Issuing Authority: Medical Director, Laboratory Services Date Issued: July 4, 2008 Version: 2.0

Transcription

1 Page 1 of 9 Clinitek Status Purpose This is a Point of Care Test (POC) and falls under the Ministry of Health and Long-Term Care Testing Policy for Hospitals and Other Facilities. This policy states, Under current legislation, only physicians can authorize point of care testing. In these circumstances, the ordering physician must take responsibility for the tests performance and the test results produced. Physicians can either perform the test themselves or have a properly trained Registered Nurse perform the test in accordance with the following procedure. Principle The Clinitek Status is a semi-automated Urine Analyzer used for reading Clinitest chromatographic immunoassay cassettes as a qualitative method in the rapid detection of human chorionic gonadotropin (hcg) in urine specimens. Specimen Type: Random urine sample collected into a clean dry container. Approximately 200µl urine for a single test. Refrigerate samples at 2-8ºC for up to 72 hours, if the testing is not performed immediately. Bring to room temperature and mix well before assaying. Equipment and Materials Equipment: Clinitek Status Materials: Siemens Clinitest hcg cassettes (including pipettes)

2 Page 2 of 9 Preparation: Clinitest hcg cassettes come ready to use. Storage Requirements: Clinitest hcg cassettes can to be stored at room temperature or refrigerated (25º-30ºC), unopened stable until the expiry date on package. If refrigerated, bring wrapped cassettes to room temperature before opening the protective pouch to avoid condensation on the membrane. Calibration The instrument has a white calibration bar, located on the test table, and performs a calibration automatically each time the instrument is turned on and each time a test is run. Quality Control Internal QC: Each test includes two procedural controls, which indicate that sufficient sample was added for capillary flow to occur and the correct procedural technique was used. If the instrument detects a failure of either of these two procedural controls, an error is reported and the test must be repeated. External QC: BioRad Lyphocheck Quantitative Urine Control Level 1, PREGNEG BioRad Lyphocheck Quantitative Urine Control Level 2, PREGPOS Preparation: Please refer to Urinalysis QC Manual for instructions to storage and preparation and aliquot ting of PREGNEG and PREGPOS QC material 1. Package frozen QC aliquots with an ice pack to maintain frozen state 2. Forward shipment with next courier shipment to The Willett Hospital, attention Willett Urgent Care. 3. If no courier is available before material is required, forward to The Willett Hospital by taxi.

3 Page 3 of 9 Taxi fare is charged to Willett cost centre. 4. Call staff at Willett Urgent Care to notify them that QC material is on the way. 5. Once arrived at Willett, store frozen at or below 18ºC. 6. Thaw, warm to room temperature and mix before testing. 7. QC must be run weekly (Monday) and with each new lot # of Siemens Clinitest hcg 8. At the Select Ready screen, select QC Cassette due. (The QC Test screen displays) 9. Select QC Strip Test Required. (The Control Lot screen displays) 10. Enter the control lot. Use the alpha keyboard to enter text, to enter numeric text, select Select Enter. (The Control Expiration screen displays) 12. Use the arrow keys to indicate the control lot expiration date. 13. Select Enter (The Cassette Lot screen displays) 14. Use the alpha keyboard to enter text, to enter numeric text, select Select Enter (The Prepare Test screen displays) 16. Select Start 17. Run the test Procedure: A Positive and Negative Quality Control specimen must be run at least weekly by a trained operator. Assay both levels of QC in the same manner as a patient sample. Refer to instructions following. Pregnancy control results will transfer automatically to the LIS by the Cobas IT software and must fall within the acceptable ranges before accepting patient results. QC data will be monitored by the POC coordinator. On-line retention time for QC is 2 years.

