Owners manual

Multi-Drug
Rapid Test Midstream
(Oral
Fluid)
Package
lnsert
A
rapid test
for the
simultaneous,
qualitative
detection of multiple
drugs and drug
metabolites in
human
saliva.
For healthcare
professionals
including
professionals
at
point
of
care
sites.
lmmunoassay
for
in
vitro
diagnostic use only.
IINTENDED
USEI
The
Multi-Drug
Rapid
Test
Midstream
for
AMP
/MET /COC
/OPl
/THC
/PCP /MTD
/MDMA
/OXY ICOT
IRzIBZOIKET is
a
lateralflow
chromatographic immunoassay for
the
qualitative
detection of multiple
drugs and drug metabolites
in
saliva at
th6 following
cut.ofi
concentrations:
I
SUMMARYI
The Multi-Drug Rapid Test
Midstream for AMP
/MET
/COC
lOPl ffHC /PCP
/MTD
/[\,4DMA
/OXY
/COT
IKZ
IBZA
and their metabolites is
a rapid,
saliva
screening
test that
can be
performed
without
lhe
use
of
an
instrurnent.
The
test utilizes monoclonal
antibodies to
selectively detect elevated
levels
of specific
drugs
in human
saliva
Amphetamine
{AMP}
Amphetamine is
a
sympathominetic
amine with
therapeutic
indications.
The
drug
is
ofien
self-administered
by
nasal inhalation
or oral
ingestion.
Depending
on the
route
of
adrlinistration,
amphetamine
can
be detected
in
oral-fluid
as early as
5-I0
minutgs following
use'. Amphetamine
can be detected
in
oralfluids
for
up
lo72 hours
after
use'.
The
amphetarnine
assay
contained
within
the Multi-Drug Rapid Test
Midstream
yields
a
positive
result
when
the amphetamine
concentration
in oral fluid exceeds S0ng/ml.
Metharnphetamine
(MET)
lletlramphetamine
is-a
poient
stimulant
chemically
related
to
amphetamine but
with
greater
CNS stimulation
properties.
The drug
is
often self-administered
by nasal
inhalation,
smoking
or oral ingestion.
Depending
on
the
route
of
administra$on, methamphetamine
can
be
detected
in
oral
fluid
as early as 5-10
minutes
fo[owing
use'. Methamphetamine
can
be detected in
oral
fluids
for
up to
72
hours
after use'.
The
Methamphetamine
assay contained within
the Multi-Drug Rapid Test Midstneam
yields
a
positive
reqult
when
the methamphetamine
concentration in
bralffuid exceeds S0ng/inL.
Cocaine
(COCI
Cocaine is a
potent
central nervous
system
(CNS)
stimulant
and
a
local
anesthetic derived
from
the
coca
plant
(erythroxylum
coca). The
drug
is
often
self-administered
by
nasal
inhalation, intravenous injection
and
Fee-base smoking,
Depending
on the
route
of
administration,
cocaine
and metabolites
benzoylecgonine and ecgoninq
methyl
ester
can
be
detected in oral fluid
?s.
qarl.y.
as
5-10 minutes fotlowing.yse'.
,
Cocaine
and
benzoylecgonine
can
be
detected
in
oral
fluids
for
up to 24
hours
after
use
.
The
cocaine assay c.ontained within
the Multi-Drug
Rapid
Test
Midstream for cocaine and
opiates
yields
a
positive
result
when the
cocaine
metabolite in
oralfluid exceeds
Z0ng/mL.
Opiatet
(OPIIMOP)
The
drug
class opiates
refers
to any drug that is
derived
from
the
opium
poppy,
including
naturally
occurring compounds
such as morphine
and codeine and semi-synthetic drugi
such as heroin.
Opiates act to control
pain
by depressing
the central
nervous system,
The
drugs dernonstrate addictive
properties
when
used fbr
sustained
periods
of time;
symptoms
of
withdrawal
may
include
sweating, shaking,
nausea
and
irritability.
Opiates
can
be
taken
orally or
by injection
routes including
intravenous,
intramuscular and
subcutaneous: illegal
users
may
also
take the
intravenously
or by nasal
inhalation.
