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Troubleshooting Guide December 2006 Version 3.0.doc TROUBLESHOOTING GUIDE
DRUGS OF ABUSE
BY: Innovacon, Inc.
4106 Sorrento Valley Blvd.
San Diego, CA 92121
Troubleshooting Guide December 2006 Version 3.0.doc INTRODUCTION: The purpose of this guide is to assist our partners in troubleshooting any foreseen or unforeseen events that may occur while running Innovacon drugs of Abuse tests. All Innovacon drug of abuse panels are rapid visual immunoassay for the qualitative detection of drug and drug metabolites in human urine. All panels and all formats provide 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, but the use of Liquid Chromatography/mass spectrometry (LC/MS) for confirmation testing is increasing. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are indicated. In addition to the drugs of abuse assays, the One Step S.V.T. (Specimen Validity Test) is a semi-quantitative color comparison screen for the detection of adulterants. Within one minute (1) of the pads being activated by the urine sample, the color that appears on the pads can be compared with the printed color chart on the canister or color chart enclosed in the kit box. The S.V.T. also 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. Troubleshooting Guide December 2006 Version 3.0.doc
BACKGROUND:
Amphetamine(s)
Amphetamine is a stimulant drug that is used in treatment of ADHD, narcolepsy and obesity. Most
positive results originate from legitimate, prescription use of the drug. Illicitly, the drug is occasionally
diverted from legitimate prescriptions and sold on the streets.
Technical Notes
1. Common cross-reactants: Prescription appetite suppressants such as Phentermine, other amphetamine-like prescription drugs; Ecstasy-like club drug called MDA (which is a metabolite of MDMA). In addition, there are several therapeutic agents, such as Benzphetamine, that metabolize to amphetamine (and methamphetamine) in the body and will produce positive drug test results. It is also important to note that amphetamine is a metabolite of methamphetamine and will appear in the urine of a person who has taken methamphetamine. 2. Current US SAMHSA “screening” cutoff is 1,000 ng/mL 3. Current GC/MS (industry standard) confirmation cutoff is 500 ng/mL. 4. Proposed changes in SAMHSA are: a. To lower the screening cutoff to 500 ng/mL b. Change target drug from D-amphetamine (historical) to D-methamphetamine c. Change the GC/MS confirmation to 250 ng/mL 5. Outside the US, amphetamine screening cutoffs may be 300 ng/mL. 6. INNOVACON manufactures amphetamine assays with cutoff levels of 1,000 and 300 ng/mL. Both assays are FDA cleared and target d-amphetamine as the primary antigen. Troubleshooting Guide December 2006 Version 3.0.doc
Methamphetamine(s)
Methamphetamine is a stimulant drug that is very rarely prescribed, but there is a form
(stereoisomer) of methamphetamine that is used in the Over-the-Counter Vick’s Inhalers. Most
positives are the result of illegal use; the drug is made illegally from pseudoephedrine.
Technical Notes
1. About 4-7% of a methamphetamine dose is broken down to amphetamine by the body
2. Common cross-reactants: metabolites of Ephedrine, Ranitidine (Zantac), and MDMA. In
addition, there are several therapeutic agents, such as Benzphetamine, that metabolize to methamphetamine (and amphetamine) in the body and will produce positive drug test results. It is also important to note that amphetamine is a metabolite of methamphetamine and will appear in the urine of a person who has taken methamphetamine. 3. Current US SAMHSA cutoff: grouped together with Amphetamine(s) is 1,000 ng/mL 4. Current GC/MS (SAMHSA) confirmation cutoff is 500 ng/mL; MUST ALSO HAVE AT LEAST 200 ng/mL of amphetamine in the urine to report a viable “methamphetamine” positive z Change the screening cutoff to 500 ng/mL z Change target drug from D-amphetamine (historical) to D-methamphetamine z Change the GC/MS confirmation to 250 ng/mL; amphetamine must still be present in the urine “around cutoff” to report a methamphetamine positive GC/MS result. methamphetamine assays with cutoff levels of 1,000, 500 and 300 ng/mL. The 500 and 1,000 ng/mL assays are FDA cleared; the 300 ng/mL assay is for outside the US only. All three assays target d-methamphetamine as the primary antigen. Troubleshooting Guide December 2006 Version 3.0.doc
Cocaine
Cocaine is a stimulant drug and local anesthetic drug that is derived from the coca plant; the drug is
rarely prescribed. Most drug test positives are from illegal use; “crack” is a “free-base” form of
cocaine that is more readily bio-available.
