Urinalysis:
CLINITEK Status Connect System with Siemens Microalbumin Creatinine Reagent Strips
Prepared By	____________________________________Date: _______________
Approved By	____________________________________Date: ________________
Effective Date	________________________________________
Discontinued Date: _______________________________(retain this procedure for at least two years)
Supersedes an Earlier Procedure: _____________(Y or N)
Earlier Procedure Discontinuance Date: ___________________	
The medical/laboratory Director or the Director’s designee will review all copies of this procedure at least once a year. The Director should keep a log of the copies being maintained.
Reviewed By	Date	Comments	

			

			

			

			

Urinalysis: CLINITEK Status Connect System with Siemens Microalbumin Creatinine Reagent Strips
Principle of the Test
CLINITEK® Microalbumin Reagent Strips for urinalysis are read by the CLINITEK Status® Connect System.  Test pads include the following assays:
•	Albumin
•	Creatinine
In addition to these test results, an albumin-to-creatinine ratio is determined, reported and printed. The analyzer is a reflectance spectrophotometer that analyzes the intensity and color of the light reflected from the reagent areas. The microprocessor converts the readings into clinically meaningful results that are shown on the display, or printed by the internal printer.

Edit the above list and the following table to omit tests that your laboratory does not perform.
	Chemical Principles of the CLINITEK Microalbumin Reagent Strips
Test Name	Chemical Principle	
Albumin	This test is based on dye binding using a high affinity sulfonephthalein dye.  At a constant pH, the development of any blue color is due to the presence of albumin. The resulting color ranges from pale green to aqua blue.	
Creatinine	This test is based on the peroxidase-like activity of a copper creatinine complex that catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3,’ 5,5’-tetramethylbenzidine. The resulting color ranges from orange through green to blue.	

Clinical Application and Usefulness
CLINITEK Microalbumin Reagent Strips are for in vitro diagnostic use in the near patient point-of-care and centralized laboratory locations. The strips are intended for use by clinicians in the detection of patients at risk of developing kidney damage. The strips provide semi-quantitative results which you can use for screening samples for microalbuminuria. Positive results should be confirmed with quantitative methods for albumin.
Microalbuminuria has been reported to be an early predictor of the development of glomerular damage in the absence of overt nephropathy.  Patients with diabetes and hypertension are the primary risk groups.  Patients who have been exposed to nephrotoxins or who suffer from immune disorders form the secondary risk groups.  Microalbuminuria has also been reported as an early predictor of the development of pre-eclampsia during pregnancy.
Note: As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

Specimen Collection and Handling 
Use the following guidelines for specimen collection and handling, storage, and rejection and referral criteria.
Specimen Collection and Storage
		BIOHAZARD 
All products or objects that come in contact with human or animal body fluids should be handled, before and after cleaning, as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing.	
•	Obtain a fresh, random urine specimen.  A first-morning specimen is recommended.  The specimen should be at room temperature for less than two hours before testing. 
•	Collect the urine in a clean, dry, covered container. 
•	The urine specimen should be well mixed and uncentrifuged. If the urine depth in its container is less than 1 inch, pour the specimen into a narrow tube.
•	To avoid contamination of the specimen, any cultures ordered on the same specimen should be set up before performing the urinalysis.
•	If testing is delayed longer than 2 hours after collection, the specimen should be refrigerated for preservation. Allow the urine specimen to return to room temperature before testing.
Specimen Rejection Criteria
Add your laboratory-specific rejection criteria here
Do not accept the specimen based on the following criteria:
•	Specimens that have remained at room temperature for longer than two hours
•	Specimens with urine preservatives other  than boric acid at a concentration of 1.0 g/L
•	Specimens arriving in homemade containers such as  glass jars and pill bottles
•	Specimen containers that leak
If an unacceptable specimen is received, note the reason for rejection on the test requisition and request a new, acceptable specimen from the patient. Acceptable collection container and collection instructions should be provided to the patient.
Specimen Referral Criteria
Add your laboratory-specific referral criteria here

