Performance Evaluation of Three On-Site Adulterant - Journal of

Journal of Analytical Toxicology, Vol. 26, October 2002

Performance Evaluation of Three On-Site Adulterant Detection Devices for Urine Specimens*

Michelle R. Peace I and Lisa D. Tarnai 2,*

1Medical College of Virginia Campus at Virginia Commonwealth University, Richmond, Virginia 23298-0165, 2Scientific Testing Laboratories, Inc., Richmond, Virginia 23236

Abstract

The performance of three on-site adulterant detection devices that assess the integrity of urine specimens collected for drug-of-abuse testing was evaluated: the Intect TM 7, MASK Ultra Screen | and Adultacheck TM 4. Jntect 7 simultaneously tests creatinlne, nitrite, glutaraldehyde, pH, specific gravity, and the presence of bleach and pyridinium chlorochromate (PCC). Mask Ultra Screen tests creatinine, nitrite, pH, specific gravity, and oxidants, and Adultacheck 4 tests creatinine, nitrite, glutaraldehyde, and pH. Urine specimens were prepared with the Substance Abuse and Mental Health Administration regulated analytes at 50% above the cut-off concentrations. Stealth TM, Urine Luck TM, Instant Clean ADD-IT-ive TM, and KLFAR were added individually to the drug- added urine specimens so that their concentrations reflected the "optimum" usage reported in their package inserts and 25% above and below that optimum. Stealth is reported to be peroxidase; Urine Luck is believed to be PCC; Instant Clean ADD-it-ive reportedly contains glutaraldehyde, and Klear is a nitrite. The following diluents/adulterants were added at 25%, 33%, and 50% of the volume of drug-added urine: distilled water, bleach, ammonia, and vinegar. Of the devices tested, Intect 7 proved to be the most sensitive, and it correctly indicated the presence of adulterant or diluent in all samples tested. In order to do so, all indication pads had to be assessed in concert. Adultacheck 4 specifically assesses four characteristics of urine integrity and is therefore very limited in detecting the use of several popular adulterants that are commercially available. Although it correctly assessed the four characteristics, it did not detect the use of Stealth, Urine Luck, or Instant Clean ADD-it-ive. Mask Ultra Screen can potentially detect a broader range of adulterants than Adultacheck 4. However, in practice, it only detected them at levels well above their optimum usage, making it less efficacious than Intect 7. Clearly, the specific identification of an adulterant is a trade-off for sensitive detection of several adulterants.

Introduction

In response to the unrelenting prevalence of drug usage,

* Presented in part at the 30th Annual Meeting of the Society of Forensic Toxicologists, New Orleans, Louisiana, October 4, 2001.

f Author to whom correspondence should be addressed. Emaih [email protected].

President Ronald Reagan signed an Executive Order to institute workplace urine drug testing in 1986 (1). By 1997, 81% of large U.S. corporations were engaging in employee drug screening (2), up from 25% in 1985. In 1998, the Clinton administration developed a program to promote the national adoption of drug-free workplace programs, which encompassed drug education, therapy, and testing in the private workforce.

As a result of increased regulation and monitoring, an industry to invent ways to defeat drug tests developed. Products that claim to mask the presence of drugs, dilute drugs and metabolites in urine, or detoxify urine have become relatively cheap and readily available via the internet and drug para- phernalia magazines. This industry has also moved rapidly to change the formulations of their adulterants in order to cir- cumvent detection and changing testing procedures in the fed- erally regulated urine drug-testing lab. Therefore, the forensic urine drug testing (FUDT) lab has been challenged to not only assess the usage of drugs but also to evaluate the integrity of urine submitted by an individual.