Technical Notes
1. Cocaine is extensively metabolized in the body to benzoylecgonine, ecognine methyl ester and
2. Common cross-reactants: there are No KNOWN cross-reactive compounds with urine-based cocaine immunoassays but the Innovacon Cocaine assay is considered very sensitive to low levels of benzoylecgonine in urine. 3. Current US SAMHSA “screening” cutoff: 300 ng/mL 4. Current GC/MS (industry standard) confirmation cutoff: 150 ng/mL of benzoylecgonine 5. Proposed changes in SAMHSA are to lower the screening cutoff to 150 ng/mL 6. Proposed change to GC/MS confirmation level is to lower it to 100 ng/mL of benzoylecgonine 7. INNOVACON manufactures Cocaine assays with cutoff levels of 300 and 150 ng/mL. Both are FDA cleared and target benzoylecgonine as the primary antigen. Troubleshooting Guide December 2006 Version 3.0.doc
Opiates
Opiates are a large “class” of drugs used legally for pain-relief (morphine) and cough suppression
(codeine). Heroin (diacetylmorphine) is an illegal opiate made from the opium poppy. In addition to
the primary opiates, “synthetic opiates” are often used in pain relief. The original intent of creating
synthetic opiates was to increase pain relief tendencies and reduce likelihood of dependence;
synthetic opiates include hydrocodone (Vicodan), oxycodone (Oxycontin), hydromorphone
(Dilaudid). Most synthetic opiates do not cross react very well with morphine-based opiate tests.
Technical Notes
1. Common cross-reactants: Poppy seeds contain codeine/morphine and, as such, can cause a
2. Current US SAMHSA “screening” cutoff: 2,000 ng/mL 3. Current GC/MS (industry standard) confirmation cutoff: 2,000 ng/mL for codeine and/or 4. Other cutoff: 300 ng/mL Opiate cutoff was the historical SAMHSA cutoff; still used on occasion outside regulated drug testing (clinical, OUS) 5. Codeine and heroin metabolize to morphine in the body. Codeine is also eliminated 6. Innovacon manufactures Opiate assays with cutoff levels of 300 and 2,000 ng/mL. Both are FDA cleared and target morphine as the primary antigen. In addition, INNOVACON has an oxycodone-specific assay which is described in more detail later in this guide. Troubleshooting Guide December 2006 Version 3.0.doc
PCP
Phencyclidine (PCP) is a hallucinogen drug originally made for anesthetic use in humans. It’s use
in humans was discontinued due to “negative side effects.” There is no current legal use of the
drug in humans. The use of PCP illegally is rarer now than before, but is sometimes seen in large,
metropolitan areas such as LA and Detroit.
Technical Notes
1. PCP is liquid; marijuana joints are sometimes dipped into PCP (“sherm”)
2. Common
Venlafaxine (Effexor), Lamotrigine (Lamictal) 3. Current SAMHSA “screening” cutoff: 25 ng/mL 4. Current GC/MS (industry standard) confirmation cutoff: 25 ng/mL 5. Innovacon manufactures a PCP assay with a cutoff level of 25 ng/mL. Troubleshooting Guide December 2006 Version 3.0.doc Marijuana (THC)
THC (tetrahydrocannabinol) is a hallucinogenic, sedative drug considered the primary active
compound of the 400+ chemicals in the cannabis sativa plant. While there is some legal use of
THC, such as the prescription Marinol (Dronabinol) used for wasting in cancer/HIV patients, most
THC drug test positives are the result of illicit use. Marijuana is the number 1 illegal drug in the US
Technical Notes
1. THC breaks down extensively in the body; most common metabolite is THC-COOH. This
metabolite is also referred to as “carboxy-THC” or “THCA.” 2. Common cross-reactants: the consumption of Sustiva (efavirenz), an HIV treatment drug, is known to produce metabolites that cross-react on many THC assays. Also, the INNOVACON test is considered “very sensitive” to low levels in urine 3. Current US SAMHSA “screening” cutoff: 50 ng/mL 4. Current GC/MS (industry standard) confirmation cutoff: 15 ng/mL of THC-COOH 5. No proposed changes to cutoffs in SAMHSA 6. Innovacon manufactures a THC assay with a cutoff level of 50 ng/mL for THC-COOH. Troubleshooting Guide December 2006 Version 3.0.doc
Benzodiazepines
Benzodiazepines are a large “class” of drugs used primarily for sedation and anxiety relief. Examples
of Benzodiazepines include diazepam (Valium), chlordiazepoxide (Librium), alprazolam (Xanax), and
clonazepam (Klonopin). Most benzodiazepine use in the US is due to prescription use, but some
benzodiazepines are diverted for illegal consumption. Outside the US, particularly in Europe,
benzodiazepines are more widely abused.
