User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
18 19
Conditions for Authorization
The Proof Diagnostics COVID-19 Test Letter of Authorization
1
, along
with the authorized Fact Sheet for Healthcare Providers, the authorized
Fact Sheet for Patients and authorized labeling are available on the FDA
website: https://www.fda.gov/medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-authorizations-medical-devices/vitro-
diagnostics-euas.
However, to assist in using the Proof Diagnostics COVID-19 Test, the
relevant Conditions of Authorization are listed below:
• Authorized laboratories using your product will include with the
test result reports, all authorized Fact Sheets. Under exigent
circumstances, other appropriate methods for disseminating these
Fact Sheets may be used, which may include mass media.
• Authorized laboratories using your product will use your product as
outlined in the Proof Diagnostics COVID-19 Test System User Manual
and Quick Reference Instructions. Deviations from the authorized
procedures, including the authorized instruments, authorized clinical
specimen types, authorized control materials, other authorized
ancillary reagents and authorized materials required to use your
product are not permitted.
• Authorized laboratories that receive your product will notify the
relevant public health authorities of their intent to run your product
prior to initiating testing.
• Authorized laboratories using your product will have a process in place
for reporting test results to healthcare providers and relevant public
health authorities, as appropriate.
• Authorized laboratories will collect information on the performance of
your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email:
[e-mail]) and Proof Diagnostics (TBD)
any suspected occurrence of false positive or false negative
1 The letter of authorization refers to “Laboratories certied under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet
the requirements to perform high, moderate 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” as “authorized laboratories.”
results and signicant deviations from the established performance
characteristics of your product of which they become aware.
• All operators using your product must be appropriately trained
in performing and interpreting the results of your product, use
appropriate personal protective equipment when handling this kit
and use your product in accordance with the authorized labeling.
• Proof Diagnostics, authorized distributors and authorized
laboratories using your product will ensure that any records
associated with this EUA are maintained until otherwise notied
by the FDA. Such records will be made available to the FDA for
inspection upon request.
Reporting Test Results
Test results should be reported to state and local public health authorities
in accordance with applicable local, state or territorial laws within 24
hours of test completion. Consult your local, state or territorial health
authorities for further information on reporting SARS-CoV-2 test results.
Clinical Performance
The clinical performance characteristics of the Proof Diagnostics
COVID-19 Test were evaluated in a multi-site prospective study in the
U.S. in which patients were sequentially enrolled and tested. A total of
three investigational sites throughout the U.S. participated in the study.
Testing was performed by operators with no laboratory experience and
who are representative of the intended users at CLIA-waived testing
sites. In this study, testing was conducted by a minimum of four intended
users. No training on the use of the test was provided to the operators.
Operators used the Quick Reference Instructions to perform testing. To
be enrolled in the study, patients had to be symptomatic and suspected/
at-risk asymptomatic individuals at the participating study centers.
External control testing, using the Proof Diagnostics COVID-19 Test
External Positive and Negative Controls, was performed prior to sample
testing for each Proof Lab and by each user.