increased blood pressure and cardiac arrhythmias. multi-CLIN™ More acute responses produce anxiety, paranoia, Drug Screen Test Device hallucinations, and psychotic behavior. The effects of Amphetamines generally last 2-4 hours following use Instruction Sheet for testing of any and the drug has a half-life of 4-24 hours in the body. About 30% of Amphetamines are excreted in the urine combination of the following drugs: in unchanged form, with the remainder as hydroxylated AMP/BAR/BZO/COC/THC/MDMA/OPI/ and deaminated derivatives. It is also important to note OXY/PCP/PPX/TCA that Amphetamine is a metabolite of Methamphetamine and will appear in the urine of a person who has taken A rapid, one step screening test for the simultaneous, Methamphetamine. d-Methamphetamine, commonly qualitative detection of multiple drugs and drug known as crystal”, ice” and “speed”, metabolizes into d- metabolites in human urine with on-board procedural Amphetamine, which will be detected by the controls. Amphetamine (AMP) assay on this device.

For professional, in vitro diagnostic use only. The multi-CLIN™ Drug Screen Test Device yields a INTENDED USE positive result when Amphetamines in urine exceed The multi-CLIN™ Drug Screen Test Device is a lateral 1,000 ng/mL. This is the suggested screening cut-off for flow chromatographic immunoassay for the qualitative positive samples set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).1 detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations: (BAR) Test Calibrator Cut-off Barbiturates are central nervous system depressants. Amphetamine (AMP) d-Amphetamine 1,000 ng/mL They are used therapeutically as , hypnotics, Barbiturates (BAR) 300 ng/mL and . Barbiturates are almost always (BZO) 300 ng/mL taken orally as capsules or tablets. The effects Cocaine (COC) Benzoylecgonine 300 ng/mL resemble those of intoxication with . Chronic Marijuana (THC) 11-nor-∆9-THC-9 COOH 50 ng/mL use of barbiturates leads to tolerance and physical Methylenedioxymeth- 3,4-Methylenedioxy- 500 ng/mL dependence. amphetamine (MDMA) methamphetamine Opiates (OPI) 300 ng/mL Short acting Barbiturates taken at 400 mg/day for 2-3 (OXY) Oxycodone 100 ng/mL months can produce a clinically significant degree of (PCP) Phencyclidine 25 ng/mL physical dependence. Withdrawal symptoms Propoxyphene (PPX) Propoxyphene 300 ng/mL experienced during periods of drug abstinence can be Tricyclic Anti- Nortriptyline 1,000 ng/mL severe enough to cause death. depressants (TCA) Only a small amount (less than 5%) of most This assay provides only a preliminary analytical Barbiturates are excreted unaltered in the urine. The test result. A more specific alternate chemical approximate detection time limits for Barbiturates are: method must be used in order to obtain a Short acting (e.g. Secobarbital) 100 mg PO (oral) 4.5 days confirmed analytical result. Gas chromatography/ Long acting (e.g. ) 400 mg PO (oral) 7 days2 mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and The multi-CLIN™ Drug Screen Test Device yields a professional judgment should be applied to any positive result when the Barbiturates in urine exceed drug of abuse test result, particularly when 300 ng/mL. preliminary positive results are indicated. BENZODIAZEPINES (BZO) SUMMARY Benzodiazepines are medications that are frequently The multi-CLIN™ Drug Screen Test Device is a rapid prescribed for the symptomatic treatment of anxiety urine screening test that can be performed without the and sleep disorders. They produce their effects via use of an instrument. The test utilizes monoclonal specific receptors involving a neurochemical called antibodies to selectively detect elevated levels of gamma aminobutyric acid (GABA). Because they are specific drugs in urine. safer and more effective, Benzodiazepines have replaced barbiturates in the treatment of both anxiety AMPHETAMINE (AMP) and insomnia. Benzodiazepines are also used as Amphetamine is a Schedule II controlled substance ® sedatives before some surgical and medical available by prescription (Dexedrine ) and is also procedures, and for the treatment of seizure disorders available on the illicit market. Amphetamines are a and alcohol withdrawal. class of potent sympathomimetic agents with therapeutic applications. They are chemically related to Risk of physical dependence increases if the human body’s natural catecholamines: epinephrine Benzodiazepines are taken regularly (e.g., daily) for and norepinephrine. Acute higher doses lead to more than a few months, especially at higher than enhanced stimulation of the central nervous system normal doses. Stopping abruptly can bring on such and induce euphoria, alertness, reduced appetite, and symptoms as trouble sleeping, gastrointestinal upset, a sense of increased energy and power. feeling unwell, loss of appetite, sweating, trembling, Cardiovascular responses to Amphetamines include weakness, anxiety and changes in perception. Only trace amounts (less than 1%) of most 1 Benzodiazepines are excreted unaltered in the urine; to light, difficulty in focusing, and blurred vision in some most of the concentration in urine is conjugated drug. users. Its mechanism of action is thought to be via The detection period for the Benzodiazepines in the release of the neurotransmitter serotonin. MDMA may urine is 3-7 days. also release dopamine, although the general opinion is