Technical Notes
1. Common cross-reactants: Sertraline (Zoloft). Of note, given the large number of benzodiazepine drugs (35+), be aware that GC/MS labs will not be able confirm for all of them. 2. NOT A SAMHSA-regulated drug, so cutoffs are usually country specific 3. Common US “screening” cutoff: 300 ng/mL 4. Some products/countries use 200 ng/mL screening cutoff 5. GC/MS confirmation cutoffs vary but usually range from 100-200 ng/mL 6. Again, GC/MS labs are limited by the number of benzodiazepines they identify on their GC/MS 7. Innovacon manufactures BZO assays with cutoff levels of 300 and 200 ng/mL; both target Troubleshooting Guide December 2006 Version 3.0.doc
Barbiturates
Barbiturates are another large “class” of drugs. They are used primarily for controlling epilepsy; some
use for migraine relief (butalbital) and drug-induced comas for head trauma (pentobarbital). Examples
of Barbiturates include phenobarbital, pentobarbital (used for head trauma) and butalbital (Fiorinal).
Most barbiturate positive drug tests are due to prescription use; barbiturates are rarely diverted for
illegal consumption. Some countries have heroin “cut” with phenobarbital.
Technical Notes
1. Common cross-reactants: Possibly Phenytoin which is chemically-related to barbiturates and 2. NOT A SAMHSA-regulated drug 3. Common US “screening” cutoff: 300 ng/mL 4. GC/MS confirmation cutoffs vary but usually range from 100-200 ng/mL 5. GC/MS labs are limited by the number of barbiturates they identify on their GC/MS analyses 6. Innovacon manufactures a barbiturate assay with a cutoff level of 300 ng/mL; the target antigen Troubleshooting Guide December 2006 Version 3.0.doc
Methadone
Methadone is an analgesic compound that is most commonly used to treat heroin/opiate addiction. In
addition, the drug may be prescribed for pain relief. Patients prescribed methadone for opiate addiction
are considered to be in “methadone maintenance.” Patients in methadone maintenance are drug tested
commonly to ensure they are (1) taking their methadone and (2) not taking heroin/opiates or other
drugs.
Technical Notes
1. Methadone is eliminated in the urine as parent drug and as metabolites. The metabolites EDDP and EDMP are VERY different in structure from parent methadone, so they do not react with the drug test. 2. NOT A SAMHSA-regulated drug 3. Common US “screening” cutoff: 300 ng/mL 4. GC/MS confirmation cutoffs: 300 ng/mL 5. Most screening tests do not detect MTD metabolites (EDDP or EDMP). If a patient is an “extensive metabolizer,” they may not have any parent MTD in the urine 6. Innovacon manufactures a methadone assay with a cutoff level of 300 ng/mL. Troubleshooting Guide December 2006 Version 3.0.doc
Tricyclic Antidepressants
TCAs are a “class” of drugs used for treating depression. TCAs are the “older” antidepressants.
Examples of TCAs include amitriptyline, nortriptyline, desipramine and clomipramine. New
antidepressant drugs like Prozac, Paxil, Zoloft are NOT TCAs and, as such, will not cross react on the
TCA assay.
Technical Notes
1. TCAs have a very low “lethal dose.” Since patients taking TCAs have a higher likelihood of suicidal tendencies, TCAs are often implicated in overdose situations. 2. Common cross-reactants: large doses of carbamazepine (Tegretol) metabolites, other 3. NOT A SAMHSA-regulated drug class 4. Common US “screening” cutoff: 1,000 ng/mL 5. Other “screening” cutoff: 300 ng/mL 6. TCAs cannot be analyzed by GC/MS very well, so they are often “confirmed” by HPLC or 7. Innovacon manufactures a TCA assay with a cutoff level of 1,000 ng/mL Troubleshooting Guide December 2006 Version 3.0.doc
Oxycodone
Oxycodone is a member of the “synthetic” opiate class. The drug is used for pain relief (most
commonly for chronic pain); oxycodone prescriptions are often diverted and sold on the street for illegal
use. Brand names of oxycodone include: Percodan, Percocet and Oxycontin. Oxycontin is a “time
released” formula of oxycodone. Overdoses are most often the result of people crushing the time-
released Oxycontin pills and consuming the crushed powder in one dose.
