Pharmchem had speculated that earlier research results indicating the. After the skin is cleaned with al cohol, the patch is applied to the wearer, and the absorbent pad collects the wearers sweat, over a period of a week or more. Sweat patches and contamination foland, wickens, roper. Susceptibility of pharmchektm drugs of abuse patch to. We are committed to providing reliable, innovative and valuefocused substance abuse screening products and lab services to government, criminal. Prior research has shown that false positives using the patch could arise from both. Pharmchems contract laboratory employs procedures substantially equivalent to those required by samhsa for urine testing. The pharmchek sweat patch overlay is made of the same adhesive material as the sweat patch and is intended for longterm wear.
Us probation offices, the sweat patch, manufactured by pharmchem. The false positives appear to result from environmental contamination of the sweat patch that can occur in two ways. Shortterm sweat patch application and removal schedule. Unlike sensitivity, specificity is greatly influenced by the number of false positives. Pharmchem will be employing procedures substantially equivalent to those required by samhsa for urine testing. He said most doctors use their experience and a good physical exam along with tests to come to a diagnosis. A disadvantage is that the actual wearing of the patch is not observed. Pharmchem had speculated that earlier research results. Other than cfwo, one may ask whether false positive results may arise from the. Comparison of urine to sweat patch test results in court. A largescale field trial of the sweat patch was performed by pharmchem laboratories in. Will the pharmchek sweat patch be positive if the target drug is not consumed.
In the present case, the subpoenaed documents pertain to tests performed or commissioned by pharmchem to determine the susceptibility of the sweat patch to false positive results. Drug administration cleared the pharmchem sweat patch technology back in 1990. Comparison of urine to sweat patch test results in court ordered. In addition to the federal courts, judges in the clark county las vegas family courts have been using the patch when parents in custody battles make allegations of drug use.
Nonnegative screening results are confirmed using the goldstandard gcms methodology to produce evidentialquality results. The primary importance of this study is that it demonstrates a significant possibility of false positive sweat patch test results when the patch is used in a reallife situation. Add the sweat patch overlay to the sweat patch drug test or the sweat patch with extended opiate panel drug test. The patch is then sent to pharmchem and the results are delivered in a week. Utility of sweat patch testing for drug use monitoring in outpatient. Susceptibility of pharmchek tm drugs of abuse patch to.
Indeed, one study indicates that even when application and removal is performed by scientists, in a laboratory setting, contamination can result in false positives. The sweat patch specimen container for collection is a class i and ii device, and is a noninvasive tool, which collects excreted sweat for testing in clinical trials and research studies. False positive drug patch testing im currently using a drug patch for the courts and its been testing positive, ive been clean for over 60 days. Cone 1997 found many benefits in using this type of patch, including high subject acceptability, low incidence of allergic reactions to the patch. Years of experience with these procedures have demonstrated that there is a negligible problem with false positives. We studied this question directly, even though there is a strong theoretical reason not to believe in such possibility. Probation officers like to keep this patch on for 1014 days, however, the patch tape doesnt last in its newly applied condition for more than 2 days, even with the overlay. All sweat patch drug tests are analyzed by a certified laboratory. Pharmchem officials have themselves admitted that a there is a risk of false positives during application and removal. Researchers then wiped the skin with isopropyl alcohol before applying the patch. See levisky, bowerman, jenkins, and karch, drug deposition in adipose tissue and skin. In a letter to shareholders from the companys website, the company provides financial information for its year ended 20. Public defender us attorney dropped the case right after pharmchem testified.
The patchs opponents believe that low threshold raised the risk of false positives. The sweat patch has a long history of successful defenses against court challenges. Cutoff levels correspond to levels of detection in urine. The second confirmation method, called gcms for gas chromatographymass spectrometry, is the same process used in regular urine testing.
