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Specific Gravity Test - Urine Specific Gravity Testing Analysis

Specific gravity tests for sample dilution.  Urine specific gravity is a test that measures the concentration of particles in the urine.

 

Normal specific gravity range in urine

 The normal range of specific gravity in human urine is from 1.003 to 1.030. Values outside this range may be the result of specimen dilution, adulteration or may be indicative of a number of health related problems.

Urine sample adulteration is serious problem in forensic urine drug testing.  Sample adulteration is usually achieved by substitution, dilution or the addition of adulterants including so called “masking agents” sold commercially.

Adulteration is defined as the tampering or manipulation of a urine specimen with the intention of altering the test results. The use of adulterants can cause false negative results in drug tests by either interfering with the screening test and/or destroying the drugs present in the urine. Dilution may also be employed in an attempt to produce false negative drug test results. Clinically, the accepted method to test for adulteration or dilution is to determine certain urinary characteristics such as creatinine, pH, and specific gravity and to detect the presence of glutaraldehyde, nitrite and oxidants /pyridinium chlorochromate (PCC) in urine.

The specific gravity of urine

When looking at the results of a urine test (urinalysis test), specifically the results of the specific gravity urine test a person could deduce certain information regarding the health of the test subject.  Any such deductions should be confirmed by further tests. Using a urine test is a quick and inexpensive way to check the specific gravity in your urine, and is one of our test kit products that can be done in the privacy of your home.

The results of specific gravity levels in urine: shows the concentrating and diluting ability of the kidneys.

 

Abnormal specific gravity values may indicative of

 

Reduced specific gravity:  excess fluid intake (may be an attempt to alter the urine prior to a drug test), diabetes insipidus – central or nephrogenic, certain renal (kidney) diseases, renal (kidney) failure (i.e., los of ability to reabsorb water), diabetes mellitus, pyelonephritis

 

Raised specific gravity:  dehydration, diarrhea, excessive sweating, vomiting, water restriction, glucosuria, heart failure (related to decreased blood flow to the kidneys), renal aterial stenosis, adrenal insufficiency, nephrosis, congestive cardiac-failure, liver disease

 

Constant specific gravity:  chronic renal disorder

 

Urine Specific Gravity Test
Description

#DUC-111 - One Step Specimen Validity Test (SVT) (25 tests per bottle). 

Urine Adulteration Test Strips provide rapid, semi-quantitative detection of 7 parameters (Creatinine, Nitrite, Glutaraldehyde, pH, Specific Gravity, Oxidants / pyridinium chlorochromate (PCC) in human urine.

  • 7 testing parameters
  • Easy to interpret color chart
  • 2 year shelf life
  • 1 minute read time
RETAIL $39.95     Our Price Only $17.95 each (bottle of 25).
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A rapid, one step screening test for the simultaneous detection of Creatinine, Nitrite, Glutaraldehyde, pH, Specific Gravity, and Oxidants/Pyridinium Chlorochromate (PCC) in human urine.

For forensic use only.

INTENDED USE

The One Step S.V.T. is a semi-quantitative, color comparison screen for the detection of creatinine, nitrite, glutaraldehyde, pH, specific gravity, and oxidants / pyridinium chlorochromate (PCC) in human urine.

This test provides a preliminary screen only. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Abnormal results should be sent to a laboratory for confirmation.

 

SUMMARY

Each of the plastic strips contains six (6) chemically treated reagent pads. One (1) minute following the activation of the reagent pads by the urine sample, the colors that appear on the pads can be compared with the printed color chart on the canister. The color comparison provides a semi-quantitative screen for creatinine, nitrite, glutaraldehyde, pH, specific gravity, and oxidants / pyridinium chlorochromate (PCC) in human urine which can help assess the integrity of the urine sample.

 

What is adulteration?

Adulteration is the tampering of a urine specimen with the intention of altering the test results. The use of adulterants can cause false negative results in drug tests by either interfering with the screening test and/ or destroying the drugs present in the urine. Dilution may also be employed in an attempt to produce false negative drug test results.

One of the best ways to test for adulteration or dilution is to determine certain urinary characteristics such as creatinine, pH, and specific gravity and to detect the presence of glutaraldehyde, nitrite and oxidants /pyridinium chlorochromate (PCC) in urine.

  • Creatinine is a waste product of creatine; an amino-acid contained in muscle tissue and found in urine. 1 A person may attempt to foil a test by drinking excessive amounts of water or diuretics such as herbal teas to “flush” the system. Creatinine and specific gravity are two ways to check for dilution and flushing, which are the most common mechanisms used in an attempt to circumvent drug testing. Low creatinine and specific gravity levels may indicate dilute urine. The absence of creatinine (<5mg/dl) is indicative of a specimen not consistent with human urine.

  • Specific gravity tests for sample dilution. The normal range is from 1.003 to 1.030. Values outside this range may be the result of specimen dilution or adulteration.

  • Nitrite tests for commonly used commercial adulterants such as Klear or  Whizzies. They work by oxidizing the major cannabinoid metabolite THC-COOH.2 Normal urine should contain no trace of nitrite. Positive results generally indicate the presence of an adulterant.

