Accu-Stat Home Multi-Drug Test Marijuana (THC) Cocaine (COC) Opiates (OPI) Methamphetamines (mAMP) Amphetamines (AMP) CLIA Waived Instruction Booklet One Step Multi-Drug Screen Test Confidential Results in 5 minutes Easy to read Before You Begin Read all of the information in this pamphlet before performing the test. First, make sure you are familiar with the test kit contents shown below. Store at room temperature 40-86F (4-30C) in the sealed pouch, away from direct sunlight. Do not use after the expiration date stamped on the foil pouch containing the AccuStat test device. Materials Provided One (1) Accu-Stat Drug Test Device One (1) Instruction Booklet One (1) Specimen Vail & Confidential numbered sticker for confirmation One (1) Pre-addressed Mailing box One (1) Transportation pouch with absorbent strip If any item is missing from your kit please call 888-882-7739 Materials Needed But Not Provided Clean container for sample (urine) collection What is the intended use for the Accu-Stat Multi-Drug Test Accu-Stat Home Multi-Drug Test is a screening test, which provides immediate information about the possible use of marijuana, cocaine, opiates, methamphetamines, and amphetamines. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. Accu-Stat Home Multi-Drug Test is a screening test. It is only the first step in a twostep process for determining the presence of drugs of abuse in a urine sample. Within 5 minutes you will obtain a preliminary screening result. If you obtain a negative, preliminary screening result, this means the sample did not contain marijuana, cocaine, opiates, methamphetamines or amphetamines, or the sample did not contain an amount of any of those drugs above the cut-off level and are not detectable by this screening method. If you obtain a positive, preliminary screening result, this means the sample may contain detectable levels of one or more of the drugs listed above and you should take the second step in the process and send the urine sample to our laboratory for confirmation of the positive preliminary screening result. Purchase price includes cost of confirmation testing. An Overview of Steps to be Performed Read all of the test instruction booklet before testing. Check kit contents Collect urine sample Perform the test Read the results If the result is “negative” you do not need further testing If the result is a “positive” screening result, prepare sample and mail to the lab for confirmation. Confirmation shipping instructions are found on page __ Call 888 882-7739 in 5 to 7 business days after the sample has been received by the laboratory. Use your confidential ID number to obtain results. No information will be given without this number. Collecting the Urine Sample All tests for drugs of abuse are only as good as the sample being tested. Fresh urine does not require any special handling or pretreatment. Urine samples should be collected so that testing may be performed as soon as possible after the sample has been collected in a clean glass or plastic cup. Accu-Stat testing can be performed on a “fresh” warm urine sample. Accu-Stat testing should not be performed on chilled, refrigerated samples. Generally the ideal time to collect a urine sample is several hours after suspected drug use. The timing of the sample collection is extremely important in detecting any drug of abuse because each drug is cleared by the body at different rates and is detected in the urine at different times. An Alert for Parents Testing Children Regarding Altering of Urine Sample Obtaining an unaltered urine sample is critical to getting an accurate result. The sample must not be altered or tampered with in any way. Precautions should be taken to minimize the possibilities of the sample being altered. Have your child wash his or her hands with soap and warm water prior to collecting their urine sample. Make sure soap has been adequately rinsed off and both hands are thoroughly dried. Search the child’s clothing for materials that could be used to alter the sample. Where possible, turn off the water to the bathroom sinks, toilets, and tub and instruct child that water is not to be turned on. Add blue coloring agent or food coloring to the toilet bowl and tank to reduce the opportunity of diluting the urine sample. Restricting access to bathroom and kitchen cabinets will minimize the possibility of adding household cleaning agents, vinegar, bleach, detergents, or other chemicals, which may interfere with obtaining a “clean” sample and reliable screening result. The decision to take these precautionary measures is strictly a choice you make, to assure yourself of testing the best possible specimen. DO NOT REUSE THE TEST KIT To test a new specimen, use a new collection container, and test device. The test kit CANNOT be used to retest the same specimen. Collecting the Right Amount of Urine for Testing The Accu-Stat Home Multi-Drug Test requires just 25m/l of urine (approx. 1 oz.) to complete the initial screening for the presence of drugs and to have enough sample left for confirmation testing, if needed. 1. Bring the pouch to room temperature before opening. Open the sealed pouch, remove the Accu-Stat Multi Drug Test Device, and discard the desiccant pouch. 2. Wash your hands with soap and warm water. 