Reagents
Use the following guidelines for reagent storage, stability, ingredients, preparation, and calibration
Storage and Stability
•	Store CLINITEK Microalbumin Reagent Strips at room temperature, 15 to 30°C.
•	Do not store the reagent strips in direct sunlight. Protection from exposure to light, heat and ambient moisture is mandatory to guard against altered reagent reactivity.
•	Store the unused reagent strips in the original bottle. Transferring unused reagent strips to other containers may cause the strips to deteriorate and become unreactive.
•	Do not remove the desiccants from bottle.
•	Do not use the reagent strips beyond the expiration date.
•	Initial and date the reagent bottle when you first open it.
•	Do not remove the strip from the bottle until immediately before use. Replace cap immediately and tightly after removing the strip. 
•	Avoid touching the test areas (pads) of the reagent strip.
•	Discoloration or darkening of the reagent areas may indicate deterioration. If this happens, confirm the expiration date and the check performance with known negative and positive controls. If acceptable results are not obtained, discard the deteriorated strips and retest using a new, unopened bottle of reagent strips.
	Reagent Ingredients
The CLINITEK Microalbumin Reagent Strips contain the following ingredients: 
Edit this list to omit the tests your laboratory does not perform
Test	Ingredients	
Albumin 	1.9% w/w bis (3',3"-diiodo-4',4"-dihydroxy-5',5"-dinitrophenyl)-3,4,5,6-tetrabromosulfonephthalein; 94.2% w/w buffer; 3.9% w/w nonreactive ingredients.	
Creatinine	2.5% w/w copper sulfate; 4.5% w/w diisopropylbenzene dihydroperoxide; 2.0% w/w 3,3',5,5'-tetramethylbenzidine; 56.4% w/w buffer; 34.6% w/w nonreactive ingredients.	
The strips have been determined to be nonhazardous under the guidelines issued by OSHA in 29 CFR 1910.1200(d).
Reagent Special Preparation 
No special preparation for the reagent strips is required.
Instrument Operation and System Description
The CLINITEK Status Connector is intended for use with the CLINITEK Status+ Analyzer. Together, the two analyzers compose The Clinitek Status Connect System. The Connector also supports importing certain information using an optional bar code scanner. The system is intended for in vitro diagnostic use in the following areas:
•	Semi-quantitative detection  of albumin and creatinine in urine samples
•	Semi-quantitative calculation of an albumin-to-creatinine ratio in urine samples 
The optical system consists of six light-emitting diodes, a light guide, mirror, lens and detector. Light from the LEDs travels along the light guide and reflects off the calibration bar, strip or cassette onto the mirror. It is then directed through an aperture on the lens, from where it is focused onto the detector. The light intensity detected is converted into electrical impulses, which are processed by the instrument microprocessor, and converted into clinically meaningful results. 
System Start-up and Maintenance 
The test table insert and the test table should be kept clean if the analyzer is to operate properly.
WARNING: Do not autoclave the test table or test table insert.
WARNING: Care should be taken not to scratch the white calibration bar. If it is scratched or scuffed, obtain a new test table. Solvents of any kind must not be used to clean the bar.
Refer to your CLINITEK Status+ Analyzer Operator’s Manual for detailed cleaning and maintenance instructions.
System Start-up 
The system is turned on by pressing the on/off button located at the front of the instrument. The analyzer automatically runs a system diagnostic check during which it performs a series of electronic, signal and memory checks. The Select Ready screen displays after system initialization.
Calibration 
The CLINITEK Status Connect System performs a “self-test” and calibration each time you power on the system. The analyzer performs an automatic calibration each time you run a test. The white calibration bar (on the test table) provides NIST traceable calibration. 
Enabling the Connector to Communicate with the Analyzer
1.	At the Select Ready screen, select Instrument Set up.  The Choose Settings screen displays.
2.	Use the arrow keys to select Instrument Settings.
3.	Choose Select.  The Instrument Settings screen displays.
4.	Use the arrow keys to select Connectivity.
5.	Choose Select.  The Connectivity screen 1 of 2 displays.
6.	To enable communication between the instrument and the connector, select Enabled.  To prevent communication, select Disabled.
7.	Select Previous.
8.	Select Done twice to return to the Select Ready screen. 
Managing the Operators List
To manage the Operators List, you can enable or disable authorized operator options, and add operator IDs.
Setting Operators IDs
1.	At the Select Ready screen, select Instrument Set Up.  The Choose Settings screen displays.
2.	Use the arrow keys to select Instrument Settings.
3.	Choose Select.  The Instrument Settings screen displays.
4.	Use the arrow keys to select Authorized Operator.
5.	Choose Select.  The Authorized Operator screen displays.
6.	To permit access only by authorized operators, select Enabled.  To allow all operators access to the system, select Disabled.
7.	For Enabled, see Adding Operator IDs below to add at least one operator.  If Disabled is selected, select Done 3 times to return to the Select Ready screen.
Adding Operator IDs
1.	At the Authorized Operator’s Screen, select Add Operator.
2.	Enter the new Operator ID.  Use the alpha keyboard to enter text.  To enter numeric text, select 123.
