Sweat Patch Drugs of Abuse Patch

American Screening Corp's Sweat Patch Drug Test, uses sweat as the specimen source. It provides an alternative to urine collection and offers a number of advantages. Because the sweat patch is worn on the skin for up to 14 days, it not only acts as a deterrent to continued drug use, but also increases the window of detection to include any period when it is worn. With sweat testing - unlike urine - the parent drug as well as the drug metabolite can typically be detected. Therefore, it is easier to identify which drug was actually taken. The following are the advantages of the SWEAT PATCH DRUG TEST

• Increased window of detection
• Acts as a deterrent to drug abuse
• Patch has a identification number to ensure patch is not substituted.
• Detects Parent Drug and Drug Metabolites
• Variable Removal Date
• Quick Application & Removal
• No Urine Collections
• No Sample Substitution
• No Sample Dilution
• Screens for: Marijuana, Cocaine, Opiates, Amphetamine/Methamphetamine & PCP

Price Includes:

• 10 Sweat Patch Drug Tests
• 10 Chain of Custodies
• 10 Transport Specimen Bags
• 10 Alcohol Pads
• Confirmation from GC/MS SAMHSA certified Drug Testing Laboratory
• Supplies for Patch Application and Removal.
• Client is responsible for mailing patches back to lab, we recommend US Postal.

Summary of Sweat Patch Drug Test Application:

1. Clean Skin With Alcohol Wipe.

2. Place Patch Over Skin.

3. Rub Around Absorbent Pad.

4. Remove Patch Window Frame.

5. Rub Around Edge Of Patch .

Summary of Sweat Patch Drug Test Removal:

1. Donor Peels Outer Cover of Patch Down.

2. Remove Absorbent Pad.

3. Place Absorbent Pad in Bag.

4. Remove Barcode Label.

5. Peel Off Security Seal.

6. Send Sweat Patch to Lab.

Price includes all listed above.

 

Return Instructions

Use the address included on the Chain of Custody form to send the test to the lab..

 

The Sweat Patch Drugs of Abuse Patch tests for Cocaine, Opiates, Amphetamines, Marijuana, & PCP.

Drug or Drug Class Analyte	Patch Screening	Drug or Drug Class Analyte	Patch Confirmation LC/MS/MS
Cocaine	EIA 10 ng/ml	Cocaine Benzoylecgonine	10 ng/ml 10 ng/ml
Opiates	EIA 10 ng/ml	Heroin 6-MAM Morphine Codeine	10 ng/ml 10 ng/ml 10 ng/ml 10 ng/ml
Amphetamines	EIA 10 ng/ml	Amphetamines Methamphetamine	10 ng/ml 10 ng/ml
Marijuana	EIA 1.5 ng/ml	Marijuana	.5 ng/ml
Phencyclidine	EIA 7.5 ng/ml	Phencyclidine	7.5 ng/ml

Reliability/False Positives

Will "passive" or inadvertent environmental exposure to a drug cause a positive test result?

We studied this question directly, even though there is a strong theoretical reason not to believe in such possibility. The absorption pad of the patch is protected from the environment by a layer of film composed of polyurethane coated with adhesive. The polyurethane film is a "semi-permeable membrane” which allows the transfer of water vapor and gases. Initial studies involving this concern were conducted by applying drugs to the exterior of the patch and subsequently collecting and analyzing the absorption pad. No drugs were found in these experiments.

Subsequent experiments have involved variations of these initial experiments and have incorporated such variations as wetting the absorbent pad with various solutions and buffers, varying the pH of the of the solution containing drugs that was applied to the exterior of the polyurethane membrane, and varying the temperature and time that the varying solutions are allowed to sit or incubate on the exterior of the polyurethane membrane.

These studies have demonstrated that when both the inside and the outside of the patch were dry, no drug transfer could be noted. Under certain conditions, the outer polyurethane membrane can be altered and made permeable to the diffusion of applied drugs onto the absorption pad. However these conditions are not what one would realistically expect to encounter in real world situations.

Will the Sweat Patch be positive if the target drug is not taken?

This question was addressed directly in clinical trials by applying patches to self-reported non-users. The drugs that were tested for were not found in patches from non-users. From this we conclude that any “normal” constituents of sweat do not produce positive results.

