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 stratied
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 dened as
the lowest concentration where 3 out of 3 replicates were detected as
positive for SARS-CoV-2. The LoD was then conrmed 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%