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Multi-Drug Screen Urine Test
With Adulteration Assay
INSTRUCTIONS FOR USE
One Step Assay
market as an illicit drug; and fatalities have occurred when used in combination with Rapid Visual Results
For Qualitative In Vitro Diagnostic Use
Buprenorphine is administered clinically by intravenous, intramuscular or sublingual routes. Buprenorphine is metabolized by N-dealkylation to form the INTENDED USE
pharmacologically Norbuprenorphin e. Both norbuprenorphine are also glucuronidated to the clinically inactive conjugates The Multi-Drug of Abuse Urine Test is a rapid qualitative immunoassay for buprenorphine-3-beta-D-glucuronide and norbuprenorphine-3-beta-D-glucuronide . screening potential abuse of one or more drugs. The device detects any Buprenorphine and its metabolite norbuprenorphine (along with the glucuronide combination of one up to twelve drugs or drug metabolites at or above the forms) are both excreted in urine during the course of several days. Buprenorphine specified cut-off levels. It is for health care professional use only. and its metabolites are eliminated mainly in the feces (68%), with a small proportion excreted in urine (27%). It was reported that urine samples taken from patients who had received treatment for 2 weeks with 4 mg of buprenorphine daily (sublingually) showed buprenorphine concentrations ranging from 54 to 260 ng/ml 24 hours after the dose. It was found in another study that the concentrations of the unconjugated BUP/NBUP
Buprenorphine/Norbuprenorphine buprenorphine and unconjugated norbuprenorphine in the urine samples collected 10 hours after a single dose intramuscular injection of 0.3 mg buprenorphine were 500 pg/ml and 2 ng/ml, respectively. The concentration of the metabolite norbuprenorphine is usually higher than Methamphetamine buprenorphine. The median ratio of buprenorphine to norbuprenorphine is dependent Methamphetamine on the time between sampling and dose intake. It was reported that in suspected abusers, the ranges were 2.3 to 796 ng/ml for unconjugated buprenorphine and 5 to Methamphetamine 2580 ng/mL for unconjugated norbuprenorphine. It was also found that the MOR/OPI2000
Morphine/Opiates of free buprenorphine and norbuprenorphine in urine may be relatively MOR/OPI300*
Morphine/Opiates small (<1 ng/mL) if taken in clinically administered doses, but can reach up to 20 ng/mL if abused. Benzodiazepines (BZD)
including Alprazolam, Diazepam, Lorazepam, Triazolam, Chlordiazepoxide, Flurazepam and Temazepam are sedative, hypnotic and anti- Marijuana/Hashish anxiety drugs commonly used as tranquilizers. Most benzodiazepines are extensively MDMA or Ecstasy metabolized in the liver and excreted in the urine as metabolites. The benzodiazepines *Not SAMHSA levels. **Combined con centrations of Buprenorphine (BUP) have a low potential for physical or psychological dependence. However, the same as and Norbuprenorphine (NBUP). ***SAMHSA has not recommended the other central nervous system stimulating drugs, they may induce drowsiness and screening cutoff levels for positive specimens. ****The BAR, BZD, TCA test muscle relaxation. Chronic abuse of benzodiazepines may result in intoxication, will yield preliminary positive results when BAR, BZD, and TCA is ingested at similar to drunken behavior. Overdose and extended usage of benzodiazepines may or above therapeutic doses. There are no uniformly recognized drug levels for lead to coma and possibly death. Benzodiazepines may remain effective for 4-8 barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of hours. The members of the benzodiazepine family are absorbed at different rates and abuse urine test device shows the drug was or was not present at the cutoff their effects may vary with the absorption rate. They are excreted in the urine primarily as their parent compounds or an inactive metabolite (oxazepam glucuronide) that are only detectable for one (1) to two (2) days. Oxazepam, a This test provides only a preliminary result. A more specific alternate chemical common metabolite of many benzodiazepines that is also a marketed drug (Serax), method must be used in order to obtain a confirmed analytical result. Gas may remain detectable if in urine for up to one week. That makes oxazepam a useful Chromatography / Mass Spectrometry (GC/MS) or High Performance marker of benzodiazepines abuse.
Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse Cocaine (COC and COC150)
test result, particularly when preliminary positive results are obtained. is a nervous system stimulant that can be addictive. Cocaine may appear in urine for only few hours after use, whereas the benzoylecgonine, a hydrolytic degradation product of cocaine, may be detectable in urine over 2 days after taking Amphetamine (AMP and AMP300)
cocaine. Therefore the detection of benzoylecgonine in human urine is widely used to evaluate cocaine usage.