Using an
immunoassay
cutoff level
of 40
ng/mL,
codeine can be detected
in
the oral fluid
within
I
hour
following
a
single oral
dose
and
can
remain
detectable
for 7-21 hours
after
the dose'.
Heroin
metabolite 6-monoacetylmorphine
(6-MAM)
is found
more
prevalently
in
excreted
unmetabolized, and
is
also the major
metabolic
product
of codeine and
heroin.
The
opiates assay
contained
within
the
Multi-Drug Rapid
Test Midstream
yields
a
positive
result
when the
opiates concentration in
oral
fluid
exceeds
40
ng/mL.
Marijua4a
(THC)
11"-n6r-Ae-tdtrahydrocannabinol-9-carboxylic
acid
(A9-THC-COOH),
the metabolite
of
THC
(A'-tetrahydrocannabinol),
is detectable in
saliva
shortly
after use.
The
detection
of the
drug
is thought
to
be
primarily
due
to the direct exposure
of
the drug to the rnouth
(orral
anfl
smoking administrations)
and the
subsequent
seguestering
of the drug in
the buccal cavity'.
Historicalstudies have
shown a window of detection for
THC in
saliva of
up to
14 hours
after
drug
use3.
The THC
assay
pontained
within the
Multi-Drug Rapid Test Midstream
yields
a
positive
result
when the
A"-tetrahydrocannabinol
concentration
in oralfluid
exceeds
SOng/mL.
Phencyclidine
{PCP)
Phencyclidine,
the
hallucinogen commonly referred
to as Angel Dust,
can be detected
in
saliva as a result
of the exchange
of
the
drug between the
circulatory system and
the oral
cavity.
ln
a
paired
serum and saliva
sample collection
of
100
patients
in
an Emergency
Department, PCP
waq
detected
in
the
saliva of
79
patients
at
levels
as
low
as 2
ng/ml
and
as high
as oo0 ng/mLa.
The
PCP assay_ contained within the Multi-Drug
Rapid Test
Midstream
yields
a
positive
result when the PCP
concentration
in
oral fluids
exceeds
'l0ng/mL.
Methadone
(MTD)
Methadone
is
a
narcotic
analgesic
prescribed
for the
management of
moderate
to
severe
pain
and
for
the treatment
of opiate dependence
(heroin,
Vicodin, Percocet, morphine).
Methadone is
a
long
acting
pain
reliever
producing
effects that
last from
twelve to forty:eight
hours. ldeally,
methadone frees
the client
from the
pressures
of obtaining illegal heroin, from
the dangers of
injection, and from
the emotional roller coaster
that most opiates
produce.
Methadone, if
taken
for
long
periods
and at
large
doses, can lead to a very long
withdrawal
period.
The withdrawals from
rnethadone
are
more
prolonged
and troublesome
than those
provoked
by heroin cessation,
yet
the
substitutlon
and
phased
removal
of methadone is an
acceptable method of
detoxification
for
patients
and therapists.
The
MTD
assay contained
within
the Multi-Drug Rapid
Test
Midstream
yields
a
positive
reSult
when the MTD concentration in
saliva
exceeds 30nglmL.
Oxycodone
(OXY)
Oxycodone
is a
semi-synthetic
opioid with
a
shuctural similarity
to codeine. The
drug
is
manufactured
by
modifying
thebaine,
an alkaloid
found in
the opium
poppy.
Oxycodone,like
all opiate agonists,
provides
pain
relief
by acting on
opioid
receptors in
the spinal
cord,
brain,
and
possibly
directly
in
the affected tissues.
Oxycodone
is
prescribed
for the relief
gf
moderate
to hiqh
pain
under the well-known oharmaceutical trade names of OxvContin*'.
Tylox@, Percodin@
and Percocet@.
While Tyl6x@.
Percodan@
and Percoceto
coritiin
onti
small
doses of
oxycodone
hydrochloride
combined with
other analgesics such
as
acetaminophen
or
aspirin,
OryContin consisls
solely of oxycodone hydrochloride in
a
tirne-release form, Oxycodone is
known
to
metabolize by denrethylation into
oxynnrphone
and noroxycodone.
The
OXY assay_
contained
within
the Multi-Drug Rapid Test
Midstream
yields
a
positive
result
when the OXY
concentration
in
saliva exceeds
Z0ng/mL.
