+ All Categories
Home > Documents > Test Instruction/ Question & Answer Handbook 5 - · PDF fileTest Instruction/ Question &...

Test Instruction/ Question & Answer Handbook 5 - · PDF fileTest Instruction/ Question &...

Date post: 27-Mar-2018
Category:
Upload: phamcong
View: 226 times
Download: 5 times
Share this document with a friend
32
Test Instruction/ Question & Answer Handbook 5 1 Place Red Sticker/ (PIN) Identification Number from Labeled Vial HERE 9150T.5 Online results available 24/7 at www.phamatech.com TOO MUCH URINE WILL FLOOD TEST DEVICE
Transcript

Test Instruction/Question & Answer

Handbook5

1

Place Red Sticker/ (PIN)Identification Number

from Labeled VialHERE

9150T.5

Online results available 24/7 at www.phamatech.comTOO MUCH URINE WILL FLOOD TEST DEVICE

At Home™ Drug TestA parenting tool for randomscreening for the presence of

Drugs of Abuse in urine

IMPORTANTRead entire Test Instruction

Handbook before use

WARNINGS ANDPRECAUTIONS

This test is only the First Step in a Two Step processfor determining the presence of drugs of abuse. Youmust consult your health care provider or refer all"preliminary" results to the laboratory in order toobtain step two: a confirmed result.

Judgment should be applied to any drug of abuse testresult, particularly when initial results are "prelimi-nary." Remember, without proper confirmation test-ing you cannot accept any result this test gives asbeing positive.

2

KIT CONTENTSFamiliarize yourself with the contents of this kit:

TESTING MATERIALS

1 Test Instruction/Question & Answer Handbook

1 At Home™ Drug Test Device (in a foil pouch)

1 Collection Cup(with a temperaturemonitoring strip)

3

CONFIRMATION MATERIALS1 Labeled transport vial (for

shipping “preliminary” sampleto the laboratory for confirmation,located inside the pre-addressedmailing box)

1 Personal Identification Number(on red label located on thetransport vial)

1 Plastic transport bag

1 Pre-addressedmailing box

If any component is missing from this kit youmust call our customer service hotline at877-HOME-TEST (877-466-3837). Please haveyour Personal ID Number available.

4

Your Personal Identification Number (PIN) is located on a twopart tag which can be found on the labeled vial. Detach thewhite and red portion and place the red sticker on page 1 ofthis handbook in the space provided, leaving the whiteportion attached to the vial.

5

What is the At Home™ Drug Test?

At Home™ Drug Test is a drug screening, and ifneeded, confirmation service. It provides prelim-inary urine screening results for thedetection/presence of the following drugs ofabuse: methamphetamines, amphetamines, mari-juana (THC), cocaine and opiates (heroin). It isintended for home use. For assistance in col-lecting a sample, use of this product or refer-ral, call our Customer Service Hotline at1-877-HOME-TEST (877 466-3837).

When is the best time to collect a sample?

The sample should be collected as soon as possi-ble after suspected drug use. Timing is veryimportant in detecting any drug of abuse. This isbecause each drug is cleared by the body and isdetected in the urine at different times and rates.Please consult the chart provided in the Question& Answer section for further information.

How much sample do I need?Fill the Labeled Vial two-thirds (2/3) full and �llthe Collection Cup to the 30 ml mark.

-

6

Urine Sample Collection1. Have the Collection Cup and Labeled Vial ready.

2. Check to make sure that the number on the LabeledVial matches your Personal Identification Number.

3. Wash your hands with soap and warm water.

4. Urinate directly into the Collection Cup (withTemperature Monitoring Strip). Fill the cup toabove the 60 ml mark. It is OK to have extrasample. Wipe any splashes or spills that may beon the outside of this cup. DO NOT DIP DEVICEYET!!!

5. Immediately check the temperature monitoring strip.The temperature should read between 90ºF and 100ºF.If the temperature is not in this range, the samplemay be altered and another sample should becollected. For more information about tampering,please read the section "A Special Note to ParentsAbout Sample Tampering".

6. Before inserting test device into urine sample, openthe Labeled Vial and carefully pour the urine from theCollection Cup INTO the Labeled Vial. Fill the vial toabout 2/3 full and tightly close the cap.

7. IMPORTANT: The rest of the urine should be enoughto reach the 30 ml mark on the Collection Cup. ANYMORE THAN THIS IS TOO MUCH AND MAY FLOODDEVICE.

7

8. Wash and dry hands.

9. Set the Collection Cup and Labeled Vial asidewhile you review the test instructions.

A special note to parents about tampering:A good urine sample is very important to gettingan accurate result. It is very important that thesample to be screened has not been altered ortampered with in any way.