The multi-CLIN™ Drug Screen Test Device yields a that this is a secondary effect of the drug. The most positive result when the Benzodiazepines in urine pervasive effect of MDMA, occurring in virtually all exceed 300 ng/mL. people who took a reasonable dose of the drug, was to produce a clenching of the jaws.4

COCAINE (COC) The multi-CLIN™ Drug Screen Test Device yields a Cocaine is a potent central nervous system (CNS) positive result when the Methylenedioxymeth- stimulant and a local anesthetic. Initially, it brings about amphetamine in urine exceeds 500 ng/mL. extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and spasms. In OPIATES (OPI) large amounts, cocaine causes fever, Opiate refers to any drug that is derived from the unresponsiveness, difficulty in breathing and opium poppy, including the natural products, morphine unconsciousness. and , and the semi-synthetic drugs such as

Cocaine is often self-administered by nasal inhalation, heroin. is more general, referring to any drug that acts on the opioid receptor. intravenous injection and free-base smoking. It is excreted in the urine in a short time primarily as Opioid analgesics comprise a large group of substances Benzoylecgonine.3 Benzoylecgonine, a major metabolite which control pain by depressing the central nervous of cocaine, has a longer biological half-life (5-8 hours) system. Large doses of morphine can produce higher than cocaine (0.5-1.5 hours), and can generally be tolerance levels, physiological dependency in users, and detected for 24-48 hours after cocaine exposure.3 may lead to substance abuse. Morphine is excreted