Cotinine
(COT)
Cotinine
id
the first-stage metabolite
of nicotine,
a
toxic
alkaloid
that
produces
stimulation of
the
autonomic
ganglia"and
central nervous
system
when in humani.
Nicotine is
a
drug
to
which virtually
every member
of a tobacco-smoking
society
is
exposed whether
through
direct contact or secsnd-hand inhalation.
ln addition
to tobacco, nicotine is
also
cornmercially
available as the
active
ingredient
in smoking replacement
therapies such
as
nicotine
gum,
transdermal
patches
and nasal sprays.
Although
nicotine is excreted
in
saliva,
the
relatively
short half-life
of
the drug makes
it an
unreliqble maker for
tobacco
use.
Cotinine, however,
demonstrates a
substantially longer
half-life than nicotine
bears
a
high
correlation
with
plasma
cotinine
leyels and
hbs been
found
to be the best makdr for
smoking status
compared
with saliva nicotine
measurement,
breath
carbon monoxide testing
and
dlasma
thlocyanate
testing.
The
window
of detection
for
cotinine
in
saliva
at
a cutofi
level'of
20
ng/mlis expected-to
be up to
1-2
days after
nicotine
use.
ii[Ih;;i"
ffi
ioxymethamphetamine
(MD
MA]
Methylenedioxymethamphetamine (ecstasy)
is
a designer drug
first
syntlresized in 1914
by
a German
drug company for
the treatment of
obesity.
Those who
take the
drug
frequently
report adverse
effects, such
as increased
muscle
tension and sweating. MDMA i5 not
clearly
a stimulant, although it has, in
comnpn
with
amphetamine drugs, a
capacrty to
increase
blood
pressure
and
heart
rate.
MDMAdoes
produce
some
perceptual
changes in the form
of
increased
sensitivity
to
light,
difficulty
in
focusing,
and blurred vision in-some
users.
lts
mechanism
of action is thought to
be
via release
of
the
neurotransmitter
serotonin. MDMA
may
also
release dopamine,
although
the
general
opinion is that
this
is
a seoondary
effect
of
the
drug
(Nichols
and
Oberlender,
1990).
The most
pervasive
effect of MDMA,
occuring in
virtually
all
people
who took
a reasooable
dose of the
drug,
was to
produce
a denching of
the
jaws.
The MDMA
assay
contained
within
the Multi-Drug Rapid Test Midstream
yields
a
positive
result when
the MDMA
concentration
in
saliva exceeds 50ng/ml.
Synthetic Marijuana
(K2)
Synthetic Marijuana or
K2
is
a
psychoactive
herbal
and chemical
product
that, when
consumed, mimics the
effects of
Marijuana.
lt is
best
known
by the brand
names K2 and
Spice, both
of
wfiich
have largely
becorne
genericized
trademarks
used to refer
to any
synthetic Marijuana
product.
The
studies suggest
ttnt
synthetic
marijuana
intoxication ii
associatedwithacutepsychosis,worseningofpreviouslystablepsychoticdisorders,and
also may have the
ability
to.
trigger
a
qhronic
(long-term)
psychotic
disorder among
vulnerable
individuals
such
as
those
with
a
family
history of mental
illness.
Elevated levels
of oral fluid/saliva
metabolites are found
within hours
of exposure and
rernain detectable window
up to 24-48
hours after smoking
(depending
on
usage/dosage).
The K2
as9?y contained within
the Multi-Drug Rapid Test Midstream
yields
a
positive
rasult
when the
K2 concentration in
saliva exceeds 20ng/mL
Benzodiazepines
(BZO)
Benzodiazepines are
medications
that are frequently
prescribed
for
the symptomatic
treatrnent of anxiety and
sleep disorders. They
produce
their
effects via
specifib receptors
involving
a neuroch-emical
called
gamma
aminributyric
acid
(GABA).
Becaube
they
are bafer
and npre
effective, Benzodiazepines have replaced
Barbiturates in
the treatment
of both
anxiety
and
insomnia.