4 Page 4 of 9 Procedure 1. Press the instrument "On (Φ) button. The system will automatically perform a quick system diagnostic test. 2. Turn the table insert so cassette holder is facing upwards. 3. On the Select screen press Cassette Test screen button. 4. On the Operator ID screen select Use Last Operator or Enter New Operator ID. Key in the number from the front of the operator s BCHS badge. Press Enter. 5. Note: If a number gets keyed incorrectly use the button to erase the number or letter and retype. The Back key can also be pressed to return to the previous screen. 6. Press Enter New Patient. Verify the patient s name to be tested and the urine is correctly labeled. 7. Using the ABC button, enter the Patient s name (maximum of 20 characters). The space bar is located at the bottom of the screen between the period (.) and the dash (-) symbols. If running a Quality Control test, enter QCPOS or QCNEG Press Enter when completed. 8. Enter the Patient ID using the number keypad and press Enter when done. If running a second test on the same patient, the Recall Patient button can be pressed. Use the up and down arrow buttons to scroll through the list of patients; the most recent testing will be at the top. Once the patient is highlighted, touch the Select button. 9. At the Enter Strip Lot# Screen Select Use Last Lot or enter new strip data, select Enter new lot and expiration. 10. Use the alpha keyboard to enter text, to enter numeric text, select Remove a cassette from the pouch and place it onto the test table. 12. Touch the Cassette Test screen, make sure the test table insert has the cassette holder facing upward, set up to receive the sample cassette. When the cassette, pipette and

5 Page 5 of 9 urine sample are ready, touch Start to begin. There are 8 seconds allowed to aliquot and process the sample cassette, instructions following. 9. Holding the pipette at a slight angle, squeeze the upper bulb and draw enough sample into the pipette to fill the stem completely, with an overdrawn amount going into the reservoir (lower bulb). 10. Discharge the sample in the pipette stem into the sample well of the test cassette by squeezing the upper bulb in one squeeze. The excess fluid will remain in the reservoir. Do not push or pull the test table. 11. The test table will automatically be pulled into the instrument. When the analysis is complete, the Results screen will be displayed. 12. Remove the cassette when the analysis is complete. Reporting Results Reference Interval: None Procedure for Abnormal Results: none Reporting Format: Results are reported as Positive, Borderline repeat in 2 weeks suggested or Negative The Control (C) and Reference (R) regions meet minimum intensity specifications. Interpretation: POSITIVE: The instrument will automatically determine if the Test (T) region intensity is equal to or more intense than a 25 mlu/ml urine sample and confirm that the Control (C) and Reference (R) regions meet minimum intensity specifications. BORDERLINE: Result is indeterminate. Repeat in hours. NEGATIVE: The instrument will automatically determine that the Test (T) region is less intense than the 25 mlu/ml hcg concentration level that the device can detect, and confirms that the Control (C) and Reference (R) regions meet minimum intensity specifications. INVALID: The instrument will automatically determine if a procedural error or test reagent deterioration has occurred by confirming that the Control (C) and Reference (R) regions meet

6 Page 6 of 9 minimum intensity specifications. If not, the user will be advised to repeat the test and contact the Laboratory Technical Specialist if the problem persists. Procedure Notes Test is available during Willett Urgent care operational hours, 7 days a week and may be ordered Routine, Urgent or Stat. Limitations of the Procedure Negative test results in patients suspected to be pregnant should be retested with a sample obtained hours later, or by performing a quantitative assay. Dilute urines (low specific gravity) may not have representative levels of hcg. False negative results may occur if levels of hcg are below the sensitivity of the test (25 miu/ml). Note: This comment is included with all Negative results If pregnancy is still suspected, repeat test in 48 hours on a first morning specimen or a serum BHCG test can be ordered. If results are suspect a serum BHCG or a quantitative BHCG can be tested if there is an appropriate sample. Maintenance Daily: Remove the test table insert and thoroughly clean. Rinse both sides of the table insert under running water. Dry and replace insert on the test table. Run QC Weekly: Remove the test table by pulling it slowly out of the analyzer. Lift the test table insert from the test table, drain the drip tray if necessary. Wipe down the test table with a GLUCO-CHLOR pad or 70% isopropyl swab being careful NOT to touch the white calibration bar. Repeat cleaning procedure with a cotton swab moistened with water and dry thoroughly with a soft cloth or lint free tissue, again not touching the white calibration strip. Reinsert the test table into the analyzer by holding the table at the end opposite the white calibration bar, with the white calibration bar facing upwards. Push the test table firmly but slowly, just over halfway into the analyzer. Replace the test table insert. Run QC White Calibration Bar: Remove the test table by pulling it slowly out of the analyzer. Check the white calibration bar on the test table for dirt or discolouration. If the white calibration bar