The multi-CLIN™ Drug Screen Test Device yields a unmetabolized, and is also the major metabolic product of codeine and heroin.3 positive result when the cocaine metabolite in urine exceeds 300 ng/mL. This is the suggested screening The multi-CLIN™ Drug Screen Test Device yields a cut-off for positive samples set by the Substance positive result when the concentration of opiates Abuse and Mental Health Services Administration exceeds the 300 ng/mL cut-off level. (SAMHSA, USA). OXYCODONE (OXY) MARIJUANA (THC) Oxycodone is a semi-synthetic opioid with a structural THC (∆9--tetrahydrocannabinol) is the primary active similarity to codeine. The drug is manufactured by ingredient in cannabis (marijuana). When smoked or modifying thebaine, an alkaloid found in the opium orally administered, THC produces euphoric effects. poppy. Oxycodone, like all opiate agonists, provides Users have impaired short term memory and slowed pain relief by acting on opioid receptors in the spinal learning. They may also experience transient episodes cord, brain, and possibly directly in the affected tissues. of confusion and anxiety. Long-term, relatively heavy Oxycodone is prescribed for the relief of moderate to use may be associated with behavioral disorders. The high pain under the well-known pharmaceutical trade peak effect of marijuana administered by smoking names of OxyContin®, Tylox®, Percodan® and occurs in 20-30 minutes and the duration is 90-120 Percocet®. While Tylox, Percodan and Percocet contain minutes after one cigarette. Elevated levels of urinary only small doses of oxycodone hydrochloride combined metabolites are found within hours of exposure and with other analgesics such as acetaminophen or aspirin, remain detectable for 3-10 days after smoking. The main OxyContin consists solely of oxycodone hydrochloride in 9 a time-release form. metabolite excreted in the urine is 11-nor-∆ - tetrahydrocannabinol-9-carboxylic acid (∆9-THC-COOH). Oxycodone is known to metabolize by demethylation The multi-CLIN™ Drug Screen Test Device yields a into oxymorphone and noroxycodone. In a 24-hour positive result when the concentration of THC-COOH urine, 33-61% of a single, 5mg oral dose is excreted in urine exceeds 50 ng/mL. This is the suggested with the primary constituents being unchanged drug (13- screening cut-off for positive samples set by the 19%), conjugated drug (7-29%) and conjugated 3 Substance Abuse and Mental Health Services oxymorphone (13-14%) . The window of detection for Administration (SAMHSA, USA). 1 oxycodone in urine is expected to be similar to that of other such as morphine. METHYLENEDIOXYMETHAMPHETAMINE (MDMA) Methylenedioxymethamphetamine (ecstasy) is a The multi-CLIN™ Drug Screen Test Device yields a designer drug first synthesized in 1914 by a German positive result when the oxycodone level in urine drug company for the treatment of obesity. Those who exceeds 100 ng/mL. At present, the Substance Abuse take the drug frequently report adverse effects, such as and Mental Health Services Administration (SAMHSA) increased muscle tension and sweating. MDMA is not does not have a recommended screening cutoff for clearly a stimulant, although it has, in common with oxycodone positive samples. amphetamine drugs, a capacity to increase blood PHENCYCLIDINE (PCP) pressure and heart rate. MDMA does produce some Phencyclidine, also known as PCP or Angel Dust, is a perceptual changes in the form of increased sensitivity hallucinogen that was first marketed as a surgical 2 anesthetic in the 1950’s. It was removed from the The multi-CLIN™ Drug Screen Test Device yields a market because patients receiving it became delirious positive result when the concentration of Tricyclic and experienced hallucinations. Antidepressants in urine exceeds 1,000 ng/mL.

Phencyclidine is used in powder, capsule, and tablet PRINCIPLE form. The powder is either snorted or smoked after The multi-CLIN™ Drug Screen Test Device is an mixing it with marijuana or vegetable matter. immunoassay based on the principle of competitive Phencyclidine is most commonly administered by binding. Drugs which may be present in the urine inhalation but can be used intravenously, intra-nasally, sample compete against their respective drug and orally. After low doses, the user thinks and acts conjugate for binding sites on their specific antibody. swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the During testing, a urine sample migrates upward by devastating effects of Phencyclidine. capillary action. A drug, if present in the urine sample below its cut-off concentration, will not saturate the PCP can be found in urine within 4 to 6 hours after use binding sites of its specific antibody. The antibody will and will remain in urine for 7 to 14 days, depending on then react with the drug-protein conjugate and a visible factors such as metabolic rate, user’s age, weight, colored line will show up in the test line region of the 5 activity, and diet. Phencyclidine is excreted in the specific drug strip. The presence of drug above the cut- urine as an unchanged drug (4% to 19%) and off concentration will saturate all the binding sites of conjugated metabolites (25% to 30%).6 the antibody. Therefore, the colored line will not form in the test line region. The multi-CLIN™ Drug Screen Test Device yields a positive result when the phencyclidine level in urine A drug-positive urine sample will not generate a exceeds 25 ng/mL. This is the suggested screening colored line in the specific test line region of the strip cut-off for positive samples set by the Substance because of drug competition, while a drug-negative Abuse and Mental Health Services Administration urine sample will generate a line in the test line region (SAMHSA, USA). because of the absence of drug competition.

