McKESSON MCK03-4490 Drugs of Abuse Push-Button Test Cup User Guide

MCK03-4490 Drugs of Abuse Push-Button Test Cup
User Guide

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.

TEST PROCEDURE

1. 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.
2. Push the white knob all the way into the body. Make sure the specimen fills the bottom chamber of the cup.
3. 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.
ADULTERATION ASSAY
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.
Negative:
Both C-line and T-line are present. Even a faint T-line is negative.

Negative for all 6 drugs tested

Invalid:
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

QUALITY CONTROL:

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):

• 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
PVN A0920
Made in USA

References

• NIDA.NIH.GOV | National Institute on Drug Abuse (NIDA)

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