The detection of amphetamines in human urine has been widely used to assess the abuse of amphetamines. Amphetamines are central nervous system stimulating drugs. Methamphetamine (MET, MET500 and MET300)
They may induce alertness, wakefulness, increased energy, reduced hunger and overall feeling of well being. Overdose and extended usage of amphetamines may Methamphetamine in overdosage causes restlessness, confusion, anxiety, lead to substance abuse, which may cause severe and/or permanent damage hallucinations, cardiac arrhythmias, hypertension, hyperthermia, circulatory collapse, human nerve system. Amphetamines appear in the urine within three hours after convulsions, and coma. Methamphetamine has been implicated in fatal poisonings administration (any type), and be present for about 24-48 hours after the last dose.
following both intravenous and oral administration. Chronic abusers may develop paranoid psychosis. D-Methamphetamine (d-desoxyephedrine, Desoxyn, Methedrine) Barbiturates (BAR)
is the N-methyl derivative of amphetamine. It is utilized in the treatment of obesity. Methamphetamine is administered by oral, nasal insufflation, or intravenous injection Barbiturates are central nervous system depressants and used as hypnotic sedatives. with duration of 2-4 hours. Methamphetamine undergoes some N-demethylation to Overdose and extended usage of barbiturates may lead to severe and/or permanent amphetamine, its major active metabolite. During normal conditions, up to 43% of a damage to the human nervous system. Barbiturates are classified as (1) ultra-short, dose is eliminated with about 4-7% as amphetamine. In acidic urine, up to 76% is (2) short-intermediate, and (3) long-acting. The duration range of the ultra short- found as unchanged drug and 7% as amphetamine in 24 hours, whereas in alkaline acting compounds, secobarbital, pentobarbital etc. is from fifteen (15) minutes to six urine the corresponding values are 2% and less than 0.1%. Methamphetamine urine (6) hours. The duration range of the intermediate acting compounds, amobarbital, concentrations of 0.5-4.0 mg/L are commonly observed during the first 24 hours after etc. is from three (3) to twenty-four (24) hours. The duration range of the long-acting ingestion of 10 mg. Methamphetamine concentrations of 24-333 mg/L (average, 142) were observed in the urine of methamphetamine abusers.
compounds, phenobarbital etc. is from fifteen (15) to forty-eight (48) hours. The most commonly abused barbiturates are short- and intermediate-acting agents. PI2000 and MOR/OPI300)
The long-acting agents are rarely subject to abuse. Barbiturate derivatives are Morphine is a popular marketed drug (Serax) for treatment of moderate to severe excreted into urine in varying amounts of unchanged drug and metabolites. Long- pain. It is also a common metabolite of opiates [morphine, codeine (methyl- acting barbiturates are excreted with a higher percentage of unchanged drug in the morphine), and heroin (semi-synthetic derivatives of morphine)]. The opiates are urine, while shorter-acting barbiturates, secobarbital and amobarbital, are extensively either by smoking, intravenous injection, intramuscular injection or oral metabolized and excreted in the urine with a smaller percentage of unchanged drugs. ingestion. Adverse or toxic effects of opiates usage include pupillary constriction, constipation, urinary retention, nausea, vomiting, hypothermia, drowsiness, dizziness, apathy, confusion, respiratory depression, hypotension, cold and clammy skin, coma, Buprenorphine is an analgesic drug. It is also used in heroin substitution and and pulmonary edema. Death may occur following an overdosage. detoxification treatment. With this increased medical use, it also occurs on the black 33-2898 REV K 020609 Page 1 Multi-Drug Screen Urine Test
With Adulteration Assay
The duration of effect of morphine is 3-6 hours. Morphine is metabolized extensively, marijuana and hashish. Cannabinoids have been used as central nervous system with only 2-12% excreted as unchanged morphine in the urine. Heroin is rapidly depressants. Overdose and extended usage of cannabinoids may lead to substance metabolized to morphine in the body; the pattern of urinary excretion of heroin is abuse, which may cause severe and/or permanent damage to the human nerve system. similar to that of morphine. Codeine is also extensively metabolized, 10-15% of the The detection of THC in human urine is widely used to evaluate the abuse of dose is demethylated to form morphine and norcodeine. It has been reported that the cannabinoids .
unchanged morphine may remain detectable in urine for up to one week, which make morphine a marker of opiates abuse.