In an effort to help FUDT labs assess the integrity of urine specimens, the Substance Abuse and Mental Health Services Administration (SAMHSA) developed the following guidelines that define the characteristics of an adulterated urine specimen: for an adulterated sample, pH >_ 11 or _< 3 and nitrite ___ 500 lJg/mL; a dilute sample, creatinine < 20.0 mg/dL and specific gravity < 1.003; and a substituted sample, creatinine _< 5.0 mg/dL and specific gravity _< 1.001 or _> 1.020 (3). These guidelines have also been adopted by manufacturers who design devices that test the integrity of urine. The purpose of this research was to evaluate the performance of three on-site adulterant detection devices. Intect 7, Mask Ultra Screen, and Adul- tacheck 4 are manufactured to assess the integrity of urine specimens collected for drugs-of-abuse testing. Intect 7 assessed the presence of creatinine, nitrite, pH, specific gravity, glutaraldehyde, bleach, and pyridinium chlorochromate (PCC). The Mask Ultra Screen tested creatinine, nitrite, pH, specific gravity, and oxidants, and Adultacheck 4 assessed creatinine, nitrite, glutaraldehyde, and pH.

Urine specimens were first prepared with the SAMHSA-regulated analytes at 50% above the cut-off concentrations. The pre-packaged adulterants Stealth, Urine Luck, Instant Clean

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ADD-it-ive, and Klear were added individually to the drug-added urine specimens such that their concentrations reflected the "optimum" usage reported in their package inserts and 25% above and below that optimum. Distilled water, bleach, ammonia, and vinegar were added to individual drug-added specimens at 25%, 33%, and 50% of the volume of urine. Drug concentrations were measured semi-quantitatively using an en- zyme immunoassay prior to adulteration; the adulterant detection devices were tested according to package inserts, and the post-adulterant drug-added urine samples were re-assessed for drug concentration, pH, specific gravity, nitrite, and creatinine.

Materials

Adulterant detection screening products The Intect 7 Urine Adulteration Test Strip from Branan Med-

ical Corporation (Irvine, CA), Mask UltraScreen Dip and Read Reagent Strips for adulterated urines from Kacey, Inc. (Asheville, NC), and Adultacheck 4 from Roche Diagnostics (Indianapolis, IN) were acquired. In general, the products uti- lize specific chemical reactions at each indicator pad to assess normal urine constituents and common adulterants. Color changes on each pad indicated either a value for that test or a positive or negative result.

Intect 7 assessed the presence of creatinine, nitrite, pH, specific gravity, glutaraldehyde, bleach, and PCC. The creatinine pad indicated either 0, 10, 20, 50, or 100 mg/dL, with a color range from tan to dark blue. The nitrite pad indicated either 0.0, 0.1, 0.2, 0.5-5.0, or > 5 mg/dL and ranged from white to hot pink. Glutaraldehyde had either a positive (brown) or negative (light tan) indication. The pH pad indicated 2, 3, 4, 5-9, 10, 11, or 12, ranging from orange to green to brown. Specific gravity indicated either 1.000, 1.003, 1.005, or > 1.020 with a color change through green or orange. The bleach pad indicated positive (pale blue) or negative (white). The formation of brown or blackish bIue on this pad also indicated the presence of other oxidative adulterants. The PCC pad, which also indicated other oxidants, read either positive (dark blue) or negative (white). The color chart that the test strip was compared with designated the values that were "abnormal" and "normal" (4).

The Mask Ultra Screen tested creatinine, nitrite, pH, specific gravity, and oxidants. The creatinine level was indicated as "Neg", 10, 20, 50, or 200 mg/dL, ranging from yellow to orange. The specific gravity pad indicated 1.000, 1.005, 1.015, 1.025, > 1.030, or > 1.040, with a color range from green to yellow. The pH pad indicated either 2, 3, 4, 5, 6, 7, 9, or > 11 with a color range from pink to blue. The nitrite pad indicated "Neg", 100, 250, 500, and 1000 IJg/mL with a color that was either white or a range of pinks and reds, and the oxidant pad indicated either positive (any color) or negative (white). The color chart to which the test strip was compared designated which values were abnormal and normal (5).