PROPOXYPHENE (PPX) Internal Procedural Controls Propoxyphene is a narcotic analgesic compound To serve as an internal procedural control, the test bearing structural similarity to methadone. Darvocet™, includes both a Positive and Negative Control Region. one of the most common brand names for the drug, Positive Control contains 50-100 mg of propoxyphene napsylate and When the test is manufactured, an antigen-BSA 325-650 mg of acetaminophen. After a typical 100 mg conjugate is striped in the Positive Control Region oral dose of propoxyphene napsylate, peak plasma (POS) with a water-soluble blue dye as a visual concentrations of 0.05 µg/mL to 0.1 µg/mL are marker. The positive control antigen is included in the achieved from 2 to 2½ hours post dose. Repeat doses label pad. When the test is run properly, the migration of propoxyphene at 6-hour intervals leads to increasing of the sample will make this blue line disappear. plasma concentrations, with a plateau after the ninth Therefore, the absence of a line in the Positive Control dose at 48 hours. In the case of overdose, Region (POS) serves as an internal positive procedural propoxyphene blood concentrations can reach control. The presence of a blue line in the Positive significantly higher levels. Control Region (POS) could indicate that an Propoxyphene is metabolized in the liver to yield immunochemical reaction did not occur and the results norpropoxyphene. Norpropoxyphene has a longer half- should be considered invalid. life (30 to 36 hours) than parent propoxyphene (6 to 12 Negative Control hours).5 A line in the Negative Control Region (NEG) confirms The multi-CLIN™ Drug Screen Test Device yields a that proper volume of sample has been added and positive result when the concentration of Propoxyphene membrane wicking has occurred. There must be a line or Norpropoxyphene in urine exceeds 300 ng/mL. At present in the Negative Control Region (NEG) for the present, the Substance Abuse and Mental Health test results to be valid.

Services Administration (SAMHSA) does not have a The absence of a Positive Control line confirms the recommended screening cutoff for propoxyphene internal procedural control and, along with the positive samples. appearance of the Negative Control line, the TRICYCLIC ANTIDEPRESSANTS (TCA) validity of the test results. If the test is working TCA (Tricyclic Antidepressants) are commonly used for properly, a line should always appear in the the treatment of depressive disorders. TCA overdoses Negative Control Region (NEG) and NO line should can result in profound central nervous system appear in the Positive Control Region (POS). depression, cardiotoxicity and anticholinergic effects. REAGENTS TCA overdose is the most common cause of death from prescription drugs. TCAs are taken orally or sometimes Each test line contains anti-drug mouse monoclonal by injection. TCAs are metabolized in the liver. Both antibody and corresponding drug-protein conjugates. TCAs and their metabolites are excreted in urine mostly Control line contains goat anti-rabbit IgG polyclonal in the form of metabolites for up to ten days. antibodies and rabbit IgG.

3 PRECAUTIONS First, confirm the validity of the results by • For professional, in vitro diagnostic use only. reviewing the Negative and Positive Control Lines. • Do not use after the expiration date. If there is a line in the Positive Control Region • The test device should remain in the sealed pouch (POS), the result is INVALID. There must be a line until use. in the Negative Control Region (NEG) for the result • All samples should be considered potentially to be VALID. Before interpreting testing results, hazardous and handled in the same manner as an make sure that there is no line next to “POS” and a visible line next to “NEG”. [See image (3).] infectious agent. • The used test device should be discarded according NEGATIVE RESULT:* A colored line appears in the to federal, state and local regulations Negative Control region (NEG), no line appears in STORAGE AND STABILITY the Positive Control Region (POS) and a colored Store as packaged in the sealed pouch at 2-30°C. The line appears in the Test region next to a specific test device is stable through the expiration date printed drug tested. Up to four colored lines may appear in on the sealed pouch. The test device must remain in each result window. One line will be in the Negative the sealed pouch until use. DO NOT FREEZE. Do not Control region (NEG). Up to three lines will be next to use beyond the expiration date. the drug names in the Test region. This negative result means that the drug concentration in the urine sample SAMPLE COLLECTION AND PREPARATION is below the detectable level for a certain drug tested. Urine Assay *NOTE: The shade of the colored line(s) in the Test The urine sample must be collected in a clean and dry region may vary. The result should be considered container. Urine collected at any time of the day may negative when there is even a faint color line. be used. Urine samples exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to POSITIVE RESULT: A colored line appears in the obtain a clear supernatant for testing. Negative Control region (NEG), no line appears in the Positive Control Region (POS) and NO line Sample Storage appears in the Test region next to the name of a Urine samples may be stored at 2-8°C for up to 48 certain drug tested. The positive result means that hours prior to testing. For prolonged storage, samples the drug concentration in the urine sample is greater may be frozen and stored below -20°C. Frozen than the detectable level for a certain drug tested. samples should be thawed and mixed well before testing. INVALID: No line appears in the Negative Control MATERIALS region (NEG) and/or a line appears in the Positive Control Region (POS). Not enough sample volume or Materials Provided incorrect procedural techniques are the most likely • Test devices reasons for an invalid result. Review the directions for • Disposable droppers use and repeat the test with a new test device. If the • Package insert problem continues, contact Technical Service. • Procedure card QUALITY CONTROL Materials Required But Not Provided A procedural control is included in the test. The • Sample collection container presence of a red line in the Negative Control region • Timer (NEG) and the absence of a line in the Positive Control • Positive and Negative Controls Region (POS) are considered internal procedural DIRECTIONS FOR USE controls. This confirms sufficient sample volume, adequate membrane wicking and correct procedural Allow test device and urine sample to reach room technique. temperature (15-30°°°C) before testing. The internal procedural controls contained within the 1. Remove the test device from the sealed pouch. Use device satisfy the daily control testing requirement it as soon as possible. provided they are used in conjunction with a 2. Place the test device on a clean and level surface. comprehensive laboratory Quality Assurance program. Add 100µL of urine (3 full drops using the included pipette) to each of the sample wells of the test It is recommended that external positive and negative device. [See image (1).] Start the timer. Avoid controls be tested when a new kit is opened, after trapping air bubbles in the sample well. prolonged kit storage and as deemed necessary by your internal laboratory procedures.