Technical Notes
1. The structure of oxycodone is not close enough to codeine or morphine to ensure the drug is 2. Not part of the SAMHSA Opiate Class 3. Screening cutoff: 100 ng/mL 4. GC/MS Confirmation cutoff: 100 ng/mL 5. Most laboratories will not automatically confirm for oxycodone if a specimen is “opiate positive.” Oxycodone-specific confirmation must be requested. 6. Innovacon manufactures an oxycodone-specific assay with a cutoff level of 100 ng/mL. The OXY assay also shows some cross reactivity to hydrocodone (Vicodan, Lortab); 1,562 ng/mL of hydrocodone produces a positive OXY test result. Troubleshooting Guide December 2006 Version 3.0.doc
Propoxyphene
Propoxyphene is a narcotic analgesic structurally related to Methadone; the drug is used for the relief of
mild to moderate pain. Brand names of propoxyphene include: Darvon and Darvocet. Propoxyphene is
often dosed in combination with Aspirin and Acetaminophen.
Technical Notes 1. Although structurally related to methadone, ppx will not cross react on the INNOVACON 2. PPX is not part of the SAMHSA-regulated drug testing menu 3. US Screening cutoff: 300 ng/mL 4. GC/MS Confirmation cutoff: 300 ng/mL for PPX or metabolite, Nor-PPX 5. Most laboratories will not automatically confirm for Propoxyphene. Propoxyphene-specific 6. Innovacon manufactures a propoxyphene-specific assay with a cutoff level of 300 ng/mL. The assay has an equal affinity to the metabolite nor-propoxyphene. Troubleshooting Guide December 2006 Version 3.0.doc MDMA/Ecstasy
Ecstasy (MDMA) is a stimulant and hallucinogen structurally related to Methamphetamine; the drug was
once used for psychotherapy, but is now a Schedule 1 drug in the US (no approved medical use). The
chemical name for Ecstasy is 3,4-methylenedioxymethamphetamine, hence the “MDMA” abbreviation.
MDMA metabolizes to many compounds, but the most notable one is MDA
(methylenedioxyamphetamine) which is chemically related to amphetamine.
Technical Notes 1. The structure of MDMA is similar enough to cross-react on the MAMP assays, but the sensitivity (cutoff) isn’t ideal. As a result, the MDMA-specific assay was developed. The MDMA assay is reactive to Ecstasy/MDMA at level of 500 ng/mL. This assay is also sensitive to MDA and MDEA (methylenedioxyethylamphetamine). 2. Not part of current SAMHSA guidelines 3. Screening cutoff: 500 ng/mL 4. Confirmation cutoff: varies, but 250-500 ng/mL is typical 5. Proposed changes in SAMHSA are to add MDMA as a component of the “Amphetamine/Methamphetamine” drug class. 6. Innovacon manufactures an MDMA-specific assay with a cutoff level of 500 ng/mL. The MDMA-specific assay is also sensitive to MDA and MDEA (methylenedioxyethylamphetamine). Troubleshooting Guide December 2006 Version 3.0.doc Definitions: FALSE POSITIVES: False positives are defined by a human urine specimen yielding positive results with an Innovacon drug of abuse test, then testing negative on a LOD (Limit of Detection) gas chromatography/ mass spectrometry test. A false positive result in any Immunoassay is most likely cause by cross-reactivity. The collector needs to verify that the donor has given an accurate list of any medication, prescription and/or over-the-counter. Please review with cross-reactivity table enclosed in this guide. FALSE NEGATIVES: False negatives are defined by a human urine specimen yielding negative results with an Innovacon drug of abuse test, then testing positive on a gas chromatography/ mass spectrometry test at levels at least 2 times the stated cut-off level. INVALID RESULTS: Invalid results are defined by an absence of a control line on an Innovacon drug of abuse test. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. SCREENING TESTS: All Innovacon drug of abuse tests are screening tests that provide only a preliminary analytical test result. The purpose of a screening test is to rule out negative specimens from specimens that may contain drugs. As with most immunoassays the test is looking for class of drug, many different chemicals and compounds fall into this category. Not all specimens that have screened positive will confirm positive. CONFIRMATION TESTING: All preliminary positive immunoassay results should be confirmed by a more specific alternative method. In drugs of abuse testing the gold standard of confirmation is Gas Chromatography/mass spectrometry (GC/MS) and/or Liquid Chromatography/mass spectrometry (LC/MS). GC/MS and/or LC/MS testing is performed on any specimen that screens positive it will confirm a specific analyte in the class of drug such as Benzoylecgonine when a specimen screens positive for Cocaine. Liquid Chromatography/mass spectrometry is a fairly new confirmation method in drugs of abuse testing, it is believed that it will become prevalent in the field. SAMHSA: SAMHSA is an acronym for Substance Abuse Mental Health Services Administration which is the governing agency that establishes the cutoff concentrations used in regulated drug testing in the United States. SAMHSA was formally known as NIDA (National Institute for Drug Abuse) hence the term of the NIDA 5 drug panel. Regulated drug testing in the United States is limited to testing for 5 drugs (Cocaine, THC, PCP, Opiates, Amp/Methamp). Troubleshooting Guide December 2006 Version 3.0.doc