7 Page 7 of 9 is clean and unmarked, replace the test table into the analyzer by holding the table at the end opposite the white calibration bar, with the white calibration bar facing upwards. Push the test table firmly but slowly, just over halfway into the analyzer. If the white calibration bar is dirty or discoloured, gently wipe and clean it with a new cotton swab or lint-free cloth dampened with distilled water. Allow the calibration bar to air dry and inspect again for dust, scratches or foreign material. If the bar cannot be cleaned or is still marked, obtain a new test table. Reinsert the test table as described above. Run QC Analyzer: Turn the analyzer off by pressing the on/off button for 2 seconds. Wipe the outside, including the display, with a damp (NOT wet) cloth. Replacing the Paper Roll - A paper-out icon appears in the top of the title bar when the printer paper/label roll needs replacing. - An advisory message will be displayed on the main Select screen. - Instructions are found on the inside of the printer paper compartment cover, or to view instructions on the display touch the Error Report selection area, or follow the instructions listed below. - To replace: 1) Open the printer cover by pulling up on the tab. 2) Open the paper roll compartment cover by pressing down on its tab and pulling out. 3) Lift the paper holding arm into the open, upright position. 4) Place the new paper roll into the printer paper compartment with the paper unrolling from underneath and toward the compartment wall. 5) Feed the paper up along wall and through the printer. Once there are approximately 4 of paper through the printer then feed the edge of the paper through the printer cover. 6) Push the paper holding arm down in to the closed position. 7) Close the printer and paper roll covers by clicking them into position. Troubleshooting There are four type of Error messages: I. Disable Errors: Errors may occur which disable the instrument until corrected. All selection areas on the screen will be disabled. II. Other errors: Sample testing may be affected but other instrument functions are available. III. Advisory Messages: Errors of less importance will be displayed on the Select screen. When corrective action has been taken, the message will be removed from the

8 Page 8 of 9 IV. display. If more than one message is present, clearing the first message will enable the second message to be displayed. Results Alert: If an error occurs during testing and the test cannot continue because of the error, the message will appear on the Results Alert screen. The test will be cancelled and the test table will be extended so that the urinalysis strip can be removed. Common Errors: Paper Out: refer to Maintenance Section, Replacing the Paper. Common Error Codes: refer to following table Error Code Description Action E10 or e48 Loss of test results 1. Switch the instrument off by pressing the on/off button for 2 seconds Switch the instrument on again by pressing the on/off button Repeat the test. E11 Failure of test table. 1. Make sure that the test table is in place. Move the test table in or out of the instrument slightly to reposition the test table. 2. If the error remains, with the instrument powered on, unplug the power cord from rear of the instrument and plug back in. Turn instrument on by pressing the gray power button. 3. If the error remains with the test table in place, call the Core Lab Technical Specialist. E24 No printer paper. Replace the printer paper. Refer to instructions above. E25, E64 or E65` Failure of automatic calibration. Clean the calibration strip, refer to method above. If the error remains after cleaning, contact the Core Lab Technical Specialist. E27 Set up failure. 1.Switch the instrument off by pressing the on/off button for 2 seconds. 2. Switch the instrument on again by pressing the on/off button. E28 Printer error. Lift the printer cover and push the paper holding arm back into position. Refer also to replacing printer paper method above.

9 Page 9 of 9 E57 E59 E60 E63 E61 Missing strip Inverted strip Tilted strip Failure to find end of strip - positioned on the test table. Dry strip. positioned on the test Repeat the test ensuring that the strip is positioned on the test table. Repeat the test ensuring that the strip is in contact with the sample. table. E67 or E68 Insufficient Sample A sample flow issue with the cassette test may have been detected. One or more of the test indicator lines may be missing or indiscernible from the background, or not enough sample was applied to the cassette. E02, E12, E20, E62 or any codes for computer software failure Contact the Core Lab Technical Specialist. References Clinitek Status Operator s Manual Siemens Clinitest hcg Pregnancy Test Insert