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MULTISTIX 10 SG test for Glucose, Bilirubin, Ketone (Acetoacetic

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MULTISTIX 10 SG test for Glucose, Bilirubin, Ketone (Acetoacetic Powered By Docstoc
					Visual Urine Dipstick Testing
STUDY MATERIAL

MULTISTIX10 SG test for Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in Urine. The Point of Care Testing (POCT) program at Vanderbilt University Medical Center (VUMC) is overseen and coordinated by the POCT Steering Committee as chartered by the Medical Center Medical Board. The POCT Steering Committee administers the program with the primary goal of meeting clinical need in the most cost-effective manner possible. In order to provide for both regulatory compliance and appropriate utilization of POCT, any clinical area wishing to perform POCT must be approved by the POCT Steering Committee and must maintain acceptable performance according to criteria set forth in Hospital Policy 20-23. I. PRINCIPLES:

The reaction of Bayer Multistix 10 SG test strips depends on color development as an indicator of the concentration of the following test reactions.
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The pH test reaction uses methyl red/bromthymol blue indicator system, which provides pH readings from 5.0 - 8.5. The color of the test pad changes from orange to green to blue in this range of pH. The glucose test is based on a double sequential enzyme reaction, which requires glucose oxidase, peroxidase, and potassium iodide. A glucose specific enzyme, glucose oxidase, catalyzes the formation of gluconic acid and H 202 from the oxidation of glucose. The enzyme peroxidase catalyzes the reaction of H 202 with a potassium iodide chromogen to oxidize the chromogen to colors ranging from green to brown. The protein reaction uses tetrabromophenol blue reagent buffered at a pH of 3. This colorimetric method is based on a concept known as the ―protein error of indicators,‖ where the point of color change of certain buffered pH indicators is different in the presence or absence of protein. Colors range from yellow (negative) through yellow-green, green, and blue-green, as positivity increases. The protein test pad is more sensitive to albumin than globulins (such as gamma-globulin, Bence Jones, hemoglobin, and mucoprotein), and a negative result does not necessarily rule out the presence of these other proteins The ketone reaction uses sodium nitroprusside reagent, which, in the presence of acetoacetic acid produces a color change from buff-pink (negative) to purple as ketone concentration increases. Acetone and B-hydroxybutyric acid are not detected with this method. The bilirubin reaction occurs when bilirubin reacts with diazonium salt (2,4 dichloroaniline) to form a tan color.

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Urobilinogen reaction is due to the reaction of urobilinogen with diethylaminobenzaldehyde, (in an acid medium), producing a pink-red color.

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Leukocyte Esterase reaction is due to derivatized pyrrole amino acid ester and diazonium salt. Leukocytes of the granulocyte series contain the enzyme, esterase, in their granules. This enzyme catalyzes the hydrolysis of the amino acid ester to liberate the pyrrole compound, in turn reacting with the diazonium salt, resulting in a purple color. Nitrite reaction occurs when Nitrite reacts with p-arsanilic acid yielding a diazonium compound which, in turn, couples with a quinolin reagent to produce a uniform pink color. Pink spots or edges should not be interpreted as positive. The Specific Gravity test reaction is based on apparent pka change of certain pretreated polyelectrolytes in relation to ionic concentration. In the presence of an indicator, color ranges from deep blue-green in urine of low ionic concentration through green and yellow-green in urines by increasing ionic concentration. This reaction employs 2.8% w/w bromthymol blue, 68.8% w/w/ poly (methyl vinyl ether/maleic anhydride); 28.4% w/w/ sodium hydroxide. Blood reaction is based on the peroxidase-like activity of hemoglobin, which catalyzes the reaction of diisopropylbenzene dihydroperoxide and uses 3, 3’5, 5’ tetramethylbenzidine. Blood is detected as intact red cells or as free hemoglobin, although the reagent pad is much more sensitive to the latter. The reaction is based on the liberation of oxygen from peroxide by the peroxidase-like activity of heme. In this test a benzidine compound is oxidized to a colored product ranging from orange to green to dark blue. SCOPE OF PRACTICE:

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II.

Urine reagent strip testing may be performed by VUMC RN’s, LPN’s, Patient Care Partners/Technicians, Operating Room Technicians, and Nursing Externs working in areas/units approved by the POCT Steering Committee to perform point of care urine reagent strip testing. To maintain this privilege, testing must be performed in accordance with VUMC hospital POCT policy. All staff performing testing must attend POCT orientation, annual proficiency testing, and follow established testing protocol.

