NexScreen Cup. Urine Drug Screen * READ POLICY PRIOR TO STARTING TUTORIAL

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Gwenda Walters
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1 NexScreen Cup Urine Drug Screen * READ POLICY PRIOR TO STARTING TUTORIAL

2 Before Testing a Patient Orient yourself to your working area: Locate the NexScreen Cup. Locate testing supplies: Positive and Negative Liquid Quality Control Solution. Disposable Gloves. Timer (or clock). IDA page for your nursing unit.

3 Qualified Personnel Testing personnel are required to take the Initial Orientation and Training, Competency Exam, and a second Competency Exam within the first year of certification for this POCT. Competency exams are then required annually thereafter.

4 NexScreen Cup Testing using the NexScreen Cup is considered Waived in complexity by the FDA. Purpose: used for the rapid detection of drugs in human urine at the point of care.

Equipment for Testing NexScreen Cup Store as packaged in the sealed pouch at 18-30 C.

5 Equipment for Testing NexScreen Cup Store as packaged in the sealed pouch at C. Good to use until the expiration date printed on the sealed pouch. The NexScreen Cup must remain sealed within the pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

6 Equipment for Testing Detectabuse STAT-Skreen Liquid Control Urine 20mL: Positive Control Stable for one year from the date received when stored at 2-8 C and protected from light. Opened vial is good for one time use only. Must test positive on the NexScreen Cup.

7 Equipment for Testing Negative Liquid Urine Control, 20mL Stable until the expiration date when stored at 2-8 C and protected from light. Open vial is good for one time use only. Must test negative on the NexScreen Cup. Disposable Gloves Timer (or clock) Temperature Log

8 Quality Control Internal QC Included and performed with each patient test. Indicated by a line in the control region. If there is no line within the control region, the test is considered invalid. Document internal QC with patient test results.

Quality Control External QC Positive and negative

30 days), and, Whenever shipments of new control

materials (new lot number), new test kits (current

9 Quality Control External QC Positive and negative liquid QC must be performed: Monthly (once every 30 days), and, Whenever shipments of new control materials (current lot number), new control materials (new lot number), new test kits (current lot number), or new test kits (new lot number) are received.

Drug Screen External Quality Control Test Record.

10 Quality Control Procedure Document lot numbers of the vials of positive and negative QC on the NexScreen Urine Drug Screen External Quality Control Test Record. Check the expiration dates to ensure the solutions are not expired.

11 Quality Control Procedure Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.

12 Quality Control Procedure Open the vial of positive liquid QC. Pour entire contents of the vial into the NexScreen Cup and tighten lid completely. Remove peel off label. Read results at exactly 5 minutes.

13 Quality Control Procedure Document results of test in the corresponding area of the QC test record. Perform the same steps for the negative QC solution. Dispose of used test cup in a biohazard container.

14 Patient Testing Procedure To perform patient testing, first verify the correct patient using two forms of identification (full name and date of birth). Explain the procedure to the patient and/or family. Observe universal precautions and wear gloves and other PPE as needed.

15 Patient Testing Procedure Remove anything from the restroom that could be added to the specimen. Things that may interfere with the test (but are not limited to) include: Soap Bleach Vinegar Salt Tap/Toilet Water

16 Patient Testing Procedure In the presence of the patient, remove the NexScreen Cup from the sealed foiled pouch (with affixed temperature strip), attach patient ID label to test cup, and hand it to the patient.

17 Patient Testing Procedure Have the patient urinate directly into the NexScreen Cup and return it immediately. Fresh urine is required. Tighten the lid completely, turning it as much as possible to prevent leakage. Write down the time the specimen was collected on the test cup.

Patient Testing Procedure Verify that there is enough of the specimen (above the 30mL minimum line) to perform the test. Verify that the specimen is near body temperature (90-100 F/32-38 C).

18 Patient Testing Procedure Verify that there is enough of the specimen (above the 30mL minimum line) to perform the test. Verify that the specimen is near body temperature ( F/32-38 C). A green dot on the temperature strip indicates specimen temperature. If there is no temperature reading or it is out of range, the sample should be discarded and a new sample should be collected with a new test kit.

19 Patient Testing Procedure Remove peel off label. Read results at exactly 5 minutes. Document all test results along with internal QC results. Discard the test cup in a biohazard container after testing.

20 Interpretation of Results Test results show as the presence or absence of red/pink lines on each strip. Any evidence of a line is a line, no matter how faint. Each strip has 2 possible lines.

The lower line Test Line Its presence means the test is negative for that drug.

21 Interpretation of Results The upper line Control Line Its presence means the test is working. Its absence means the test is invalid. The lower line Test Line Its presence means the test is negative for that drug. Its absence means the test is positive for that drug. NOTE: The test line meaning is exactly opposite of urine pregnancy test kits and is therefore counter-intuitive. Pay close attention! NEGATIVE POSITIVE INVALID

22 Interpretation of Results If a patient result is invalid due to absence of the control line in the control region, discard the cup and start over with a new, unopened test cup. NexScreen Cup positive results are presumptive positive and require confirmation if clinically necessary or desired.

Limitations Liquid Quality Control have been tested and found negative for the antibody to HIV 1&2 and HCV, and nonreactive for HBsAg, however, this product should be treated as any other potentially

23 Limitations Liquid Quality Control have been tested and found negative for the antibody to HIV 1&2 and HCV, and nonreactive for HBsAg, however, this product should be treated as any other potentially infectious agent. NexScreen cup is designed for the detection of drugs of abuse and their metabolites in human urine only. There is the possibility that false results will occur due to the presence of interfering substances in the urine and/or factors beyond the control of the manufacturer, e.g., technical or procedure errors associated with the testing. The test is a Qualitative Screening Assay and is not suggested for Quantitative determination of drug levels or level of intoxication. Adulterants such as bleach or other strong oxidizing agents can cause erroneous test results when added to urine specimens regardless of the analysis method used. If adulteration is suspected, obtain another urine specimen. If the result of the testing cup is presumptively positive and is inconsistent with clinical expectations and pharmacy history, it is recommended that a new, untested sample is sent to the Clinical Laboratory for confirmatory testing. Positive results for some drugs may be caused by prescription drug use.

24 For Further Questions or Information Contact POCT Services SFGH-POCT.org

CHEMSTRIP 10 Urine Test Strips * READ POLICY PRIOR TO STARTING TUTORIAL

CHEMSTRIP 10 Urine Test Strips * READ POLICY PRIOR TO STARTING TUTORIAL Before Testing a Patient Orient yourself to your working area: Locate the test strips. Locate testing supplies: Specimen cup Absorbent