MDMA (Ecstasy, XTC)
Methadone (MTD)
MDMA is an abbreviation of the chemical methylenedioxymethamphetamine. It also has street names such as Ecstasy, X, XTC, E, Love Doves, Clarity, Adam, Disco Methadone, also called Dolophine, Methadose and Amidone, possesses many of the Biscuits, and Shamrocks. MDMA is a stimulant with hallucinogenic tendencies. It is pharmacologic properties of morphine and is approximately equipotent as an described as an empathogen since it releases mood-altering chemicals, such as analgesic when administered parenterally. Unlike morphine, however, methadone produces marked sedative effects with repeated administration as a result of drug cartooning and L-dopa, in the brain and may generate feelings of love and friendliness. MDMA is a Class A drug, in the same category as heroin and cocaine. Methadone has been used as a major substitute for opiates, such as heroin, morphine, and codeine in drug maintenance treatment clinics. The adverse effects of MDMA use include elevated blood pressure, hyperthermia, administered either orally or by intravenous or intra-muscular injection. The duration anxiety, paranoia, and insomnia. Overdoses of MDMA can be fatal, often resulting in of effect of methadone is 12-24 hours. Its major urinary excretion products are heart failure or heat stroke. methadone, EDDP (2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine), and EMDP (2-ethyl-5-methyl-3, 3-diphenylpyrrolidine). The percentage of methadone excreted MDMA belongs to a "family" of man-made drugs; its "relatives" are MDA unchanged in urine is 5-50%, much higher than EDDP and EMDP, of the dose in 24 (methylenedioxyamphetamine), the parent drug of MDMA, and MDEA hours. Large individual variations in the percentage of unchanged methadone (methylenedioxyethylamphetamine), also know as EVE, the sister of MDMA. They excreted in urine have been observed due to urine pH, urine volume, dose and rate of all have the amphetamine-like effects. MDMA is administered either by oral metabolism, etc. Methadone has been found remaining in urine at levels higher than ingestion or intravenous injection. MDMA tablets come in different sizes and colors, 1,000 ng/ml 24 hours after overdose. Therefore the concentration of methadone in and often have logos such as doves on them. Its clinical dose is 50-100mg; the human urine has been used as a marker of methadone abuse. threshold toxic dose is 500mg. The effects of the MDMA begin 30 minutes after taking. They peak in an hour and last for 2-3 hours. Sixty five percent (65%) of Oxycodone (OXY)
MDMA is excreted unchanged in urine and it is detectible in the urine for up to 3 days after use. Oxycodone is a semi-synthetic opioid with a structure similar to codeine. It is prescribed for the relief of moderate to severe pain. Like all opiate agonists, oxycodone provides pain relief by acting on opioid receptors in the spinal cord, brain, PRINCIPLE OF THE PROCEDURE
and possibly directly in the affected tissues. Oxycodone is a central nervous system The Multi-Drug of Abuse Urine Test de vice consists of any combination depressant that may cause drowsiness, dizziness, lethargy, weakness and confusion. between one (1) to twelve (12) individual test strip(s) for the drug(s) being Toxicity in an overdose of oxycodone can lead to stupor, coma, muscle flaccidity, tested. The assay is a one-step late ral flow chromatographic immunoassay severe respirator depression, hypotension, and stripiac arrest. based on the principle of competition for limited antibody binding sites between Oxycodone is metabolized by demethylation into oxymorphone and noroxycodone. the drug or drug metabolite(s) in the sample and a drug-protein conjugate After a single 5 mg oral dose, 13-19% of the oxycodone is excreted as unchanged in a immobilized on a porous membrane support. 24-hour urine collection. The time window for detection of oxycodone in urine is expected to be similar to that of other opioids such as morphine. During test, the urine sample migrates to the testing area of the membrane by capillary action, mobilizing the colored antibody conjugates. Then the antibody Phencyclidine (PCP)
conjugates move along the membrane to the testing area. In the absence of the drug or if the drug concentration is below the cutoff limit in the sample, the Phencyclidine (PCP), also called Angel Dust, Hog, and Killer Weed, is a popular colored conjugates attach to the drug antigen immobilized in the test line region, drug of abuse, as well as being a legitimate veterinary tranquilizer. It is self- forming a burgundy-colored band (T line). When the drug is present in the administered either by smoking, nasal insufflation, intravenous injection or by oral sample, the drug or drug metabolite(s) compete for the limited antibody binding ingestion. Its duration of effect is 2-4 hours, and psychosis may last for weeks. PCP sites. If the drug concentration is at or above the cutoff limit, the drug will has three major metabolites; however, the percentage of an intravenous dose excreted saturate all the binding sites of the antibody, preventing the attachment of the unchanged in urine is 30-50% in the 72 hours. Only 2% of a dose in excreted in feces. colored conjugates to the antigen in the test line area of the membrane. An average of 77% of an intravenous dose is excreted in urine and feces in 10 days. Therefore the colored line will not form. Therefore, the PCP in human urine has been used as a marker of PCP abuse. Concentrations of unchanged drug in the urine of ambulatory users of PCP are most The control line (C line) serves as an internal quality control of the system. It frequently between 0.04 and 3.4mg/L.
