User's Manual

PROOF DIAGNOSTICS COVID-19 TEST SYSTEM
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Analytical Reactivity (Inclusivity)
The inclusivity of the Proof Diagnostics COVID-19 Test was evaluated
using in silico analysis of the assays primers and probes in relation to [#]
SARS-CoV-2 sequences available in the GISIAD gene database for N gene.
Results TBD
Analytical Specicity (Cross-Reactivity or Exclusivity)
Analytical specicity of the Proof Diagnostics COVID-19 Test was
evaluated by preparing triplicate negative nasal swabs spiked with each
of the cross-reactivity organisms listed below. Swabs were placed into
the sample vial and processed and analyzed as per the User Manual.
No cross-reactivity was observed.
Cross-Reactivity With Various Organisms
PATHOGEN CONCEN-
TRATION
(PFU/ML)
SARS-
COV-2
DETECTED
PATHOGEN CONCEN-
TRATION
(PFU/ML)
SARS-COV-2
DETECTED
Adenovirus (71) TBD RSV (type A) TBD
Parainuenza
virus type 1
TBD RSV (type B) TBD
Parainuenza
virus type 2
TBD
Human
Metapneumo-
virus
TBD
Parainuenza
virus type 3
TBD Enterovirus
(EV68)
TBD
Parainuenza
virus type 4 a
TBD Human
Rhinovirus
TBD
Inuenza virus
A/New Cale-
donia/20/99
(H1N1)
TBD Human
coronavirus
NL63
TBD
Inuenza virus
A/Beijing/
262/95 (H1N1)
TBD Human
coronavirus
HKU1
TBD
Inuenza virus
A/NewYork/
55/2003 (H3N2)
TBD Human
coronavirus
229E
TBD
Inuenza virus
B/Florida/4/2006
TBD Human
coronavirus
OC43
TBD
SARS-corona-
virus
TBD MERS-
coronavirus
TBD
Chlamydia
pneumoniae
TBD TBD
Haemophilus
inuenzae
TBD TBD
Legionella
pneumophila
TBD TBD
Mycobacterium
tuberculosis
TBD TBD
Streptococcus
pneumoniae
TBD TBD
Streptococcus
pyogenes
TBD TBD
Bordetella
pertussis
TBD TBD
Mycoplasma
pneumoniae
TBD TBD
Pneumocystis
jirovecii
TBD TBD
Candida
albicans
TBD TBD
Pseudomonas
aeruginosa
TBD TBD
Pooled human
nasal wash
N/A TBD