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EVA
LUA
TIO
N O
F TH
E D
IAG
NO
STIC
HYB
RID
S D
3D
UET
DFA
INFL
UEN
ZA A
/RES
PIR
ATO
RY
VIR
US
AN
D D
3 D
UET
D
FA R
SV/R
ESPI
RA
TOR
Y VI
RU
S SC
REE
NIN
G K
ITS
FOR
TH
E D
ETEC
TIO
N O
F R
ESPI
RA
TOR
Y VI
RU
SES
FRO
M
CLI
NIC
AL
SPEC
IMEN
SA
. Mun
son,
D. B
enni
on, D
. Pom
bo, K
. Gib
son
and
P. M
agee
. LD
S In
term
ount
ain
Labo
rato
ry, S
alt L
ake
City
, Uta
h
Am
ende
d Ab
stra
ctIn
trod
uctio
n: T
he ra
pid
dete
ctio
n of
resp
irato
ry v
iruse
s (in
fluen
za A
, B,
para
influ
enza
1, 2
, 3, a
deno
viru
s an
d R
SV) b
y di
rect
imm
unof
luor
esce
nce
(DFA
) ha
s ha
d a
sign
ifica
nt im
pact
on
patie
nt m
anag
emen
t and
, mor
e re
cent
ly,
ther
apeu
tic o
ptio
ns. T
he tw
o pr
edom
inan
t viru
ses
iden
tifie
d du
ring
the
win
ter
resp
irato
ry s
easo
n ar
e in
fluen
za A
and
resp
irato
ry s
yncy
tial v
irus
(RSV
). T
he
new
D3
Due
t DFA
Influ
enza
A/ R
espi
rato
ry V
irus
Scre
enin
g K
it an
dD
3 D
uet D
FA
RSV
/Res
pira
tory
Viru
s Sc
reen
ing
Kit
(Dia
gnos
tic H
ybrid
s ,
Athe
ns, O
H) a
llow
, by
the
use
of fl
uoro
phor
e Ph
ycoe
ryth
erin
, the
spe
cific
iden
tific
atio
n of
thes
e tw
o vi
ruse
s, re
spec
tivel
y, w
hile
scr
eeni
ng fo
r the
oth
er 6
resp
irato
ry v
iruse
s.
Obj
ectiv
e: T
he p
urpo
se o
f thi
s st
udy
was
to e
valu
ate
the
perf
orm
ance
of t
he D
3 D
uet D
FA In
fluen
za A
/ Res
pira
tory
Viru
s Sc
reen
ing
Kit
and
D3
Due
t DFA
R
SV/R
espi
rato
ry V
irus
Scre
enin
g K
it w
ith th
e D
3 U
ltra
DFA
scr
eeni
ng re
agen
t (D
HI)
and
Sim
ulFl
uor™
Res
pira
tory
Scr
een
reag
ent (
CH
EMIC
ON
Inte
rnat
iona
l, Te
mec
ula,
CA)
. M
ater
ials
and
met
hods
: 319
spe
cim
ens
(nas
opha
ryng
eal [
NP]
sw
abs,
NP
aspi
rate
s, N
P w
ashe
s an
d br
onch
ial w
ashe
s) w
ere
proc
esse
d ac
cord
ing
to
stan
dard
labo
rato
ry p
ract
ices
for t
he p
repa
ratio
n of
cel
l spo
ts fo
r DFA
test
ing.
C
ell s
pots
wer
e st
aine
d w
ith th
e fo
ur re
agen
ts a
ccor
ding
to m
anuf
actu
rer’s
in
stru
ctio
ns.
Res
ults
:
1-Fl
u A/
RSV
dua
l inf
ectio
n w
as d
etec
ted
by b
oth
D3
Due
t Kits
. †
1-R
SV/P
arai
nflu
enza
3 d
ual i
nfec
tion
was
det
ecte
d by
the
D3
Due
t RSV
/Res
py
Con
clus
ions
: Th
e D
3 D
uet D
FA In
fluen
za A
/ Res
pira
tory
Viru
s Sc
reen
ing
Kit
corr
elat
ed c
ompl
etel
y w
ith th
e D
3 U
ltra
DFA
scr
eeni
ng re
agen
t (D
HI).
