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Warnings and Precautions
Warnings
For prescription use only. For in vitro diagnostic use only. For Emergency Use
Authorization Only.
This test has not been FDA cleared or approved but has been authorized for
emergency use by FDA under an EUA for use by authorized laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
263a, that meet the requirements to perform moderate or high complexity tests.
This test 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 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
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated or authorization is revoked sooner.
Do not use kits or reagents after the expiration dates shown on the labels.
Ensure test is run away from direct sunlight.
Do not use damaged test kit. Do not reuse the test kit.
Human serum and plasma samples should be considered as potentially infectious.
Operators should wear protective clothing, masks, gloves and take other appropriate
safety precautions to avoid or reduce the risk of infection.
Precautions
When working with chemicals, always wear a suitable lab coat, disposable gloves, and eye
protection goggles. For more information, please consult the appropriate safety data sheets
(SDSs).
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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