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In order for a hair sample to test positive, the metabolite of the drug will be detected if the donor has physically ingested the drug.  Our Laboratory uses detection levels that follow government recommendations.

Why use Hair Testing?

When compared to other forms of testing (urine, blood, oral fluids), hair samples can detect a longer period of drug use.  For example, urinalysis can only detect most drugs within 2-3 days of use with the exception of marijuana, which may be detected for a longer period of time.  After this period, a donor will be free of the drug, test negative and slip through the screening process.  This is important in pre-employment testing where most candidates are aware that a drug test might be required and can abstain accordingly.  With hair samples, the only time limitation for detecting drug usage is imposed by the length of the donors hair.  The industry standard is to test 1.5 inches of head hair for a 90 day history.

Why is hair testing the best method of detecting substance abusers?

  • Hair testing offers the longest window of detection (90 days standard test).

  • Hair specimens cannot be adulterated or substituted.

  • Collection is safe and simple without the hazards associated with the handling of body fluids.

  • Pricing is competitive with other methods even before the potential costs of employing a drug user are considered.

Pros and Cons of Hair Drug Testing:

Pros: This method has the longest drug detection window. For the majority of drugs the window of use is about 90 days or more. This method is also very donor friendly. Adulteration is the hardest to do with this method. This test is also very dependable and accurate.

Cons: The biggest disadvantage to this method is that you have to have a lab run the test and obtain the results. Because of this extra step, it can take a few extra days to get your test results. Another disadvantage is that it most likely will not pick up very recent drug use. Hair test kits are also the most expensive drug test kits because of the necessity of using a lab for the testing.

Marijuana Hair Drug Test
Description

 

Hair Drug Test (5 panel hair follicle drug test):

Marijuana, Opiates, Cocaine, Methamphetamines, & PCP.

 


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RETAIL $99.95.  OUR PRICE $57.95 each.

 

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MRO - Medical Review Officer Services
Description

 

 

#LAB-MRO Service - Medical Review Officer review / confirmation of Lab results.

RETAIL $28.95.  OUR PRICE $14.95 each.

 

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Hair Testing Questions & Answers

 

1. What is Hair Drug Testing?
Since hair growth is fed by the bloodstream, the ingestion of drugs of abuse is revealed by analyzing a small sample of hair. Our testing method measures the drug molecules embedded inside the hairshaft, eliminating external contamination as a source of a positive test result. Hair testing results cannot be altered with shampoos, bleaches or other external chemicals.

 

2. What drugs are included in a standard Hair Drug Test?
Cocaine (cocaine & benzoylecgonine), marijuana, opiates (Codeine, Morphine & 6-monacteyl morphine), methamphetamine, (Meth/amphetamine & Ecstasy), and phencyclidine (PCP). These are the five drug classes are mandated for testing by the Federal Government.

 

3. What time period does a standard test cover?
A standard screen covers a period of approximately 90 days. The hair sample is cut as close to the scalp as possible and the most recent 1.5 inches are tested.

 

4. How effective is Hair Testing in detecting drug users?
In side-by-side comparison studies with urinalysis, hair drug testing has uncovered significantly more drug use. In two independent studies hair drug testing uncovered 4 to 8 times as many drug users as urinalysis.

Hair Folicle

5. How fast does head hair grow?
Studies indicate that head hair grows on the average approximately 1.3 cm (or 1/2 inch) per month. This growth rate varies slightly (estimated at .2 cm per month, consequently there is some ( 1 week) time variation possible.

 

6. How much hair is needed?
A standard screen with GC/MS confirmation requires 60+ milligrams
of hair or approximately 90 to 120 strands. The thickness of different types of head hair (thick brown vs. thinning gray) is the reason for this variation.

 

7. How does Hair Testing compare to urinalysis?
The primary differences are:
1) wider window of detection
2) inability to tamper with the test.

Cocaine, methamphetamine, opiates and PCP are rapidly excreted and usually undetectable in urine 72 hours after use. The detection period for hair is limited only by the length of the hair sample and is approximately 90 days for a standard screen.

