User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
6 7
Test Kit Storage and Use
Store Test Cartridges, swabs and sample vials at room temperature
(15 to 30°C or 59 to 86°F) in their original packaging away from
direct sunlight.
All Test Kit consumables (cartridges, swabs and sample vials) are
single use only.
Do not remove the Test Cartridges, swabs or sample vials from their
packaging until immediately prior to use.
The Proof Diagnostics Test System
Proof Lab
Proof Diagnostics
COVID-19 Test Kit
Quality Controls
Internal Control
The COVID-19 Test Kit also includes an Internal Control for the presence of
human RNA. Human beta-actin primers are included in the Proof Cartridge
amplication reaction to ensure the presence of human cellular RNA in the
test sample and are used in determining the nal test result.
External Positive and Negative Controls
Proof Diagnostics recommends positive and negative controls be purchased
separately from ZeptoMetrix (Buffalo, NY). Details are provided below.
Positive Control: SARS-Related Coronavirus 2 (SARS-CoV-2)
External Run Control. Catalog Number: NATSARS(COV2)-ERC1
Negative Control: SARS-Related Coronavirus 2 (SARS-CoV-2)
Negative Run Control. Catalog Number: NATSARS(COV2)-NEG1
The external positive and negative controls will monitor the entire test.
External controls shall be evaluated:
Once with each new reader set up.
Once with each new lot of Test Kits received.
Once with each new operator.
When problems with testing are suspected or identied.
As necessary to conform with local, state and/or federal regulations,
accrediting requirements or your lab’s standard quality control
procedures.
If correct results are not obtained, discard the Test Cartridge and repeat
the test with a new Test Kit. If the subsequent test fails, report the problem
to Proof Diagnostics technical support (TBD).
Nasal Swab Sample Vial Exact Volume
Transfer Pipette
Test Cartridge
LED Display
Lid