Page 15 - HSP-Assure Test Booklet FDA Auth Booklet - FINAL 8_2020

FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus

Assure COVID-19 IgG/IgM Rapid Test Device - Assure Tech. (Hangzhou Co., Ltd) Disease 2019

July 6, 2020 (COVID-19)

This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the
Assure COVID-19 IgG/IgM Rapid Test Device.
This test detects human SARS-CoV-2 IgM and
IgG that are generated as part of the human
Assure COVID-19 IgG/IgM Rapid Test Device is
authorized for the detection of IgG and IgM antibodies adaptive immune response to the COVID-19 virus
to SARS-CoV-2 in human venous whole blood (sodium and is to be performed only using human venous
EDTA), serum, or plasma (sodium EDTA). whole blood, serum, or plasma specimens.

All individuals whose specimens are tested immune response to SARS-CoV-2, indicating recent or
with the test will receive the Fact Sheet for prior infection.
Recipients: Assure COVID-19 IgG/IgM Rapid
Test Device. • Assure COVID-19 IgG/IgM Rapid Test Device should not
be used to diagnose or exclude acute infection and
should not be used as the sole basis for treatment or
What are the symptoms of COVID-19? patient management decisions. Direct testing for SARS-
Many individuals with confirmed COVID-19 have CoV-2 should be performed if acute infection is
developed fever and/or symptoms of acute respiratory suspected.
illness (e.g., cough, fever, difficulty breathing). The current • Assure COVID-19 IgG/IgM Rapid Test Device is
information available to characterize the spectrum of authorized for use in laboratories certified under the
clinical illness associated with COVID-19 suggests that Clinical Laboratory Improvement Amendments of
symptoms include cough, shortness of breath or dyspnea, 1988 (CLIA), 42 U.S.C. §263a, that meet
fever, chills, myalgias, headache, sore throat or new loss requirements to perform moderate or high
of taste or smell. Based on what is known about the virus complexity tests.
that causes COVID-19, signs and symptoms may appear
any time from 2 to 14 days after exposure to the virus. • Please refer to the Assure COVID-19 IgG/IgM Rapid
Based on preliminary data, the median incubation period Test Device instructions for use for additional
is approximately 5 days, but may range 2-14 days. information.

Public health officials have identified cases of COVID-19 Specimens should be collected with appropriate infection
infection throughout the world, including the United States, control precautions. Current guidance for COVID-19
which poses risks to public health. Please check the CDC infection control precautions are available at the CDC’s
webpage for the most up-to-date information. website (see links provided in “Where can I go for

What do I need to know about COVID-19 antibody updates and more information” section).
testing?
Current information on COVID-19 for healthcare providers Use appropriate personal protective equipment when collecting
and handling specimens from individuals suspected of having
is available at CDC’s webpage, Information for Healthcare
Professionals (see links provided in “Where can I go for COVID-19 as outlined in the CDC Interim Laboratory Biosafety
Guidelines for Handling and Processing Specimens Associated
updates and more information” section).
with Coronavirus Disease 2019 (COVID-19). For additional
information, refer to CDC Interim Guidelines for Collecting,
• Assure COVID-19 IgG/IgM Rapid Test Device Handling, and Testing Clinical Specimens from Persons Under
can be ordered by healthcare providers to test Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)
human venous whole blood (sodium EDTA), (see links provided in “Where can I go for updates and more
serum, or plasma (sodium EDTA) for use as an information” section).
aid in identifying individuals with an adaptive

Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

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