Protocol - On-site Urine Drug Screen
Protocol Name from Source:This section will be completed when reviewed by an Expert Review Panel.
Description:A CLIAwaived Multidrug Cup is an immunochromatographic assay for rapid, on-site qualitative detection of drug combinations and their principal metabolites in urine at specified cut-off concentrations, based on the Substance Abuse and Mental Health Services Administration (SAMHSA) drug cut-off concentrations. The multidrug cup may be used to test any number of drugs (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, opiates, oxycodone, phencyclidine, and tricyclic antidepressant).
A CLIAwaived Multidrug Cup is an immunochromatographic assay for rapid, qualitative detection of drug combinations and their principal metabolites in urine at specified cut-off concentrations. The multidrug cup may be used to test any number of drugs, from a single drug up to 11 different drugs. The drug combinations may be composed of any of the following drugs, at the noted cut-off concentrations:
Reagents and Material Provided
1. Test Devices
Contains dye-conjugated antibody and immobilized antigen in protein matrix with sodium azide.
2. Test Instructions
Complete instructions guide can be viewed here: http://www.cliawaived.net/items/addonfiles/1347_CLIA_waived_drug_testing_cup_urine.pdf.
3. Negative Control I
Contains buffered protein solution with sodium azide.
4. Amphetamine Positive Control
Contains AMP at 3000 ng/ml in a buffered protein solution with sodium azide.
5. Barbiturates Positive Control
Contains BAR at 1000 ng/ml in a in a buffered protein solution with sodium azide.
6. Benzodiazepines Positive Control
Contains BZD at 1000 ng/ml in a buffered protein solution with sodium azide.
7. Cocaine Positive Control
Contains COC/BEG at 1000 ng/ml in a buffered protein solution with sodium azide.
8. Marijuana Positive Control
Contains THC at 150 ng/ml in a buffered protein solution with sodium azide.
9. Methadone Positive Control
Contains MAD at 1000 ng/ml in a buffered protein solution with sodium azide.
10. Methamphetamine Positive Control
Contains MET at 3000 ng/ml in a buffered protein solution with sodium azide.
11. Opiates Positive Control
Contains OPI/MORE at 5000 ng/ml in a buffered protein solution with sodium azide.
12. Oxycodone Positive Control
Contains OXY at 300 ng/ml in a buffered protein solution with sodium azide.
13. Phencyclidine Positive Control
Contains PCP at 100 ng/ml in a buffered protein solution with sodium azide.
14. Tricyclic Antidepressant Positive Control
Contains TCA at 3000 ng/ml in a buffered protein solution with sodium azide.
Warnings and Precautions
1. Do not use the test device beyond the expiration date.
2. Urine specimens may be infectious; properly handle and dispose of urine in the toilet by draining it out of the test device. Fasten cap on the device and throw the empty urine cup in the garbage.
3. Visually inspect the foil package to insure it is intact. If the package is not intact, the integrity of the device might be compromised.
Storage and Stability
Store test kit below 28°C, do not freeze. If stored at 2°-8°C, allow the test kit to reach room temperature (15°-28°C) before performing the test. Refer to the expiration date for stability.
Specimen Collection and Preparation
The CLIAwaived Multidrug device employs a thermal strip that should be checked immediately after collection to validate urine specimen. Substance Abuse and Mental Health Services Administration (SAMHSA) regulations specify that any temperature below 90.5°F must be considered adulterated. No additive or preservatives are required.
The Substance Abuse and Addiction Working Group identified the CLIAwaived Multidrug device as being the one used by SAMHSA. To aid comparability, the Working Group recommended that the investigator record the make and manufacturer of the device being used for testing.
- Do not break the seal of the pouch until ready to begin testing.
- Remove the test cup from the foil pouch.
- Collect urine specimen directly into the test cup. Ensure that the sample amount meets the minimum level as indicated on the side of the test cup.
- Read the results at 5 minutes. Do not interpret results after 30 minutes.
Note: The result must be interpreted at five minutes. Waiting more than five minutes may cause the reading to be inaccurate. To avoid confusion, discard the test device after interpreting the result.
Interpretation of Results
Positive: A rose-pink band is visible in each control zone (top band). No color band appearing in the appropriate test zone (bottom band) indicates a preliminary positive result for the corresponding drug of that specific test zone. Send urine specimen to a certified laboratory for confirmation.
Negative: A rose-pink band is visible in each control zone and the appropriate test zone, indicating that the concentration of the corresponding drug of that specific test zone is below the detection limit of the test.
Invalid: If a color band is not visible in each of the control zones, the test is invalid. Another test should be run to re-evaluate the specimen.
Note: There is no meaning attributed to line color intensity or width.