Results of these studies are represented in Hypothesis 3 of SECTION 4 DISCUSSION in each summary book given to the FDA as part of the submission for the drug.
In addition, while drugs may be present in the environment in certain situations and even possibly present on skin surfaces, none of these studies has demonstrated in realistic scenarios that the transfer of such environmental drugs into patches worn by those individuals present in these environments.

Will drugs other than the target drugs produce false positives?

This is not directly addressed in our studies - but was also not thought by FDA to be necessary. The testing procedure that was cleared by the FDA requires GCMS confirmation testing of initial immunoassay test positives. This is the same procedure required by SAMHSA (formerly NIDA) in the testing of urine samples. GCMS (and its successor LS/MS/MS) confirmation is scientifically capable of distinguishing the target drug from other drugs that might be present in sweat, preventing false positives.

A second important point is that "parent" drugs, rather than just drug metabolites, are found in sweat after drug use. "Parent" drug is the same chemical compound that was taken by the drug user (example, heroin). Drug metabolites are "breakdown products" of the parent drug. Many drugs such as codeine and heroin produce the same metabolites in urine, so a urine test cannot reliably distinguish between them. Because sweat contains both the parent drug and the metabolites, the test can tell which drug has been taken.

Is the laboratory process subject to false-positive error?

Our lab will be employing procedures substantially equivalent to those required by SAMHSA for urine testing. Years of experience with these procedures have demonstrated that there is a negligible problem with false positives. As an additional safeguard, our lab utilizes blind quality assurance samples in the testing process.

Detection Periods

Detection periods for the Sweat Patch must be thought about in terms that are a bit different from urine testing. The Sweat Patch is a collection device designed to retain evidence of drug use for an extended period of time. That means that drugs excreted through sweat because of drug use at any time during the wearing of the patch will be collected, retained, and detected during analysis. If a Sweat Patch were worn for 7 days, for example, it might be positive because of drug use on Day 1 or on Day 6.

How long does it take for drugs to be excreted through sweat after a single drug use?

Clinical trial data from the administration of known amounts of drug show that essentially all of the drugs detectable with the patch are excreted over a period of about 2 - 3 days. This is quite similar to the elimination period for drugs in urine. The difference is that the Sweat Patch is constantly sampling the sweat and retaining all evidence of drug use.

How long after use must the Sweat Patch be worn in order to produce a positive result?

Data from clinical trials show that patches worn at least 24 hours after drug use can reliably test for that drug.

Adulterants

Solvents, such as chloroform or acetone, have been applied to the covering of the Sweat Patch. They bubble and shrivel the Sweat Patch covering and evidence of trying to tamper with these chemicals would be very easily noticed.

In order to adulterate the Sweat Patch a substance would have to penetrate the outside covering of the patch. The only feasible method that has been tried is to inject substances into the Sweat Patch with a hypodermic needle. Part of the removal process for the patch includes holding the outside cover of the used Sweat Patch to the light to see if there are signs of needle holes.

Sweat Patch Wear Period

How long can a person wear the PharmChekâ Drugs of Abuse Patch?

The skin has between 15 to 20 layers of skin cells. The top layer of cells is constantly being shed. The factor that determines how long a person can wear a Sweat Patch is how long it takes for enough skin cells to be shed that the adhesive coating on the patch is completely covered with skin cells and can no longer stick to testing subject’s body.

This length of time varies between person-to-person and skin type to skin type. From our wear tests we have observed that most people can wear the patch for 7 to 10 days. The Michigan Pilot Study showed 87% of the people who wore the patch could wear it for 14 days. There is no known consistent health concerns associated with wearing the Sweat Patch for periods longer than 14 days if the skin around and under the Sweat Patch appears healthy and blemish-free.

Understanding ASC'S Drugs of Abuse Patch Test Results

The Sweat Patch provides an innovative approach to the detection drugs of abuse in sweat. To let you (the probation/parole officer, the pretrial services officer, the Drug Court officer, the hearing officer or the substance abuse professional) use the Drug Test patch effectively, it is important that you understand how to interpret sweat test results with confidence and how to distinguish between sweat and urinalysis test results. It is hoped this understanding can help you determine whether or not drug use has occurred and whether there is a legitimate reason for the presence of drug(s).