The Adultacheck 4 assessed creatinine, nitrite, glutaraldehyde, and pH. The creatinine pad indicated 0, 10, 20, 50, 100, or 400 mg/dL with a range of colors from white to purple. The nitrite pad indicated "Neg", 0.1-0.2, 0.5-5.0, or > 15 mg/dL with

a range from light red to burnt red. The glutaraldehyde pad indicated either positive (dark blue) or negative (white), and the pH pad indicated either 2, 3, 4, 4.5, 5, 8, 9, or > 10 with a color range from dark red to dark blue. The enclosed color chart used to compare the test strip designated the values or colors that were abnormal or normal (6).

Urine specimens Ag-Tetrahydrocannabinolic acid (THCA), morphine (OPI),

amphetamine (AMP), phencyclidine (PCP), and benzoylecgo- nine (BE) were purchased from Radian Corporation (Austin, TX). Urine specimens were prepared by adding these drugs to drug-free urine obtained from a volunteer at 50% above the SAMHSA-regulated screening cut-off concentration for each drug (Table I).

Adulterants Stealth from Liberty Research (Portland, OR), Urine Luck

from Spectrum Laboratories (Cincinnati, OH), Instant Clean ADD-it-ive from Health Tech (Macon, GA), and Klear from Test- clear (Oklahoma City, OK) were purchased incognito in April 2001. At the time of testing, Stealth was reported to be a peroxidase, Urine Luck was believed to be PCC, Instant Clean ADD-it-ive reportedly contained glutaraldehyde, and Klear was a nitrite (7). Distilled water, bleach, ammonia, and vinegar were purchased from a local grocer.

Testing equipment and materials A Hitachi 717 Analyzer was used to semiquantitatively ana-

lyze the urine specimens. THCA and OPI were analyzed with a Microgenic EIA reagent, and PCP, AMP, and BE were analyzed with a Dade Behring EMIT II Syva reagent. The nitrite was measured with a SAMHSA-validated colormetric reagent that was prepared in-house. Creatinine was assessed with the Roche creatinine Jaff4 reagent. The pH for all urine specimens were checked with an Axiom Diagnostics pH reagent and some specimens were re-measured with a Coming 220 pH meter. Specific gravity was measured using an Atago Uricon-NE refractometer.

Methods

Sample Preparation The urine samples were prepared with THCA, OPI, PCP, AMP,

and BE at 50% above the SAMHSA regulated screening cut-off

Table I. SAMHSA Screening Cut-off Concentrations Versus Drug Concentrations Prepared for Test Urine Specimens

SAMHSA Regulated Screening Urine Specimen Drug Cut-off Concentrations (ng/mL) Concentrations (ng/mL)

THCA 50 75 OPI 2000 3000 AMP 1000 1500 PCP 25 37.5 BE 300 450

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concentration. Stealth, Urine Luck, Instant Clean Add-it-ive, and Klear were added at levels to bracket the optimum usage designated in the package inserts. The instructions for Stealth and Klear designated 60 mL of urine for proper use and optimum results; therefore, this volume was adopted as the nominal volume of urine for all the adulterants and the direc- tions were followed accordingly. In order to bracket this optimal usage, the volume of urine was varied by 25%. The result was three different volumes of urine (45, 60, and 80 mL) to which the adulterants were added. Distilled water, bleach, ammonia, and vinegar were added to individual drug-added urines at 25%, 33%, and 50% of the volume of urine in order to investi- gate the impact of various potential volumes used to dilute urine. Two different urine specimens were prepared as con-

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trols. One control specimen contained drugs but no adulterants, though the other was completely void of both drugs and adulterants.

Pre- and post-adulteration testing The pre-adulterant drug concentrations were measured semi-

quantitatively with the respective reagents on the Hitachi 717. Creatinine, specific gravity, pH, and nitrite were also measured pre-adulteration. To simulate the latest time in which urine samples might be tested in an FUDT lab, drug concentrations, creatinine, specific gravity, pH, and nitrite were re-measured four days after adulterants were added and the adulterant detection devices were tested. Any specimens that had a pH < 4.5 and > 8.0 with the Axiom pH reagent were re-analyzed using

the pH meter. The performance of each adulterant and diluent to "detoxify" the urine was analyzed by comparing pre- and post-adulterant drug concentrations, and the effect that each adulterant and diluent had on creatinine, specific gravity, pH, and nitrite was assessed.

