Protocol - On-site Urine Drug Screen

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).

Specific Instructions

This protocol can be combined with the "Duration of Abstinence – Substance Use" protocol to support or refute a subjects 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 individuals 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.

Availability

Available

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Protocol

Intended Use

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:

Drug Class	Abbreviations	Sensitivity
Amphetamine	AMP	1000 ng/ml
Barbiturates	BAR	300 ng/ml
Benzodiazepines	BZD	300 ng/ml
Cocaine/Benzoylecgonine	COC/BEG	300 ng/ml
Marijuana	THC	50 ng/ml
Methadone	MAD	300 ng/ml
Methamphetamine	MET	1000 ng/ml
Opiates/Morphine	OPI/MOR	2000 ng/ml
Phencyclidine	PCP	25 ng/ml
Tricyclic Antidepressant	TCA	1000 ng/ml

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.
*Optional:*
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.

Test Procedure

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 Required

Supervised urine collection is required by a same-sex observer

Equipment Needs

Drug test cups, timer or clock.

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	No
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Bioassay

Lifestage

Adolescent, Adult, Senior

Participants

Adolescents and adults aged 13 years and older

Selection Rationale

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).

Language

English

Standards

Standard	Name	ID	Source
Human Phenotype Ontology	Positive urine opioid test	HP:0500113	HPO
Human Phenotype Ontology	Positive urine methadone test	HP:0031841	HPO
Human Phenotype Ontology	Positive urine cocaine test	HP:0500108	HPO
Human Phenotype Ontology	Positive urine cannabinoid test	HP:0500110	HPO
Human Phenotype Ontology	Positive urine benzodiazepines test	HP:0500111	HPO
Human Phenotype Ontology	Positive urine barbiturate test	HP:0500109	HPO
Human Phenotype Ontology	Positive urine amphetamine test	HP:0500112	HPO
caDSR Form	PhenX PX510601 - Onsite Urine Drug Screen	6214996	caDSR Form

Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Substance Abuse and Mental Health Services Administration (SAMHSA), drug cut-off concentrations, multidrug cup

Source

For test kits, please contact:

CLIAwaived.com
11578 Sorrento Valley Road
Suite 25/26
San Diego, CA 92121
858-481-5031

General References

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.

Protocol ID

510601

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX510601_Adequate_Volume_Obtained
	PX510601060000	Adequate volume of urine was obtained:	N/A
PX510601_Amphetamine
	PX510601070000	Amphetamine	N/A
PX510601_Barbiturates
	PX510601080000	Barbiturates	N/A
PX510601_Benzodiazepines
	PX510601090000	Benzodiazepines	N/A
PX510601_Cocaine
	PX510601100000	Cocaine/Benzoylecgonine	N/A
PX510601_Expiration_Date_Day
	PX510601030100	Expiration date of kit: Day	N/A
PX510601_Expiration_Date_Month
	PX510601030200	Expiration date of kit: Month	N/A
PX510601_Expiration_Date_Year
	PX510601030300	Expiration date of kit: Year	N/A
PX510601_Make_And_Manufacturer
	PX510601020000	Make and manufacturer of the equipment used:	N/A
PX510601_Marijuana
	PX510601110000	Marijuana	N/A
PX510601_Methadone
	PX510601120000	Methadone	N/A
PX510601_Methamphetamine
	PX510601130000	Methamphetamine	N/A
PX510601_Opiates
	PX510601140000	Opiates/Morphine	N/A
PX510601_Oxycodone
	PX510601150000	Oxycodone	N/A
PX510601_Phencyclidine
	PX510601160000	Phencyclidine	N/A
PX510601_Temperature_Of_Specimen
	PX510601010000	Temperature of specimen from the CLIA waived more Multidrug device thermal strip: ______ F show less	N/A
PX510601_Time_Began
	PX510601040100	Time test began	N/A
PX510601_Time_Began_AmPm
	PX510601040200	Time test began: Am or Pm	N/A
PX510601_Time_Ended
	PX510601050100	Time test ended	N/A
PX510601_Time_Ended_AmPm
	PX510601050200	Time test ended: Am or Pm	N/A
PX510601_Tricyclic_Antidepressant
	PX510601170000	Tricyclic antidepressant	N/A

Assessment of Substance Use and Substance Use Disorders

Measure Name

On-site Urine Drug Screen

Release Date

February 24, 2012

Definition

Bioassay used to detect recent illegal drug use.

Purpose

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.

Keywords

Amphetamine, Barbiturates, Benzodiazepines, Bioassay, Buprenorphine, cannabis, cocaine, Codeine, Drug, ecstasy, heroin, marijuana, MDA, MDEA, MDMA, Methadone, methamphetamine, Methylenedioxymethamphetamine, Methylenedioxyamphetamine, Methylenedioxyethylamphetamine, Morphine, Opiates, phencyclidine, SAA, substance use, Tricyclic Antidepressant, urine, Assessment of Substance Use and Substance Use Disorders

Measure Protocols

Protocol ID	Protocol Name
510601	On-site Urine Drug Screen

Publications

There are no publications listed for this protocol.