At this time there are no known adulterants for hair tests. Since hair tests analyze the drugs inside the hairshaft, external contaminants/chemicals have no effect.  Additional advantages include non-intrusive collection procedures, virtual elimination of test evasion; greater accuracy through test repetition capability.  The combination of an increased window of detection and resistance to evasion makes Hair Testing far more effective than urinalysis in correctly identifying drug users.

 

8. How soon after use can a drug be detected in hair?
It takes approximately 4-5 days from the time of drug use for the affected hair to grow above the scalp. Body hair growth rates are generally slower and cannot be utilized to determine a timeframe of drug use.

 

9. What is the shortest time period that can be accurately evaluated?
The minimum time period is approximately one month (1/2 inch). Body hair can be used if head hair is too short for a test. If body hair is used the timeframe represented by the test is approximately one year, due to the different growth pattern in hair below the neck.

 

10. Can tests be run on people with little or no hair?
Hair can be collected from several head locations and combined to obtain the required amount of hair. In addition, body hair may be used as a substitute to head hair. In the rare case where no hair is collectable, complete urine/adulteration testing may have to be utilized.

 

11. Does body hair give the same type of results as head hair?
Yes, body hair can be used to test for the five standard drug classes, though body hair growth patterns are different than head hair. Most body hair is replaced within approximately one year. This means a test done with body hair will be reported as drug usage during approximately a one year timeframe.

 

12. Can hair collected from a brush be used?
Yes, but the test will be reported as having an "anonymous" donor. We cannot attribute the sample to any specific person and we cannot determine the timeframe of the test, so the test result is not legally defensible. The test will only report that the sample submitted had the reported drug metabolite components.

 

13. How does Omega Laboratories establish its cut-off levels?
Omega follows the cut-off levels generally accepted industry-wide and recommended by the U.S. Department of Health & Human Services.

 

14. Does Omega Laboratories perform GC/MS confirmation of all positive hair results?
Yes. Omega provides confirmation utilizing GC/MS for all specimens that screen potentially positive (opiates, PCP, methamphetamine, cocaine and marijuana).

 

15. Can Hair be affected by cross-reacting substances such as over-the-counter medications?
Enzyme-immunoassay antibodies (EIA), similar to those used to test urine, are used for the initial screening test for drugs of abuse in hair; therefore the potential for substances such as over-the-counter medications to cause a false positive screening result does exist. To provixe accurate results Omega confirms all positive results by GC/MS.

 

16. Does external exposure to certain drugs, like marijuana or crack smoke, affect the Hair Test results?
Omega testing looks for the metabolite by-product of drug ingestion that is deposited inside the hairshaft by the bloodstream. For example, to rule out the possibility of external contamination for marijuana smoke creating a false positive, Omega reports a positive result only when it detects the metabolite (i.e. THC-COOH) . This metabolite is only produced by the body and cannot be an environmental contaminant.

 

17. Is Omega Laboratories' internal chain-of-custody comparable to a urinalysis laboratory test procedure?
Omega's internal chain-of-custody is modeled after the requirements in the SAMHSA guidelines.

 

18. How long are positive and negative test reports kept on file?
Test reports are retained for a period of three years or as mandated by law.

 

19. What is done with the excess hair that is not tested?
The hair not used from the time period being tested (i.e. three months equals 3.9 cm) is stored in the chain-of-custody sample acquisition pouch. Negative hair is stored for three months. Positive hair is stored for one year.

 

20. What experience does Omega Laboratories have provided Expert Witness Testimony?
Omega Laboratories' forensic experts have qualified as expert witnesses in Ohio, New York State, California, Texas, Nevada, Oklahoma, Alabama and Arizona in over 250 civil, criminal, and Superior Court trials.

 

21. What other drugs are available to be tested in hair analysis?
Currently, nicotine, methadone, simple benzodiazepines, tricyclic antidepressants assays and mescaline have been detected in hair. However, many details such as cutoff levels and dose response relationships have not yet been established for these compounds, though, detection of these compounds is possible by special arrangement with the Laboratory.


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Give Us A Call:  (801) 596-2709

 

Click here for Multi-Panel Urine Drug Tests (to test for 2 to 12 drugs in one test).