III.
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PURPOSE:
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Bayer Multistix 10 SG and other various Bayer reagent test strips are used as a screening procedure to monitor carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract functions. It is recommended that a confirmation microscopic exam be performed on the original sample if any of the following are positive:  Blood, Protein, Nitrite, Leukocyte Further evaluation or tests may be performed on the original sample if the following are positive:  Bilirubin, Ketones IV. SPECIMEN COLLECTION: A. Conditions for Patient Preparation  Follow Patient Preparation and Collection Procedure for Point of Care Testing policy. B. Specimen Type  At least 12mls of urine (first morning urine recommended) C. Handling Conditions  Use Standard Precautions  Collect in a clean, dry container.  Do not centrifuge  Use of preservatives is not recommended.  Test urine immediately. Refrigerate if testing cannot be performed within one hour of voiding and let it return to room temperature before testing.  Urine with prolonged exposure to room temperature and light may yield altered results for bilirubin, urobilinogen, pH, glucose, and nitrite tests. V. REAGENTS/SUPPLIES: Bayer Multistix 10 SG reagent test strips (based on dry weight at time of impregnation)  Glucose: 2.2% w/w glucose oxidase;1.0% w/w peroxidase; 8.1% w/w potassium iodide; 69.8% w/w buffer; 18.9% w/w nonreactive ingredients  Bilirubin: 0.4% w/w 2,4-dichloroaniline diazonium salt; 37.3% w/w buffer; 62.3% w/w nonreactive ingredients  Ketone: 7.1% w/w sodium nitroprusside; 92.9 % w/w buffer  Specific Gravity: 2.8% w/w bromthymol blue; 68.8% w/w poly(methyl vinyl ether/maleic anhydride); 28.4%w/w sodium hydroxide

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Blood: 6.8% w/w diisopropylbenzene dihydroperoxide; 4.0% w/w 3,3’,5,tetramethylbenzidine; 48.0% w/w buffer; 41.2% non-reactive ingredients
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pH: 0.2% w/w methyl red; 2.8% w/w bromthymol blue; 97.0% w/w inactive ingredients protein: 0.3% w/w tetrabromphenol blue; 97.3% w/w buffer; 2.4% w/w nonreactive ingredients Urobilinogen: 0.2% w/w p-diethylaminobenzaldehyde; 99.8% w/w nonreactive ingredients Nitrite: 1.4% w/w p-arsanilic acid; 1.3% w/w 1,2,3,4-tetrahydrobenzo(h)quinolin-3-ol; 10.8% w/w buffer; 86.5% w/w nonreactive ingredients. Leukocytes: 0.4% w/w derivatized pyrrole amino acid ester; 0.2% w/w diazonium salt; 40.9% w/w buffer; 58.8% w/w nonreactive ingredients

BIO-RAD Control System - Urine control Level I and Level II : Human erythrocytes, constituents of animal origin, chemicals, and preservatives. VI. STORAGE AND STABILITY:        VII. Reagent strips must be stored in the original capped vial at room temperature (below 85 degrees F/ 30 degrees C). Replace cap immediately after removing test strip. Opened reagent strips may be used until the printed expiration date on the vial if quality control testing is acceptable. BIO-RAD qUAntify control Levels 1 and 2 will be stable until the manufacturer’s expiration date when unopened controls are stored at 2-8°C (36-46°F). Vials of BIO-RAD qUAntify control Levels 1 and 2 once opened will be stable for 31 days when stored tightly capped at 2-25°C (refrigerated or room temperature). All reagent strips and quality control (QC) must be labeled with staff initials and a valid expiration date. Do not freeze control solution Do not store reagent strips in direct sunlight

CALIBRATION: N/A

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QUALITY CONTROL (QC): Control systems evaluate the accuracy of testing technique, as well as the function and stability of the products used. Quality Control (Level I –negative and Level II-positive) must be tested every 24 hours on each open bottle of Multistix 10SG reagent strips that are being used for patient testing.

Quality Control Testing Procedure: 1. Check the expiration date on the control bottle—(expires 1 month after
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2. 3. 4. 5.

6. 7.

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opening) and verify the lot # of the Control Package Insert matches the lot # of the control solution. Allow control solution to reach room temperature (15-30 minutes). Verify the reagent strips are in-date for use. Remove reagent strip and immediately recap the vial. Shake control bottle gently, to mix and remove dropper cap. Invert control bottle and apply control material directly across each pad by gently squeezing the bottle, making sure not to touch tip of bottle to test strip pads and each pad is wet. Wipe bottle tip and replace cap. Remove excess control by tilting the reagent strip on its edge to blot. (This will prevent color pads from running together) Read the color reactions by comparing each pad to the corresponding test on the label’s color chart. Each test should be read at the manufacturer’s designated times printed on the label. Record each test result as it is read. Compare results to the Control Package Insert written on POCT QC log.