should always appear as a burgundy-colored band regardless of the presence of the drug. Propoxyphene (PPX)
The adulteration control strip in the sample well of the device has 6 pads each of which includes an indicator reagent that reacts with components in the urine Propoxyphene is a prescription drug for the relief of pain. Propoxyphene hydrochloride (Darvon, Dolene, and others) is available in 32mg and 65mg capsules; sample effecting color changes. Results are obtained by comparing the color of propoxyphene napsylate (Darvon-N) is available in 100mg tablets or as a suspension. each pad with that of the corresponding pad in the color chart provided. The It is structurally related to methadone. Overdose of the drug can affect the brain region and cause euphoria as many opioids do. The progressive symptomatology of Creatinine: Tests for sample dilution. Creatinine reacts with a creatinine
propoxyphene includes analgesia, stupor, respiratory depression, and coma, etc. The indicator in an alkaline condition to form a purplish-brown color complex. The half-life of propoxyphene is 8-24 hours. Following oral administration, propoxyphene concentration of creatinine is directly proportional to the color intensity of the reaches its peak in 1 to 2 hours. There is great variability between subjects in the rate of clearance. The percentage of excreted unchanged propoxyphene in urine is less than 1%. The major metabolite of propoxyphene is norpropoxyphene. Therefore, the Nitrate: Tests for the presence of exogenous nitrite. Nitrite reacts with an
detection of norpropoxyphene is widely used for the testing of propoxyphene abuse. aromatic amine to form a diazonium compound in an acid medium. The The half-life of norpropoxyphene is about 30 hours, and its accumulation with diazonium compound in turn couples with an indicator to produce a pink- repeated doses may be responsible for some of the toxicity observed.
red/purple color.
Glutaraldehyde: Tests for the presence of ex ogenous aldehyde. The aldehyde
Tricyclics (TCA)
group on glutaraldehyde reacts with an indicator to form a pink/purple color complex. Tricyclic Antidepressants (TCA) are a group of antidepressant drugs that contain three fused rings in their chemical structure. TCA can be taken orally or pH: Tests for the presence of acidic or alkaline adulterant. This test is based
intramuscularly (IM). The progressive symptomatology of TCA includes agitation, on the well-known double pH indicator method that gives distinguishable colors confusion, hallucinations, hypertonicity, seizures, and EKG changes. The half-life of over wide pH range. The colors range from orange (low pH) to yellow and TCA varies from few hours to few days. The commonly used tricyclic green to blue (high pH). antidepressants are excreted with a very low percentage of unchanged drugs in the Specific Gravity: Tests for sample dilution. This test is based on the apparent
urine, less than 1%. Therefore, detecting TCA or metabolites of TCA in human urine pKa change of certain pretreated polyelectrolytes in relation to the ionic has been used for screening the abuse of TCA. This test is able to detect concentration. In the presence of an indicator, the colors range from dark blue amitriptyline, desipramine, imipramine and nortriptyline at a cut off level of 1,000 or blue-green in urine of low ionic concentration to green and yellow in urine of higher ionic concentration. Marijuana (THC)
Oxidants: Tests for presence of oxidizing reagents. In this reaction, a color
indicator reacts with oxidants such as bleach, hydrogen peroxide or pyridinium
Tetrahydrocannabinols (THC, ?-9-THC, ?-1-THC) are the most active of the chlorochromate to form a blue or brown color complex. Other colors may principle constituents, as well as the major metabolites, of cannabinoids such as indicate the presence of other oxidants. 33-2898 REV K 020609 Page 2 Multi-Drug Screen Urine Test
With Adulteration Assay
REAGENTS AND MATERIALS SUPPLIED
Read results between 4-7 minutes.