 

FOR MORE INFORMATION ON OTHER DRUGS OF ABUSE, SEE THE INFORMATION BELOW.

TO PURCHASE INSTANT DRUG TEST KITS AND SUPPLIES, JUST CLICK ON ONE OF THE LINKS TO THE LEFT....


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One Step Single/Multi-Drug Screen Test Panel
Package Insert for 1 to 10 Drug Screen Panel Dip
Instruction Sheet for testing of any combination of the following drugs:
AMP, BAR, BZO, COC,THC, MTD , mAMP, OPI, PCP AND TCA

Amphetamine (AMP)
Barbiturates (BAR)
Benzodiazepines (BZO)
Cocaine (COC)
Marijuana (THC)
Methadone (MTD)
Methamphetamine (mAMP)
Opiate (300 ng/ml) (OPI 300 or MOP 300)
Opiate (OPI) (2000 ng/ml)
Phencyclidine
Tricyclic Antidepressant (TCA)
Non Cross-Reacting Compounds

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine. For healthcare professionals and professionals at point of care sites. For professional in vitro diagnostic use.
INTENDED USE
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The One Step Multi-Drug Screen Test Panel is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations: 300 ng/mL Benzoylecgonine (Cocaine metabolite), 1,000 ng/mL Amphetamine, 1,000 ng/mL Methamphetamine, 50 ng/mL 11-nor-.9 -THC-9- COOH (THC), 2,000 ng/mL Opiate, 25 ng/mL Phencyclidine, in urine.