3. Wait for the colored lines(s) to appear. [See image (2).] The results should be read at 5 minutes. Test results will be stable for at least 8 hours after test initiation. RESULT INTERPRETATION [Please refer to image (4).] 4 External Positive and Negative Controls are available 3. Adulterants, such as bleach and/or alum, in urine separately. Please contact your distributor for a list of samples may produce erroneous results regardless approved controls that have been validated with the of the analytical method used. If adulteration is muIti-CLIN™ Drug Screen Test Device. Use of any suspected, the test should be repeated with another other control material is not advised and could produce urine sample. irregular results. 4. A Positive result does not indicate level or User should follow Federal, State and Local guidelines intoxication, administration route or concentration in for quality control testing. urine. LIMITATIONS 5. A Negative result may not necessarily indicate drug- free urine. Negative results can be obtained when 1. The multi-CLIN™ Drug Screen Test Device drug is present but below the cut-off level of the provides only a qualitative, preliminary analytical test. result. A secondary analytical method must be used 6. Test does not distinguish between drugs of abuse to obtain a confirmed result. Gas chromatography/ and certain medications. mass spectrometry (GC/MS) is the preferred 1 7. A positive test result might be obtained from certain confirmatory method. foods or food supplements. 2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine sample may cause erroneous results.

1 2

Wait 5 minutes Add 100µL of urine to read results. (3 drops using pipette) to EACH sample well.

ID DATE

NEG NEG NEG NEG

POS POS POS POS VALID INVALID INVALID INVALID RESULT RESULT RESULT RESULT POS NEG RESULT POS THC COC AMP NEG VAL

ID NEG NEG NEG NEG DAT ID BZO MDMA

POS NEG OXY AMP TCA OPI E INV RESULT COC PPX

D ALI BAR PCP POS BAR TCA BZO NEG THC POS POS

POS NEG POS POS INV RESULT D ALI POS NEG POS PCP OPI MDMA NEG INV RESULT D ALI POS PPX OXY NEG

3 4

Interpret Results at 5 minutes. Confirm validity of results by checking NEG and POS Control Regions. INVALID RESULTS There should be NO line in the Positive Control Region (POS) and a visible line in the Negative Control Region (NEG). NEG NEG VALID RESULT, AMP AMP NEGATIVE for COC COC NEG NEG NEG ALL ANALYTES THC THC AMP AMP AMP SHOWN POS POS COC COC COC THC THC THC POS POS POS NEG VALID RESULT, NEG VALID RESULT, AMP POSITIVE for AMP EXAMPLES OF POSITIVE for COC COC ALL ANALYTES COC VALID RESULTS THC SHOWN THC POS POS