Adulterant detection device protocols The protocols for each of the adulterant de-

tection devices were essentially the same. The strips were dipped into the urine specimens, removed immediately, and blotted to remove excess urine. The results on the indicator pads were compared within a given timeframe to a reference color chart supplied with the devices. The indicator pads on Intect 7 were all read in i min (4). The indicator pads on the Mask and Adultacheck test strips were read at varying time intervals. For Mask, nitrite and pH were read immediately, specific gravity was read in 45 s, and creatinine and oxidants were read in 60 s (5). For Adultacheck, nitrite, pH, and glutaraldehyde were read immediately and the creatinine was read between 15 and 30 s after blotting (6).

Adulterant detection device screening Adulterant detection device screening was

performed such that the analyst did not know which adulterant was present in the urine. All urine specimens were at room tempera- ture, and the adulterants were added and mixed well. Because the devices were manufactured to be used on-site at the time of urine collection, adulterant screening proceeded immediately as previously described. Each device was tested 20 times in each drug-adulterant scheme. The results were recorded according to the value assigned to different colored pads on the reference color charts for each device. All results were organized and assessed according to their respective drug- adulterant urine schemes after all testing was

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Journal o f Analytical Toxicology, Vol. 26, October 2002

completed. For reporting purposes, the results were interpreted as either abnormal or normal according to the package insert for each device.

Results and Discussion

Effect of adulterants on drug concentrations The set-up of this study allowed for some insight as to the

performance of the common commercial adulterants or of readily available common household diluents to dilute, detoxify, or mask the drug in urine. It is difficult to draw many conclusions from these analyses as there was only one urine sample to screen per adulterant drug scheme. However, a few observations can be made. In general, the readily available household adulterants appeared to have performed better than the commercial pre-packaged adulterants (Figure 1). In order for

the drugs to still screen positive, approximately 70% of the drug needed to be recovered post-adulteration. Bleach appeared to be the most successful in "detoxifying" the urine at all drug concentrations except for PCP, which showed an increase in drug recovery. Previous studies have shown that bleach at 5-10% concentrations led to false negative results in drug positive samples (8). Also, the increase in PCP concentration was more than likely not an aberration because it has been reported on several occasions that some adulterants have performed opposite to their intended purpose (9,10). BE and PCP appeared the most sensitive to the ammonia at all concentrations. The BE result is substantiated by a prior study that resulted in a false negative BE, even though all other drug concentrations still reported positive (10). THCA was most sensitive to vinegar in this study, which is also substantiated by a prior study in which THCA was the only analyte negatively affected by vinegar (9). Water exhibited an obvious dilution effect that for the most part did not decrease drug recovery to less

Table II. Results of the Adulterant Detection Devices Tested in Commonly Available Diluents*

Intect 7 25% 33% 50% Mask 25% 33% 50% Adultacheck 25% 33% 50%

Bleach Creatinine N* A A Nitrite N N N Glutaraldehyde N N N pH N N N S.G. N N N Bleach A A A PCC A A A

Creatinine N A N Creatinine A A A Nitrite N N N Nitrite N N N Oxidants N N N Glutaraldehyde N N N pH N N N pH N N N S.G. N N N

Ammonia Creatinine N N N Nitrite N N N Glutaraldehyde N N N pH A A A S.G. N N N Bleach N N N PCC N N N

Creatinine N N N Creatinine N N N Nitrite N N N Nitrite N N N Oxidants N N N Glutaraldehyde N N N pH N N N pH A A A S.G. N N N

Water Creatinine N N N Nitrite N N N Glutaraldehyde N N N pH A A N S.G. N N N Bleach N N N PCC N N N

Creatinine N N N Creatinine N N N Nitrite N N N Nitrite N N N Oxidants N N N Glutaraldehyde N N N pH N N N pH N N N S.G. N N N

Vinegar Creatinine N N N Nitrite N N N Glutaraldehyde N N N pH A A A S.G. N N N Bleach N N N PCC N N N

Creatinine N N N Creatinine N N N Nitrite N N N Nitrite N N N Oxidants N N N Glutaraldehyde N N N pH A A A pH A A A S.G. N N N

* o o The diluents were added to urine specimens at 25 %, 33 '/o, and 50% of the volume of urine. Each device was tested 20 times in each adulterant scheme. * Abbreviations: S.G., specific gravity; N, normal; and A, abnormal.

