MCK03-4490 Drugs of Abuse Push-Button Test Cup
Drugs of Abuse Push-Button Test Cup
This is a CLIA-Waived Test. You need a CLIA certificate of waiver to perform the test in waived settings. Go to http://www.cms.hhs.gov/CLIA/ for more information.
- Fill the cup with a fresh urine specimen and secure the lid onto the cup. Immediately check the temperature strip on the cup.The specimen level must be between Min and Max marks. Test specimens within 2 hours of sample collection. Do not use urine samples exhibiting visible precipitations. Equilibrate test device to room temperature before testing.
- Push the white knob all the way into the body. Make sure the specimen fills the bottom chamber of the cup.
- Read results at 5 minutes. Do not read results after 7 minutes.
INTERPRETATION OF RESULTS
Read each test independently. Do not compare the color intensity of one test to another. Do not compare the color intensity of the Cline to the T line.
Refer to the package insert for interpretation of the adulteration assay
DRUG SCREENING ASSAY
Preliminary Positive: Only a C-line appears.Preliminary Positive for test 2 and test 3
Note: Preliminary positive results should be confirmed with a more specific method. GC/MS or HPLC is a preferred confirmatory method.
Both C-line and T-line are present. Even a faint T-line is negative.
Negative for all 6 drugs tested
If no lines are present, or only a test line appears, the test is invalid. In this case, do not report test results. Repeat the test with a new device.
Invalid for tests 4 and test 5
You should run positive and negative external quality controls monthly, with a new shipment or new lot of test devices. Contact the device manufacturer at 1-877-204-5071 for assistance.
QUESTIONS AND ANSWERS:
1. What does the multi-drug of abuse urine test do?
The multi-drug of abuse urine test is a drug-screening test. It provides preliminary results for the detection of one or more of the drugs of abuse at the specified concentrations (cutoff levels):
|BUP/NBUP||Buprenorphine/ Norbuprenorphine||10 ng/ml|
|XTC||MDMA or Ecstasy||500 ng/ml|
* There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressants in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
2. What is the cutoff level?
A cutoff level for a drug is the concentration of the drug in a urine sample, at or above which the test is positive and below which the test is negative.
3. How do I know if the test works properly?
For the test to work properly, the Cline must appear. If no C line develops within 5 minutes on a test strip, the test is not working correctly. The result is Invalid. In this case, do not report the test results. Repeat the assay with a new device. If the test is still invalid, stop using the test device. Contact the manufacturer at 1-877-204-5071.
4. What does it mean if the T line is very faint?
The appearance of a T line indicates the test is negative. A very faint T line is considered negative for the test.
5. What does it mean if one T line is darker than the other?
Read each test independently. Do not compare the color of one test to another.
6. Does a positive screen test mean that you have found drugs of abuse?
No. Positive results must be confirmed by a more specific method. GC/ MS or HPLC is the preferred method.
7. What are the limitations of the test?
- This device provides only a preliminary test result. You must use a more specific method to obtain a confirmed result.
- This product is for testing human urine only.
- The urine sample is perishable. The lab must test the sample within 2 hours of sample collection.
- Adulterants such as bleach or alum may produce erroneous test results. When suspected, collect a fresh specimen. Repeat the test with a new device.
- Do not use samples in which bacterial contamination is suspected.
- Do not use the device if you are color-blind.
- Dark urine samples may interfere with the test.
- Samples containing structurally related compounds may interfere with the test. See the Cross-Reactivity section in the package insert.
8. Additional Resources
www.drugabuse.gov National Institute on Drug Abuse Phone: 301-443-1124
Avoid storage in direct sunlight/fluorescent lighting and store in a cool, dry, and well-ventilated area.
General Questions? Call 1-800-777-4908
Distributed by McKesson Medical-Surgical Inc.
Richmond, VA 23233
Made in USA