OPIATES (OPI 300)
Opiates refers to any drug that is derived from the opium
poppy, including the natural products, morphine and codeine, and the semi-synthetic
drugs such as heroin. Opioid is more general, referring to any drug that acts on the
opioid receptor.
Opioid analgesics comprise a large group of substances which control pain by
depressing the central nervous system. Large doses of morphine can produce higher
tolerance levels, physiological dependency in users, and may lead to substance abuse.
Morphine is excreted unmetabolized, and is also the major metabolic product of codeine
and heroin. Morphine is detectable in the urine for several days after an opiate dose.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of opiate exceeds the 300 ng/mL cut-off level.
OPIATES (2000)
Opiates refers to any drug that is derived from the opium poppy,
including the natural products, morphine and codeine, and the semi-synthetic drugs such
as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor.
Opioid analgesics comprise a large group of substances which control pain by
depressing the central nervous system. Large doses of morphine can produce higher
tolerance levels, physiological dependency in users, and may lead to substance abuse.
Morphine is excreted unmetabolized, and is also the major metabolic product of codeine
and heroin. Morphine is detectable in the urine for several days after an opiate dose.4
The Rapid Exams Multi-Drug Test yields a positive result when the morphine
in urine exceeds 2,000 ng/mL. This is the suggested screening cut-off for positive
specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
OXYCODONE (OXY)
Oxycodone, [4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-morphinan-6-one, dihydrohydroxycodeinone] is a semi-synthetic opioid agonist
derived from thebaine, a constituent of opium. Oxycodone is a Schedule II narcotic
analgesic and is widely used in clinical medicine. The pharmacology of oxycodone is
similar to that of morphine, in all respects, including its abuse and dependence liabilities.
Pharmacological effects include analgesia, euphoria, feelings of relaxation, respiratory
depression, constipation, papillary constriction, and cough suppression.
Oxycodone is prescribed for the relief of moderate to high pain under pharmaceutical
trade names as OxyContin® (controlled release), OxyIR®, OxyFast®(immediate release
formulations), or Percodan® (aspirin) and Percocet® (acetaminophen) that are in
combination with other nonnarcotic analgesics. Oxycodone’s behavioral effects can
last up to 5 hours. The controlled-release product, OxyContin®, has a longer duration of action (8-12 hours).
The Rapid Exams Multi-Drug Test yields a positive result when the Oxycodone in
urine exceeds 100 ng/mL.
PHENCYCLIDINE (PCP)
Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950’s. It
was removed from the market because patients receiving it became delirious and experienced hallucinations.
Phencyclidine is used in powder, capsule, and tablet form. The powder is either
snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is
most commonly administered by inhalation but can be used intravenously, intra-nasally,
and orally. After low doses, the user thinks and acts swiftly and experiences mood
swings from euphoria to depression. Self-injurious behavior is one of the devastating
effects of Phencyclidine.
PCP can be found in urine within 4 to 6 hours after use and will remain in urine
for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight,
activity, and diet.5 Phencyclidine is excreted in the urine as an unchanged drug (4% to
19%) and conjugated metabolites (25% to 30%).6
The Rapid Exams Multi-Drug Test yields a positive result when the phencyclidine
level in urine exceeds 25 ng/mL. This is the suggested screening cut-off for positive
specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
NOTE:
Effexor Tablets (venlafaxine hydrochloride) a treatment for depressive, anxiety
and social disorder have shown to cause false positive urine results for Phencyclidine
(PCP). Positive urine screening should always be confirmed by GCMS.
PROPOXYPHENE (PPX)
Propoxyphene (PPX) is a mild narcotic analgesic found
in various pharmaceutical preparations, usually as the hydrochloride or napsylate salt.
These preparations typically also contain large amounts of acetaminophen, aspirin, or
caffeine. Peak plasma concentrations of propoxyphene are achieved from 1 to 2 hours
post dose. In the case of overdose, propoxyphene blood concentrations can reach
significantly higher levels. In human, propoxyphene is metabolized by N-demethylation to
yield norpropoxyphene. Norpropoxyphene has a longer half-life (30 to 36 hours) than
parent propoxyphene (6 to 12 hours). The accumulation of norpropoxyphene seen with
repeated doses may be largely responsible for resultant toxicity.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Propoxyphene or Norpropoxyphene in urine exceeds 300 ng/mL.
TRICYCLIC ANTIDEPRESSANTS (TCA)
TCA (Tricyclic Antidepressants) are
commonly used for the treatment of depressive disorders. TCA overdoses can result in
profound central nervous system depression, cardiotoxicity and anticholinergic effects.
TCA overdose is the most common cause of death from prescription drugs. TCAs are
taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and
their metabolites are excreted in urine mostly in the form of metabolites for up to ten days.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Tricyclic Antidepressants in urine exceeds 1,000 ng/mL.
BUPRENORPHINE (BUP)
Buprenorphine is a semisynthetic opioid analgesic
derived from thebain, a component of opium. It has a longer duration of action than
morphine when indicated for the treatment of moderate to severe pain, peri-operative
analgesia, and opioid dependence. Low doses buprenorphine produces sufficient
agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids
without experiencing withdrawal symptoms. Buprenorphine carries a lower risk of
abuse, addiction, and side effects compared to full opioid agonists because of the
“ceiling effect”, which means no longer continue to increase with further increases in
dose when reaching a plateau at moderate doses. However, it has also been shown
that Buprenorphine has abuse potential and may itself cause dependency. Subutex®,
and a Buprenorphine/Naloxone combination product, Suboxone®, are the only two
forms of Buprenorphine that have been approved by FDA in 2002 for use in opioid
addiction treatment. Buprenorphine was rescheduled from Schedule V to Schedule III
drug just before FDA approval of Suboxone and Subutex.
The Rapid Exams Multi-Drug Test yields a positive result when the concentration
of Buprenorphine in urine exceeds 10 ng/mL.
PRINCIPLE
The Rapid Exams Multi-Drug Test is an immunoassay based on the
principle of competitive binding. Drugs which may be present in the urine specimen
compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a urine specimen migrates upward by capillary action. A drug, if
present in the urine specimen 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 will saturate all the binding sites of the
antibody. Therefore, the colored line will not form in the test line region.
A drug-positive urine specimen will not generate a colored line in the specific test
line region of the strip because of drug competition, while a drug-negative urine 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.
REAGENTS
The test contains a membrane strip 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, Cocaine,
Methamphetamine, Methylenedioxymethamphetamine, Morphine, THC, Phencyclidine,
Benzodiazepines, Methadone, Barbiturates, Propoxyphene, Oxycodone, Tricyclic
Antidepressants, or Buprenorphine.
PRECAUTIONS
· For Professional Use Only. · For In Vitro Diagnostic Use Only.
· Do not use after the expiration date. · The test panel should remain in the sealed
pouch until use. · While urine is not classified by OSHA or the CDC as a biological
hazard unless visibly contaminated with blood, the use of gloves is recommended
to avoid unnecessary contact with the specimen. · The used test card and urine
specimen should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at
2-30°C (36-86°F). The test is stable through the expiration date printed on the sealed
pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do
not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container.
Urine collected at any time of the day may be used. Urine specimens exhibiting visible
precipitates should be allowed to settle to obtain a clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C (36-46°F) for up
to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored
below -20°C. Frozen specimens should be thawed and mixed well before testing.
MATERIALS PROVIDED
· Test devices · Desiccant · Package insert / Instructions · Color Procedure Card (for tests with Adulterations strips)
Materials Required But Not Provided
· Specimen collection container (free w/min. 25) · Disposable gloves · Timing device (i.e. timer, clock, watch, etc.)