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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
SUMMARY
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AMPHETAMINE (AMP)
Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human bodys natural catecholamines: epinephrine and norepinephrine. Acute higher does lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power. Cardiovascular responses to Amphetamines include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, and psychotic behavior. The effects of Amphetamines generally last 2-4 hours following use, and the drug has a halflife of 4-24 hours in the body. About 30% of Amphetamines are excreted in the urine in unchanged form, with the remainder as hydroxylated and deaminated derivatives.
The AMP One Step Amphetamine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Amphetamine in urine. The AMP One Step Amphetamine Test Strip yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.
BARBITURATES (BAR)
Barbiturates are central nervous system 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 400mg/day for 2-3 months produces a clinically significant degree of physical dependence. Withdrawal symptoms experienced during periods of drug abstinence can be severe enough to cause death.
Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in urine. 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 days1
The One Step Drug Screen Test yields a positive result when the Barbiturates in urine exceeds 300ng/ml.
BENZODIAZEPINES (BZO)
Benzodiazepines are medications that are frequently prescribed for 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 trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating and trembling, weakness, anxiety and changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in urine; most of the concentration in urine is conjugated drug. The detection period for the Benzodiazepines in urine is 3 7 days.
The One Step Drug screen Test Card yields a positive result when the Benzodiazepines in urine exceeds 300 ng/ml.
COCAINE (COC)
Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic. Initially, it brings about extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and spasms. In large amounts, cocaine causes fever, unresponsiveness, and difficulty in breathing and unconsciousness.
Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is excreted in the urine in a short time primarily as Benzoylecgonine1,2. Benzoylecgonine, a major metabolite of cocaine, has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours), and can generally be detected for 24-48 hours after cocaine exposure2.
The COC One Step Cocaine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of cocaine metabolite in urine. The COC One Step Cocaine Test Strip yields a positive result when the cocaine metabolite in urine exceeds 300 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
MARIJUANA (THC)
THC (.9--tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed learning. They may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioral disorders. The peak effect of smoking marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-.9-tetrahydrocannabinol-9-carboxylic acid (.9-THC-COOH).
The THC One Step Marijuana Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of marijuana in urine. The THC One Step Marijuana Test Strip yields a positive result when the concentration of marijuana in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA). 3
METHADONE (MTD)
Methadone is a narcotic pain reliever for medium to severe pain. It is also used in the treatment of heroin (opiate dependence: Vicodin, Percocet, Morphine, etc.) addiction. Oral Methadone is very different than IV Methadone. Oral Methadone is partially stored in the liver for late use. IV Methadone acts more like heroin. In most states you must go to a pain clinic or a Methadone maintenance clinic to be prescribed Methadone.
Methadone is a long acting pain reliever producing effects that last from twelve to forth-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.1
The MTD One step Methadone test yields a positive result when Methadone in urine exceeds 300 ng/ml.
METHAMPHETAMINE (mAMP)
Methamphetamine is an addictive stimulant drug that strongly activates certain systems in the brain. Methamphetamine is closely related chemically to amphetamine, but the central nervous system effects of Methamphetamine are greater. Methamphetamine is made in illegal laboratories and has a high potential for abuse and dependence. The drug can be taken orally, injected, or inhaled. Acute higher does lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power. Cardiovascular responses to Methamphetamine include increased blood pressure and cardiac arrhythmias. More acute responses produce anxiety, paranoia, hallucinations, psychotic behavior, and eventually, depression and exhaustion.
The effects of Methamphetamine generally last 2-4 hours and the drug has a half-life of 9-24 hours in the body. Methamphetamine is excreted in the urine primarily as amphetamine and oxidized and deaminated derivatives. However, 10-20% of Methamphetamine is excreted unchanged. Thus, the presence of the parent compound in the urine indicates Methamphetamine use. Methamphetamine is generally detectable in the urine for 3-5 days, depending on urine pH level.
The mAMP One Step Methamphetamine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Methamphetamine in urine. The mAMP One Step Methamphetamine Test Strip yields a positive result when the Methamphetamine in urine exceeds 1,000 ng/mL.
OPIATE (300 ng/ml) (OPI 300 or MOP 300)
Opiate 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 dose 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 OPI One Step Opiate Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of morphine in urine. The OPI One Step Opiate Test Strip yields a positive result when the morphine in urine exceeds 300 ng/mL.
OPIATE (OPI) (2000 ng/ml)
Opiate 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 dose 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 OPI One Step Opiate Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of morphine in urine. The OPI One Step Opiate Test Strip 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).
PHENCYCLIDINE
Phencyclidine, also known as PCP or Angel Dust, is a hallucinogen that was first marketed as a surgical anesthetic in the 1950s. 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, users 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 PCP One Step Phencyclidine Test Strip is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of phencyclidine metabolite in urine. The PCP One Step Phencyclidine Test Strip yields a positive result when the phencyclidine metabolite 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).
TRICYCLIC ANTIDEPRESSANT (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 One Step Drug Screen Tests yields a positive result when the Tricyclic Antidepressant in urine exceeds 1,000 ng/ml.
PRINCIPLE
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The One Step Multi-Drug Screen Test Panel 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
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The test panel contains specific mouse monoclonal antibody, goat polyclonal antibody and drug protein conjugates.
PRECAUTIONS
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For healthcare professionals and professionals at point of care sites.
For in vitro diagnostic use only. Do not use after the expiration date.
The test panel should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test panel should be discarded according to federal, state and local regulations

STORAGE AND STABILITY
Kit can be stored at room temperature or refrigerated at 2-30C. The test panel is stable through the expiration date printed on the sealed pouch. The test panel must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
MATERIALS PROVIDED
Test panels
Package insert
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection container
External controls
Timer
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 centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing.
SPECIMEN STORAGE
Urine specimens may be stored at 2-8C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20C. Frozen specimens should be thawed and mixed well before testing.
QUALITY CONTROL
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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.
Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS
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1. The One Step Multi-Drug Screen Test Panel provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography and mass spectrometry (GC/MS) is the preferred confirmatory method. 3,4,7
2. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A Positive result does not indicate level or intoxication, administration route or concentration in urine.
5. A Negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
6. Test does not distinguish between drugs of abuse and certain medications.
PERFORMANCE CHARACTERISTICS - ACCURACY
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A side-by-side comparison was conducted using The One Step Single Drug Test and commercially available drug rapid tests. Testing was performed on approximately 300 specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.
TEST Compounds Contributed to the Totals of GC/MS