3.	Select Enter.  The Authorized Operator screen displays the Operator ID and which functions the operator can perform.
4.	To edit this Operator ID, select Edit.
5.	To edit which functions this Operator ID can access, select Edit.  The Authorized Operator-Operator access screen displays 1 of 2 displays.
6.	To allow this operator to run patient tests, select Enabled.  To prevent patient tests, select Disabled.
7.	To allow this operator to run QC tests, select Enabled.  To prevent QC tests, select Disabled.
8.	Select Next.  The Authorized Operator-Operator access screen 2 of 2 displays.
9.	To allow this operator to recall results, select Enabled.  To prevent recall results, select Disabled.
10.	To allow this operator to set up the instrument, select Enabled.  To prevent instrument setup, select Disabled.
11.	Select Done twice.  The Authorized Operator-Operators list screen displays.
12.	Select Exit.
13.	Select Done 3 times to return to the Select Ready screen.
Scanning Patient Information
To require patient information entry only by scanning:
1.	At the Select Ready screen, select Instrument Set Up.  The Choose Settings screen displays.
2.	Use the arrow keys to select Operator and Patient Information.  
3.	Choose Select.  The Input Settings screen displays.
4.	Select Custom Set Up.
5.	Select Next.  The Custom Settings-Operator screen 1 of 5 displays.
6.	Select Next.  The Custom Settings-Patient Information screen 2 of 5 displays.
7.	Select Bar Code Reader Settings.  The Patient Information screen displays.
8.	To permit entry of patient information by either bar code scanner or manually, select Disabled.
9.	Select Done.  The Customs Settings Patient Information screen 2 of 5 displays.
10.	Select Next 4 times.
11.	Select Done twice to return to the Select Ready screen.
Managing Strip Lot Number and Expiration Date
Setting Strip Information Prompt
1.	At the Select Ready screen, select Instrument Set Up.  The Choose Settings screen displays.
2.	Use the arrow keys to select Instrument Settings.  
3.	Select Enter.  The Instrument Settings screen displays.
4.	Use the arrow keys to select Urinalysis Test Settings.
5.	Choose Select.  The Urinalysis Test Settings screen displays.
6.	Select Next.  The Urinalysis Test screen displays.
7.	To prompt for strip information before each test, select Enabled.  To bypass a prompt to enter strip information before each test, select Disabled.
8.	Select Done 3 times to return to the Select Ready screen.
Entering the Strip Lot Number and Expiration Date
1.	At the Select Ready screen select Strip Test.  The Strip Screen displays.
2.	To use the last strip number and begin the test, select Use Last Lot.  To enter new strip data, select Enter new lot and expiration.  The Strip Lot screen displays.
3.	Enter the strip lot number.  Use the alpha keyboard to enter text.  To enter numeric text, select 123.
4.	Select Enter.  The Strip Expiration screen displays.
5.	Use the arrow keys to indicate the strip expiration date.
6.	Select Enter.  The Prepare Test screen displays.
7.	Select Start.
Note:  If using the optional barcode reader, this information can automatically be entered with a single scan when prompted.
Setting Up QC Strip Tests
Accessing QC Strip Set Up
1.	At the Select Ready screen, select Instrument Set Up.  The Choose Settings screen displays.
2.	Use the arrow keys to select Instrument Settings.
3.	Choose Select.  The Instrument Settings screen displays.
4.	Use the arrow keys to select QC Settings.
5.	Choose Select.  The QC Settings screen displays.
6.	For QC strip test, select Set Up.  The QC Settings-Strip test screen 1 of 3 displays.    
Setting QC Strip Tests
1.	To allow QC prompts, select Enabled.  To prevent QC prompts, select Disabled.
2.	To require QC tests when they are due and not permit patient tests, select Required.  To permit patient tests even if a QC test is due, select Reminder.
3.	Select Next.  The QC Settings-Strip Test screen 2 of 3 displays.
4.	To have the instrument determine QC pass or fail, select Instrument.  To have the operator determine QC pass of fail, select Operator.
5.	To permit patient tests if the QC test fails, select Yes.  To prevent patient tests if the QC test fails, select No.
6.	Select Next.  The QC Settings-Strip test screen 3 of 3 displays.
Defining QC Strip Test Controls
1.	To set the number of levels to complete a QC test, select 1, 2 or 3.
2.	For each control set in Step 1, select the corresponding Control Level, 1, 2, or 3.
3.	Select Enter Name of Control.  The Name of Control screen displays.
4.	Enter the name of this control.  Use the alpha keyboard to enter text.  To enter numeric text, select 123.
5.	Select Enter.  The Control Level 1-Strip test screen displays.
6.	Select Enter Name of Level.  The Name of Level screen displays.
7.	Enter the name of this level.  Use the alpha keyboard to enter text.  To enter numeric text, select 123.
8.	Select Enter.  The Control Level 1-Strip test screen displays.
9.	Choose Select Strip Type.  The QC Strip Type-Select Strip for this QC level screen displays.
10.	Use the arrow keys to select the strip type.
11.	Choose Select.  The Control Level 1-Strip Test screen displays.
Setting QC Strip Test Pass/Fail Ranges
1.	Select Set Pass Ranges.  The QC Level 1-Tests and Pass Ranges screen 1 of 3 displays.
2.	Select Set.  The QC Level 1-Tests and Pass Ranges screen 1 of 3 displays.
3.	Enter the pass ranges for microalbumin, and creatinine as directed.  Select Next to advance through all 3 screens.  When pass ranges for all tests are entered, the QC Level 1-Tests and Pass Ranges screen 3 of 3 displays.
4.	Select Done.  The Control Level 1-Strip Test screen displays.