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than 70% until it was 50% of the total volume of drug-added urine.

All four commercially available adulterants (Stealth, Urine Luck, Klear, and Instant Clean Add-it-ive) caused false-negative results in THCA and OPI despite barely affecting the other analytes (Figure 1). Although Urine Luck led to a negative result at all concentrations of adulterant testing, the least concentrated adulteration reduced the drug concentration to just below the cutoff. The remaining adulterants eliminated the ability to detect THCA and OPI (Figure 1).

Performance of adulterant detection devices For all three adulterant detection screening products (In-

tect 7, Mask, and Adultacheck), both control urine specimens (no adulterant/no drugs and no adulterant/drugs added) were completely normal. Because the performance of the devices


was being analyzed, each device was tested 20 times using the same urine specimen for each scheme. All repetitions of every indicator pad on every device indicated the same final result of either normal or abnormal. Intect 7 proved to be the most sensitive device for detecting any adulteration or dilution (Table II and III). It correctly indicated the presence of an adulterant or diluent in all samples tested at all concentrations with only one exception. The 50% water dilution showed a normal result, but the specimens with less water resulted in an abnormal pH. With all dilutions of ammonia, vinegar, and water, the abnormal specimen indication was by an abnormal pH reading. In all of the dilutions of the commercially available adulterants and bleach, the abnormal results for each scheme were reinforced by an abnormal indication on several detection pads. For example, Klear, which is reported to be a nitrite, had an abnormal reading on the nitrite indication pad as well as the bleach and

Table III. Results of the Adulterant Detection Devices Tested in Commercially Available Adulterants*

Intect 7 -25% Optimum 25% Mask -25% Optimum 25% Adultacheck -25% Optimum 25%

Klear Creatinine N t N N Nitrite A A A Glutaraldehyde N N N pH N N N S.G, N N N Bleach A A A PCC A A A

Creatinine N N N Creatinine N N N Nitrite A A A Nitrite A A A Oxidants N N N Glutaraldehyde N N N pH N N N pH N N N S.G. N N N

Instant Clean Add-it-ire Creatinine N N N Nitrite N N N Glutaraldehyde N N N pH A A A S.G, N N N Bleach A A A PCC A A A

Creatinine N N N Creatinine N N N Nitrite N N N Nitrite N N N Oxidants N N N Giutaraldehyde N N N pH A A A pH A A A S,G. N N N

Urine tuck Creatinine N N N Nitrite N N N Glutaraldehyde N N N pH N N N S.G. N N N Bleach A A A PCC A A A

Creatinine N N N Creatinine N N N Nitrite N N N Nitrite N N N Oxidants N N A Glutaraldehyde N N N pH N N A pH N N N S.G. N N N

Stealth Creatinine N N N Nitrite N N A Glutaraldehyde N N N pH N N N S.G. N N N Bleach A* A* A* PCC A A A

Creatinine N N N Creatinine N N A Nitrite A A A Nitrite N N N Oxidants A A A Glutaraldehyde N N N pH N N N pH N N N S.G. N N N

* The adulterants were added to urine specimens according to the package inssert to reflect optimum usage and then at • 25% of that optimum. Each device was tested 20 times in each adulterant scheme.

'~ Abbreviations: S.G., specific gravity; N, normal; and A, abnormal. * Oxidant present.

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PCC indication pads. The ability for Intect 7 to respond in this fashion allows it to non*specifically analyze the integrity of urine.

