User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
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• Inadequate or inappropriate sample collection, storage and transport
may yield false test results.
• Please follow the instructions provided in this manual to obtain
accurate results. Ensure the Proof Lab Reader and Test Kit are
maintained at room temperature: 15 to 30°C (59 to 86°F).
• Ensure the Proof Lab Reader and Test Kit are maintained at room
temperature: 15 to 30°C (59 to 86°F).
• Do not use the Test Cartridge if the packaging appears damaged or
the expiration date has passed.
• Do not use the swab or sample vial if the packaging appears damaged.
• For use with nasal swabs only.
• Only use the swab included with the Proof Diagnostics COVID-19
Test Kit.
• The Proof Lab Reader must be placed on a stable, level surface away
from direct sunlight or other heat sources.
General Safety
WARNING: To reduce the risk of electrical shock:
• Do not attempt to disassemble the Proof Lab. The Proof Lab contains
no user serviceable parts. For technical assistance, see “Support” on
page 31.
• Disconnect the device from the main power outlet before cleaning.
Do not attempt to clean inside the cartridge insertion slot.
• Do not immerse the device in liquid.
• Only wipe the external surfaces of the device using the recommended
cleaning agents. (For further information, see “Cleaning the Device”
on page 25.)
Biohazards
WARNING: To reduce the risk of exposure to any biological hazards:
• Always ensure that proper laboratory procedures are followed when
handling and disposing of potentially hazardous material.
• Dispose of used and unused kit contents as biohazardous waste
according to federal, state and local regulatory requirements.
• The use of Nitrile, Latex or other suitable safety gloves is strongly
recommended while using the Proof Diagnostics Test System.
Introduction
About
Coronavirus disease (COVID-19) is an infectious respiratory disease
caused by a novel human coronavirus and named by the World Health
Organization (WHO) as severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2). The COVID-19 virus spreads primarily through droplets of
saliva or discharge from the nose when an infected person coughs
or sneezes. While most people infected with the COVID-19 virus will
experience only mild to moderate respiratory illness, the disease can
also cause severe respiratory illness and death. The WHO declared the
disease a pandemic in early 2020.
The COVID-19 assay is a rapid molecular in vitro diagnostic test utilizing
isothermal nucleic acid amplication and CRISPR-mediated detection of
the resulting amplicon.
The Proof Diagnostics Test System signicantly reduces the amount of
time taken for COVID-19 testing with results typically available in about
30 minutes.
Intended Use
The Proof Diagnostics Test System is a molecular diagnostic test used
for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA
in nasal swabs taken from individuals who are suspected by a healthcare
professional of having COVID-19 or individuals at risk due to contact
with COVID-positive individuals. Testing of nasal swabs using the Proof
Diagnostics COVID-19 Test is limited to laboratories certied under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
§263a, that meet the requirements to perform moderate, high or waived
complexity tests. This test is authorized for use at the Point of Care (POC),
i.e., in patient care settings operating under a CLIA Certicate of Waiver,
Certicate of Compliance or Certicate of Accreditation.
Results are for the identication of SARS-CoV-2 RNA. The SARS-CoV-2
RNA is generally detectable in nasal specimens during the acute phase
of infection. Positive results are indicative of the presence of SARS-
CoV-2 RNA; clinical correlation with patient history and other diagnostic