The most important concept to understand is how detection periods of drugs in sweat differ from those in urine. While the overall detection period for a single drug use is the same in urine and sweat, the Sweat Patch is a collection device designed to retain evidence of drug use (drug molecules found in sweat) for an extended period of time. One can think of this device as a storage container that continually collects sweat while the patch is worn. Drugs excreted through sweat after drug use can be collected and stored on the cellulose absorption pad and detected during analysis at a Clinical Reference Laboratory. Consequently while the results from the sweat patch cannot be used to reflect the dose of drug taken or the time of use, it does provide an extended detection window. If a positive Sweat Patch contains a high level of drug, it cannot be determined if multiple small doses or one large dose of drug is the cause of the level of drug detected. A positive Sweat Patch cannot show when drug use occurred. If a patch is worn for 7 days, for example, it might be positive because of drug use on Day 1 or on Day 6 of the patch wear period. A positive patch result indicates drug use occurred during the patch wear period or 24-48 hours before Drug Test Sweat patch application, or up to 24 hours prior to the patch removal. Based on several studies in which individuals were given drugs, that the patch must be worn for a minimum of 24 hours. This allows sufficient collection of the sweat to permit a valid analysis.

A urine drug test measures the level of drug(s) in urine at the time the specimen is collected. Unlike sweat testing, which provides a detection period equal to the length of time the Sweat Patch is worn, the detection periods of drugs in urine can vary. Different drugs leave the body over various time intervals. The time varies depending on the drug, the dose administered and the frequency of drug use. In general, drugs can be detected in urine up to 72 hours after a single drug use.

Another important factor in interpreting Sweat Patch drug test results is the understanding that sweat analysis allows our lab to identify the “parent” drug. With urine tests, the laboratory usually identifies drug metabolites or breakdown products to determine if drug use occurred. This is best illustrated by the identification of cocaine in sweat. When an individual uses cocaine, the body converts the cocaine to several different forms or metabolites. While non-metabolized cocaine and these other metabolites can be found in urine, the sample must be collected within 6-12 hours after cocaine use. Consequently the substance that is tested for in urine is the primary cocaine metabolite benzoylecgonine. The substances that can appear in sweat include cocaine (parent drug), benzoylecgonine and ecgonine methyl ester (both of these are breakdown products). Because the sweat patch functions as a storage device, these drugs are retained on the absorption pad and can be subsequently detected. This concept holds true for opiates (codeine, morphine, heroin) as well as tetrahydrocannabinol (marijuana).

It is also important to note that our lab will not provide a confirmed positive result for Cocaine or Methamphetamine unless the actual metabolite of each drug is also detected at or above the limit of detection (LOD). This reporting requirement eliminates the possibility of environmental contamination. The only way the drug metabolite is produced in the system is by actual ingestion (use) of the drug.

The following information provides details regarding each of the drugs tested for using the Sweat Patch.

Cocaine

Cocaine has a very short detection time in urine. Cocaine is metabolized by plasma and liver esterases to ecgonine methyl ester and by hydrolysis to benzoylecgonine. One reason benzoylecgonine is detected in urine is it can be detected for a much longer time than cocaine itself. Use of the sweat patch makes it more likely to identify a cocaine user due to the ongoing collection of sweat. Benzoylecgonine, which is the most common metabolite in blood and urine, is not found in high concentrations in sweat. Cocaine predominates in sweat after cocaine use. The medical community uses TAC (tetracaine, epinephrine, cocaine) as a topical preparation prior to various surgical procedures and may use cocaine by itself as a topical anesthetic for various ear, nose, throat and bronchoscopy procedures. However, cocaine is structurally unique and does not resemble any of the other topical analgesics, such as NovocainÒ, XylocaineÒ (Lidocaine), Benzocaine, Procaine, Prilocaine, etc. Although these compounds have analgesic properties, there is no structural similarity to cocaine or its metabolite (benzoylecgonine).

Opiates

The four opiates analyzed using Sweat Patch drug test are heroin, 6-monoacetyl morphine (6-MAM), morphine and codeine. Heroin is quickly hydrolyzed in the body to form the metabolite 6-MAM which is then broken down into morphine. In sweat, occasionally morphine is not found after heroin use. Heroin and 6-MAM are predominant in sweat after heroin use. The rate at which heroin hydrolyzes in the body makes it extremely difficult to detect heroin in urine. Therefore most heroin use is suggested by the presence of morphine above certain levels, and confirmed by testing the urine for the presence of 6-MAM. Poppy seeds are known to cause positive test results for morphine in urine. However, poppy seeds will not test positive for heroin or 6-MAM in sweat.