  • Glutaraldehyde tests for the presence of an aldehyde. Adulterants such as UrinAid and Clear Choice contain glutaraldehyde which may cause false negative screening results by disrupting the enzyme used in some immunoassay tests.³ Glutaraldehyde is not normally found in urine; therefore, detection of glutaraldehyde in a urine specimen is generally an indicator of adulteration. 

  • pH tests for the presence of acidic or alkaline adulterants in urine. Normal pH levels should be in the range of 4.0 to 9.0. Values outside of this range may indicate the sample has been altered.

  • Oxidants/PCC (Pyridinium Chlorochromate) tests for the presence of oxidizing agents such as bleach and hydrogen peroxide. Pyridinium chlorochromate (sold under the brand name UrineLuck) is a commonly used adulterant.³ Normal human urine should not contain oxidants or PCC.

PRINCIPLE

The test is based on the color derived from the chemical reaction between the chemical reagent on each test pad and the urine sample.

REAGENTS

Adulteration Pad

Reactive indicator

Buffers and non-reactive ingredients

Creatinine

0.04%

99.96%

Nitrite

0.07%

99.93%

Glutaraldehyde

0.02%

99.98%

pH

0.06%

99.94%

Specific Gravity

0.25%

99.7%

Oxidants / PCC

0.36%

99.64%

 

PRECAUTIONS

  • For forensic use only.  Do not use after the expiration date.

  • The adulteration strips should remain in the sealed canister until use.

  • All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

  • The used test strip should be discarded according to federal, state and local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed canister at 15-30°C. The test strips must remain sealed in the canister until use. DO NOT FREEZE.  Do not use beyond the expiration date.  Avoid direct exposure to sunlight.


 

SPECIMEN COLLECTION AND PREPARATION

Urine Assay

The urine specimen must be collected in a clean and dry container. Test urine as soon as possible after collection.

 

Specimen Storage

For best results, test specimens immediately following collection. Storage of urine specimens should not exceed 2 hours at room temperature or 4 hours refrigerated (2-8°C) prior to testing.

 

MATERIALS

Materials Provided

  • Each canister contains 25 S.V.T. Strips

  • Package insert

Materials Required But Not Provided

  • Timer

DIRECTIONS FOR USE

  1. Allow the adulteration strip to equilibrate to room temperature (15-30 C) prior to testing.

  2. Remove the strip(s) from the canister and recap tightly.

  3. Dip test strip into the urine specimen and remove immediately.

  4. Blot the test gently on its side to remove excess urine. NOTE: It is important to blot the test strip for consistent results.

  5. Read results in one (1) minute by comparing each pad with the color chart printed on the canister. Do not interpret test results after 4 minutes.

  6. If the test indicates adulteration, refer to your Drug Free Policy for guidelines on handling adulterated specimens.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

Semi Quantitative results are obtained by visually comparing the reacted color blocks on the strip to the printed color blocks on the canister. No instrumentation is required.

Quality Control

Control standards are not supplied with this kit. However, it is recommended that positive and negative specimens or controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

 

LIMITATIONS

1.      The adulteration tests included with this product are meant to aid in the determination of abnormal specimens. While comprehensive, these tests are not meant to be an “all-inclusive” representation of possible adulterants.

2.      Creatinine: Normal creatinine levels are between 20 and 350 mg/dL.  Under rare conditions, certain kidney diseases may show dilute urine.

3.      Nitrite: Nitrite is not a normal component of human urine. However, nitrite found in urine may indicate urinary tract infections or bacterial infections. Nitrite levels of > 20 mg/dL may produce false positive glutaraldehyde results.

4.      Glutaraldehyde: Is not normally found in urine.  However certain metabolic abnormalities such as ketoacidosis (fasting, uncontrolled diabetes or high-protein diets) may interfere with the test results.

5.      Specific Gravity: Elevated levels of protein in urine may cause abnormally high specific gravity values.

6.      Oxidants/PCC: Normal human urine should not contain oxidants or PCC.  The presence of high levels of antioxidants in the specimen, such as ascorbic acid, may result in false negative results for the oxidants/PCC pad.

BIBLIOGRAPHY OF SUGGESTED READING

1.      Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986, 1734.

2.      Tsai, S.C. et.al., J. Anal. Toxicol. 1998; 22 (6): 474

3.      Cody, J.T., “Specimen Adulteration in drug urinalysis. Forsenic Sci. Rev., 1990, 2:63.

4.      Mikkelsen, S.L. et.al., Clin. Chem. 1988; 34: 648

5.      Hardman J, Limbird LE (Eds). Goodman & Gilman’s The

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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 body’s 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 1950’s. It was removed from the market because patients receiving it became delirious and experienced hallucinations.
Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is most commonly administered by inhalation but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the devastating effects of Phencyclidine.
PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight, activity, and diet.5 Phencyclidine is excreted in the urine as an unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%).6
The 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 2-30°C. 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 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.
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
ñ-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-â-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

 
 

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