5 PERFORMANCE CHARACTERISTICS Predicate Test % Agreement Method Results with Predicate Accuracy Pos. Neg. Test A side-by-side comparison was conducted using the Pos. 140 0 AMP >99% multi-CLIN™ Drug Screen Test Device and Neg. 3 307 commercially available drug rapid tests. Testing was Pos. 103 0 BAR >99% performed on 1,704 samples previously collected from Neg. 0 307 Pos. 122 1 subjects presenting for Drug Screen Testing. BZO >99% Presumptive positive results were confirmed by Neg. 0 302 Pos. 132 4 GC/MS. Negative urine samples were screened initially COC 99% by Predicate test. The following compounds were Neg. 0 308 Pos. 132 0 THC 98% quantified by GC/MS and contributed to the total Neg. 9 307 amount of drugs found in presumptive positive urine Pos. 91 1 samples tested in the following clinical studies: MDMA >99% Neg. 0 301 Pos. 149 0 Compounds Contributed to the Totals of OPI Test >99% GC/MS Neg. 0 300 Pos. 141 2 AMP Amphetamine multi-CLIN™ OXY >99% BAR Secobarbital, , Phenobarbital, Neg. 0 307 Pos. 89 0 Oxazepam, Nordiazepam, , α-OH, PCP >99% BZO Test Device Screen Drug Desalkylflurazepam Neg. 0 301 Pos. 135 0 COC Benzoylecgonine PPX >99% THC 11-nor-∆9-tetrahydrocannabinol-9-carboxylic acid Neg. 0 305 3,4-Methylenedioxymethamphetamine, Pos. 54 0 MDMA TCA >99% Methylenedioxyamphetamine Neg. 0 316 OPI Morphine, Codeine OXY Oxycodone Analytical Sensitivity PCP Phencyclidine A drug-free urine pool was spiked with drugs to various PPX Propoxyphene concentrations. >99% agreement with expected results TCA Nortriptyline was found at ± 50% cut-off for each drug tested (with a The following results were tabulated: 95% confidence interval).

Method GC/MS Analytical Specificity The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by the multi-CLIN™ Drug Screen Test Device at 5 minutes.