AMP Amphetamine

BAR Secobarbital, Butalbital, Phenobarbital, Pentobarbital

BZO Oxazepam, Nordiazepam, a-OH-Alprazolam, Desalklflurazepam

COC Benzoylecgonine

THC 11-nor-.9-tetrahydrocannabinol-carboxylic acid

TEST Compounds Contributed to the Totals of GC/MS

MTD Methadone

mAMP Methamphetamine

OPI Morphine, Codeine

PCP Phencyclidine

TCA Nortriptyline

The following results are tabulated from these clinical studies:
Forty (40) clinical samples for each drug were run using each of the One Step Single Drug tests by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained Laboratory personnel.
*Note: TCA was based on HPLC data.
Precision
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A study was conducted at three physician offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of 50% and 25% cut-off level, was labeled as a blind and tested at each site. The results are given below:









Analytical Sensitivity
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A drug-free urine pool was spiked with drugs to the concentrations at 50% cut-off and 25% cut-off. The results are summarized below.
Drug conc. (Cut-off range) n AMP BAR BZO COC THC MTD mAMP OPI PCP TCA
- + - + - + - + - + - + - + - + - + - +
0% Cut-off 30 30 0 30 0 30 0 30 0 30 0 30 1 30 0 30 0 30 0 30 0
-50% Cut-off 30 30 0 30 0 30 0 30 0 30 0 29 1 30 0 30 0 30 0 30 0
-25% Cut-off 30 30 0 27 3 26 4 30 0 12 1 24 6 30 0 30 0 19 11 22 8
Cut-off 30 18 12 22 8 12 18 4 26 1 29 21 9 18 12 30 17 16 14 12 18
+25% Cut-off 30 1 29 7 23 3 27 0 30 1 29 2 28 1 29 30 26 6 24 7 23
+50% Cut-off 30 0 30 2 28 0 30 0 30 0 30 0 30 0 30 0 30 0 30 0 30
Analytical Specificity
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The following table lists the concentration of compounds (ng/mL) that are detected positive in urine by The One Step Multi-Drug Screen Test Panel at 5 minutes.
AMPHETAMINE
D-Amphetamine 1,000
D,L-Amphetamine sulfate 3,000
L-Amphetamine 50,000
()3,4-Methylenedioxyamphetamine 2,000
Phentermine 3,000
Secobarbital 300
Amobarbital 300
Alphenol 150
Aprobarbital 200
Butalbital 75
Butethal 2500
Cyclopentobarbital 100
Pentobarbital 600
Phenobarbital 300
Benzodiazepines
Oxazepam 300
Alprazolam 196
a-Hydroxyalprazolam 1262
Bromazepam 1562
Chlordiazepoxide 1562
Chlordiazepoxide HCI 781
Clobazam 98
Clonazepam 781
Clorazepate dipotassium 195
Delorazepam 1562
Desalkyflurazepam 390
Diazepam 195
Estazolam 2500
Flunitrazepam 390
( + ) Lorazepam 1562
RS-Lorazepam glucuronide 156
Midazolam 12500
Nitrazepam 98
Norchlordiazepoxide 195
Nordiazepam 390
Temazepam 98
Triazolam 2500
COCAINE ng/ml
Benzoylecgonine 300
Cocaine HCl 780
Cocaethylene 12,500
Ecgonine HCl 32,000
MARIJUANA (THC)
11-nor-.9 -THC-9 COOH 50
Cannabinol 20,000
11-nor-.8-THC-9 COOH 30
.8 -THC 15,000
.9 -THC 15,000
Methadone
Methadone 300
Doxylamine 50000
METHAMPHETAMINE
D-Methamphetamine 1,000
-Hydroxymethamphetamine 30,000
L-Methamphetamine 8,000
()-3,4-Methylenedioxymethamphetamine 2,000
Mephentermine 50,000
OPIATES ng/ml
Morphine 2,000
Codeine 2,000
Ethylmorphine 5,000
Hydrocodone 12,500
Hydromorphone 5,000
Levophanol 75,000
6-Monoacetylmorphine 5,000
Morphine 3--D-glucuronide 2,000
Norcodeine 12,500
Normorphone 50,000
Oxycodone 25,000
Oxymorphone 25,000
Procaine 150,000
Thebaine 100,000
PCP
Phencyclidine 25
4-Hydroxyphencyclidine 12,500
TCA
Nortriptyline 1,000
Nordoxepine 1,000
Trimipramine 3,000
Amitriptyline 1,500
Promazine 1,500
Desipramine 200
Imipramine 400
Clomipramine 12,500