25 test devices, each sealed in a foil pouch with a desiccant and a dropper II. DROPPER METHOD (Recommended for small sample volumes.)
pipette (20 devices for 7-12 test panel) Set the device on a clean and level surface. the provided dropper to pick up the urine sample, fill the sample 1 package insert (Instructions for Use) Transfer all of the urine sample in the dropper to the sample well of MATERIALS REQUIRED BUT NOT PROVIDED
the device. Avoid trapping air bubbles in the sample well. Specimen collection container External positive and negative controls PRECAUTIONS
The instructions must be followed exactly to obtain accurate results. Do not open the sealed pouch, unless ready to conduct the assay. 3. Do not use expired devices. Dispose of all specimens and used assay materials as potentially bio- Do not use the test if you are colored-blind. STORAGE AND STABILITY
Store the product at room temperature 15-30° C (59-86°F). Each device may be used until the expiration date printed on the label if it remains For a 2-sided panel (7-12 tests), turn the device over to the other side sealed in its foil pouch. and add a full dropper of urine sample (up to the mark on the Do not freeze and/or expose the kit
dropper) to the sample well on side 2. Start the timer. to temperatures over 30°
Read results between 4-7 minutes. SPECIMEN COLLECTION
INTERPRETATION OF RESULTS
men must be collected in a clean container. Do not Each test strip is labeled with abbreviations for a test. For example, "COC" is combine specimens. for cocaine test. A complete list for each test can be found in the intended use Specimens may be kept at 15-30° C (59-86°F) for 8 hours, at 2-8°C for up section on Page 1. to 3 days and at -20°C or lower for long term storage. IMPORTANT:
Read each test independently.
ASSAY PROCEDURE
Do not compare color intensity of one test to anther.
Do not compare color intensity of the T line to the C line.
IMPORTANT: REFRIGERATED SPECIMENS AND OTHER TEST
Do not read adulteration results after 2 minutes or drug test after
MATERIALS, INCLUDING DEVICES, MUST BE EQUILIBRATED TO
seven (7) minutes
ROOM TEMPERATURE BEFORE TESTING.
ADULTERATION ASSAY
Bring the pouch to room temperature before opening. Between 1-2 minutes after sample addition, compare the color of each pad with Remove the test device from the sealed pouch and label it with specimen that of the corresponding pad in the color chart attached to the back of this insert. Changes in color after 2 minutes are of no value to interpretation. The 6 Remove the cap from the device, add urine sample to the device using pads, as read from left to right in the sample well, assess the following either "Dip Method (I)" or "Dropper Method (II)" as follows: parameters: CR NI GL pH SG OX
CR (creatinine) tests for sample dilution. Daily creatinine excretion, related to
I. DIP METHOD
muscle mass of the human body, is usually constant. The DOT guideline states Dip the sample well end of the device into the specimen. that creatinine levels less than 20 mg/dl in urine specimens indicate adulteration, regardless of factors such as age, sex, diet, muscle mass and local population distribution.
NI (Nitrite) is not a normal component of urine. Nitrite levels less up to 3.6
mg/dl may be found in some urine specimens due to urinary tract infections,
bacterial contamination or improper storage. A nitrite level above 7.5 mg/dl is considered abnormal. GL (Glutaraldehyde) is not a natural component of human urine and its
presence indicates adulteration. False positive results may arise when ketone
Note: Immerse the sample well
bodies are present. Ketone bodies may appear in urine when a person is in completely in the urine sample.
ketoacidosis, starvation or other metabolically abnormal conditions. Make sure the tip of the arrows in
pH Tests : Normal urine pH ranges from 4.5 to 8.0. Values below pH 4.0 or
the device's window is above the
above pH 9.0 are indicative of adulteration. urine sample surface.
SG (Specific Gravity): Random urine samples may vary in specific gravity
from 1.003-1.030. Normal adults with normal diets and normal fluid intake will have an average urine specific gravity of 1.016-1.022. Elevated urine specific gravity may be obtained in the presence of moderate quantities of protein. DOT guidelines state that a urine specimen with specific gravity level less than 1.003 is an indication of adulteration. Specific gravity and creatinine values should be considered together to provide a better picture of whether the sample is adulterated. Start the timer. OX (Oxidants): The presence of oxidizing reagents in the urine is indicative of
Remove the device from the specimen after 10 seconds. adulteration since oxidizing reagent are not normal constituents of urine. Replace the cap back onto the device. Set the device on a clean and Oxidizing reagents include bleach, Hydorgen Peroxide, Pyridinium level surface.