Positive Positive Negative Negative Negative* Negative* Near Near cutoff Near cutoff with GC/MSwith Compound ng/mL % agreement (<-25% cutoff) Positive (cutoffPositive (>+25% cutoff) cutoff to cutoff) to +25% cutoff) Negative (-25% Negative AMPHETAMINE + 0 0 6 20 114 d-Amphetamine 1,000 AMP 98% - 300 2 6 2 0 d,l-Amphetamine 3,000 + 0 1 3 3 96 l-Amphetamine 50,000 BAR 99% - 300 0 5 1 1 p-Hydroxyamphetamine 3,125 + 0 1 1 3 136 3,4-Methylenedioxyamphetamine (MDA) ng/mL2,000 BZO >99% - 300 2 6 1 0 Phentermine 3,000 + 0 2 15 14 105 COC 96% - 300 3 5 0 0 BARBITURATES + 0 9 7 11 105 THC 95% Secobarbital 300 - 300 9 2 3 2 300 + 0 0 4 6 82 MDMA 99% Alphenol 150 - 300 0 1 0 0 200 + 0 2 7 10 130 OPI 98% 75 - 300 0 0 0 0 Butalbital 2,500 + 0 1 2 2 138 OXY 99% Butethanol 100 - 300 2 4 1 0 400 + 0 4 0 11 74 PCP 99% Cyclopentobarbital 600 - 300 0 0 1 0 Pentobarbital 300 + 0 0 0 2 143 PPX >99% - 300 0 4 1 0 Phenobarbital 100 + 0 13 9 14 18 TCA** 94% - 300 16 0 0 0 BENZODIAZEPINES * Negative urine samples were screened by predicate Oxazepam 300 tests and approximately 10% were confirmed Alprazolam 196 negative by GC/MS. Alprazolam, α-OH 1,262 **Note: TCA concentration was based on HPLC data. 1,562 1,562 6 Compound ng/mL Compound ng/mL 98 Normorphone 100,000 781 Oxymorphone 780 195 Procaine 100,000 1,562 Thebaine 25,000 Desalkylflurazepam 390 195 PHENCYCLIDINE 2,500 Phencyclidine 25 390 4-Hydroxyphencyclidine 12,500 (±) 1,562 RS-Lorazepam glucuronide 156 PROPOXYPHENE 12,500 d-Propoxyphene 300 98 Norpropoxyphene 300 Norchlordiazepoxide 195 Nordiazepam 390 TRICYCLIC ANTIDEPRESSANTS 98 Nortriptyline 1,000 2,500 Amitriptyline 1,500 Clomipramine 12,500 COCAINE Cyclobenzaprine 6,250 Benzoylecgonine 300 Desipramine 200 Cocaine 780 Doxepin 2,000 Cocaethylene 12,500 Imipramine 400 Ecgonine 32,000 Maprotiline 2,000 Nordoxepin 1,000 MARIJUANA (THC) Perphenazine 50,000 11-nor-∆9 -THC-9 COOH 50 Promazine 1,500 Cannabinol 20,000 Promethazine 25,000 11-nor-∆8-THC-9 COOH 30 Trimipramine 3,000 ∆8 -THC 15,000 ∆9 -THC 15,000 Precision A study was conducted at three physician offices for METHYLENEDIOXYMETHAMPHETAMINE Amphetamine, Barbiturates, Benzodiazepines, 3,4-Methylenedioxymethamphetamine (MDMA) 500 Cocaine, Marijuana, Methylenedioxymethamphetamine, l-Methamphetamine 100,000 Opiates, Oxycodone, Phencyclidine, Propoxyphene 3,4-Methylenedioxyamphetamine (MDA) 3,000 and Tricyclics by untrained operators using three 3,4-Methylenedioxyethylamphetamine (MDEA) 300 different lots of product to demonstrate the within run, between run and between operator precision. An OPIATE 300 (OPI) identical panel of coded samples, containing drugs at Morphine 300 the concentration of ± 50% cut-off level was labeled as Codeine 300 a blind and tested at each site. The correlation with Ethylmorphine 6,250 Hydrocodone 50,000 expected results was >99% across all lots and sites Hydromorphone 3,125 (with a 95% confidence interval). Levorphanol 1,500 6-Monoacetylmorphine 400 Effect of Urinary Specific Gravity Morphine 3-β-d-glucuronide 1,000 Urine samples of low, normal and high specific gravity Norcodeine 6,250 (1.004-1.034) were spiked with drugs at ±50% cut-off Normorphone 100,000 levels and analyzed. The results demonstrate that Oxycodone 30,000 varying ranges of urinary specific gravity do not affect Oxymorphone 100,000 the test results. Thebaine 6,250 Effect of the Urinary pH OXYCODONE Urine samples with pH ranges from 5-9 in 1 pH unit Oxycodone 100 increments were spiked with drugs at ±50% cut-off 6-Acetylcodeine 100,000 levels and analyzed. The results demonstrate that Codeine 25,000 varying ranges of pH (5-9) do not interfere with the Dihydrocodeine 12,500 performance of the test. Ethylmorphine 25,000 Hydrocodone 6,250 Hydromorphone 12,500 Levorphanol 100,000 6-Monoacetylmorphine 100,000 Morphine 100,000 Morphine 3-β-d-glucuronide 100,000 Norcodeine 100,000 