A rapid test for the simultaneous, qualitative detection of
multiple drugs and drug metabolites in human saliva CE certified
The Multi Drug Rapid Test Midstream for AMP /MET /COC /OPI /THC
/PCP /MTD /MDMA /OXY /COT /K2 /BZO /KET /BAR /BUP /TML /6-MAM /FYL
/ALC is a lateral flow chromatographic immunoassay for the
qualitative detection of multiple drugs and drug metabolites in
saliva at the following cut-off concentrations:
|Marijuana (THC)||11-nor-D9 -THC-9 COOH||50|
|Synthetic Marijuana(K2)||JWH -018, JWH- 073||25|
This assay provides only a preliminary analytical test result. A
more specific alternate chemical method must be used in order to
obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) and gas chromatography/tandem mass
spectrometry (GC/MS/MS) are the preferred confirmatory methods.
Professional judgment should be applied to any drug of abuse test
result, particularly when preliminary positive results are
The Multi-Drug Rapid Test Midstream for AMP /MET /COC /OPI /THC
/PCP /MTD /MDMA /OXY /COT /K2 /BZO/KET/BAR/BUP/TML/6-MAM/FYL/ALC
and their metabolites is a rapid, saliva screening test that can be
performed without the use of an instrument. The test utilizes
monoclonal antibodies to selectively detect elevated levels of
specific drugs in human saliva
Amphetamine is a sympathomimetic amine with therapeutic
indications. The drug is often self-administered by nasal
inhalation or oral ingestion. Depending on the route of
administration, amphetamine can be detected in oral fluid as early
as 5-10 minutes following use1. Amphetamine can be detected in oral fluids for up to 72 hours
The amphetamine assay contained within the Multi-Drug Rapid Test
Midstream yields a positive result when the amphetamine
concentration in oral fluid exceeds 50ng/ml.
Methamphetamine is a potent 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 administration,
methamphetamine can be detected in oral fluid as early as 5-10
minutes following use1. Methamphetamine can be detected in oral fluids for up to 72 hours
The Methamphetamine assay contained within the Multi-Drug Rapid
Test Midstream yields a positive result when the methamphetamine
concentration in oral fluid exceeds 50ng/ml.
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 free-base smoking. Depending on the route
of administration, cocaine and metabolites benzoylecgonine and
ecgonine methyl ester can be detected in oral fluid as early as
5-10 minutes following use1. Cocaine and benzoylecgonine can be detected in oral fluids for up
to 24 hours after use1.
The cocaine assay contained within the Multi-Drug Rapid Test
Midstream for cocaine and opiates yields a positive result when the
cocaine metabolite in oral fluid exceeds 20ng/ml.
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 drugs such as heroin.
Opiates act to control pain by depressing the central nervous
system. The drugs demonstrate addictive properties when used for
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 1 hour following a
single oral dose and can remain detectable for 7-21 hours after the
dose2. 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.
11-nor-D9-tetrahydrocannabinol-9-carboxylic acid (D9-THC-COOH), the metabolite of THC (D9-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 mouth (oral and smoking
administrations) and the subsequent sequestering of the drug in the
buccal cavity3. Historical studies have shown a window of detection for THC in
saliva of up to 14 hours after drug use3.
The THC assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the D9-tetrahydrocannabinol concentration in oral fluid exceeds 50ng/ml.
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. In a paired
serum and saliva sample collection of 100 patients in an Emergency
Department, PCP was detected in the saliva of 79 patients at levels
as low as 2 ng/ml and as high as 600 ng/ml4.
The PCP assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the PCP concentration in oral fluids
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. Ideally, 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 methadone are more prolonged and troublesome than
those provoked by heroin cessation, yet the substitution 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
Oxycodone is a semi-synthetic opioid with a structural 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 of moderate to high pain
under the well-known pharmaceutical trade names of OxyContin®, Tylox®, Percodan® and Percocet®. While Tylox®, Percodan® and Percocet® contain only small doses of oxycodone hydrochloride combined with
other analgesics such as acetaminophen or aspirin, OxyContin
consists solely of oxycodone hydrochloride in a time-release form.
Oxycodone is known to metabolize by demethylation into oxymorphone
The OXY assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the OXY concentration in saliva
Cotinine is the first-stage metabolite of nicotine, a toxic
alkaloid that produces stimulation of the autonomic ganglia and
central nervous system when in humans. Nicotine is a drug to which
virtually every member of a tobacco-smoking society is exposed
whether through direct contact or second-hand inhalation. In
addition to tobacco, nicotine is also commercially 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 unreliable maker for tobacco use.
