to collect mucous • Squeeze swab several • Results ready in 15
and cells, and gently remove. more times. minutes.
• Repeat for other nostril.
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Restricted © Siemens Healthineers., 2021CLINITEST Rapid COVID-19 Antigen Test designed for easy
interpretation without lab equipment
Control Line
Read Area
Test Line
Sample Pad
Negative Result Positive Result
Author | Department 8
Restricted © Siemens Healthineers., 2021CLINTEST Rapid COVID-19 Antigen Test detects the nucleocapsid protein found within the
SARS CoV-2 virus
Membrane protein
Spike protein
Nucleocapsid protein
Bound to RNA
Envelope protein
To expose the nucleocapsid protein,
the buffer solution dissolves the virus
envelope and deactivates the virus
SARS CoV-2 Virus 9
Restricted © Siemens Healthineers., 2021CLINITEST Rapid COVID-19 Antigen Test Strip
Components
Nitrocellulose Membrane Wicking/Waste Material
Patient sample
Conjugate Pad Test line Control line Mylar Backing
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Restricted © Siemens Healthineers., 2021CLINITEST Rapid COVID-19 Antigen Test Strip
Immunochemical Reaction
Negative test line Control line
Nucleocapsid protein
Negative Sample
Anti-nucleocapsid antibody
No SARS-CoV-2
nucleocapsid
+ = Anti-nucleocapsid antibody
bound to gold-sol
protein present
Goat Anti-Mouse IgG
Positive test line Control line
Positive Sample
SARS-CoV-2
nucleocapsid
+ =
protein present
Remaining sample is
absorbed by waste pad
Gold labeled mouse monoclonal antibody to Immobilized Mouse Monoclonal Goat Anti-Mouse IgG
SARS-CoV-2 nucleocapsid protein Antibody to SARS-CoV-2
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Nucleocapsid Protein Capture
Unrestricted
Restricted©
© Siemens
SiemensHealthineers.,
Healthineers, 2021
AntibodyClinical performance: how well does the test perform in its
intended setting?
Demonstrated performance with anterior nasal samples
Criteria to evaluate clinical Siemens Abbott
Abbott PanBio Roche BD Veritor
Healthineers BinaxNOW
performance
Sensitivity 97.3% 91.1% N/A 84.6% 84.0%
Clinical sensitivity Specificity 100% 99.7% N/A 98.5% 100%
Compared to Compared to nasal
Clinical specificity nasopharyngeal PCR PCR results
results
Days post symptom onset
Size of clinical cohort Demonstrated performance with nasopharyngeal samples
Complexity of trial design Siemens
Abbott PanBio Roche
Abbott
BD Veritor
(sites, operators) Healthineers BinaxNOW
Sensitivity 98.3% 91.4% 96.5% N/A N/A
Specificity 99.6% 99.8% 99.7% N/A N/A
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Data is publicly available from manufacturer instructions for use and websites; sources on file Restricted © Siemens Healthineers., 2021Clinical performance: how well does the test perform in its
intended setting?
How many days after the onset of symptoms can the test be used?
Criteria to evaluate clinical
Days post symptom onset
performance
0 1 2 3 4 5 6 7 8 9 10
Clinical sensitivity
BD Veritor
Clinical specificity
Days post symptom onset Abbott BinaxNOW
Size of clinical cohort Siemens Healthineers
Complexity of trial design
(sites, operators)
Higher days post symptom onset
means more patients can be tested!
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Data is publicly available from manufacturer instructions for use and websites; sources on file Restricted © Siemens Healthineers., 2021Clinical performance: how well does the test perform in its
intended setting?
CLINITEST Rapid COVID-19 Antigen Test: demonstrated performance with
nasopharyngeal samples
Criteria to evaluate clinical PCR
performance Positive Negative Total
CLINITEST Rapid Positive 117 3 120 97.50% PPV
Clinical sensitivity
COVID-19 Antigen Negative 2 743 745 99.73% NPV
Clinical specificity Test Total 119 746 865
98.3% 99.6%
Days post symptom onset Demonstrated Demonstrated
Sensitivity Specificity
Size of clinical cohort
Size of clinical cohort
Complexity of trial design
(sites, operators) Siemens
Abbott PanBio Roche
Abbott
BD Veritor
Healthineers BinaxNOW
# of patients 865 241 426 460 226
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Data is publicly available from manufacturer instructions for use and websites; sources on file Restricted © Siemens Healthineers., 2021Clinical performance: how well does the test perform in its
intended setting?
CLINITEST Rapid COVID-19 Antigen Test clinical study design
Criteria to evaluate clinical
performance 7 clinical trial locations in the United States
Clinical sensitivity
Clinical specificity
Days post symptom onset Wide range of clinical and non-clinical settings,
including a university, hospital, and community
Size of clinical cohort clinic
Complexity of trial design
(sites, operators)
Testing conducted by 24 different healthcare
professionals unfamiliar with testing procedure
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Restricted © Siemens Healthineers., 2021Analytical performance: how well does the test perform under
laboratory conditions?
Lower Limit of Detection CLINITEST Rapid COVID-19 TCID 50/mL
The smallest amount of an analyte that can reliably Antigen Test has a high
degree of analytical
be detected and statistically distinguished from a
sensitivity
blank sample
495
TCID50
“Median Tissue Culture Infectious Dose”
140 141 157
115
Unit used by virologists to measure the amount of
Siemens
BD Veritor
Healthineers
Abbott
BinaxNOW
Roche
Abbott
Panbio
virus required to infect a sample under laboratory
conditions
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Data is publicly available from manufacturer instructions for use and websites; sources on file Restricted © Siemens Healthineers., 2021Competitive summary: how does Siemens Healthineers win?
Siemens Healthineers Abbott Abbott Roche Becton Dickinson
CLINITEST Rapid COVID-19 BinaxNOW Covid-19 Ag PanBio COVID-19 Ag Rapid SARS-CoV-2 Rapid Antigen BD Veritor System for
Antigen Test Card Test Device Test Rapid Detection of SARS-
CoV-2
Results interpretation Visually Read Visually Read Visually Read Visually Read Requires Analyzer
Specimen types Nasopharyngeal, Nasal Nasal Nasopharyngeal, Nasal Nasopharyngeal Nasal
Days post symptom 10 days 7 days Not Indicated Not Indicated 5 days
onset
AN sample sensitivity/ 97.3% / 100% 84.6% / 98.5% 91.1% / 99.7% N/A 84.0% / 100%
specificity
NP sample sensitivity/ 98.3% / 99.6% N/A 91.4% / 99.8% 96.5% / 99.7% N/A
specificity
Clinical cohort 865 NP, 237 AN 460 patients 241 patients 426 patients 226 patients
patients
Lower limit of 115 TCID50/mL 141 TCID50/mL 157 TCID50/mL 495 TCID50/mL 140 TCID50/mL
detection
Regulatory approvals CE Mark CE Mark CE Mark CE Mark
FDA EUA FDA EUA
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Data is publicly available from manufacturer instructions for use and websites; sources on file Restricted © Siemens Healthineers., 2021Thank you for your time!
CLINITEST and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. 18
Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.
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