7 Cross-Reactivity Oxalic acid Oxolinic acid Oxymetazoline Papaverine A study was conducted to determine the cross- Pemoline Penicillin-G reactivity of the test with compounds in either drug-free Pentazocine Phenelzine urine or Amphetamine, Barbiturates, Benzodiazepines, Pheniramine Phenothiazine Cocaine, Marijuana, Methylenedioxymethamphetamine, Trans-2-phenylcyclopropylamine l-Phenylephrine β-Phenylethylamine Phenylpropanolamine Opiates, Oxycodone, Phencyclidine, Propoxyphene (±) Phenylpropanolamine (d/l-Norephedrine) Prednisolone and Tricyclic positive urine. The following compounds Prednisone 5-β-pregnane-3α, 17α, 21-triol-20-one show no cross-reactivity when tested with the multi- Procaine d/l-Propranolol d-Pseudoephedrine Quinacrine CLIN™ Drug Screen Test Device at a concentration Quinine Quindine of 100 µg/mL. Ranitidine Riboflavin Salbutamol Salicylic acid Non-Cross Reacting Compounds Serotonin Sodium chloride Acetaminophen Spironolactone Sulfamethazine Acetophenetidin N-Acetylprocainamide Sulfamethoxazole Sulfisoxazole Acetylsalicylic acid Albumin Sulindac Tetracycline Albuterol Aminopyrine Tetrahydrocortisone 3-acetate Tetrahydrozoline Amoxapine Amoxicillin Theophylline Thiamine Ampicillin Apomorphine Thioridazine Thiothixene l-Ascorbic acid Aspartame l-Thyroxine Tobramycin Atropine Baclofen Tolbutamide Tramadol Benzilic acid Benzocaine Trazodone Trimethobenzamide Benzoic acid Benzphetamine* Triamterene Trifluoperazine Bilirubin d/l-Brompheniramine Trimethoprim Tryptamine Buprenorphine Buspirone d/l-Tryptophan Tyramine Caffeine Cannabidiol d/l-Tyrosine Uric acid Chloralhydrate Verapamil Zomepirac Chloramphenicol Chloroquine Chlorothiazide d/l-Chlorpheniramine *Parent compound only Chlorpromazine Chlorpropamide Chlorprothixene Cimetidine Clonidine BIBLIOGRAPHY Clozapine Cortisone l-Cotinine Creatinine 1. Procedures for Transportation Workplace Drug and Deoxycorticosterone R(-)Deprenyl Alcohol Testing Programs, 49 CFR 40. Reprinted by the Dextromethorphan Diclofenac Department of Transportation, Drug and Alcohol Policy Dicyclomine Diflunisal and Compliance Office, 400 7th St., SW, Washington, DC Digitoxin Digoxin 20590, (202) 366-3784. (+)-cis-Diltiazem Dimenhydrinate 2. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders 4-Dimethylaminoantipyrine Diphenhydramine 5,5-Diphenylhydantoin Disopyramide Company. 1986, 1734. Dopamine Doxylamine 3. Baselt R. Disposition of Toxic Drugs and Chemicals in Man, Droperidol Ecgonine methyl ester 6th Ed. Biomedical Publications. 2002. EDDP * 4. Climko RP. Ecstacy: A Review of MDMA and MDA. Int’l J EMDP Ephedrine Psychiatry in Medicine. 16(4); 1986-1987, 359-372. l-Ephedrine [1R,2S](-)Ephedrine 5. Hardman J, Limbird LE (Eds). Goodman & Gilman’s The l-Epinephrine (±)Epinephrine th Pharmacological 1 Basis 1 of 1 Therapeutics, 1 0 1 Ed., Erythromycin β-Estradiol McGraw-Hill Publishing. 2001, 598. Estrone-3-sulfate Ethanol (Ethyl alcohol) Ethyl-p-aminobenzoate Etodolac Famprofazone Fenfluramine Fenoprofen Furosemide Gentamicin Gentisic acid d(+)Glucose Guaiacol Glyceryl Ether Haloperidol Hemoglobin Hydralazine Hydrochlorothiazide Hydrocortisone o-Hydroxyhippuric acid p-Hydroxymethamphetamine p-Hydroxynorephedrine Hydroxyzine Ibuprofen Indomethacin Insulin Iproniazid l-Isoproterenol Isoxsuprine Kanamycin Ketoprofen Labetalol Lidocaine Lindane Lithium Loperamide Meperidine Mephentermine Methadone d-Methamphetamine

Methaqualone Methoxyphenamine Methylphenidate Metoprolol Metronidazole Nalidixic acid Nalorphine Manufactured by ACON Laboratories, Inc. San Diego, CA 92121 Naloxone Naltrexone multi-CLIN™ is a trademark of ACON Laboratories, Inc. α-Naphthaleneacetic Acid Naproxen Niacinamide Nifedipine DN: 1150288602 Nimesulide Norethindrone  Eff.Date:2005-09-02 Norfluoxetine Noscapine d/l-Octopamine Orphenadrine

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