Limitations of the Test
- This product is designed to be used for the detection of drugs of abuse and their metabolites in human urine only.
- Although the test is very accurate, there is the possibility false results will occur due to the presence of interfering substances in the specimen sample.
- The test is a qualitative screening assay and is not suggested for quantitative determination of drug levels in urine, or the level of intoxication.
- Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens, can cause erroneous test results regardless of the analysis method used.
If adulteration is suspected, obtain another urine specimen.
Personnel and Training RequiredSupervised urine collection is required by a same-sex observer
Drug test cups, timer or clock.
|Average time of greater than 15 minutes in an unaffected individual||No|
|Specialized requirements for biospecimen collection||No|
Mode of Administration
Collected by Study Staff
Adolescent, Adult, Senior
This protocol can be combined with the "Duration of Abstinence – Substance Use" protocol to support or refute a subject's response, and thus improve the validity of self-report.
Further, this protocol provides only preliminary data which may be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS) used in the "Lab-Based Urine Drug Analysis" measure. Clinical considerations and professional judgment should be applied to any drug test result, particularly when preliminary positive results are indicated.
The Substance Abuse and Addiction Working Group acknowledges that the following questions may gather sensitive information relating to the use of substances and/or illegal conduct. If the information is released, it might be damaging to an individual's employability, lead to social stigmatization, or lead to other consequences.
Most researchers assure confidentiality as part of their informed consent process, as required by their institutional review boards. When assessing minors with these questions, it may be necessary to obtain informed consent from a parent of the adolescent. Further assurance of confidentiality may be obtained by applying to the National Institutes of Health (NIH) for a Certificate of Confidentiality, which helps researchers protect the privacy of human research participants. The procedures for the Certificate of Confidentiality can be found at the Grants Policy website of the NIH: http://grants1.nih.gov/grants/policy/coc/index.htm.
February 24, 2012
DefinitionBioassay used to detect recent illegal drug use.
This assay is used to detect whether or not the participant has recently used illegal drugs. Urine drug testing can confirm the presence of a drug or the use of multiple drugs.
Urine testing is considered less "biased" than self-report but is less sensitive as a measure of change or predictor of other outcomes. Conversely, self-reported measures of the recency or frequency of use are more sensitive measures of change but also subject to more bias and under-reporting. Combining on-site urine testing with self-report and prompting when they disagree can minimize bias while maximizing sensitivity to change.
The CLIAwaived Multidrug Cup is an easy, fast, on-site, qualitative, visually read competitive binding immunoassay method for screening without the need for instrumentation. The method employs a unique mixture of antibodies to selectively identify the drugs of abuse and their metabolism in test samples with a high degree of sensitivity. The sensitivity of the CLIAwaived Multidrug is set as required for the screening immunoassays of these drugs in the reference guidelines set by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services (DHHS).
|Common Data Elements (CDE)||Drug Abuse Urine Screening Positive Negative Code||3332426||CDE Browser|
Process and Review
This section will be completed when reviewed by an Expert Review Panel.
For test kits, please contact:
11578 Sorrento Valley Road
San Diego, CA 92121
Scott, C. K., & Dennis, M. L. (2009). Results from two randomized clinical trials evaluating the impact of quarterly recovery management checkups with adult chronic substance users. Addiction, 104(6), 989-971.
U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. (2008, November 25). Mandatory guidelines for federal workplace drug testing programs (Section 3.4: Analytes and their cutoffs effective date: October 1, 2010, pp. 71880–71881). Federal Register, 73, 71858–71907.
|Variable Name||Variable ID||Variable Description||Version||dbGaP Mapping|
|PX510601_Temperature_Of_Specimen||PX510601010000||Temperature of specimen from the CLIA waived Multidrug device thermal strip: ______ F||4||N/A|
|PX510601_Make_And_Manufacturer||PX510601020000||Make and manufacturer of the equipment used:||4||N/A|
|PX510601_Expiration_Date_Day||PX510601030100||Expiration date of kit: Day||4||N/A|
|PX510601_Expiration_Date_Month||PX510601030200||Expiration date of kit: Month||4||N/A|
|PX510601_Expiration_Date_Year||PX510601030300||Expiration date of kit: Year||4||N/A|
|PX510601_Time_Began||PX510601040100||Time test began||4||N/A|
|PX510601_Time_Began_AmPm||PX510601040200||Time test began: Am or Pm||4||N/A|
|PX510601_Time_Ended||PX510601050100||Time test ended||4||N/A|
|PX510601_Time_Ended_AmPm||PX510601050200||Time test ended: Am or Pm||4||N/A|
|PX510601_Adequate_Volume_Obtained||PX510601060000||Adequate volume of urine was obtained:||4||N/A|