Benzodiazepines are also
used as sedatives before
some surgical
and
medical
procedures,
and
for
the
treatment
of
seizure
disorders and
alcohol withdrawal,
Risk
of
physical
dependence
increases
if
Benzodiazepines
are taken
regularly
(e.9.,
daily)
for rnore
than
a few rnonths,
especially at
higher than
normal
doses. Stopping abruptly
can
bring on such symptoms as troirble
sl-eepin{",
gastrointestinal
upset, fee[irig
[nwell,'loss
of
appetite, sweating, trembling,
weakness, anxiety
and
changes
in
perception.
The
BZO
assay_ contained within the Multi-Drug
Rapid Test Midstream
yields
a
positive
result when
the BZO concentration in
saliva exceeds
30nglmL..
Ketamine
(KET)
Ketamine is
a dissociative anesthetic
developed
in
1963 to replace PCP
(Phencyclidine).
While Ketamine is
still
used in human
anesthesia
and
veterineiry
medicine, it is
tiecomin!;
increasingly abused
as
a street
drug.
Ketamine is molecularly
similar to PCP
and
thus
creates
similar effects
including
numbness, loss
of coordination,
sense
of
invulnerability,
muscle rigidity,
aggressive /
violent
behavior,
sluned or blocked speech,
exaggerated
sense
of strength, and a blank stare. There
is depression of respiratory
function- but not of
the
ce4tral
nervous
system, and
cardiovascular function
is
maintained.
The
effects of Ketamine
generally
last 4-6 hours
following
use
.
The
KET as!?y
contained
within
the
Multi-Drug Rapid Test Midstream
yields
a
positive
result
when the KET
concentration
in
saliva exceeds S0ng/mL
IPRINCIPLEI
The Multi-Drug
Rapid
Test
Midstream
for AMP /MET /COC
/OPl /THC /PCP
/MTD
/MDMA
/OXY /COT
IKZ
IBZOIKET is
an immunoassay
based on
the
principle
of
competitive binding.
Drugs that_may be
present
in
the oral fluid
specimen compete
against
their
respective
drug
conjugate
for binding
sites on their
specific antlbody.
During
testing,
a
portion
of
the
oral
fluid
specimen migrates
upward
by
capillary action.
A
drug, if
present
in the
oralfluid
specirnen below
its
cut.off
concentration,
will not
saturate
the
binding
sites of
its
specific antibody.
The antibody
will
then react with the drug-protein
conjugate and a
visible
colored
line
will
show up
in
the test line region
of
the specific drug
strip.
The
presence
of drug above
the cut-off concentration in the
oral
fluid
specimen
will
saturate all the binding sites of the
antibody.
Therefore,
the
colored
line
will
not
form
in
the
test
line
region:
A drug-positive oral
fiuid specimen will not
generate
a colored
line
in
the specific test
line
region of
the strip because
of drug competition, while a drug-negative
oral fluid specimen
will
generate
a
line in
the
test line region
because of the absence of drug competition.
To
serve
as a
procedural
control, a colored line will
always appear at the control
line region,
indicating
that
proper
volume
of specimen
has
been added
and membrane
wicking
has
occurred.
r
REAGENTSI
The
test contains
membrane
strips
coated with drug-protein
conjugates
(purified
bovine
albumin) on the
test
line,
a
goat
polyclonal
antibody
against
gold-protein
conjugate at
the
control
line,
and
a dye
pad
which
contains
colloidal
gold
particles
coated
with mouse
monoclonal antibody
specific
to
Amphetamine, Methamphetamine,
Cocaine,
Opiates,
A9-THC-COOH,
Phencyclidine,
Methadone, Oxycodone,
Cotinine,
Benzodiazepines,
i$ruUm,l+",3il'si"dioxymeth
a
mpheta mine
an
d synth
eti c
M
a
rijuana .
.
Do not use after
the expiration date.
.
The
test
should remain in
the
sealed
pouch
until use,
.
Saliva
is
not
classified
as biological hazard
unless derived from
a dental
procedure.
r
The
used collector
and Midstream should be
discarded according to
federal,
state and
local reoulations.
I
STORAGE AND
STABIL]TYI
Store as
packaged
in the
sealed
pouch
at 2-30"C. The
test
is
stable through
the
expiration
date
printed,
on
tle,seqled
pouch.