Amphetamines

Amphetamine and methamphetamine have relatively short detection times in urine. Depending on urine pH, the average detection period of amphetamine and methamphetamine after use is 12-72 hours. Amphetamine and methamphetamine can appear unchanged in sweat 2-4 hours after use. However, the patch should be worn for at least 24 hours after use to collect enough drug to be identified. Since the detection period of these two drugs in urine is very short, it is possible to have a positive sweat test result for a patch that was worn for 7 days but negative urine tests during those same 7 days. There are some medications prescribed by physicians that contain amphetamines. These medications can be prescribed for attention deficit disorder (ADD), obesity or narcolepsy.

Phencyclidine

Phencyclidine (PCP) is a fat-soluble drug which is detected in sweat as parent drug. There are no legal medical uses of PCP. Phencyclidine is used legitimately only as a veterinary tranquilizer.

Marijuana

Tetrahydrocannabinol (THC) is the psychoactive ingredient found in marijuana. It is rapidly absorbed through the lungs during smoking. Like cocaine, marijuana use is determined by detecting the metabolite of THC in urine. Since THC is fat-soluble and is eliminated by the body slowly, interpreting sweat test results to determine if additional marijuana use occurred can be complex. Parent THC is found in sweat after smoking marijuana. MarinolÒ (synthetic marijuana) may be used for stimulating appetite and preventing weight loss in patients with AIDS and treating nausea and vomiting associated with cancer chemotherapy. Currently there are no published studies that have determined if MarinolÒ will produce a positive sweat test, although it is theoretically feasible.
For more discussion on technical issues regarding ASC's sweat patch, please call our Technical Support Department at 318-227-4994.

No Test Criteria

Sweat Patch

In order for a Sweat Patch to be tested these criteria must be met: If any of these test criteria are missing the laboratory personnel are under instructions not to test the Sweat Patchbecause the results may not be defensible in court.

1. The absorption pad must be accompanied by the 2nd (middle) ply of the Sweat Patch chain-of-custody form.

2. The absorption pad from the Sweat Patch must be placed in the small specimen bag; the bag must be sealed with the security seal.

3. A barcode label from the chain-of-custody form must be fixed to the specimen bag and the label must match the barcode on the chain-of-custody form.

4. The Trained Observer must have signed both the “Observer’s Certification at Sweat Patch Application” and the “Observer’s Certification At Sweat Patch Removal”.

5. The Donor must have signed or initialed on the line in the box labeled “Donor Completes”.

6. If the patch polyurethane film, or any other object accompanies the absorption pad in the specimen bag, the specimen is considered contaminated and WILL NOT be tested in the laboratory.

7. If an incompletesweat patch is submitted for laboratory analysis (example: only half of the absorption pad is submitted) the specimen will not be tested.

8. If the absorption pad has an unusual appearance or color, the sample WILL NOT be tested.

Contradications and Complications

The Sweat Patch is not designed to be applied to skin, which is compromised, by lesions, abrasions, cuts, lacerations, wounds, scars, ulcerations, infections, or dermatological irritations. This product is not intended as a wound dressing. This product is not designed or intended for use except as indicated.

Even though the patch is designed to be hypoallergenic, occasionally there may be some irritations associated with the Sweat Patch.

Warning: The Sweat Patch contains no chemical compounds that are known to cause skin irritation. Should excessive skin irritation occur during wear, the Sweat Patchshould be removed and the skin treated appropriately.

Water Vapor v/s Glandular Sweat

From your training, you have learned that the patch allows water vapor (insensitive sweat) to pass through the pores in the plastic covering because of their small molecular size. If the individual wearing the patch is involved in athletic activity, physical labor, or works in a hot environment, they will produce glandular sweat. Glandular sweat is liquid and has a much larger molecular structure. This sweat will not pass through the pores of the plastic covering, but will collect in the area where the cellulose pad is located. Please inform the individual wearing the patch that they should not press on the patch or try to squeeze out the liquid sweat. Their body will naturally reabsorb this excess moisture in a matter of hours. It is not unusual for the absorbent pad to lose its rectangular shape. When removing the pad for shipment, be sure to include all pieces if the pad is broken apart.