The
PE
labe
led
antib
ody
iden
tifie
d th
e ta
rget
viru
s w
ith 1
00%
sen
sitiv
ity/s
peci
ficity
. The
re
mai
ning
FIT
C la
bele
d an
tibod
ies
also
had
a 1
00%
sen
sitiv
ity/s
peci
ficity
. The
D3
Due
t DFA
RSV
/Res
pira
tory
Viru
s Sc
reen
ing
Kit
faile
d to
det
ect 1
pos
itive
RSV
cu
lture
. The
PE
labe
led
antib
ody
iden
tifie
d th
e ta
rget
viru
s w
ith 9
9% s
ensi
tivity
an
d 10
0% s
peci
ficity
. The
rem
aini
ng F
ITC
labe
led
antib
odie
s ha
d a
100%
se
nsiti
vity
/spe
cific
ity. T
he C
hem
icon
Sim
uFlu
or™
Res
pira
tory
Scr
een
reag
ent
was
som
ewha
t les
s se
nsiti
ve fo
r bot
h th
e de
tect
ion
of R
SV (9
6%) a
nd fo
r de
tect
ion
of F
lu A
(79%
). Th
e ab
ility
to ra
pidl
y de
tect
influ
enza
A a
nd R
SV
spec
ifica
lly w
ithin
a re
spira
tory
scr
eeni
ng p
ool w
ill re
duce
turn
aro
und
time
to
resu
lts, t
echn
ical
tim
e by
elim
inat
ing
addi
tiona
l cel
l spo
ts a
ndty
ping
, as
wel
l the
ex
pens
es re
latin
g to
add
ition
al v
irus
iden
tific
atio
n pr
oced
ures
.. St
udy
Obj
ectiv
eD
eter
min
e th
e pe
rform
ance
cha
ract
eris
tics
of th
e D
iagn
ostic
Hyb
rids
D3
Due
t DFA
Influ
enza
A/R
espi
rato
ry V
irus
Scr
eeni
ng K
it an
d th
e D
3 D
uet D
FA R
SV
/Res
pira
tory
Viru
s S
cree
ning
Kit
whe
n di
rect
ly s
tain
ing
fresh
resp
irato
ry s
peci
men
s as
com
pare
d to
that
of D
iagn
ostic
Hyb
rids
D3
Ultr
a D
FA S
cree
ning
Rea
gent
and
sim
ulta
neou
sly
to C
hem
icon
S
imul
fluor
™R
espi
rato
ry S
cree
ning
Rea
gent
.
Met
hods
Thre
e hu
ndre
d-ni
nete
en p
rosp
ectiv
e re
spira
tory
spe
cim
ens
wer
e co
llect
ed a
t a la
rge,
wes
tern
Uni
ted
Sta
tes
refe
renc
e la
bora
tory
usin
g ap
prov
ed c
olle
ctio
n m
etho
ds fo
r nas
opha
ryng
eal a
spira
tions
, na
soph
aryn
geal
was
hing
s, n
asop
hary
ngea
l sw
abs,
bro
nchi
oalv
eola
r la
vage
, tra
chea
l asp
iratio
ns a
nd s
puta
, res
pect
ivel
y. P
atie
nt s
ex, a
ge a
nd
spec
imen
sou
rce
wer
e re
cord
ed fo
r eac
h sp
ecim
en (s
ee ta
ble
#2).
Eac
h sp
ecim
en w
as p
roce
ssed
and
fixe
d to
slid
es u
sing
the
man
ufac
ture
r’s
prod
uct i
nser
t ins
truct
ions
for e
ach
of th
e ki
ts u
sed.
Con
trol s
lides
wer
e al
so in
clud
ed w
ith e
ach
day’
s st
ain
batc
h to
insu
re fu
nctio
nalit
y of
the
resp
ectiv
e st
ains
. Sta
inin
g w
as p
erfo
rmed
acc
ordi
ng to
man
ufac
ture
r’s
inst
ruct
ion
and
exam
ined
usi
ng a
UV
mic
rosc
ope
with
a b
road
-ban
d fil
ter
syst
em th
at c
aptu
res
fluor
esce
nce
from
bot
h FI
TC a
nd p
hyco
eryt
hrin
la
bels
. Res
ults
of t
he re
spec
tive
Due
t sta
ins,
Ultr
a sc
reen
ing
reag
ent a
nd
Che
mic
on S
imul
fluor
™du
al s
tain
wer
e re
cord
ed. D
iscr
epan
t ana
lysi
s w
as a
ccom
plis
hed
by c
ultu
re a
nd v
irus
iden
tific
atio
n us
ing
eith
er D
3 U
ltra
or C
hem
icon
resp
irato
ry v
irus
iden
tific
atio
n sy
stem
s.
Sum
mar
y of
Res
ults
One
-hun
dred
forty
-one
of t
he 3
19 s
peci
men
s w
ere
dete
rmin
ed to
be
posi
tive
by D
iagn
ostic
Hyb
rids
D3
Ultr
a D
FA R
espi
rato
ry V
irus
Scre
enin
g R
eage
nt. T
he d
istri
butio
n of
pos
itive
sam
ples
by
viru
s is
olat
ed is
lis
ted
belo
w in
Tab
le #
1. T
he D
3 D
uet D
FA In
fluen
za A
/Res
pira
tory
Viru
s S
cree
ning
Kit
was
abl
e to
det
ect
all v
iruse
s de
tect
ed b
y D
3 U
ltra
for a
100
% s
peci
ficity
and
sen
sitiv
ity,.
