Policy: | Certification: | Testing Prerequisites: | Specimen: | Materials: | Procedure: | Patient Result | Limitations: | Results Derivation: | Expected Result(s) | Quality Control: | Infection Control: | References:
The Cholestech LDX Lipid Panel and Glucose tests are CMS “Waived” status, obviating Equivalent QC and Calibration Verification as stated in CLIA regulations. This test is performed as a definitive function to monitor patient’s Cholesterol, Triglycerides, HDL and Glucose. Results of the test could trigger therapeutic interaction without reflex laboratory analysis.
A certified operator may perform a Lipid Panel and Glucose using the Cholestech LDX Analyzer, Established Quality Control and Infection Control Policies are followed.
The Cholestech LDX System combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, Triglycerides and glucose. The sample is applied to a Cholestech LDX cassette. The cassette is then placed into the Cholestech LDX Analyzer where the plasma is separated from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and Triglycerides reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate and magnesium acetate precipitating reagent. The filtrate is transferred to HDL cholesterol reaction pads and/or glucose, depending on the cartridge used. The Cholestech LDX analyzer measures total cholesterol and HDL cholesterol by an enzymatic method. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-Ethyl-N-sulfohydroxypropyl-m-toluidine, sodium salt to form a purple colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.
The Cholestech LDX Analyzer measures Triglycerides by an enzymatic method based on the hydrolysis of Triglycerides by cholesterol esterase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3-phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol, HDL cholesterol and Triglycerides. The resultant color in all reactions is measured by reflectance photometry. The Cholestech LDX Analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading (%R) to the total cholesterol, HDL cholesterol, Triglycerides and glucose concentrations in mg/dl.
1. Orientation, authorization and competency of staff and licensed practitioners performing POCT are provided by the director’s (named on the CLIA certificate) designee as indicated in the “Point of Care (POCT) Program” procedure.
2. Whole Blood Lipid Panel Testing will be performed only by certified operators.
A. To be certified, an operator must successfully complete the requirements of the Whole Blood Lipid Panel Testing; POCT - Operator Certification Record. He/she must have read and understood the principles written into the Capillary Puncture Procedure (See IV. of this procedure) and the Cholestech LDX Lipid Panel and Glucose, Whole Blood; POCT procedure
B. If the individual seeking certification is unable to demonstrate acceptable capillary-puncture technique and/or is unable to demonstrate acceptable testing technique, he/she must be retrained and successfully retested for authorization to perform POCT for whole blood lipid panel.
C. Recertification is required annually:
a. If the previously certified operator has successfully performed and documented the test two times or less in the last 12 months, he/she will:
1. Perform a quality control test on the Cholestech LDX Analyzer.
2. Review the Cholestech LDX Lipid Panel and Glucose, Whole Blood; POCT Policy/Procedure.
3. Complete the Cholestech LDX Lipid Panel and Glucose, Whole Blood; POCT self-instructional/competency documentation packet.
b. If the certified operator has successfully performed the test more than twice in the last 12 months, he/she will review the current policy/procedure, and complete the Cholestech LDX Lipid Panel and Glucose, Whole Blood; POCT self-instructional/competency documentation packet but will not have to demonstrate proficiency with another authorized operator.
D. The certification record of operators and instructors will be maintained at the site.
1. Cleaning and Maintenance of the meter when necessary.
A. Cleaning is required for infection control.
Notes: Do not use any solvents.
Do not allow water or cleaner to run down into the instrument when cleaning.
B. Perform the following each time the meter is cleaned; (gloves are worn):
Be sure the monitor is off. Clean the exterior surface of the meter using a disposable washcloth dampened with the site’s approved contact germicide. Do not spray germicide directly on the meter.
2. The only designated analyzer for the Cholestech LDX Lipid Panel and Glucose, Whole Blood; POCT Program is the Cholestech LDX Analyzer.
35 – 60 µl capillary whole blood collected in a Cholestech heparinized capillary tube is typically the specimen of choice, however, venous whole blood collected in a lithium heparin tube may also be used. Capillary whole blood should be run within 5 minutes of collection. Venous whole blood specimens should be run within 30 minutes of collection and be at room temperature when run.
The patient should fast for twelve hours before the sample is collected.
Note: It is absolutely essential that the capillary puncture for lipid panel testing produce a free-flowing, hanging drop of blood. Anything short of this will simply not generate reliable results! If the puncture does not produce a free flowing, hanging drop of blood, THE TEST MUST NOT BE RUN.
