COVID-19 (IGG/IGM) RAPID ANTIBODY TEST - ARTG 341411 - INDIGENOUS ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
COVID-19 (IgG/IgM) Rapid Antibody Test ARTG 341411
The Simple COVID-19
Rapid Antibody Test
Innovative, all-in-one point of care test for the qualitative detection of IgG and IgM
antibodies to SARS-CoV-2 virus in whole blood, serum, or plasma samples.
Unlike standard multi-component rapid test kits, the
AtomoRapid™ COVID-19 (IgG/IgM) Rapid Antibody Test is a single-use,
integrated device that gives an accurate result in just 15 minutes.
Intended for identifying persons who may have been exposed and developed
an immune response to the SARS-CoV-2 virus, the test is entered in the
Australian Register of Therapeutic Goods ARTG 341411 and is available now in
Australia for use by healthcare professionals.
SIMPLE AND ACCURATE
The all-in-one AtomoRapid™ Unmatched Usability
COVID-19 (IgG/IgM) Rapid
Antibody Test simplifies the
test procedure by removing
the need for multiple test
components.
• Ergonomic design eliminates Built-in Safety Lancet
common user errors and improves
test performance
Accurate Blood
Collection
• Easy-to-use and requires only
minimal training Prick the finger
• No need for ancillary test
Collect blood
components, simplifying supply sample
chain requirements
Test Strip
• No risk of needlestick injury, as
auto-retracting lancet is double Easy-to-Read Results
shielded after use for safe disposal
Transfer blood
Results Interpretation sample
• Unique blood collection mechanism
collects exactly the required
volume of blood to ensure optimal Negative
test performance
Easy-to-Read
• Blood sample is delivered cleanly Result
Positive
to the test strip, ensuring reliability,
and further simplifying the test
Add buffer
procedure solution
PROVEN
Clinically Proven
Sensitivity Specificity
Developed in partnership with French biotechnology specialist
96.8%* NG Biotech, the AtomoRapid™ COVID-19 (IgG/IgM) Rapid
Antibody Test has demonstrated excellent performance in
100%*
multiple independent clinical evaluations internationally.
The Platform You Can Trust
The AtomoRapid™ COVID-19 (IgG/IgM) Rapid Antibody Test incorporates
Atomo’s award-winning ‘Galileo’ integrated diagnostic test platform – designed
and developed in Australia – for peerless safety and utility.
Atomo Diagnostics is a global leader in the design of medical devices for blood-
based diagnostic testing. Headquartered in Sydney, Australia, the company is the
recipient of multiple awards for innovation. Recognised worldwide for the ease-
of-use of its diagnostic test products, Atomo manufactures the first and only HIV
self-test to have been approved for sale in Australia.
* Van der Werf S et al (2020). Performance evaluation report for the detection of anti SARS-CoV-2 antibodies. National Reference
Centre for Respiratory Infection Viruses (including influenza), Institut Pasteur, Paris.
Available Now for Healthcare Professionals in Australia.
The AtomoRapid™ COVID-19 (IgG/IgM) Rapid Antibody Test
has been developed for healthcare professionals and is available for use
by registered medical practitioners; healthcare professionals in residential
and aged care facilities; pathology laboratories; Commonwealth, State,
or Territory departments of health, and agencies acting of their behalf.
PRODUCT SPECIMEN FORMAT PACK SIZE STORAGE PRODUCT CODE
AtomoRapid™ Whole blood, All-in-One 5 Tests 4 – 30˚C ARCV001-01
COVID-19 (IgG/ serum, System 24 months
IgM) Rapid plasma
Antibody Test
Contact us today for more information
or purchasing enquiries:
LBL-079-01
covid@atomodiagnostics.com
atomodiagnostics.com
You can also read
