Qclearninglab.org



Title: Urine Drug Screen Using Alere iScreenDx Multi-Drugs of Abuse Dip Test Function: Care of Patient Scope: Effective Date: Reviewed Dates: Revision Dates: I. PURPOSE: To provide instructions for performing urine drug screening (UDS) using the Alere iScreenDx Multi-Drugs of Abuse Dip Test. II. POLICY:Urine drug screen testing is performed following these instructions to ensure accurate results. III. RESPONSIBILITY: It is the responsibility of all Practice and TRC staff to ensure the requirements of this policy are met. IV. PROCEDURE: i. Principle: The Alere iScreenDx Multi-Drugs of Abuse Dip Test is a competitive immunoassay in which immobilized drug conjugates compete with the drug(s) present in the urine for limited antibody binding sites. If an applicable drug is present in the urine, it competes with the drug conjugate, and when a sufficient amount of drug is present, it saturates the antibody binding sites, not allowing any color change to occur. ii. Materials: i. Alere iScreenDx Multi-Drugs of Abuse Dip Test device (IS10BupDX) i. Keep test device in original sealed pouch until ready for use. ii. Discard test device if package is ripped or torn. iii. Store test devices at room temperature (35.6-86°F). iv. Do not use beyond expiration date. v. Drug classes and detection limits included in the IS10BupDX device: Drug/Class (Test ID) Detection Limit (ng/mL)Cocaine (COC) 300Morphine (MOP) 300Methamphetamines (MET) 500Cannabinoids (THC) 50Amphetamines (AMP) 1000Benzodiazepines (BZO) 300Barbiturates (BAR) 300Methadone (MTD) 300Oxycodone (OXY) 100Buprenorphine (BUP) 10ii. iScreen Urine Drug Controls (external controls) i. The controls are stable for 31 days or until the expiration date, whichever comes first when stored tightly capped at 2 to 8°C (35.6 to 46.4°F). iii. Specimen Requirements: i. Use with urine specimens only. Do not centrifuge or add preservatives to urine. ii. Test specimens as soon as possible after collection, preferably during the same day. If a specimen has been refrigerated, bring it to room temperature prior to testing. iii. Have patient collect urine in a collection cup. iv. Quality Control: 1. Quality control results must be reviewed and acceptable prior to reporting patient results. a. Internal Quality Control: An internal procedural control has been built into the test to ensure that the test is performed properly. The appearance of a line in the control region (C) serves as the internal procedural control to verify that the reagents in the test are still working, and that the test is valid. b. External Quality Control: External quality control must be performed: i. On all new lots and new shipments of test devices ii. At least monthly on test kits in storage iii. If suspect that the test kit has been stored improperly iv. If suspect that the test kit is not working properly v. If have had repeated invalid test results 2. External QC procedure: i. Allow controls to come to room temperature before use. ii. Then, gently swirl or invert before use. Do not shake. iii. Pour the entire contents of the positive control vial into a urine cup labeled “positive control”. Pour the entire contents of the negative control vial into a urine cup labeled “negative control”. iv. Proceed to test each control using the same procedure for testing patient specimens below. v. The positive control must test positive on all drug classes on the iScreenDx dip test device. The negative control must test negative on all drug classes. vi. If the controls do not perform as expected, do not report patient results. Repeat testing, and then contact the Laboratory if results are still unacceptable. vii. Document Quality Control results on the External Control Log. v. Patient Specimen Testing Procedure: 1. Collect urine in a collection cup. 2. Remove the test device from the sealed pouch by tearing at the notch. 3. Detach the bottom cover and dip the sample pads of the Dip Test device straight into the urine. Dip for a minimum of 10 seconds. Dip up to, but not beyond the tip of the arrows. 4. Remove the test device from the sample and re-attach the bottom cover. 5. Once the control band (C) appears (in 5 minutes or less) results are ready to interpret. Read results at 5 minutes. 6. Important: Read each test result independently. Do not compare color intensity of one test to another. Samples with faint test bands at the test regions should be considered negative. vi. Results Interpretation: i. NEGATIVE: The presence of a colored band at the control region (C) and a colored band at a specific test region regardless of the intensity indicate that the result is NEGATIVE for that particular drug class. ii. POSITIVE: The presence of a colored band at the control region (C) and the absence of a colored band at the specific test region indicate a POSITIVE result for that particular drug class. iii. INVALID: No band appears at the control region (C). The test is invalid even if there is a band in the test region. Repeat test using a new device. If results are still invalid, contact the Laboratory for assistance. Examples of results: NOTE: These results are for illustration purposes only; see the explanations above for interpretation of results. vii. Reference Range: All Drug Classes: Negative viii. Limitation of the Procedure: There is a possibility that technical or procedural error, as well as other substances in certain food and medication, may interfere with the test and cause false results. ix. Result Reporting: Document result in EMR. eClinical Works: Order In House lab named Alere iScreenDX Multi-Drugs of Abuse Dip Test lab: Open the order and insert the collection date and click on the results tab: On the results tab mark the lab as received (done) and enter the results in the appropriate fields: Scroll to the right to enter additional fields. V. APPENDIX: External Control Log VI. REFERENCES: A. Alere iScreenDx Multi-Drugs of Abuse Dip Test package insert revision A, 3/2013. B. Alere iScreen Urine Drug Controls package insert revision A, 4/2011 Approved by: ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download