The following steps are things you can do tominimize or reduce the possibility that the sam-ple has been tampered with:

Make sure the faucets in the bathroom basin andshower are turned off tightly and the childshould be instructed not to turn them on. Placeblue coloring into the toilet. This will help todiscourage the use of any water sources to dilutethe specimen. Tape medicine cabinet door closed.Check the child's clothing to ensure that they donot have access to or anything in their possessionthat would be used to tamper with the specimen.

Whether or not you as a parent makes a decisionto use any of these options is your choice. Thisdecision is best made after careful considerationbased upon your knowledge of the child.Preferably, the child should be tested randomly.

8

Performing the At Home™ Screening Test:1. Begin in a well-lit place. Have a watch or timer ready.

2. Make sure the sample and test components are atroom temperature before testing.

3. Open the foil pouch at the notch and remove theAt Home™ Drug Test Device. Take care not to touchthe test area of the device.

4. Insert the test device directly into the Collection CupDO NOT insert the device any deeper into the samplethan shown by the "Max Urine Level" line.

5. Allow device to remain in the urine sample for 10minutes.

6. Read the result at ten (10) minutes. You will see a redcolor appear in the “Result Ready” window on theright.

7. As you watch the test develop you may notice thatthe urine sample moves up the test device. In mostcases the control line "C" will become visible beforethe test line "T" does. This is normal and means thetest is developing properly.

8. Read test results immediately after 10 minutes haveelapsed.

IMPORTANT: After 15 minutes or when the “ResultExpired”window turns red results are no longer validand should not be read.

9

Reading the Results: Using the TimerWhen the “RESULTREADY” window iscompletely filled withred color, or almostcompletely covered withred color that reachesthe top of the window,test results are ready toread.

When the red colorbecomes clearly visibleat the bottom of the“RESULT EXPIRED”window, test resultsshould no longer beread. Results must nowbe considered invalid.

RESULTREADY

RESULTREADY

RESULTEXPIRED

RESULTEXPIRED

10

Reading the Results

NEGATIVE RESULTSfor all drugs testedNegative: A negative result isindicated by two (2) rose pinkcolor bands (of any intensity),one in the control region AND one in the test region.This result means that the urine screened negative.

REMEMBER - EVEN A VERY FAINT LINE IS A NEGATIVERESULT

PRELIMINARY RESULTfor Cocaine (example)Preliminary: A single rose pinkcolor band which appears inthe control region, and NO linein the test region means theurine screen is considered to be

PRELIMINARY POSITIVE. The urine sample must besent to the laboratory for further testing. More thanone test may be “preliminary”.

NO RESULTfor THC and Opiates (example)No Result: A test must beconsidered No Result if nobands appear or if a bandappears in the test region "T"without a band in the control region "C". Thepresence of a control band is necessary to confirmassay performance and must always appear.

Understanding the Result

Each At Home™ Drug Test is made to detect the pres-ence of the following drugs: ecstasy and metham-phetamines, amphetamines, THC (marijuana),cocaine and opiates. The test detects any or all ofthese drugs when they are above the detection limitof the test.

What does a negative test result mean?This means that if the sample was collected proper-ly and if the test was performed according to direc-tion, then probably none of the five drug familiesscreened were present in the sample.

However, if drug use is still suspected, you may wishto re-screen at a later time.

What does a preliminary test result mean?This means that the test has reacted with somethingin the sample and must be sent to the lab for a moreaccurate test. Please review the Test Limitations fol-lowing this section.

First, and most important: BE PATIENT. The resultyou obtained is called "preliminary" for a reason.The sample MUST be tested by our clinical laborato-ry in order to determine if a drug of abuse is actual-ly present. You will never know for sure withouttaking the second step.

11

12

Remember, screening is the first step in atwo part system:

Step 1: Screen out (eliminate) the negativesamples.

Step 2: Send any sample which does notgive a negative result to a laboratoryfor further testing.

Test Limitations:

Failure to use this kit as directed may resultin an insufficient sample or an inaccuratescreening result.

This test can be used on urine samples only.No other fluids have been evaluated. Do notuse this device to test anything but urine.

Our laboratory must receive an adequateamount of sample to perform confirmationtesting.

The urine sample is perishable. Old urinesamples may not be suitable for testing.

13

You cannot retrieve your confirmed resultwithout knowing your Personal IdentificationNumber (PIN).

Certain foods and medicines, diet plan drugsand nutritional supplements may cause afalse positive test result with this product.

The possibility exists that substances andfactors not described in this directionalinsert may interfere with the test, causingfalse results (e.g. technical or proceduralerror).