Chlorochromate, etc. 33-2898 REV K 020609 Page 3 Multi-Drug Screen Urine Test
With Adulteration Assay
If test pads indicate an invalid sample for the assays, note the information on the PERFORMANCE CHARACTERISTICS
DRUG ASSAY
Preliminary Positive:
A comparison study was performed at two Physician's Office Laboratories If the C line appears and there is no T line, the test is positive for that drug. (POL) and a Reference Laboratory. Samp les were blind labeled and tested for More than one test may be Preliminary Positive. each analyte (drug or drug metabolite). Each sample was tested at each site, with the multi-drug of abuse urine test device, and compared to GC/MS or Note: Positive results should be conf irmed with a more specific method.
HPLC/MS results. The test results are grouped into drug free, below 75% cutoff GC/MS or HPLC is a preferred confirmatory method.
(Negative), above 125% cutoff (Positive), between 75% cutoff and cutoff, between cutoff and 125% cutoff according to the analyte concentrations from GC/MS for all analytes except BUP/NBUP and TCA, which was tested with HPLC/MS. Overall, this device agrees with the results from the selected Preliminary Positive
analytical method more than 90% for each analyte. The test results are for test 2 and test 3
tabulated below. Negative:
Multi-Drug of Abuse Urine Test If both C line and T line appear on a test, the test is negative for that drug. If both C line and T line appear for all tests, the urine specimen is negative for all the drugs tested. Negative for all 6 drugs
Note: Even a very faint T line is negative.

Invalid:
If no C line develops within 4 minutes on any test strip, the test is invalid. In this case, do not report test results. Repeat the assay with a new test device. If the result is still invalid, stop using the test device. Contact the manufacturer. Invalid for test 4 and
QUALITY CONTROL
Built-in Control Features:
This test contains a built-in control feature, the C line. The presence of the C line indicates that an adequate sample volume was used and that the reagents migrated properly. If a C line does not form, the test is considered invalid. In this case, review the whole procedure and repeat the testing with a new device. External Quality Control:
Users should always follow the appropriate federal, state, and local guidelines concerning the running of external quality controls. SAMHSA recommends that the concentration of drug(s) in positive and negative controls be approximately 25% above and below the cutoff concentration of the assay. LIMITATIONS
This kit is for professional in vitro diagnostic use only. Results obtained by this device provide only a preliminary qualitative analytical test result. A more specific alternate method must be used in order to obtain a confirmed analytical result.
This product is designed for testing human urine only. Adulterants such as bleach or other strong oxidizing agents may produce erroneous test results. When suspected, collect a fresh specimen and repeat the test with a new device. Samples in which bacterial contamination is suspected should not be used. These contaminants may interfere with the test and cause false results. EXPECTED VALUES
This test is capable of detecting each drug and/or drug metabolite specified in human urine at or above its specific cutoff concentration indicated in the intended use section on page 1. 33-2898 REV K 020609 Page 4 Multi-Drug Screen Urine Test
With Adulteration Assay
Multi-Drug of Abuse Urine Test Compounds
Compounds
Alprazolam Lormetazepam Bromazepam Medazepam Nitrazepam Chlonazepam Nordiazepam Triazolam Flurazapam Lorazepam Isoxsuprine Benzoylecgonine COC150 Cocaine
Isoxsuprine Benzoylecgonine d-Amphetamine l-Amphetamine tamine (MDA) MET500 d-Methamphetamine
l-Amphetamine d-Amphetamine tamine (MDA) MET300 d-Methamphetamine
l-Amphetamine d-Amphetamine tamine (MDA) Multi-Drug of Abuse Urine Test Morphine- Ethyl Morphine glucuronide Hydro morphine Meperidine MOR300 Morphine