Excess Hair

If a prospective Donor has excessive hair on the parts of the body recommended for Sweat Patch application, do not shave the area. If excess hair is not able to be determined visually, apply a Sweat Patch. If the Sweat Patch adhesive does not provide a complete seal around the absorbent pad because of the hair, consider using an alternative application site. This donor may not be a good candidate to wear the sweat patch and another method of testing for drugs should be considered.

Intermittent Itching

The most common adverse reaction to the Sweat Patch is intermittent itching. For the most part this is not an allergic reaction but a sensitivity to the patch, which may occur for a short period of time. This can be caused by soaps, perfumes or other skin preparations trapped under the patch adhesive. If intermittent itching occurs it is up to the judgment of the Trained Observer to determine whether the donor is uncomfortable enough that the patch should be removed and the individual should be tested by another method or at another time.

Mechanical Skin Injury

If the patch is put onto the Donor's skin and the skin is not flexed, the non-elastic patch covering can pull on the more elastic skin surface as the Donor moves. This can cause a line of small skin eruptions at the edge of the patch where it is pulling on the skin.

If this happens, remove the Sweat Patch. Apply another sweat patch drug test on a different area of the body that is properly flexed.

Chemical Reaction

The adhesive of the Sweat Patch Drug Test or the substances that the skin is releasing can occasionally cause a chemical reaction with the skin. The usual reaction is a series of small skin eruptions underneath the patch or a reddening (but not an allergic reaction) under the patch.

If this happens, remove theSweat Patch Drug Test. Wash the area with soap and water. Another Sweat Patch Drug Test should be applied to a different area. If the reaction repeats itself, the second Sweat Patch Drug Test should be removed and the area washed with soap and water. The Donor should then be given a urine drug test. The urine drug test should be repeated 72 hours later.

Allergic Reaction

If the itching is continuous rather than intermittent and is accompanied by redness, swelling and heat, it may be an allergic reaction to the Sweat Patch Drug Test . If this is the case, remove the Sweat Patch Drug Test immediately and have the wearer wash the area to remove any residual adhesive that might be present. .

The most likely cause of an allergic reaction would be the adhesive on the Sweat Patch Drug Test. 3M (the manufacturer of the adhesive) has sold over a billion wound dressings made of the polyurethane film and the adhesive over the last 15 years. They have not had a serious documented allergic reaction to the wound dressing.

Alcohol Burns

The Sweat Patch Drug Test application area is cleaned before application with standard 70% isopropyl alcohol wipes. This area should be thoroughly dry (wait approximately 60 to 90 seconds) before the Sweat Patch Drug Test is applied to the skin. If all of the alcohol has not evaporated from the skin when the Sweat Patch Drug Test is applied an "alcohol burn" or red spot may develop underneath the patch. This spot is not permanent but may stay on the skin for several weeks until the layers of skin that are reddened are naturally replaced.

Hyperpigmentation

Occasionally, the Sweat Patch Drug Test may cause a temporary darkening of the area underneath the patch in people with "mid-tone" skin coloring. This is only a temporary phenomenon and will disappear after the Sweat Patch Drug Test is removed as the layers of skin cells are naturally replaced.

Reporting Complications

Small skin irruptions and intermittent itching need not be reported to American Screening Corp. Other, stronger reactions should be reported.

If a Donor does have a strong allergic reaction, report the reaction to us immediately. Since we are the distributor for the Sweat Patch Drug Test we are obligated to keep records of adverse reactions to the Sweat Patch Drug Test. There is also a Medical Device Reporting questionnaire. This questionnaire is included to help you provide American Screening Corp with information should you need to report a reaction. We will need to know the name of the Donor, the date of the reaction, a description of the reaction and a telephone number or other means to follow-up on the after affects of the reaction.

Should there be any questions about the patch or reactions to the patch call 318-227-4994. Food and Drug Administration Regulations require our manufacturer to report any complications that require medical intervention.

Sweat Patch Drug Test Frequently Asked Questions

1. Is the sweat patch new technology?

No. Drugs have been known and detected in sweat since the early 1970's. The principle challenge with respect to sweat testing has been the collection of sweat. TheSweat Patch Drug Test is a non occlusive device that facilitates the collection of sweat.

2. Are the testing procedures used for the analysis of sweat considered new technology?

No. The testing procedures used for the analysis of sweat are the same well established procedures used for the analysis of urine specimen. Specimens are screened using an enzyme immunoassay technique. Positive specimens are confirmed using liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS). Both procedures utilize certified calibrator and quality control materials.