Cotinine, however, demonstrates a substantially longer half-life
than nicotine bears a high correlation with plasma cotinine levels
and has been found to be the best maker for smoking status compared
with saliva nicotine measurement, breath carbon monoxide testing
and plasma thiocyanate testing. The window of detection for
cotinine in saliva at a cutoff level of 20 ng/ml is expected to be
up to 1-2 days after nicotine use.
Methylenedioxymethamphetamine (ecstasy) is a designer drug first
synthesized 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 is not clearly
a stimulant, although it has, in common with amphetamine drugs, a
capacity to increase blood pressure and heart rate. MDMA does
produce some perceptual changes in the form of increased
sensitivity to light, difficulty in focusing, and blurred vision in
some users. Its 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 secondary effect of
the drug (Nichols and Oberlender, 1990). The most pervasive effect
of MDMA, occurring in virtually all people who took a reasonable
dose of the drug, was to produce a clenching of the jaws.
The MDMA assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the MDMA concentration in saliva
Synthetic Marijuana (K2)
Synthetic Marijuana or K2 is a psychoactive herbal and chemical
product that, when consumed, mimics the effects of Marijuana. It is
best known by the brand names K2 and Spice, both of which have
largely become genericized trademarks used to refer to any
synthetic Marijuana product. The studies suggest that synthetic
marijuana intoxication is associated with acute psychosis,
worsening of previously stable psychotic disorders, and also may
have the ability to trigger a chronic (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 remain detectable window up to 24-48 hours
after smoking (depending on usage/dosage).
The K2 assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the K2 concentration in saliva
Benzodiazepines are medications that are frequently prescribed for
the symptomatic treatment of anxiety and sleep disorders. They
produce their effects via specific receptors involving a
neurochemical called gamma aminobutyric acid (GABA). Because they
are safer and more 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.g., daily) for more than a
few months, especially at higher than normal doses. Stopping
abruptly can bring on such symptoms as trouble sleeping,
gastrointestinal upset, feeling unwell, 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
Ketamine is a dissociative anesthetic developed in 1963 to replace
PCP (Phencyclidine). While Ketamine is still used in human
anesthesia and veterinary medicine, it is becoming 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, slurred or blocked speech, exaggerated sense of
strength, and a blank stare. There is depression of respiratory
function but not of the central nervous system, and cardiovascular
function is maintained. The effects of Ketamine generally last 4-6
hours following use .
The KET assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the KET concentration in saliva
Barbiturates are CNS depressants. They are used therapeutically as
sedatives, hypnotics, and anticonvulsants barbiturates are almost
always taken orally as capsules or tablets. The effects resemble
those of intoxication with alcohol. Chronic use of barbiturates
leads to tolerance and physical dependence.
Short-acting barbiturates taken at 400 mg/day for 2-3 months can
produce a clinically significant degree of physical dependence.
Withdrawal symptoms experienced during periods of drug abstinence
can be severe enough to cause death.
The approximate detection time limits for barbiturates are:
|Short acting (e.g. Secobarbital)||100 mg PO (oral)||4.5 days|
|Long acting (e.g. Phenobarbital)||400 mg PO (oral)||7 days2|
The BAR assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the BAR concentration in saliva
Buprenorphine is a potent analgesic often used in the treatment of
opioid addiction. The drug is sold under the trade names Subutex™,
Buprenex™, Temgesic™ and Suboxone™, which contain Buprenorphine HCl
alone or in combination with Naloxone HCl. Therapeutically,
Buprenorphine is used as a substitution treatment for opioid
addicts. Substitution treatment is a form of medical care offered
to opiate addicts (primarily heroin addicts) based on a similar or
identical substance to the drug normally used. In substitution
therapy, Buprenorphine is as effective as Methadone but
demonstrates a lower level of physical dependence. The elimination half-life of buprenorphine is 20–73 hours (mean 37).Substantial abuse of
Buprenorphine has also been reported in many countries where
various forms of the drug are available. The drug has been diverted
from legitimate channels through theft, doctor shopping, and
fraudulent prescriptions, and been abused via intravenous,
sublingual, intranasal and inhalation routes
The BUP assay contained within the Multi-Drug Rapid Test Midstream
yields a positive result when the BUP concentration in saliva
Tramadol(TML) is a quasi-narcotic analgesic used in the treatment
of moderate to severe pain. It is a synthetic analog of codeine,
but has a low binding affinity to the mu-opioid receptors. Large
doses of tramadol can develop tolerance and physiological
dependency and lead to its abuse. Tramadol is extensively
metabolized after oral administration. Approximately 30% of the
dose is excreted in oral fluid as unchanged drug, whereas 60% is
excreted as metabolites. The major pathways appear to be N- and O-
demethylation, glucoronidation or sulfation in the liver.