ADULTERATION TESTING/ SPECIMEN VALIDITY TESTING: 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 or destroying the drugs present in the urine. Diluting, flushing or adding adulterants to the sample after collection are ways that users of illicit drugs have attempted to defeat drug tests and invalidate the testing procedures. Diluting samples or adding household chemical such as detergents, bleach and soaps are some of the creative ploys that abusers have used to mask positive samples. Specimen tampering is very common in the United States and is expected to continue to grow in other areas of the world that use drug tests. There are many different types of adulterants; some are made to affect the test, others are made to affect the drug. CREATININE (DILUTION): Dilution is the most common type of adulteration. Dilution can be either “in vivo” (consuming excessive quantities of fluids in an attempt to dilute the urine) or “in vitro” (introducing liquid into a specimen that has already been collected). The intention of dilution is to make the concentration of drug in the urine lower then the detection limit (cutoff) of the test. Creatinine testing in conjunction with specific gravity testing is a good indication of dilution of the urine sample. The absence of Creatinine (<5 mg/dl) is indicative of a specimen not consistent with human urine. SPECIFIC GRAVITY: Specific gravity tests for sample dilution. Values outside the normal range may be the result of specimen dilution or adulteration. pH: pH tests for the presence of acidic or alkaline adulterants in urine. Values outside the normal range may indicate that the specimen has been altered or spiked with acidic or alkaline compounds. NITRITE: Nitrite is a compound that is introduced into a urine specimen after collection. Nitrite works by oxidizing the major cannabinoid (THC-COOH) metabolite and making it undetectable. While this mechanism does work, the time needed for the reaction to occur is usually several hours. This means that after collection of the urine the rapid test maybe positive and when the sample is tested at the laboratory the nitrate will have modified the THC metabolite making it undetectable. Some commonly used commercial adulterants that contain nitrates are “Klear, Whizzes, Mary Jane 13”. Nitrites are sometimes found in people with urinary tract or bacterial infections. GLUTARALDEHYDE: Glutaraldehyde is an older adulterant that is introduced into the urine specimen after collection. It is not believed to affect the performance of lateral flow tests. Glutaraldehyde denatures the enzyme used in EMIT-like autoanalyzer reagents. Adulterants such as UrinAid and Clear Choice contain glutaraldehyde. Glutaraldehyde is not normally found in urine. However certain metabolic abnormalities such as ketoacidosis (fasting, uncontrolled diabetes, high-protein diets) may interfere with the test results. OXIDANTS/PYRIDINIUM CHLOROCHROMATE (PCC): Like nitrite, oxidants and PCC are introduced into a specimen after collection and are primarily meant to alter the structure of THC-COOH. Some commonly used oxidants are bleach, hydrogen peroxide and Urine Luck. 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. Troubleshooting Guide December 2006 Version 3.0.doc Innovacon™ Drugs of Abuse Assays Cross-Reactivity Manual by Trade Name
COMPOUND (Generic Name)
COMPOUND (Trade Name)
Acetaminophen with Codeine (see also Paracetamol with codeine) Acetaminophen with Codeine (see also Paracetamol with codeine) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Positive for Tricyclic Antidepressants (TCA) Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Cannabinoids (THC) [Urinary metabolite(s) only; parent compound is non-reactive] Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Non-reactive Positive for Opiates (OPI/MOR) and/or Oxycodone (OXY) Positive for Opiates (OPI/MOR) and/or Oxycodone (OXY) Positive for Opiates (OPI/MOR) and/or Non-reactive Positive for Opiates (OPI/MOR) and/or Oxycodone (OXY) Positive for Opiates (OPI/MOR) and/or Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Positive for Methamphetamine (mAMP) Positive for Amphetamine (AMP) and Ecstasy (MDMA) Positive for Amphetamine (AMP) and Ecstasy Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Paracetamol (Acetaminophen) /Codeine Preparations Phenobarbitone (see also Phenobarbital) Luminal Positive for Barbiturates (BAR) Possible Positive for Barbiturates (BAR) Urinary metabolite(s) only; parent compound is Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
RESULTS
Possible Positive for Barbiturates (BAR)
Urinary metabolite(s) only; parent compound is
non-reactive Possible Positive for Barbiturates (BAR) Urinary metabolite(s) only; parent compound is Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Positive for Tricyclic Antidepressants (TCA) Urinary metabolite(s) only; parent compound is non-reactive Troubleshooting Guide December 2006 Version 3.0.doc COMPOUND (Generic Name)
COMPOUND (Trade Name)
Potential Positive for Benzodiazepines (BZO) Potential Positive for Phencyclidine (PCP) Potential Positive for Phencyclidine (PCP) Troubleshooting Guide December 2006 Version 3.0.doc FREQUENTLY ASKED QUESTIONS
1. SPECIMEN
How can specimens be stored prior to testing?