3. Have these procedures been submitted to and cleared by the Food and Drug Administration (FDA)?

Yes. The FDA, through its procedures have cleared the Sweat Patch Drug Test as both a specimen collection device and as a scientifically valid procedure for the detection of drugs in sweat.

4. Why is this different from hair testing?

Hair testing is capable of detection chronic drug use but has difficulty detecting occasional or recreational drug use.

5. What the does the sweat patch detect, and how does this differ from urine testing?

Unlike urine testing that detects drug metabolites, sweat testing detects the parent or non metabolized form of the drug. This is particularly important when testing for abused drugs such as heroin that can only be detected in urine for a short time period following use. Heroin is rapidly metabolized to 6 acetyl morphine then to morphine. Consumption of poppy seeds can also produce a positive morphine result, as can the use of a codeine based medication. Because the sweat patch can detect heroin, it can determine if a heroin user is attempting to mask the heroin use with either codeine or poppy seed use.

6. How does the sweat patch work?

The sweat patch is comprised of a white absorption pad, covered with a unique polyurethane dressing. The absorption pad of the patch is protected from the environment by a layer of film composed of polyurethane coated with adhesive. The polyurethane film is a "semi-permeable membrane” which allows the transfer of water vapor and gases. Drugs excreted in sweat are trapped by this polyurethane dressing and retained on the white absorption pad.

7. How does testing for drugs using the sweat patch differ from testing for drugs using urinalysis?

Urinalysis for drugs represents a snapshot in time. Using urine testing, drugs such as amphetamines and cocaine are cleared from the body within 72 hours from a single drug use. Opiates will typically be cleared from the body within 72-96 hours following the last use. From a single use, marijuana will clear from the body within 96 hours. Long term heavy use may be detected for up to two weeks. Phencyclidine use may be detected for up to two weeks depending on history of use. The sweat patch, unlike urine testing, functions as a storage device. Therefore, drugs used 1-2 days before the patch is applied, while the patch is worn, and up to 24 hours prior to the removal of the patch will be detected and stored in the patch. Consequently, the sweat patch is a constant monitoring device, which provides the sweat patch with a longer detection window than urine testing.

8. Is it possible to have a positive sweat patch result and a negative urine test? Why?

Yes. As indicated above, the sweat patch is a storage device and represents a much longer detection window than does testing for drugs using urine. In addition, urine tests are subject to various forms of adulteration including but not limited to hydration,
substitution and physical adulteration using products designed to affect the testing procedures.

9. Is it possible to have a positive sweat patch result and a negative hair test? Why?

Yes. It has been demonstrated that while hair testing may be able to detect chronic drug use, it cannot detect occasional drug use.

In addition, there are a number of issues that have been raised by the scientific community relative to the detection of drugs in hair. These include but are not limited to: the procedures used to wash the hair for the removal of externally deposited drugs (potential for false positive results), the procedures used for the digestion and subsequent extraction of the drugs from the hair (potential for false negative results), biases based on the color of the hair (dark hair appears to incorporate drugs at a higher rate than light colored hair), and the removal of drugs from the hair by shampoos or other hair treatment products (relaxers, dyes or other chemical treatment). At present there is no consensus regarding what the appropriate testing levels should be in hair. There is considerable variation in these testing levels depending on which laboratory performs the testing.

10. Is the sweat patch subject to adulteration?

No, not in the same sense that urine specimens can be adulterated. The sweat patch is a tamper evident device. The adhesive material used on the sweat patch penetrates the upper layer epithelial layer of the skin. When the sweat patch is removed, these epithelial skin cells adhere to the adhesive and will prevent the re-application of the sweat patch. While there have been attempts to adulterate the absorption pad by introducing common chemicals used to adulterate urine test (bleach) these attempts are very obvious. Based on the physical properties of the polyurethane covering as noted above, these chemicals will be trapped under this polyurethane covering, and in one case the bleach resulted in a second-degree chemical burn.

In addition, attempts to adulterate the sweat patch will typically result in a visible discoloration of the white absorption pad and/or discoloration or deformation of the polyurethane covering, and should be noted on the chain of custody document.

11. Is the sweat patch subject to substitution?

No. Each sweat patch has a unique identifier number imprinted above the absorption pad on the release liner. This number is recorded on the chain of custody document and must be verified when the individual reports back to have the sweat patch removed.