The ssa reported father had two positive drug patch results for cocaine in september. As an additional safeguard, pharmchem utilizes blind quality assurance samples in the testing process. Patches are often applied and removed in a probation office by probation officers who have received only a videotaped training. The high incidence of false positive sweat patch tests in relation to the sensitivity, specificity, and efficiency of the sweat patch assay is discussed. Federal court drugtesting device under fire, pharmchem. Sweat drug patch false positive results resulting in. If a patch were worn for 7 days, for example, it might be positive because of drug use 24 to 48 hours prior to the application of the sweat patch, or by drug use on day 6 24 48 hours before the patch. The authors shown below used federal funds provided by. The court finds that pharmchem sweat patch testing is reliable and accurate. Of greatest concern is the occurrence of false positives, cases where tests appear. In my practice we used to require urine as a more reliable way for verifying compliance, and rule out diversion, and the presence of illicit drugs. Drug tests not immune from false positives cbs news.
A recent study suggests that longterm storage of drugs in skin could lead to false positive test results. Hes been sober for that long as well, minus one drinking hiccup where he blew a. Pharmchem s contract laboratory employs procedures substantially equivalent to those required by samhsa for urine testing. Pharmchek sweat patch drug test the best free software. Application and removal of the sweat patch are usually performed by nonmedical personnel, in a nonclinical setting. Is the laboratory process subject to falsepositive error. Pharmchems cut off levels, measured in billionths of a gram, were approximately onethirtieth of those set by the federal government for urine testing. My brother has been on probation for almost 2 years due to a dui accident. Make sure your doctor is aware of all your meds, as other medications antidepressants, fioricet, and cough medication could come as a false positive in the screen. Application and removal of the sweat patch are usually performed by nonmedical personnel, in a nonclinical.
Additionally, the court finds that the evidence overwhelmingly supports the conclusion that the mother consumed methamphetamine that produced the positive sweat patch tests results as reported. Redwood toxicology laboratory is now part of abbott. A positive sweat patch test in relation to all negative urine tests while the patch is being worn is defined as a false positive. Of greatest concern is the occurrence of false positives, cases where tests appear positive when in fact the subject has not used the drug.
Duplicate patches also were applied in the same manner every week for the duration of the protocol 10 weeks. Any sloppiness or failure to follow proper procedures can easily result in false positives. What will cause false positive in sweat patch test. He also revealed that pharmchem was concerned enough about the patchs reliability that it contracted with an independent lab to conduct further tests.
It is well documented that the drug sweat patch by pharmchem is not only highly susceptible, but is a known defective medical device. Our portfolio offers customers bestinclass pointofcare testing and diagnostic technology that delivers trustworthy and actionable information. However, data for only 5 of these were presented in the paper. A sweat collection pad with a nonocclusive membrane, marketed by pharmchem, inc.
Franny forsman has been the head of the federal public defenders office in las vegas since 1989. At least 3 of the 7 positive sweat patch results which were labeled as false positives because of associated negative urine test results, were actually associated. False positives can result in unjust legal penalties or inappropriate sanctions from a drugtreatment program. The overlay has a window to make removal of the patch. He stated this was also specifically true of drug testing. Scientific studies have demonstrated that environmental contamination can produce false positives in the sweat patch. I recently saw a doctor speak on tv and he said up to 10% of all medical tests have either false negatives or false positives. Whenever there is a positive result, the specimen is tested again. However, the sole remaining asset is the sweat patch business which the company has not been able to sell. The sweat patch, which is marketed by pharmchem, inc. What medications or drugs will cause a falsepositive on a. Federal court drugtesting device under fire, pharmchem sweat.
An advantage is that the monitoring is continuous for the week that the patch is worn. A specificity of 100% means that if drugs are not used while the sweat patch is being worn, both the sweat patch test and the. A largescale field trial of the sweat patch was performed by pharmchem. Location pharmchem inc 2411 e loop 820 n fort worth 761186933. The key component of the pharmchek sweat patch, the membrane, has. Such false positives are a particular concern to the many individuals who have been heavy drug users, have conquered their drug habits, and are currently being tested by the sweat patch. Indeed, one study indicates that even when application and. Years of experience with these procedures have shown a negligible problem with false positives.
Most false positives could be related to over the counter meds, like vicks, sudafed, benadryl, and in a smaller measure metabolites of certain foods. Excretion of methamphetamine and amphetamine in human. Two of the five subjects tested positive for cocaine, meeker testified. As an additional safeguard, the laboratory utilizes blind quality assurance samples in the testing process. I have had on a drug patch from pharmchem since october.
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