Adulterated urine samples may produceerroneous results.

Strong oxidizing agents such as bleach canoxidize drug analytes. If a sample issuspected of being tampered with, a newsample must be obtained.

This test provides a screening result. It isnot designed to determine the actual con-centration of a drug or the level of intoxication.

Liability is limited to the purchase price ofthe kit.

14

Mailing a Urine Sample to the Laboratoryfor Confidential Confirmation Testing:

1. Remove red tag from the labeled transport vial and place on the front of this handbook. Save the handbook for retrieval of results in 3 to 10 days. The labeled transport vial must be two thirds full (2/3).

2. Place the labeled trasport vial into the plastic transport bag.

3. Seal the plastic transport bag.

4. Place the sealed plastic transport bag into the pre-addressed mailing box, secure with tape.

5. Record the date the urine sample was collected on the outside of the box.

6. The mailing box is not pre-paid. Applicable shipping charges must be paid to the carrier to ensure delivery.

7. Place the mailing box in any USPS mailbox.

IT IS IMPORTANT TO MAIL IT RIGHT AWAY! Old urinesamples may not be suitable for testing.

15

Getting the Laboratory Results

Get the identification number from the redsticker on page 1 of this booklet before youcall for your results. You must have thisnumber to obtain your laboratory testresult. Have a piece of paper and a pencilready.

Dial 1-877-HOME-TEST (877 466-3837),Monday through Friday, between 7:00 amand 5:00 pm Pacific Standard Time.

Identify yourself by your personalidentification number (PIN) only.

You will be given the laboratory result forthose tests identified as preliminarypositive.

Your result should be available 7 to 10business days after you ship your sample,but it may take longer depending uponyour location.

-

16

Results are also available on the internet atwww.phamatech.com. You must have youridentification number (PIN) to access yourresults.

Remember to have your identificationnumber handy when you call. Results willnot be disclosed without an ID number.

Please call Customer Service at 1-877-HOME-TEST (877 466-3837) for assistance.-

Drug Test Identification Code:MET Methamphetamine and Ecstasy (MDMA)AMP Amphetamine and methylenedioxyamphetamine (MDA)THC MarijuanaCOC CocaineOPI Opiates

17

Questions & Answers

18

Remember:You are not alone in the struggle

against drugs.No one is immune to these problems.

COMMUNICATE

The number one way to helpyour loved one is to

communicate your concern to them.

Frequent knowledgeablecommunication about the facts

of drug abuse can strengthen thewill of your child

to stay away from drugs.

19

Some commonly abused drugs

AmphetamineAmphetamines are central nervous stimulantswhose effects include alertness, wakefulness,increased energy, reduced hunger and anoverall feeling of well being. Large doses andlong term usage can result in higher tolerancelevels and dependency.

MDA, the parent drug of MDMA (ecstasy), isan amphetamine-like drug that has also beenabused and is similar in chemical structure toMDMA. Research shows that MDA destroysserotonin-producing neurons in the brain,which play a direct role in regulating aggres-sion, mood, sexual activity, sleep andsensitivity to pain. It is probably this actionon the serotonin system that gives MDA itspurported properties of heightened sexualexperience, tranquility and sociability.

CocaineCocaine is made from coca leaves. Its effectsinclude alertness, wakefulness, increased energyand an overall feeling of euphoria. Cocaine canbe smoked, inhaled (“snorted”) or injected.Cocaine can be a very addictive drug.

20

MethamphetamineMethamphetamine is a stimulant drug. It isused in pill form, or in powdered form bysnorting or injecting. Crystallized methamphet-amine is a smokable and more powerful formof the drug. Some of the effects of metham-phetamine use include: increased heart rate,wakefulness, physical activity and decreasedappetite. Methamphetamine use can cause irre-versible damage to the brain, producing strokesand convulsions, which can lead to death.

EcstasyEcstasy is the street name for 3,4 methylene-dioxymethamphetamine (MDMA). It combinesthe stimulating effects of methamphetaminewith a hallucinogen. Some of the effects of useinclude: increased heart rate, wakefulness,increased body temperature and rapid dehydra-tion in certain settings. Psychological effectsinclude confusion, depression, anxiety andparanoia. Use can lead to brain damage, heartand kidney failure.

OpiatesOpiates are any of the addictive narcoticdrugs. The opiates include drugs such asmorphine, heroin and codeine. Opiates canreduce attention, sensory and motor abilities.