Adultacheck 4 correctly assessed the presence of all concentrations of ammonia, bleach, and vinegar (Table II and III). It was unable to detect any of the dilutions of water. Ammonia and vinegar resulted in abnormal pH indications and the bleach gave an abnormal reading for creatinine. Adultacheck correctly assessed the presence of Klear at all concentrations by showing an abnormal result on the nitrite indication pad. It only detected the presence of Instant Clean Add-it-ive and Stealth at the high concentrations with an indication for abnormal pH and creatinine, respectively. Adultacheck was not able to detect the presence of Urine Luck at any concentration.

The Mask Ultra Screen can potentially detect a broader range of adulterants than Adultacheck with an additional indicator pad for oxidants. It performed better than Adultacheck; however, Mask did not detect two of the four diluents, ammonia and water (Table II and III). It detected bleach at all levels with an abnormal reading on the oxidant indicator pad, and assessed all vinegar concentrations correctly with an abnormal pH reading. All concentrations of Instant Clean Add-it*ive gave an abnormal pH reading as well and also an abnormal oxidant indicator at the highest concentration. Mask also correctly assessed all concentrations of Klear at the nitrite pad and detected Urine Luck at the highest concentrations on the oxidant and pH indicator pads. It also detected Stealth at all concentrations on the oxidant pad as well as the nitrite indicator pad. Although Mask was less efficacious than Intect 7, it performed better than Adul- tacheck.

Trends at specific indicator pads pH. The pH pad was an indicator of an abnormal urine spec-

imen for Intect 7 with ammonia, vinegar, water, and all concentrations of Instant Clean Add-it-ive. Adultacheck had abnormal pH readings with ammonia and vinegar and two concentrations of Instant Clean Add-it-ive, and Mask indicated an abnormal pH reading for vinegar as well as correctly assessing Instant Clean Add-it-ive. The adulterant dipstick devices iden- tify abnormal results using less stringent criteria than that of SAMHSA Therefore, post-adulteration laboratory pH testing procedures conducted per SAMHSA guidelines only identified one specimen containing the most concentrated Instant Clean Add-it-ive as adulterated because of an out-of-range pH.

Some studies have shown that bleach will make urine alkaline (11), though others have shown it to have no affect on the pH of urine (10). An explanation of these apparent discrepancies could be due to the amount of bleach added and the buffering capacity of the urine (8). This buffering capacity may explain why the pH in the urine specimens that were diluted with even large volumes of ammonia, vinegar, and bleach remained in the normal range. However, it does not explain why the adulterant detection devices indicated an abnormal pH for some of these specimens.

Creatinine. Bleach greatly affected the creatinine testing procedures. Creatinine values in the specimens with 25%, 33%, and 50% bleach were 10.3, 9.0, and 0.0 mg/dL, respectively, using the creatinine Jaffg reagent assay. The pre-adulteration urine

creatinine level was 45 mg/dL. These were the only abnormal creatinine values in all the adulterant schemes, making them the only specimens that SAMHSA would regard as abnormal based upon creatinine results. Intect 7 identified an abnormal creatinine result only at the two high bleach concentrations. Mask identified it only at the mid-concentration of bleach, though Adultacheck detected abnormal creatinine levels in all of the bleach samples. Additionally, Adultacheck assessed the creatinine level as abnormal in the highest concentration of Stealth.

Specific gravity. According to SAMHSA, creatinine should be assessed concurrently with specific gravity. Because the only samples with abnormal creatinine concentrations were the ones that had bleach as an adulterant, the specific gravities of these samples were tested with the refractometer. The sample with 50% bleach was the only sample that had an abnormal specific gravity reading at 1.021. Because the creatinine reading for this sample was 0.0, this sample would be then identified as substituted in the laboratory. And because the 25% and 33% bleach samples had specific gravity values of 1.015 and 1.018, respectively, and creatinine levels of 10.3 and 9.0 mg/dL, respectively, these samples would not be identified as either diluted or substituted by a laboratory. However, all three adulterant detection devices identified the specimens as abnormal. Intect 7 correctly indicated the presence of bleach at the pad specific for bleach.