The test Midstreams must
remain in the
sealed
pouch
until use. DO NOT FREEZE.
Do not
use bevond the
exoiration date.
(
SPECIiIIEN
COLLECTION AND PREPARATION
I
The
oralfluid specimen
should be collected
using the collector
provided
with
the kit. Follow
the
detailed Directions
for
Use below. No
other collection Midstreams
should be used with
this assay.
Oral
fluid
collected
at
any time
of the
day
may be used.
(
MATERIALSI
Materlals
Provided
o
Test
Midstream
o
Package
insert
o
Timer.
Materials
Required
but
Not Provlded
(DIRECTIONS
FOR
USEI
Allow
the test Midstream,
specimen, and/or
controls to reach room
temperature(i5-30oC)
prior
to testing. lnstruct
the donor
to
not
place
anything
in
the
mouth including food,
drink,
gum
or
tobacco
products
for
at
least 10
minutes
prior
to
collection.
1.
Bring
the
pouch
to room temperature
before opening it.
Remove the test from the sealed
pouch
and use
it within one
hour.
2. Remove
the
midstream
from
the
sealed
pouch
and
insert
the tongue under to
collect oral
fluid untiltho
control line appears.
3. Place
the
test Midstream
on a clean
and
level
surface,
See
illustration
below.
4. Read results
at
10
minutes. Do
not read results
after t
hour.
Step
I
Step
2
,#mffi-ffifi,
:#:d[tffi*]bsa'ive
,*m
Hk,".",,.
Step
3
R
hd
n
I Remo* tnt
f
c"p
I
INTERPRETATION
OF
RESULTS
I
NEGAflVE:. rffff rin"r
,sri3,l"d;1"::?r*?ti|iy:ffiJ"5trliu"
contror
resion
(c),
and
another
lpparent
colored line
adjacent should
be
in
the test
region (Drug/T).
This negative
result
indicates that the
drug concentration
is
below
the
detectable
level.
-
*NOTE:
The
shade of
color in
the test line
region
(Drug/T)
will vary,
but
it
should be
considered negative
whenever
there is
even
a
faint
line.
POSITIVE:
One colored line
appears in
the control
region
(C).
No line
appears
in
the test
region
(Drug/T)
This
positive
result
indicates
that ttie
drug.concentraiion is
above the
detectable level.
INVALID:
Control
line fails
to appear. lnsufficient
specimen
volume
or
incorrect
procedural
techniques
a1q,{he most
likely reasons for
control
line
failure. Review
the
procedure
and
repeat.the. teltlusing
a
new
test
panel.
lf the
problem persists,
discontinue
using the lot
immediatelv
and contact the manufacturer.
[OUAITY
CONTROLI
A
procedural
control
is included
in
the
test.
A
colored
line
appearing in
the control region
(C)
is considered
an
internal
procedural
mntrol. lt
confirms
bufficidnt
specimen volulme,
adequate
membrane wicking
and correct
procedural
technique
ILIilIITATIONSI
1. The Multi-Drug
Rapid
Test Midstream
provides
only a
qualitative,
preliminary
analytical
result.
A
secondary
analytical
method must
be used to
obtain a
ionfirmed
iesult.-
Gas
chromatography/mas_s
spectrometry
(GC/MS)
or
gas
chromatography/tandem
mass
spectrometry
(GC/MS/MS)
is
preferred
confirmatory methods
2. A
positive
test result
does not
indicate
the concentration
of drug in
the specimen
or the
route
of administration.
3.
A negative
result
may
not
necessarily
indicate
a drug-free
specimen. Drug may
be
present
in
the specimen
below the
cutoff
level
of the assay.
lhis assay
provicles
only
a
preliminary
analytical test
result. A
more
specilic
alternate
chemical method
must
be used
in
order to obtain
a
confirmed
analytical result. Gas
chromatographyimass
spectrometry
(GC/MS)
and
gas
chromatograflhy/tandem mass
spectrometry
(GC/MS/MS)
are
the
preferred
conflrmatory
methods. Professional
judgment
spectrometry
(GCIMS/MS)
are the
preferred
conflrmatory
methods. Frofessional
judgment
should be
applied to any drug
of
abuse test result.
particularly
when
preliminary positive
results
are
indicated.