3. Urinate directly into a clean plastic cup or container. Performing the Accu-Stat Home Drug Test If specimen has been stored or refrigerated it must be brought to room temperature before performing the actual test. 1. Using the pipette (dropper) provided, place 3 to 4 drops of urine in each of the two test wells at the bottom of the Multi-Drug Test Device. 2. The urine specimen will migrate up the test strips and will provide results in just a few minutes. 3. Results should be read in 5 to 10 minutes. Interpretation of the Results Each strip on the test device represents multiple tests. Each strip is read separately. To read your results you must look at the “T” (test) area nest to the Drug indicated by name, and the “C” (control) area of each strip. The first strip tests for methamphetamine (abbreviated mAMP) cocaine (abbreviated COC), and marijuana (abbreviated THC). The second strip tests for opiates/morphine (abbreviated OPI) and amphetamine (abbreviated AMP). There are three possible results. The first possibility is a “Negative” result. The second is a “Positive” preliminary screening result. The last is a “Retest” or “Invalid” result. A retest or invalid result means the test did not work properly and you need to retest with another test device. After adding the specimen to the two test wells at the bottom of the test device the specimen will begin to migrate (travel) up the test strips. A white/waxy line (“ghost line”) may become noticeable. This “ghost line” is not to be interpreted as a negative screening result. A negative screening result can only be based upon the appearance of a reddish/pink line, not a “ghost line.” Wait at least 5 minutes before reading the screening results. NEGATIVE:* Multiple lines appear. One red line should be in the control region adjacent to or next to the (C) and additional red or pink lines in the test region adjacent to the name of the drug being tested for. NOTE: The shade of red in the test region adjacent to the (drug abbreviation) will vary, but it should be considered negative whenever there is even a faint pink line visible. POSITIVE: One red line appears in the control region adjacent to the C. No line appears in the test region adjacent to the drug name (abbreviation). This positive result indicates that the drug being tested for is present at a concentration above the detectable level (cut-off level). INVALID: Control line fails to appear. A distinct colored line should always appear in the control region adjacent to the C. If no line appears in the control region do not interpret result. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test. If the problem persists, contact the customer service representative at the number indicated at the end of this booklet. Understanding the Results What is meant by a preliminary positive screening result? Accu-Stat Home Drug Tests are considered “screening tests”, the first step in a two-step process. If you get a preliminary positive screening result, you should take the second step and “confirm” the screening result by a more sophisticated technique known as gas chromatography/mass spectrometry (GCMS). Purchase price includes cost of confirmation testing for preliminary positive screening result. What does a negative screening result mean? This means if the sample was collected properly and if the test was performed according to the instructions, the drug is not present in the sample, or there is not enough drug present to be considered a preliminary positive screening result (above cut-off level). See cut-off levels on page 6 in this booklet. Limitations 1. You must follow the directions in this instruction booklet; failure to do so could cause inaccurate results. 2. Only human urine samples can be used with this test. 3. Our laboratory must receive a sufficient quantity of urine sample to run the confirmation test. (Approx. 1 ounce) 4. Altered urine samples may give inaccurate results 5. Urine samples are degradable. Our laboratory must receive the sample within 7 days after the sample is collected in order to get valid results. 6. Some medicines and food may give a false positive with this test. Examples are poppy seeds, diet drugs, inhalers, cough syrup, and diarrhea drugs. 7. Bleach and other strong oxidizing agents can degrade test results. If you feel a sample has been altered obtain a new sample. 8. Other circumstances and compounds not listed in this booklet could cause inaccurate screening results. 9. Drugs must be present in the urine above a certain concentration in order to be detected by the Accu-Stat™ Multi-Drug Test Device. (See cut-off levels below) 10. You must have your Identification number in order to get your confirmation results. 