Doxepin 2,000
Maprotiline 2,000
Promethazine 25,000
Effect of Urinary Specific Gravity
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Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cut-off levels respectively. The Multi-Drug Screen Test was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.
Effect of the Urinary pH
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The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with The One Step Multi-Drug Screen Test Panel. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
Cross-Reactivity
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A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or Cocaine, Amphetamine, Methamphetamine, Marijuana, Opiate or Phencyclidine positive urine. The following compounds show no cross-reactivity when tested with the One Step Multi-Drug Screen Test Panel at a concentration of 100 g/mL.
Non Cross-Reacting Compounds
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Acetaminophen Deoxycorticosterone Loperamide Promazine
Acetophenetidin Dextromethorphan Maprotiline Promethazine
N-Acetylprocainamide Diazepam MDE DL-Propranolol
Acetylsalicylic acid Diclofenac Meperidine D-Propoxyphene
Aminopyrine Diflunisal Meprobamate D-Pseudoephedrine
Amitryptyline Digoxin Methadone Quinacrine
Amoxicillin Diphenhydramine Methoxyphenamine Quinidine
Ampicillin Doxylamine Nalidixic acid Quinine
L-Ascorbic acid (-) --Ephedrine Naloxone Ranitidine
DL-Amphetamine sulfate -Estradiol Naltrexone Salicylic acid
Apomorphine Estrone-3-sulfate Naproxen Serotonin
Aspartame Ethyl-p-aminobenzoate Niacinamide Sulfamethazine
Atropine [1R,2S] (-) Ephedrine Nifedipine Sulindac
Benzilic acid (L) Epinephrine Norethindrone Temazepam
Benzoic acid Erythromycin D-Norpropoxyphene Tetracycline
Benzphetamine Fenoprofen Noscapine Tetrahydrocortisone, 3-acetate
Bilirubin Furosemide DL-Octopamine Tetrahydrocortisone 3-
() Brompheniramine Gentisic acid Oxalic acid (-D-glucuronide)
Caffeine Hemoglobin Oxazepam Tetrahydrozoline
Cannabidiol Hydralazine Oxolinic acid Thiamine
Chloralhydrate Hydrochlorothiazide Oxymetazoline Thioridazine
Chloramphenicol Hydrocortisone Papaverine DL-Tyrosine
Chlorothiazide O-Hydroxyhippuric acid Penicillin-G Tolbutamide
() Chlorpheniramine p-Hydroxyamphetamine Pentazocine hydrochloride Triamterene
Chlorpromazine 3-Hydroxytyramine Perphenazine Trifluoperazine
Chlorquine Ibuprofen Phenelzine Trimethoprim
Cholesterol Imipramine Trans-2-phenylcyclo-propylamine Trimipramine
Clomipramine Iproniazid hydrochloride Tryptamine
Clonidine () Isoproterenol L-Phenylephrine DL-Tryptophan
Cortisone Isoxsuprine -Phenylethylamine Tyramine
(-) Cotinine Ketamine Phenylpropanolamine Uric acid
Creatinine Ketoprofen Prednisolone Verapamil
  Labetalol Prednisone Zomepirac
BIBLIOGRAPHY
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1. Stewart DJ, Inaba T, Lucassen M, Kalow W. Clin Pharmacol. Ther, April 1979; 25 ed: 464, 264-8
2. Ambre J. J. Anal. Toxicol. 1985; 9:241
3. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 01986; 1735.
4. Tietz NA. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735.
5. FDA Guidance Document: Guidance for Premarket Submission for Kits for Screening Drugs of Abuse to be used by the Consumer, 199.
6. Robert DeCresce. Drug Testing in the workplace, 114.
7. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd ED. Biomedical Publ., Davis, CA 1982; 487.

 

 

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