 Quality Control Results must be within expected ranges (acceptable) before performing patient testing.  The Control Package Insert is included with each bottle of control delivered to the patient care area and must be posted in the area where reagent strip control testing is performed and recorded.  The results you obtain when running the control must match the insert.  Always replace the insert when new lot # of control is placed into use.

QUALITY CONTROL PACKAGE INSERT (Expected Results) VISUAL LEVEL II ANALYTE *This lot # will change. Control  * LOT # A2502 values may vary from lot to lot. ALWAYS make sure that the lot GLUCOSE 250-500 mg/dl # on the Control Package Insert BILIRUBIN Small - Moderate Matches the lot # on the Urine KEYTONE 15 - 40 mg/dl
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SPECIFIC GRAVITY BLOOD pH PROTEIN UROBILINOGEN NITRITE LEUKOCYTES

1.010 - 1.020 Moderate - Large 7.0 - 8.5 30 - 100 mg./dl 2 - 4 EU/dl Positive Trace - Small

control bottle. This Control Package Insert is inside each box of Controls

 IF CONTROL IS NOT WITHIN EXPECTED RANGES follow the corrective action steps outlined below B. Corrective Action 1. Check expiration dates on control bottle and urine reagent strips. If supplies are "out of date", obtain new supplies. If supplies are "in date", repeat test. 2. If control is still out of range, replace bottle of control and rerun. 3. If control is still out of range, replace vial of reagent strips and rerun. 4. If control is still out of range, call the POCT Center at 3-5707 or 3-8416 IX. PATIENT TEST PROCEDURE  Observe Standard Precautions 1. 2. 3. Mix urine well before immediately before testing. Remove one strip from reagent strip bottle and replace cap. Immerse test strip in urine (all reagent pads should be wet), then remove immediately. Remove excess urine by dragging the edge of the strip across the top of the specimen container, then blot reagent strip by tilting on its edge onto paper towel.

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Compare reagent pads to the corresponding Color Chart on the bottle label at the specified times. Record results as they are read. Since some color reactions develop over time it is important to read reactions at the recommended times. It is recommended that a microscopic exam on the original sample be performed when any of the following analytes are positive: Blood, Protein, Nitrite, or Leukocyte esterase. Additional tests may be performed if bilirubin or ketone tests are positive.
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Recommended Test Strip Read Times: Glucose 30 seconds Bilirubin 30 seconds Ketones 40 seconds Specific Gravity 45 seconds Blood 60 seconds pH 60 seconds (can read immediately) Protein 60 seconds Urobilinogen 60 seconds Nitrite 60 seconds Leukocyte esterase 60 seconds (Pos.)-120 seconds (Neg.) X. RESULT REPORTING:

Test result names may be abbreviated as shown below. You must include the units for each result where applicable, when reporting patient test results in permanent medical record. The use of symbols ( + / - ) are not acceptable when reporting out patient or QC results. TEST GLUCOSE Bilirubin Ketone Specific Gravity PH Protein Urobilinogen Nitrite Blood Leukocytes ABBREVIATIO N GLU BIL KET SG PH PRO URO NIT BLO LEU mg/dL E.U./dL mg/dL UNITS mg/dL NORMAL RANGES NEGATIVE NEGATIVE NEGATIVE 1.016 – 1.022 5.0-8.0 NEGATIVE 0.2 - 1.0 NEGATIVE NEGATIVE NEGATIVE

XI.

DOCUMENTATION:

Record the following information on the appropriate Quality Control (QC) Log Sheet:      
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Date and time of control testing. Reagent strip lot # and expiration date. Control lot # and expiration date. Control results. Any corrective action. Initials and job title of person performing testing.
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NOTE:

If quality control is not performed because patient testing is not required on a given date or shift, “No Patient Testing” must be indicated on the log sheet.

Record the following information in the patients’ medical record:    Date and time of patient testing Test strip results Initials and job title of person performing testing.

Storage refrigeration temperatures must be verified and recorded daily on provided logs. XII. QUALITY ASSESSMENT:
The manager or designee has oversight of the following requirements:

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All POCT performed in patient care areas have been approved by the Diagnostic Laboratories and the State of Tennessee. Testing is performed only by staff approved by the Diagnostic Laboratories and the State of Tennessee. All staff are trained prior to testing, and assessed for competency annually. Individuals responsible for staff training and /or compliance review, (quality control and patient documentation), have attended appropriate training sessions provided by the POCT Support Center. Initial training records, current annual competency records and ―designated‖ trainer records must be accessible. Notification to the POCT Support Center of any changes or transfer of testing personnel. Current testing procedures and accessible to all testing staff.