21

Phencyclidine (PCP) (available in #9149 only)Phencyclidine hydrochloride (or PCP), alsoknown as “angel dust”, is an hallucinogen.PCP is commonly taken orally, by inhalation,by “snorting” or by injection. The effects ofthis drug are unpredictable and variable.Users may exhibit signs of euphoria, anxiety,relaxation, increased strength, time/spacedistortions, panic or hallucination.

THC (marijuana)Tetrahydrocannabinol (THC) is an activecomponent in marijuana. Marijuana iscommonly taken by smoking, but it may alsobe eaten. Marijuana may impair learningand coordination abilities. Low concentra-tions of THC persists in urine at a detectableconcentration for many days after smoking.

Amphetamines and MDA speed, amp, bennie, chalk, black beauties

Cocaine Big C, coke, snow, flake, candy, crack, blow, rock

Methamphetamines crystal, meth, ice, glass

Methylenedioxy-methamphetamine (MDMA) Ecstasy, E, Adam, XTC, X

Opiates heroin, H, hairy hombre, horse, jones, scag

PCP angel dust, magic dust, sherms, star dust

Marijuana (THC) pot, weed, herb, bud, MJ, doobie, reefer, grass joint, homegrown, spliff

Common street names for drugs:

What is the At Home™ Drug Test?At Home™ Drug Test is a qualitative test forthe detection of five (5) drug families ormetabolites in urine; Amphetamines,Methamphetamines, Marijuana (THC),Cocaine, and Opiates.

At Home™ Drug Test allows the detection tobe done confidentially, with the name ofthe person tested unknown.

At Home™ Drug Test hot line is a source ofreferrals to healthcare services.

At Home™ Drug Test hot line is a source ofeducational information.

22

23

How long after using drugs can they bedetected in urine?

Each drug is cleared by the body at different rates.The amount of a drug (the concentration) in the body,how often the drug is taken, how the drug was taken(swallowed, inhaled, smoked or injected) as well asuser age, weight, diet and metabolic rate all play apart in detection times. A general guideline for drugdetection periods is as follows:

Drug Approximate Detection Times

Minimum Maximum

Amphetamine and MDA 2 to 7 hours 2 to 4 days

Cocaine metabolite 1.25 to 4 hours 2 to 3 days

Methamphetamine and MDMA 2 to 7 hours 2 to 4 days

Opiates 2.5 hours 2 to 3 days

Phencyclidine (PCP) 7 hours 3 to 5 days

Marijuana (THC) 6 to 18 hours up to 28 days

24

What the laboratory results mean

1. You will be told if the laboratory test result foryour urine sample was positive or negativeaccording to confirmation testing.

2. The results you receive will come from tests per-formed by laboratory professionals. These testsare run on very accurate and reliable equipment.

3. Positive results are released only when the sam-ple is confirmed to be positive using sophisti-cated techniques and equipment such as gaschromatography/mass spectrometry.

4. Samples which are screened as negative do notrequire the second (confirmation) test. This canmean several things:

a. These drugs were not used in the past fewdays prior to providing the urine sample.Therefore, they either don’t do drugs or hadnot done them just prior to testing.

b. The person may only use a small amount ofa drug, an amount too small to be detectedby the test.

25

c. A person may be taking a drug not testedfor with the At Home™ Drug Test. Only six(6) drugs are tested for and so if any otherdrugs were in use the test result would benegative. Substances such as LSD, alcohol,inhalants, benzodiazepines and anti-depressants will not be identified with thistest.

d. The sample may have been tampered withor be unsuitable due to some rare technicalinterference.

5. Certain foods and medicines such as coughsyrup, inhalers, anti-diarrhea medicines, dietplan drugs, poppy seeds may cause a positivetest result.

a. Both codeine and heroin break downto morphine in the body so a positiveresult for morphine may be from aperson taking either morphine, heroinor codeine (in cough syrup).

b. People can test positive for THC (ormarijuana) because they have beenrepeatedly around heavy marijuanasmoke even though they did not eator smoke marijuana themselves.

26

c. Certain diet plan drugs may give apositive result for amphetamine.

d. Eating enough poppy seeds maycause a positive opiate result.

6. Remember, when a drug is found in the urine,testing:

a. does not tell us how the drug got there(eaten, inhaled, smoked or injected).

b. does not distinguish a prescriptionmedicine from a drug of abuse.

c. does not tell if the positive result is from afood that someone ate.

7. In the event a positive result for a drug wasconfirmed, please consult with our staff on aproper course of action. We will help youidentify counselors who will help you. It isimportant that you remain calm and do not reactin a negative way to the situation.

8. If you have received a positive result andyou do not believe the test, please consultwith your physician. They will have yourbackground medical history and be able toprovide you with detailed information onboth the test and the meaning of the result.