5.	Select Done.  The QC Settings-Strip Test screen 3 of 3 displays.
6.	If necessary, repeat defining QC strip test controls for the next control level.
7.	When all QC levels are defined select Done.  The QC Settings screen displays. 
Setting the QC Strip Schedule
1.	For QC strip test, select Interval.  The QC Settings-Set QC Schedule for Strip Tests screen displays.
2.	To schedule QC tests by hours, select the Hours radio button and use the arrow keys to indicate the number of hours between QC tests. Go to step 7. To schedule QC tests by days, select the Days radio button and use the arrow keys to indicate the number of days between QC tests.
3.	Select Set QC Time.  The QC Settings-Set QC Time for Strip Tests screen displays.
4.	Select the 1, 2, or 3 radio button for the number of QC tests per day.
5.	Use the arrow keys to indicate time of day for each test.
6.	Select Set.  The QC Settings-Set QC Schedule for Strip Test screen displays.
7.	Select Done.  The QC Settings screen displays.
8.	Select Done 3 times to return to the Select Ready screen.
Quality Control (QC)
QC Materials
The Chek-Stix control solution is not appropriate for use with CLINITEK Microalbumin Reagent Strips. Use alternate control solutions from third party vendors.  The following controls have been tested and are compatible with CLINITEK Status Connect system: QUANTIMETRIX Dipper Urine Dipstick Control, BIO-RAD qUAntify Plus Control and BIO-RAD qUAntify Control.
Do not use water as a negative control.
QC Frequency
Remove section that does not apply to your laboratory
CLIA-waived laboratories
•	Test negative and positive liquid ready-to-use controls whenever a new reagent bottle is first opened
•	Add your laboratory-specific quality control frequency requirements here
All other laboratories
For best results, confirm the performance of the reagent strips at the start of each day and whenever a new bottle is first opened. These control specimens may also be hidden in each batch of specimens tested. 
Add your laboratory-specific quality control frequency requirements here
Troubleshooting Out-of-Range QC Values
A QC run is acceptable when all values fall within the expected ranges. 
If the QC results do not fall within the defined ranges, the run is rejected, and you must take the following corrective actions:
•	Review the instructions to ensure that the test was performed according to the procedures recommended by Siemens Healthcare Diagnostics.
•	Verify that the reagent strips and control materials are not expired.
•	If necessary, re-run the quality control samples, or contact Siemens Healthcare Technical Solutions Center at 1-877-229-3711 for more assistance.
Routine Analysis
You can operate the CLINITEK Status Connect System in two modes: Quick Test or Full Test. By default the analyzer will run a Quick Test. Refer to your CLINITEK Status+ Analyzer Operator’s Guide for a complete listing of other default settings.
Quick Test Mode
With a Quick Test, the testing begins as soon you select Strip Test on the Select Ready screen. 
WARNING: Bring the patient sample to 15 - 30°C and mix well prior to testing.
WARNING: Do not remove the strip from the bottle until immediately before use. Replace the cap immediately and tightly after removing the strip.
1.	At the main Select screen, touch Strip Test. A Prepare Test screen will appear.  Follow these steps to prepare the test:
a.	Make sure the test table insert has the reagent strip holder facing upward.
b.	Have the test strip, urine sample and paper towel ready.
2.	Touch START. Another Prepare Test screen will appear. Follow these steps to continue preparing the test:
WARNING: Once you touch the START button you have eight seconds to treat the reagent strip with the urine sample and place the strip on the test table.
a.	Dip the reagent strip into the urine sample, wetting all pads. Immediately remove the strip from the urine.
b.	Drag the edge of the strip against the side of the sample container as you remove it.
c.	Remove excess urine from the sample.
d.	Blot by touching the edge of the strip to the paper towel to remove excess urine.
WARNING: Do not lay the pads on the paper towel or cover the pads by the paper towel.
e.	Place the reagent strip in the channel of the test table with the test pads facing up. Slide the strip to the end of the channel.
WARNING: Do not push or pull the test table.
f.	At the end of the eight-second countdown, the test table and strip will automatically be pulled into the instrument.
3.	The analyzer will perform an automatic calibration and begin analyzing the strip.
WARNING: Do not move or bump the table while the instrument is calibrating.
4.	When the analysis is complete, the Results screen will display the first page of results.
5.	Touch More to display the second page of results. 
6.	Remove the used urinalysis strip from the test table and dispose of it according to your standard laboratory procedures.
7.	Touch Done to complete the test and return to the main Select screen.
Full Test 
To access the Full Test mode, customize your settings.
1.	At the main Select screen, touch Instrument Set Up. The Choose Settings screen will appear.
2.	Use the down arrow to highlight Operator and Patient Information. Touch Select. The Input Settings screen will appear.
3.	Touch the circle in the Full Test box and touch Next. An Input Settings confirmation screen will appear.
4.	Touch Done and you will return to the main Select screen.
For complete information on Instrument Set Up and customizing your test sequence, see Section 5 of your CLINITEK Status Analyzer Operator’s Manual.