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. For specimen undergoing Specimen Validity testing, for best results test specimens immediately. Storage of urine specimens should not exceed 2 hours at room temperature or 4 hours refrigerated. How should urine specimens be collected?
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 specimen for testing. Will menstrual blood have any effect on the test?
No, menstrual blood should not affect the test. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing. PROCEDURE
Q: How does the test work?
The test is a lateral flow chromatographic immunoassay for the qualitative detection of an identified drug or the identified drug metabolites in human urine. The S.V.T. test is a semi-quantitative color comparison screen for the detection of adulterants. If the test is used before the refrigerated specimen reaches room temperature, is
the result reliable?
No. If refrigerated, the test and the specimen must be at room temperature (15-30°C) before the test is performed. Specimen at body temperature does not need to reach room temperature before running the test. What factors could cause the test to be invalid?
Improper testing procedure, unsealed packaging, damaged membrane and unsuitable specimens could cause the test to be invalid. If the test strip was removed from the foil pouch and dropped on the floor prior
to using it, will it still work?
If the test is intact and the exposed membrane in the “reaction window” was not damaged, it can still be used and expected to function properly. How many tests is it possible to run at a time?
It depends on the proficiency of the user. However, even in experienced hands, we do not recommend running more than 10 tests at a time. 3. INTERPRETATION
Do I have to wait the full amount of time before reading my results?
Yes. It is important that you wait to see if a line in the test region appears before reading your result. This might take the entire suggested number of minutes for the test region line to appear. Within one minute of the urine specimen activating the pads on the adulteration strips the colors can be compared. Can the test results be read after the suggested number of minutes?
Yes. The test card and panel results remain stable for up to 1 hour after test initiation. For specimen validity testing test results cannot be read after 4 minutes. Troubleshooting Guide December 2006 Version 3.0.doc The test line is very faint and the control line is very strong at the suggested
minute read time. What does this mean?
The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line. Not applicable for Specimen Validity Testing. Does a negative result indicate drug-free urine?
A negative result does not necessarily indicate drug-free urine. Negative results may be obtained when a drug is present in the urine but below the cut-off level of the test When the specimen sample is added to the test, red/pink fluid can be seen
migrating up the membrane. Is this normal?
A red/pink background is normal as the sample flows up the test strip and will not affect the test result. As long as it does not interfere with the interpretation of the line(s), the background can be disregarded. How does one know that the test has been performed properly?
As an internal procedural control, a red line appearing in the control (C) region confirms the addition of sufficient specimen volume and the performance of correct procedural technique. A negative result is read when two distinct red lines appear, one in the control
region (C) and another in the test region (T). Do the two lines need to be of the
same intensity?
No. The intensity of the red color in the test line region (T) will vary. Any shade of a red line in the test (T) region (darker than, the same color as, or lighter than the control line) along with a red line in the control (C) region is considered a negative result. Can the result be read before the specified read time?
No. Even though a negative result may appear earlier, it is important that the test be allowed to fully develop for amount of the suggested minutes. Does the specimen need to be sent to a laboratory for confirmation?
The test provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Can the test be used beyond the expiration date?
No. The test device should not be used under any circumstances past their expiration date.

Source: http://www.drugtestsystems.com/pdf/K.O.%20Troubleshooting%20Guide%20v.3%200.pdf