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Quality control and maintenance procedures are performed, documented and reviewed for compliance by the manager or designee at least weekly, and are accessible for two years following review. Any corrective action is noted, and filed with records. Routine review of random patient medical records by manager or designee to verify compliance with patient test result documentation as described in testing procedures. Examples must be available for inspections. All testing supplies are stored and labeled according to instructions found in individual testing procedures. CAP proficiency testing, as required, is performed according to accompanying instructions and results and requested information returned to the POCT Support Center within specified time frame.
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Diagnostic Laboratories POCT Support Center Provides:      Technical support Training Content of training materials and testing procedures Validation and implementation of testing methodologies Assistance with request for testing privileges

The POCT Steering Committee is chartered by the VUMC Medical Board and has the authority to revoke testing privileges.

XIII.

LIMITATIONS: 1. Drugs that contain azo dyes (e.g. Pyridium) nitrofurantoin ( e. g. Macrodantin), and riboflavin, cause abnormal urine color and may affect the color development on the reagent pad resulting in both false positive and negative results. 2. The pH of the urine can become alkaline on standing due to release of C02 or production of ammonia by urea splitting bacteria. The pH of highly alkaline urine can appear lower due to a ―run-over‖ effect where acid buffer from the protein reagent pad runs over the adjacent pH pad. Highly pigmented urines may mask the color reaction. 3. False negatives at the trace glucose level can be seen when elevated levels of ketone or ascorbic acid are present. 4. False positive proteins may be seen with highly buffered, alkaline urines, exposure to quaternary ammonium compounds, or exposure to skin cleansers containing chlorhexidine. 5. False positive ketone results can be seen in highly pigmented urine specimens and in the presence of high levels of levodopa.

6. False negative bilirubin results may occur with old specimens due to oxidation of bilirubin, and ascorbic acid levels > 25 mg/dL. Indican and other pigmented drugs may interfere with test interpretation. 7. False positive urobilinogen results may occur with para-aminosalicylic acid (a bacterial drug) and sulfonamides. False negatives results may occur when formaldehyde is present. Highly pigmented urines may mask the color reaction. 8. Strong oxidizing agents can cause false positive leukocyte results. Falsely lowered reading may be caused by elevated: 1) glucose ( 3000 mg/dL); 2) specific gravity; 3) protein; 4) various drugs including, tetracycline, cephalothin, cephalexin and ascorbic acid. Highly pigmented urines, especially those containing azo dyes, may mask this reaction. 9. False negative nitrites may occur with: 1) ascorbic acid levels > 25 mg/dL at low nitrite levels; 2) improper bladder incubation time (< 4 hours); 3) lack of dietary nitrate; 4) high urine specific gravity.
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10. Highly buffered alkaline urines may cause low specific gravity readings relative to other methods. Elevated specific gravity readings may be obtained in the presence of moderate quantities (100 - 750 mg/dL) of protein. 11. False positive blood may occur with certain oxidizing contaminants such as hypochlorite and microbial peroxidase. Elevated specific gravity may reduce the reactivity of the test. Sensitivity: Glucose Bilirubin Ketone Blood Protein Nitrite Leukocytes Linearity: Glucose Bilirubin Ketone Specific Gravity pH Protein Urobilinogen Nitrite Blood Leukocyte 2000 Large 160 1.030 8.5 2000 8.0 Positive Large Large 75 -125 mg/dL 0.4 – 0.8 mg/dL 5 – 10 mg/dL 0.015 – 0.062 mg/dL 15 – 30 md/dL 0.06 – 0.1 mg/dL 5 –15 cells/ hpf in clinical urine

XIV.

PROCEDURAL NOTES: 1. Urine must be collected in a clean dry container free from any detergents, or disinfectant residue since the oxidants contain in such cleaning agents may cause the test areas on the urine test strips for blood and glucose to indicate false positive results. 2. Do not touch the testing area with anything except urine or control solution. 3. Do not use test strip if the testing areas are discolored. 4. Do not cut or manipulate test strips. 5. Because this test is visually read and requires color differentiation, individuals with color blindness should not interpret results. 6. If urine test strip screening is unavailable due to QC, supply or staffing issues, patient specimens must be sent to the hospital Laboratory for testing.

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XV.

SAFETY:

 Observe Standard Precautions 1. Staff using the Bayer Multistix 10 SG should use personal protective equipment (PPE) when performing urine reagent strip testing. 2. OSHA and institution protocols for handling bio-hazardous materials should be observed at all times.

XVI.

REFERENCES: 1. Bayer: MULTISTIX10SG Product Insert # AN30516C, Bayer Corporation, Elkhart, IN 46515 USA. Rev. April 1999. 2. BIO-RAD: Control System product insert #02A-975. BIO-RAD Laboratories, Clinical Diagnostics Group, 9500 Jeronimo Road, Irvine, California 92618. Rev 12-2004. 3. VUMC Hematology- Urine Reagent strip Testing Procedure, 2002 4. VUMC POCT Support Center

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