Principle: | Clinical Significance: | Certification: | Specimen: | Materials: | Reagents: | Standardization: | Procedure: | Limitations: | Results Derivation: | Expected Result(s) | Date/Time: | Recall Result: | Power ON/OFF: | Quality Control: | References:
The Clinitek Status analyzer is used for the semi-quantitative detection of albumin, bilirubin, blood (occult), glucose, ketone, leukocytes, nitrate, pH, protein, specific gravity and urobilinogen in urine samples.
When carrying out analysis on a urinalysis strip, the test table positions strip pads in the read area. The light reflected at specific wavelengths (470nm, 525nm, 565nm, 625nm, 660nm and 845nm) from the test pad is dependent upon the degree of color change in the pad and is directly related to the concentration of the particular constituent in the urine. The analyzer’s optical system reads all test pads simultaneously at all six wavelengths. The test and reference readings are then used to determine presence and/or amount of each constituent in the urine sample.
Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”
Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”.
Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”.
1. Clinitek STATUS Analyzer
2. Thermal paper (Lab Supply #HAM-225HIB)
3. Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”.
1. Siemens Multistix 10SG Urinalysis Reagent Strip (obtain from UCL Materials Management)
The instrument automatically calibrates each time a test is run. The white calibration bar on the test table provides NIST traceable calibration.
1. Preparing the specimens:
A. Match specimen container with appropriate report form.
B. Transcribe the date and time collected from the container onto the report from.
C. Mix the specimens well by gently swirling.
2. Gross Examination:
Examine the urine in the specimen container and determine its color and appearance. Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)” procedures.
Note: If the color of the urine indicates possible interference with the reaction pads, suspect results will have to be evaluated. Refer to “Evaluation of Common Interferences” table in the “Urinalysis” procedure.
3. From the ‘Select Screen’, press Strip Test.
4. Enter the Operator ID:
5. Two buttons will be displayed; the top one will be the last operator that ran a test. If you are the last operator then press the last operator button and the last operator ID will be assigned to this test.
6. If you are a new operator, press the new operator button. The “Numeric Screen” will be displayed. Type the 4 numbers of your operator ID (last 4 digits of your social security number) and press Enter.
7. The “Patient Information” screen will be displayed. Press Enter New Patient.
8. The “Numeric Screen” will be displayed. Type the patient identification number and press Enter.
9. The “Prepare Test” screen will be displayed. Press Start.
10. The next screen that appears is another Prepare Test screen. This screen prompts you through the steps to prepare the test strip. You have 8 seconds to complete the following steps.
11. Dip the Reagent strip in the urine sample, wetting all pads. Immediately remove the strip from the urine.
12. Drag the edge of the strip against the side of the sample container as you remove it.
13. Blot by touching the edge of the strip on a paper towel to remove excess urine.
14. Place the reagent strip in the channel of the table with the tests pads facing up. Slide the strip to the end of the channel.
15. At the end of the 8 second countdown, the test table and strip will automatically be pulled into the analyzer.
16. A timer will count down the time remaining in analyzing the strip results.
17. While the strip is being analyzed, a “Select Appearance” screen will be displayed. The urine sample must be visually observed and then the appropriate color and clarity must be selected.
A. If the urine sample is yellow and clear, press the Yellow and Clear button.
B. If the urine is not yellow and clear, press the Other button.
C. If you pressed the Other button, then select the appropriate color by pressing the circle button that corresponds to the correct description. (Other options are not to be used.)
D. Press Next.
E. Select the clarity by pressing the circle that corresponds to the correct description. (Other option is not to be used.)
F. Press Next.
18. After color and clarity have been entered, the next screen displayed will be either:
Analyzing - if the strip is still being analyzed, or
Results - if analyzing the strip has been completed.
19. The results will automatically be displayed.
20. If the results need to be printed, press the printer icon. Pull the paper out about an inch before tearing off the paper and place a label containing the patient name on the printout.
Refer to the Evaluation of Common Interences table in the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”.
1. The instrument results for bilirubin, protein and blood will need to be converted in accordance with the “Clinitek STATUS Result Conversion Table”.
2. Positive Bilirubin should be checked with the Ictotest.
Note: Record results of all confirmatory tests on patient report form.
3. The Clinitek STATUS automatically adds 0.005 to the Specific Gravity for samples with pH ≥ 6.5.
4. Substances that cause abnormal urine color may affect the readability of reagent areas on urinalysis reagent strips. The color development on the reagent pad may be masked, or a color reaction may be produced on the pad that could be interpreted visually and/or instrumentally as a false positive. When heavy pigmentation is present in a specimen, centrifuge the specimen at 400 rcf for five minutes and analyze the reagent strip on the supernatant. If there is still a problem with suspected false positives, a disclaimer must be applied to the results, "Disclaimer: False positive chemistry results may occur due to heavy pigmentation."
Clinitek STATUS Result
1. From the “Select” screen, press Instrument Setup.
2. A screen displays requiring a password, press Enter.
3. The “Choose Setting” screen will be displayed. Using the up and down arrow keys, highlight Date and Time Settings.
4. Using the up and down arrow keys, adjust the date and time as needed.
Use the mm/dd/yyyy format and 24 hr. Press “Choose Format” to change the format. Select the desired format and press Done.
5. Select Set to confirm the change and return to the “Choose Settings” screen. The “Choose Format” screen will be displayed.
The analyzer stores 200 patient tests.
1. From the “Select” screen, press Recall Results button.
2. The “Select Test Results” screen is displayed.
3. The test results are in chronological order. The most recent test result is displayed at the top of the screen and is highlighted.
4. Use the up and down arrow keys to scroll through the list of patient tests and highlight the patient results to recall.
5. To view details of the patient result, press the Select button. The first page of the patient’s result will be displayed on the screen. Press More to view additional results for this patient.
6. Results can be printed by pressing the Print button.
7. Press Done when you are finished viewing results.
8. You will return to the “Select Test Results” screen.
9. Press Exit to return to the main “Select” screen.
The power switch is located on the front of the instrument.
1. To power ON the instrument, press the ON/OFF button. The instrument will automatically perform a system diagnostic test and reset the test table.
2. To power OFF the instrument, hold the ON/OFF button in for at least 2 seconds. The test table will retract into the instrument.
Note: Be sure to remove the strip before turning the power OFF.
1. Refer to the “Urinalysis, Routine Chemistry Screening; Manual POC(N SPP)”.
2. Level I and Level 2 Quantimetrix Liquid Urinalysis Controls must be run when opening a new bottle of urinalysis reagent and routinely once per month.
1. Clinitek STATUS Analyzer Operator’s Manual. Bayer Healthcare Diagnostics Division. 132387 Rev.A, 2003-07.
i. September 2004 L. McGovern
ii. August 2006 L. McGovern (Revised: IX.4.)
iii. January 2007 S. Hosch (Revised: V.2.)
iv. March 2007 L. McGovern (Revised: for Cole-Taylor Urinalysis Reagent Strips)
v. December 2008 L. McGovern (Revised: for Bayer Multistix 10SG Urinalysis Reagent Strips)
vi. March 2009 L. McGovern (Revised for: Clinitek Microalbumin Reagent Strips and POCT use)
Representative: Crescent Com Health Ctr
January 2011 L. McGovern (Revised: XI.; removed clinitek microabumin rgt strips)
February 2012 L. Watters, L. McGovern (Revised: VI.2.; XV.)