User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
20 21
The performance of the Proof Diagnostics COVID-19 Test was established
with [#] nasal swabs collected from individual symptomatic patients and
asymptomatic at risk individuals who were suspected of COVID-19 under
Institutional Review Board approval and Informed Consent.
Retrospective COVID-19 Positive and Negative Samples were included in the
clinical study two weeks after prospective enrollment of subjects. These clinical
specimens are included in the study data.
Proof Diagnostics COVID-19 Test Performance Against
Comparator Method:
PROOF DIAGNOSTICS
COVID-19 TEST
CDC 2019-NOVEL CORONAVIRUS (2019-NCOV) REAL-TIME
RT-PCR DIAGNOSTIC PANEL
POSITIVE NEGATIVE TOTAL
POSITIVE
TBD TBD TBD
NEGATIVE
TBD TBD TBD
TOTAL
TBD TBD TBD
Positive Agreement: TBD/TBD TBD% (95% CI: TBD%-TBD%)
Negative Agreement: TBD/TBD TBD% (95% CI: TBD%-TBD%)
Patient Demographics
Patient demographics (gender and age) are available for the [#] samples
used in the analysis. The table below shows the positive results stratied
by patient age.
GENDER PROOF DIAGNOSTICS COVID-19 TEST
TOTAL POSITIVE PREVALENCE
MALE
TBD TBD TBD
FEMALE
TBD TBD TBD
AGE PROOF DIAGNOSTICS COVID-19 TEST
TOTAL POSITIVE PREVALENCE
≤ 5 YEARS
TBD TBD TBD
6 TO 21 YEARS
TBD TBD TBD
22 TO 59 YEARS
TBD TBD TBD
≥ 60 YEARS
TBD TBD TBD
Analytical Performance
Limit of Detection (LoD)
The limit of detection for the Proof Diagnostics COVID-19 Test was
determined by using viral genomic RNA diluted in pooled negative swab
matrix and spiked onto sterile nasal swabs. Three-fold dilutions of the
inactivated virus were prepared and then spiked onto negative nasal
swabs in replicates of 3 swabs per dilution. Swabs were then processed
to identify the preliminary LoD. The preliminary LoD was dened as
the lowest concentration where 3 out of 3 replicates were detected as
positive for SARS-CoV-2. The LoD was then conrmed with 20 replicates
at the same concentration by spiking 20 swabs and processing them in
the same manner.
This LoD study determined the lowest detectable concentration of
SARS-CoV-2 at which approximately 95% of all (true positive) replicates
tested positive. The LoD for the Proof Diagnostics COVID-19 Test was
determined to be TBD.
CONCENTRATION (PFU/ML) NUMBER OF POSITIVE/TOTAL % DETECTED
TBD TBD/20 TBD%