With a Full Test, the system prompts you to enter an Operator ID, Patient Name, or Patient ID before you run the test.
1.	At the main Select screen, touch Strip Test. The Operator ID screen will appear.
2.	If you were the last operator to enter an ID on the analyzer, touch Last Operator. The Patient Information screen will appear. Go to step 6.
3.	If you are a new operator, touch Enter New Operator ID. The Enter Operator ID screen will appear.
4.	Use the keypad to enter your ID using a maximum of 13 characters.
5.	Touch Enter. The Patient Information screen will appear.
6.	If the test sample is from a previous patient, touch Recall Patient. A list of up to 200 patients will appear on the screen.
7.	Use the up and down arrows to scroll through the patient names. Once the patient you are looking for has been highlighted, touch Select. A Prepare Test screen will appear. Go to step 13.
8.	If the test sample is from a new patient, touch Enter New Patient. The Enter Patient Name screen will appear.
9.	Use the keypad to enter the patient’s name using a maximum of 20 characters.
10.	Touch Enter. The Patient ID screen will appear.
11.	Use the keypad to enter the patient’s ID using a maximum of 13 characters.
12.	Touch Enter. A Prepare Test screen will appear.
WARNING: Bring the patient sample to 15 - 30°C and mix well prior to testing. 
WARNING: Do not remove the strip from the bottle until immediately before use. Replace cap immediately and tightly after removing the strip.
13.	Follow these Steps to prepare test:
a.	Make sure the test table insert has the reagent strip holder facing upward.
b.	Have the test strip, urine sample and paper towel ready.
14.	Touch START. Another Prepare Test screen will appear. Follow these steps to continue preparing test:
WARNING: Once you touch the START button you have eight seconds to treat the reagent strip with the urine sample and place the strip on the test table.
a.	Dip the reagent strip into the urine sample, wetting all pads. Immediately remove the strip from the urine
b.	Drag the edge of the strip against the side of the sample container as you remove it.
c.	Blot by touching the edge of the strip to the paper towel to remove excess urine. WARNING: Do not lay the pads on the paper towel or cover the pads by the paper towel.
d.	Place the reagent strip in the channel of the test table with the test pads facing up. Slide the strip to the end of the channel. 
WARNING: Do not push or pull the test table.
e.	At the end of the eight-second countdown, the test table and strip will automatically be pulled into the instrument.
15.	The analyzer will perform an automatic calibration and begin analyzing the strip.  
WARNING: Do not move or bump the table while the instrument is calibrating.
16.	When analysis is complete, the Results screen will display the first page of results.
17.	Touch More to display the second page of results. 
18.	Remove the used urinalysis strip from the test table and dispose of it according to your standard laboratory procedures.
19.	Touch Done to complete the test and return to the main Select screen.
STAT Samples 
Run the STAT samples the same way that you run other samples. Follow the directions in the earlier sections for Quick Test Mode or Full Test.
Reporting Results 
As with all in vitro diagnostic assays, each laboratory should determine its own reference range for the diagnostic evaluation of patient results. 
Reference Interval 
Add your laboratory-specific expected values here
Albumin 	 10 mg/L 	
Creatinine	10 – 300 mg/dL (random urines)	
Albumin-to-Creatinine Ratio	Normal	

