Cut-off Levels for Accu-Stat Home Drug Tests

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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 40-86F (4-30C) 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
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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
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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
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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
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