The
D3
Due
t DFA
RSV
/Res
pira
tory
Vi
rus
Scre
enin
g Ki
t fai
led
to d
etec
t one
RSV
isol
ate
dete
cted
by
D3
Ultr
a re
sulti
ng in
a s
peci
ficity
of 1
00%
an
d a
sens
itivi
ty o
f 99.
7%, r
espe
ctiv
ely.
The
Lig
ht D
iagn
ostic
s™Si
mul
fluor
®Ki
t fai
led
to d
etec
t Inf
luen
za
A in
thre
e sp
ecim
ens
and
RSV
in fo
ur s
peci
men
s re
sulti
ng in
a s
ensi
tivity
for t
he d
etec
tion
of in
fluen
za A
an
d R
SV o
f 79%
and
96%
, res
pect
ivel
y. A
ll re
sults
are
list
ed b
elow
in T
able
#1.
Dis
tribu
tion
of c
onfir
med
vi
rus
dete
ctio
ns b
y ag
e gr
oup
is a
lso
prov
ided
in T
able
#2.
Tw
o du
al in
fect
ions
wer
e de
tect
ed b
y th
e D
3 D
uet D
FA R
SV/R
espi
rato
ry V
irus
Scre
enin
g Ki
t (Fl
u A
& R
SV;
RSV
&Pa
rain
fluen
za 3
) and
one
dua
l in
fect
ion
was
det
ecte
d by
the
D3
Due
t DFA
Influ
enza
A/R
espi
rato
ry V
irus
Scre
enin
g Ki
t (Fl
u A
& R
SV).
Con
clus
ion
–Th
e ab
ility
to ra
pidl
y de
tect
influ
enza
A a
nd R
SV s
peci
fical
ly w
ithin
a re
spira
tory
scr
eeni
ng p
ool w
ill
redu
ce tu
rn a
roun
d tim
e to
resu
lts, t
echn
ical
tim
e by
elim
inat
ing
addi
tiona
l cel
l spo
ts a
nd ty
ping
, as
wel
l as
the
expe
nses
rela
ted
to a
dditi
onal
viru
s id
entif
icat
ion
proc
edur
es.
DFA
Scr
eeni
ng R
eage
ntFi
nal I
dent
ifica
tion
Neg
Pos
RSV
Flu
AFl
u A
Flu
BR
SVA
deno
Para
1Pa
ra 2
Para
3
D3
Ultr
a17
814
1N
A14
510
811
11
1
D3
Due
t Fl
uA/
Res
py*
178
129
NA
1414
510
811
11
1
D3D
uet
RSV
/Res
py*,
†17
935
107
NA
145
107
111
11
Che
mic
on
Sim
ulflu
or18
730
104
NA
115
104
111
11
305
0D
3D
uet F
lu A
/ R
espy
Neg
ativ
e
014
D3
Due
t Flu
A /
R
espy
Posi
tive
D3 U
ltra
FluA
Neg
ativ
eD
3 Ultr
a Fl
u A
Pos
itive
211
1D
3 Due
t RSV
/ R
espy
Neg
ativ
e
010
7D
3 Due
t RSV
/ R
espy
Posi
tive
D3 U
ltra
RSV
Neg
ativ
eD
3 Ultr
a R
SV P
ositi
ve
305
3Si
mul
fluor
Fl
uAN
egat
ive
011
Sim
ulflu
or
FluA
Posi
tive
D3 U
ltra
FluA
Neg
ativ
eD
3 Ultr
aFl
uAPo
sitiv
e
211
4Si
mul
fluor
R
SV N
egat
ive
010
4
Sim
ulflu
or
RSV
Pos
itive
D3 U
ltra
RSV
Neg
ativ
eD
3 Ultr
a R
SV P
ositi
ve
Influ
enza
A w
/ Inf
luen
za A
/Res
pira
tory
Due
tIn
fluen
za A
w/In
fluen
za A
/Res
pira
tory
Due
t
Influ
enza
A w
/RSV
/Res
pira
tory
Due
tIn
fluen
za A
w/R
SV R
espi
rato
ry D
uet
RSV
w/R
SV/R
espi
rato
ry D
uet
Dua
l inf
ectio
n w
/RS
V/R
espi
rato
ry D
uet
RSV
w/In
fluen
za A
/Res
pira
tory
Due
tD
ual I
nfec
tion
w/F
lu A
/Res
pira
tory
Due
t
Com
paris
on o
f Lig
ht D
iagn
ostic
s™Si
mul
fluor
®to
D3
Ultr
a R
espi
rato
ry
Com
paris
on o
f Dia
gnos
tic H
ybrid
s D
3R
espi
rato
ry D
uet D
FA K
its to
D3
Ultr
a