Critical Values
Add your laboratory-specific critical values here
Reporting Protocol for Critical Values
Add your laboratory-specific protocol for reporting results here
Units for Reporting Results
The CLINITEK Status Connect System reports results in conventional units.

Add your laboratory-specific reporting units for each test in the table below:
Test	Reporting Unit 	
Albumin	mg/L	
Creatinine	mg/dL	
Albumin-to-Creatinine Ratio	mg/g	
 Detectable Range
Reagent Area	Sensitivity	
Albumin	10 – 150 mg/L albumin	
Creatinine	10 mg/dL to 300mg/dL (absence cannot be determined)	

Acceptable Results
Add your laboratory-specific acceptance criteria here
The patient test results are acceptable and may be reported in the following cases:
•	
•	
Corrective Action 
Add your laboratory-specific repeat and corrective action protocol here
The patient test results must be repeated and corrective action taken in the following cases:
•	
•	
Procedure Notes
The procedure notes include information on the ratio calculations and the disposal of biohazardous materials.
Calculations
The CLINITEK Status Connect System reports an albumin and creatinine result and calculates the albumin-to-creatinine ratio. For more information about the calculation see the CLINITEK Status+ Analyzer Operator’s Guide.
Disposal
Dispose of hazardous or biologically contaminated materials according to the practices of your institution. Discard all the materials in a safe and acceptable manner, and in compliance with all federal, state, and local requirements.
Method Limitations
The presence of the following conditions may cause falsely elevated results with the albumin and creatinine tests:
•	Visible levels of blood 
•	Contamination of the urine specimen with soaps, detergents, antiseptics, or skin cleansers or the use of urine preservatives other than boric acid (1.0 g/L) may affect test results.
Substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips. These substances include the following types:
•	Drugs containing azo dyes, such as PYRIDIUM, AZO GANTRISIN, AZO GANTANOL
•	Drugs containing nitrofurantoin (MACRODANTIN, FURADANTIN)
•	Riboflavin
For additional information on method limitations and performance characteristics, see the CLINITEK Microalbumin Reagent Strips instructions for use package insert.
The levels of ascorbic acid normally found in urine do not interfere with these tests.
The following table includes the specific substances and conditions that may affect the test results.