27

What about False Positive Results?

A screening test can give a false positive result.Certain cross reactive substances are known tooccur. These can be present due to diet, prescrip-tion or over the counter medications, etc. This iswhy it is important to send any sample not giv-ing a negative result to the laboratory for furtherevaluation.

An analysis by the laboratory, which involvesconfirmation testing, will determine whether ornot a drug is present in the urine. If the labora-tory reports a positive result you may be assuredthat the drug was indeed present. However, itwould be incorrect to assume the urine samplecame from a drug abuser just because the resultis positive. It is necessary to determine how con-tact with the drug occurred.

Can False Negative Results occur?

If you have observed behavioral changes whichyou feel could be caused by drug abuse don’t dis-card the thought just because the test result isreported negative. A false negative result canoccur for a number of reasons. Certain productsare being marketed as a means of defeating drugtesting. These interfere with various methodsused in either the screening or confirmation tests.Drugs other than those tested for with this devicemay be involved. More often, the concentrationof the drug in the urine sample is below cut-off,or sensitivity, of the screening assay. When thisoccurs the test is reported negative. Drug testcut-off concentrations are listed below:

28

Drug Class Cut-off Concentrations (ng/ml)

Immunoassay GC/MSAmphetamines and MDA 1000 500Cocaine 300 150Methamphetamine and MDMA 500 500Opiates-morphine 300 300Marijuana (THC) 50 15Phencyclidine (PCP) 25 25

29

Additional information and resources:

The following list of organizations may be helpful toyou for counseling support and resources. Thesegroups also have an Internet address which can beaccessed for additional information.

National Clearinghouse for Alcoholand Drug Informationwww.health.org1-800-729-6686

Center for Substance Abuse Treatmentwww.health.org1-800-662-HELP

The National Council on Alcoholismand Drug Dependencewww.ncadd.org1-800-NCA-CALL

American Council for Drug Education(ACDE)www.acde.org1-800-488-DRUG

See our website for additional information at:www.phamatech.com

30

Listed below is a glossary of definitionsappropriate to drugs of abuse testing.

Cannabinoids - A family of compounds, some ofwhich are psychoactive, found in the common hempplant, or Cannabis sativa. Most of the pharmaco-logical effects are produced by delta-9-tetrahydro-cannabinol. In urine drug testing, the prior use ofmarijuana is established by the detection of metabo-lites of cannabinoids. These metabolites are gener-ally inactive, but are often present in significantquantities. The most abundant metabolite is 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid,sometimes referred to as 9-carboxy-THC. Mostimmunoassays and confirmation procedures aredirected toward this metabolite.

Confirmation - The process of using a second ana-lytical procedure to verify the presence of a specificdrug or metabolite, which is independent of the ini-tial test and which uses a different technique andchemical principle from that of the initial test toensure reliability and accuracy.

Cross Reactivity - The degree to which an anti-body interacts with antigens other than the one usedto produce the antibody. This is a property of near-ly all naturally derived antibodies.

31

Cutoff - The concentration of a target drug in a spec-imen at or above which the test is called positive andbelow which it is called negative.

False Negative - A test result which states that nodrug is present when, in fact, a tested drug or metabo-lite is present in an amount greater the threshold orcutoff amount.

False Positive - A test result which states that adrug or metabolite is present when, in fact, the drugor metabolite is not present, or is present in anamount less than the threshold or cutoff value.

GC/MS - An abbreviation for the instrumental tech-nique which couples the powerful separation poten-tial of gas chromatography with the specific charac-terization ability of mass spectroscopy.

Mass Spectrometry - Analysis using an analyticalinstrument that provides accurate information aboutthe molecular mass and structure of complex mole-cules. This technique can identify extremely smallamounts of drugs or metabolites by their mass-frag-mented spectrum.

Metabolite - Drug breakdown products.

Passive Inhalation - The exposure of non-smoking subjects, through inhalation, to side-stream smoke from active smokers, thereby rais-ing the possibility that a non-user of marijuanamay test positive for metabolites of delta-9-tetrahydro-cannabinol.

Screening Test - The initial test used to identifythose specimens which are negative or positivefor the presence of drugs or their metabolites.Negative specimens need no further examinationand need not undergo confirmation testing.

THC - Delta-9-tetrahydrocannabinol, the mostpharmacologically active of the cannabinoids(See Cannabinoids).

Confirmation Test Results are available at1- 877-HOME-TEST (1-877-466-3837)

or online at www.phamatech.com.Be sure to have your personal identification

number (PIN) to access results.

32

Manufactured by:Phamatech, Inc.San Diego, CA


Recommended