Nitrite and glutaraldehyde. Klear, the only reported nitrite adulterant used in this study, gave positive nitrite results with the in-house laboratory reagent. All of the adulterant detection devices assessed Klear correctly at all concentrations. Addi- tionally, Mask indicated an abnormal nitrite result in all concentrations of Stealth. It became apparent during the study, that Instant Clean Add-it-ive no longer contained glutaraldehyde. Neither the Intec 7 nor the Adultacheck glutaraldehyde pads identified the presence of glutaraldehyde in the specimens with the Instant Clean Add-it-ive. However, all three detection devices identified the Instant Clean Add-it-ive adulterated specimens as abnormal on different pads (Table III).

General observations. Of the devices tested, Intect 7 identified the broadest range of abnormal urine specimens. Additionally, the pamphlet for Intect 7 made allowances for the indication of adulteration schemes not specifically listed on its color comparison chart. For example, the formation of a brown-black color on the bleach indicator pad, which turns light blue in the presence of bleach, indicates the presence of a general oxidant. Mask and Adultacheck were targeted more to specific adulteration schemes. As a result, the user of adulterant detection devices must assess the requirements of the laboratory testing protocol and decide between the specific identification of an adulterant or the sensitive detection of several possible adulterants.

Regarding the actual use of the adulterant detection devices, Intect 7 was the easiest to use. The reference color chart and color spectrums of the indicator pads were sufficiently broad enough to distinguish adjacent result values. Additionally, all indicator pads were ready for comparison after i min. Both Mask and Adultacheck had slightly ambiguous color charts and indicator pads. Often, the colors were much too similar to be able to assess the appropriate result. For example, the creatinine

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range for Mask was yellow to orange with very little difference between each pad, and the creatinine pad on Adultacheck appeared to continually change, darkening and lightening. This led to some confusion as to when was the most appropriate time to read the panel in the designated 15-s range. Mask and Adul- tacheck designated different time ranges in which to assess the different indicator pads. This led to some confusion when reading the pads because they were not arranged on the strip in chronological reading stages.

Conclusions

The performance of three on-site adulterant detection devices (Intect 7, Mask Ultra Screen, and Adultacheck 4) that assess the integrity of urine specimens collected for drugs-of- abuse testing were evaluated. The testing procedure simulated an on-site testing protocol in which the urine integrity was tested immediately after collection. Consequently, the results of this study are informative for laboratories using these devices days after the urine has been collected because these devices test for the presence of the urine additives, not a change caused by these additives. Overall, Intect 7 was the easiest to use, least ambiguous, and indicated the broadest range of abnormal urine specimens. Ultimately, care must be taken in using any of these adulterant detection devices to assess the integrity of urine specimens because the standards used by each device

to define normal from abnormal may differ from the SAMHSA guidelines.

References

1. A.H.B. Wu. Integrity of urine specimens for toxicological analysis-- adulteration, mechanisms of action, and laboratory detection. Forensic ScL Rev. 10:47-65 (1998).

2. S. Curry. Big brother wants a closer look at your hair. Fortune 135" 163 (1997).

3. Department of Health and Human Services. Program Document #35 (1998).

4. Intecff M 7 package insert. Branan Medical Corporation, Irvine, CA, 2OOO.

5. Mask Ultra Screen | package insert. Kacey, Asheville, NC, 2000. 6. Adultacheck TM 4 package insert. Roche Diagnostics, Indianapolis,

IN, 1998. 7. K. Davis. Adulterant Update, National Laboratory Certification

Program Workshop. Society of Forensic Toxicologists Annual Meeting (1999).

8. J.T. Cody. Specimen adulteration in drug urinalysis. Forensic Sci. Rev. 2:63-75 (1990).

9. A. Warner. Interference of common household chemicals in immunoassay methods for drugs of abuse. Clin. Chem. 35:648-651 (1989).

10. J.T. Cody and R.H. Schwarzhoff. Impact of adulterants on RIA analysis of urine for drugs of abuse. J. Anal ToxicoL 13:277-284 (1989).

11. S.L. Mikkelsen and K.O. Ash. Adulterants causing false negatives in illicit drug testing. Clin. Chem. 34:2333-2336 (1988).

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Performance Evaluation of Three On-Site Adulterant - Journal of