Test Name	False Positive or 
Increased values	False Negative or 
Decreased values	
Albumin-to-Creatinine Ratio	•	Both the albumin and A:C ratio results should be considered when making a decision about the clinical diagnosis or need for confirmatory testing.	•	The ratio cannot be accurately determined if the creatinine result is 10 mg/dL and the albumin result is Negative.  (Omit when the strip is read visually.) A new specimen, preferably a first-morning collection, should be tested.	
Albumin	•	Highly buffered or alkaline urines
•	Contamination with quarternary ammonium compounds (from some antiseptics and detergents) or Chlorhexidine (found in some skin cleansers)		

For additional information on method limitations and performance characteristics, see the CLINITEK Microalbumin Reagent Strips instructions for use package insert.
Equipment and Supplies
Add the product-specific name of the reagent strip(s) used in your laboratory.
•	CLINITEK Microalbumin  Reagent Strips 
•	CLINITEK Status Connect System
•	Specimen collection container
•	Paper towels
References
1.	Siemens Healthcare Diagnostics CLINITEK STATUS  Connect System Operator’s Guide, 135055, Rev B, 2010-1
2.	CLINITEK Microalbumin  Reagent Strips for Urinalysis Package Insert, AN73024J Rev. 02/09
3.	Siemens Healthcare Diagnostics CLINITEK Status+ Analyzer Operator’s Guide, 135057, Rev. B, 2010-1
4.	National Committee for Clinical Laboratory Standards (NCCLS). Clinical Laboratory Procedure Manuals, Third Edition (GP2-A3), 1996    
*NCCLS is now known as: Clinical and Laboratory Standards Institute (CLSI).     
Trademark Information
CLINITEK, CLINITEK Status, and Chek-Stix and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. All other trademarks and brands are the property of their respective owners. 

Technical Assistance
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