12. What are the most common means used to try and beat the sweat patch?

A. Removal of the sweat patch sometime after application and re-attaching the patch using band-aids or other adhesives.

B. Pealing back the upper portion of the sweat patch, removing the absorption pad, and replacing the absorption pad prior to reporting back for sweat patch removal. This usually results in an absorption pad that is wrinkled, folded, creased or otherwise deformed. When this procedure is used, one side, typically the top of the sweat patch is held in place using band-aids or other adhesives. In some instances, individuals have reported back to have the sweat patch remove and the absorption pad is absent, although the release liner is still present, indicating that the pad has been physically removed from the sweat patch.

Therefore it is imperative that the protocols established for examining the sweat patch for signs of tampering be followed. While some roll up of the outer edges of the sweat patch may occur in some instances, the areas immediately surrounding the absorption pad should be adhering to the skin and otherwise intact.

13. Can the sweat patch detect multiple drug uses?

No. The sweat patch is a storage device. Consequently, multiple drug uses while wearing the patch will result in increased drug levels in the patch. However as these are accumulative, the patch cannot distinguish multiple instances of drug use.

14. What effect does hydration or flushing have on the sweat patch results?

None. Unlike urine specimens which can be diluted as a result of hydration/ flushing which may correspondingly dilute the concentration of drugs in the urine, the consumption of large amounts of fluids will not decrease the drug concentrations in the sweat patch. In fact, hydration may encourage sweat production, thus increasing the concentration of the drugs in sweat.

15. How were the testing levels for the sweat patch determined?

Scientifically using controlled dose studies in which known amounts of drugs were given to volunteers for all drugs with the exception of phencyclidine. Multiple sweat patches were applied, removed and tested from these volunteers and the data analyzed from these studies using a well-established scientific approach known as receiver operating characteristics. This approach examines the analytical data and is able to establish cutoff testing levels based on true positive; true negative; false positive; and false negative results. The testing levels submitted to, reviewed and subsequently and cleared by the FDA were established using this receiver operating characteristics approach. For example, the detection of amphetamine and methamphetamine, utilizing a 10ng/ml screening and confirmation cutoff has a true positive detection rate of 96%. This means that the testing done using these cutoff levels will correctly identify an individual that uses methamphetamine 96% of the time, but will miss 4% of the individuals that use methamphetamine.

16. Has the Sweat Patch been accepted by the Courts?

Yes. There have been many court cases, both at the Federal and local levels in which the results of the sweat patch have been challenged. There are three cases in the State of California in which the Sweat Patch has undergone a challenge under both the Kelly and Dauber Statutes, which in general asks: Is this new technology, and is this technology accepted by the scientific community? In several cases, negative urine and/or negative hair tests have been introduced as a challenge to the positive sweat patch results.

17. Is the sweat patch subject to contamination?

The sweat patch can be contaminated either during the procedure of applying the sweat patch or during the removal of the sweat patch. If the area that the sweat patch is being applied to is not properly cleaned, and drugs present on the skin's surface were not removed during the cleaning process, the drugs left on the skin's surface can be deposited on the absorption pad. If there are sufficient quantities of the drug present on the skin, a positive test could result. In addition, if the individual applying the patch has drugs on their hands or gloves, and touches the absorption pad, those drugs may cause a positive test result. Similarly, if during the removal process of the sweat patch, if the individual that removes the absorption pad from the sweat patch has drugs on their hands, or on the disposable tweezers, and these drugs are deposited in sufficient quantity onto the absorption pad, a positive test may result.

Subsequent experiments have involved variations of the initial experiments submitted to the FDA and have incorporated such variations as wetting the absorbent pad with various solutions and buffers, varying the pH of the of the solution containing drugs that was applied to the exterior of the polyurethane membrane, and varying the temperature and time that the varying solutions are allowed to sit or incubate on the exterior of the polyurethane membrane.

These studies have demonstrated that when both the inside and the outside of the patch were dry, no drug transfer could be noted. Under certain conditions, the outer polyurethane membrane can be altered and made permeable to the diffusion of applied drugs onto the absorption pad. However these conditions are not what one would realistically expect to encounter in real world situations.

18. Has the Sweat Patch been accepted by the scientific community as a means to detect drug use.

Yes. There are a number of scientific articles in peer reviewed journals that have established the use of the sweat patches a scientifically accepted tool for the detection of drug use.

For further information, please call us at 318-227-4994.