User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
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information is necessary to determine patient infection status. Positive
results do not rule out bacterial infection or co-infection with other viruses.
Testing facilities within the United States and its territories are required to
report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be
used as the sole basis for patient management decisions. Negative results
should be treated as presumptive and, if inconsistent with clinical signs
and symptoms or necessary patient management, should be tested with
different authorized or cleared molecular tests.
The Proof Diagnostics COVID-19 Test is only for use under the Food and
Drug Administration’s Emergency Use Authorization.
Principles of the Procedure
TBC
Operation
Proof Lab Test System
• 1 x Proof Lab Reader
• 1 x Quick Reference Instructions
• 1 x User Manual
• 1 x Power Cord
Proof Diagnostics COVID-19 Test Kit
• 1 x Test Cartridge
• 1 x Sample Vial
• 1 x Nasal Swab
• 1 x Exact Volume Transfer Pipette
• 1 x Quick Reference Instructions
NOTE:
• Please check all packaging and contents for any visible signs of
damage. If any damage is found, please contact Proof Diagnostics
(see “Support” on page 29).
• The Quick Reference Instructions are for reference only. It is the
responsibility of the laboratory or clinic to ensure that all users
of the Proof Diagnostics System understand how to safely and
correctly perform a test.
Required Materials
The following materials are required but not provided:
• Positive and Negative Controls (described on the following page)