11. Liability is limited to the purchase price of this kit. About the Result Government Agencies such as the Substance Abuse and Mental Health Services Agency (SAMHSA), have established “cut-off” levels when testing for drugs of abuse. AccuStat is manufactured to conform to those government guidelines. As a screening test, Accu-Stat Multi-Drug Test Device may not detect amounts of drugs in a urine sample that are below the cut-off level. In other words, though some level of drug(s) may be present in a urine sample, the sample would be considered a NEGATIVE screening result if the drug level is small. Samples at or near the cut-off level provide the greatest margin of error. The possibility exists that your child may have ingested one or more of the five drugs and, based on the time of collection and testing, his or her body metabolism, how strong and how each drug was ingested, could test negative on the Accu-Stat Home Drug Test. Cut-off Levels for Accu-Stat Home Drug Tests THC tetrahydrocannibinol 50 ng/ml COC cocaine 300 ng/ml mAMP methamphetamine 1000 ng/ml OPI opiates/morphine/heroin 2000 ng/ml AMP amphetamine 1000 ng/ml How long after using drugs, can they be detected in urine? Each drug is cleared by the body at different rates. How soon a drug may be found in the urine and how long a person will screen or test positive depends on a number of factors, including how often the drug is taken, how the drug was taken (swallowed, inhaled, smoked, or injected) as well as the age, weight, diet, and metabolic rate of the user. Drug Detection Times Minimum Maximum Marijuana (THC) 2 hours up to 40 days* Cocaine (COC) 1.25 to 4 hours 2 – 3 days Methamphetamines (mAMP) 2 - 7 hours 2 – 4 days Opiates (OPI) 2.5 hours 2 – 3 days Amphetamine (AMP) 2 – 7 hours 2 – 4 days *Sometimes longer depending on smoking pattern About Confirmation Testing CLIA Waived Professional Product does NOT include Laboratory Confirmation Accu-Stat is a preliminary screening device, the first step in a two-step process for determining the presence of drugs of abuse in a urine sample. Samples that are screened as negative do not need further examination. For a sample that is screened as positive, you should send it to our laboratory for further analysis to confirm the actual presence of the drug of abuse. Confirmation testing is performed using a combination of very sophisticated instrumentation and techniques known as gas chromatography/mass spectrometry (GC/MS), which can accurately identify a drug of abuse. Confirmation testing should be performed on all preliminary positive screening results to establish certainty. Laboratory results can be retrieved within 5 to 7 days from the time the sample is received in the laboratory. Shipping Samples for Confirmation Transfer about 1 oz. of the urine specimen into the shipping vial provided and secure and lock the lid of the vial. Remove the 2 part confidential numbered tag from preaddressed shipping box included in test kit. Place a check mark in the box for the drug or drugs that indicated a positive result. Remove the portion of the two part numbered tag that is labeled “Identification Number” from the backing and attach it to the front cover of the instruction booklet. You will need this number to obtain your laboratory results. Remove the second numbered tag (portion with checks at drugs indicated positive) and apply it to the side of the vial containing the urine specimen. Place the vial into the plastic bag supplied and seal or zip lock the bag. Place the sealed bag with the vial inside in the preaddressed mailing box. On the mailing box, indicate the date the sample was collected. The mailing box is not prepaid. To ensure prompt delivery, be sure to pay the mail service the appropriate shipping charges. To Obtain the Laboratory Results Results will be available 5 to 7 business days after the sample is received in the laboratory. Have on hand the identification number that you placed on the cover of the Instruction Booklet. Results will not be disclosed without this number. Dial 1 888 882 7739 to request the result of your test. Call Monday through Friday, between 8:00AM and 4:00PM Pacific Time. You will only need to identify your self by using the identification number. You must call within thirty (30) days. Results will be kept on file for thirty (30) days after receipt. After this period of time, all test results will be destroyed. Call CLIAwaived.com, if you need any assistance. Commonly Asked Questions Q. The marijuana test line is lighter than the lines for cocaine or Control. Does this mean some marijuana is present? A. No. The lines need not be the same shade or intensity. The control line may look darker than a test line, or vice versa. Q. How long will the colored line remain visible? A. The test should be read within 10 minutes for best results. A negative result will never disappear. Q. I am not sure of my test results. What should I do? A. The test is working properly as long as a colored line is visible in the Control region. The result is negative when there is a line next to the “Drug Name” in the Test region. The result is positive when there is no line next to the “Drug Name” in the Test region. Q. What if my child refuses to give a urine sample? A. Patiently gain your child’s cooperation with the understanding that it is their welfare that you are protecting. Be persistent without accusations, threats, or anger. If your child continues to refuse, seek professional help. Resources American Council for Drug Education www.acde.org 1-800-488-DRUG The Parent’s Resource Institute for Drug Education, Inc. (PRIDE) www.pride.org 1-800-677-7433 Center for Substance Abuse Treatment www.health.org 1-800-662-HELP Al-Anon Family Group Headquarters www.alanon.org 1-800-344-2666 The National Council on Alcoholism and Drug Dependence www.ncadd.org 1-800-NCA-CALL