Morphine- glucuronide Ethyl Morphine Meperidine Hydromorphine Oxycodone (-)-a-Methadol Oxycodone Hydrocodone morpEhtihnyel Methylphenidate Tenocyclidine Pheniramine Reproducibility of each test was determined by replicate assays of three Propoxyphene different production lots with four levels of samples: drug-free, 75% cutoff, 125% cutoff and 300% cutoff. For AMP, AMP300, BUP/NBUP, COC, COC150, Norpropoxyphene (EDDP, Methadone MOR300, OXY, THC and MDMA tests, the devices were tested for Methadone 1,350,000 Metabolite) three consecutive days, six replicates per day, for a total of eighteen tests for each control. Nortriptyline Clomipramine For BAR, BZD, MET, MOR, MTD, PCP, PPX and TCA tests, the devices were tested for five consecutive days, five times per day, for a total of 25 assays for Amitriptyline each control. The results indicate 100% precision for the replicate within each Imipramine Protriptyline lot and no appreciable inter-lot variation across the three different lots of Desipramine Perphenazine Nordoxepine Promazine Cycolbenzaprine Trimipramine The cross reactivity of the test was evaluated by spiking drug free samples with structurally related compounds. Com pounds producing positive response are Cannabonol hetamine (MDA) mphetamine(MDEA) Compounds
Compounds
d-Amphetamine d-,l-Amphetamine l-Amphetamine tamine (MDA) AMP300 d-Amphetamine
d-,l-Amphetamine l-Amphetamine tamine (MDA) Amobarbital Phenobarbital Pentobarbital Butabarbital Secobarbital Butalbital D-glucuronide ß-D-glucuronide Nalorphine 33-2898 REV K 020609 Page 5 Multi-Drug Screen Urine Test
With Adulteration Assay
Interference
To determine the interference of structurally unrelated analytes, each test analyte
was evaluated, using the analyte specific urine test device, in both drug free
urine pools and urine pools spiked with the cutof
f level of each analyte. Common substances listed in this table were found not to interfere with the test
results at the concentration of 100 µg/ml
Acetaminophen
Oxalic Acid Acetylsalicylic Acid Lidocaine Penicillin-G Amitriptyline Ampicillin Ranitidine Arterenal Cortisone Salicyclic Acid Methadone Thioridazine Trifluoperazine Benzoic Acid Biological Analytes
Concentra tion Biological Analytes
Concentration
200 µg/ml 5.0 – 9.0 Bilirubin 100 µg/ml Specific Gravity 1.002 – 1.035 g/ml 100 µg/ml Uric Acid 100 µg/ml 200 µg/ml Vitamin C 100 µg/ml Hemoglobin 100 µg/ml (L-Ascorbic Acid) There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results.(e.g., technical or procedural errors) REFERENCES
FDA Guidance for Labeling Urine Drugs of Abuse Screening Testing, Kshit Mohan, 7/21. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA): Research Monograph 73, 1986. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, 4th ED., Biomedical Publ., Davis, CA; p713-715, 1995. Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, Fed. Register. (69): 11970 (1988). Wilson, John, Abused Drugs II, a Laboratory Pocket Guide., AACC Press. Washington, DC; Gilman AG, Rall TW, Nies AS, Taylor P eds., Goodman and Gilman's the Pharmacological Basis of Therapeutics, 8th ed., New York, Pergamon Press, 1990. Dorland's Illustrated Medical Dictionary, 26 th Edition, W.B. Saunders Company, Philadelphia, PA, pp89, 1981. 4Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA): Research Monograph 73, 1986. S-J. Peroutka ed. Ecstasy: The clinical, pharmacological and neurotoxicological effects of the drug MDMA. Kluwer Academic Publishers, 1990. Temperature limitation In vitro diagnostic Contains sufficient for < n > Consult instructions for Caution, consult accompanying documents Obelis s.a Avenue de Tervueren, 34, Bte 44 B-1040 Brussels Tel.: +32.2.732.59.54 Fax: +32.2.732.60.03 Email: mail@obelis.net 33-2898 REV K 020609 Page 6

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Reglamento (ue) no 1144/2014 del parlamento europeo y del consejo, de 22 de octubre de 2014, sobre acciones de información y de promoción relativas a productos agrícolas en el mercado interior y en terceros países, y por el que se deroga el reglamento (ce) no 3/2008 del consejo

Diario Oficial de la Unión Europea REGLAMENTO (UE) N o 1144/2014 DEL PARLAMENTO EUROPEO Y DEL CONSEJO de 22 de octubre de 2014 sobre acciones de información y de promoción relativas a productos agrícolas en el mercado interior y en terceros países, y por el que se deroga el Reglamento (CE) n o 3/2008 del Consejo