The TML Rapid Test Midstream is a rapid oral fluid screening test
that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated
levels of Tramadol in oral fluid. The TML Rapid Test Midstream
yields a positive result when Tramadol in whole blood exceed 30
6-Monoacetylmorphine (6-MAM) or 6-acetylmorphine (6-AM) is one of
three active metabolites of heroin (diacetylmorphine), the others being morphine and the much less
active 3-monoacetylmorphine (3-MAM). 6-MAM is rapidly created from heroin in the body, and
then is either metabolized into morphine or excreted in the oral fluid. 6-MAM remains in the oral fluid for
no more than 24 hours. So a saliva specimen must be collected soon
after the last heroin use, but the presence of 6-MAM guarantees
that heroin was in fact used as recently as within the last day.
6-MAM is naturally found in the brain5, but in such small quantities that detection of this compound in
saliva virtually guarantees that heroin has recently been consumed.
The 6-MAM Rapid Test Midstream is a rapid saliva screening test
that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated
levels of 6-MAM in oral fluid. The 6-MAM Rapid Test Midstream
yields a positive result when 6-MAM in saliva reaches 10ng/ml. This
is the suggested screening cut-off for positive specimens set by
the Substance Abuse and Mental Health Services Administration
Fentanyl, belongs to powerful narcotics analgesics, and is a
special opiates receptor stimulant. Fentanyl is one of the
varieties that been listed in management of United Nations “Single
Convention of narcotic drug in 1961”. Among the opiates agents that
under international control, fentanyl is one of the most commonly
used to cure moderate to severe pain6. After continuous injection of fentanyl, the sufferer will have
the performance of protracted opioid abstinence syndrome, such as
ataxia and irritability etc7.8, which presents the addiction after taking fentanyl in a long
time. Compared with drug addicts of amphetamine, drug addicts who
take fentanyl mainly have got the possibility of higher infection
rate of HIV, more dangerous injection behavior and more lifelong
The FYL Rapid Test Midstream (oral fluid) is a rapid saliva
screening test that can be performed without the use of an
instrument. The test utilizes a monoclonal antibody to selectively
detect elevated levels of Norfentanyl in oral fluid. The FYL Rapid
Test Midstream (oral fluid) yields a positive result when
Norfentanyl in saliva exceeds 50ng/ml.
Two-thirds of all adults drink alcohol10. The blood alcohol concentration at which a person becomes
impaired is variable dependent upon the individual. Each individual
has specific parameters that affect the level of impairment such as
size, weight, eating habits and alcohol tolerance. Inappropriate
consumption of alcohol can be a contributing factor to many
accidents, injuries, and medical conditions
The Multi-Drug Rapid Test Midstream yields a positive result when
the concentration of Alcohol11 in saliva exceeds 0.02%
How to use?
Allow the test Midstream, specimen, and/or controls to reach room
temperature(15-30°C) prior to testing. Instruct 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. Take off the Midstream cap and insert the absorbent wick to the
mouth .put it under the tongue to collect Saliva until the control
line appears and then take out the midstream.
3. Place the test Midstream on a clean and level surface. See
4. Read results at 10 minutes. Do not read results after 1 hour
5. Read Alcohol strip result at three to Five (3-5) minutes.
Compare the color of the reaction pad with the chart on foil to
determine the relative saliva alcohol level.
INTERPRETATION OF RESULTS
(Please refer to the previous illustration)
NEGATIVE:* Two lines appear. One colored line should be in the control
region (C), and another apparent 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
POSITIVE: One colored line appears in the control region (C). No line
appears in the test region (Drug/T). This positive result indicates
that the drug concentration is above the
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test
using a new test panel. If the problem persists, discontinue using
the lot immediately and contact the manufacturer.
A procedural control is included in the test. A colored line
appearing in the control region (C) is considered an internal
procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.