Sample integrity problems can often be prevented if a warm washcloth is used to enhance capillary bed circulation in the patient’s hand for just a minute or two prior to the procedure.
A. Assemble the necessary equipment:
Note: The fingerstick device must be single-use and auto-disabling such as the MediChoice Pre-set safety lancet, 4863mc5020 through Owens and Minor.
The CDC has noted reports of increasing HBV infection outbreaks linked to diabetes care and warn that fingerstick devices should never be used for more than one person and that the single-use device should be auto-disabling.
a. single-use fingerstick device
b. Tenderfoot for heelsticks
c. MediChoice Pre-Set Safety Lancet Low Flow
d. Cotton ball or gauze pad
e. Alcohol wipe
f. Fresh, non-sterile, latex-free gloves; changed for each patient encounter.
B. Capillary Puncture on a Finger Using the site approved Blood Sampling device:
a. When possible, instruct patient to wash their hands in warm soapy water, rinse, and dry completely.
b. Place the patient’s hand in a dependent position. If the patient’s fingers are cold, wrap a warm washcloth around the fingers for several minutes prior to performing the puncture.
c. Cleanse the puncture site with an alcohol pad just prior to the procedure; allow the site to air dry. The area is then “milked” very gently to encourage capillary flow.
d. Positioning the lancet on the finger puncture site:
Position the oval opening across the long axis of the digit for a normal depth.
Position the oval opening with the long axis of the digit for a deeper puncture.
e. While applying a small amount of pressure on the blood sampling device against the puncture site, press the trigger.
f. Using a clean tissue, cotton ball or gauze; wipe away the first drop of blood.
Note: The first drop of blood is mostly tissue fluid and will not give an accurate result.
g. Gently milk the area to produce a large hanging drop of blood. Do not “squeeze” the tissue around the puncture site.
h. When testing is complete dispose of the lancet in a sharps container. Lancets are not to be reused, even on the same patient.
i. Rotate puncture sites on each patient to minimize soreness.
1. Cholestech LDX Lipid Profile-Glu test cassettes; kit contains 10 test cassettes (Cholestech #10-991)
A. The Cholestech LDX Lipid Profile test cassettes are stable until the expiration date when stored at 2 - 8°C.
B. The cassettes may be stored for up to 30 days at room temperature. Once they have been stored at room temperature, they should not be returned to the refrigerator.
C. Cassettes must be stored in the sealed foil pouches.
2. Cholestech Controls (Cholestech #10-982)
A. The Cholestech LDX Lipid Profile test controls are stable until the expiration date when stored refrigerated at 2 - 8°C.
B. Opened vials are stable for 30 days stored refrigerated at 2 - 8°C.
C. Minimize exposure to strong light. DO NOT freeze.
3. Cholestech LDX 35 µl capillary lithium heparin tubes; contains 50 tubes (Cholestech #10-940)
4. Cholestech LDX 35 µl capillary plungers; contains 50 plungers (Cholestech #10-311)
5. Mini-Pet pipette (Cholestech #11-846)
1. Mercy Family Pharmacy:
Upon the initial patient contact the pharmacist will assess and document:
A. Patient demographics
B. Risk factors for Coronary Heart Disease
C. Current or past hyperlipidemia therapy
D. Concurrent diagnosis or problems
E. Target LDL range
F. Fasting prior to test
G. Concurrent medications
H. Lifestyle modifications including diet and exercise
I. Framingham Risk Assessment if applicable according to NCEP guidelines.
The above information will be recorded on the Cholesterol Screening Form. These sheets will be placed into the patient chart or the screening day file if there’s no patient chart. Results will be given to the patient as well as noted on the Cholesterol Screening Form. Results will be sent to patient’s physician as directed by patient’s signature of release of information.
2. If the cassettes have been refrigerated, allow them to come to room temperature (at least 10 minutes) before opening.
3. Make sure the Analyzer is plugged in and has warmed up.
4. Remove the cassette from its pouch. Hold the cassette by the short side only. Do not touch the black bar or the brown magnetic strip. Place the cassette on a flat surface.
5. Press RUN. The Analyzer will do a self-test. Verify that the self-test is OK.
6. The cassette drawer will open.
7. Fingerstick sample: A fingerstick sample must be applied to the cassette within 5 minutes after collection.
A. Place the capillary tube plunger into the red end of a Cholestech heparinized capillary tube.
B. Perform fingerstick.
C. Hold the capillary tube horizontally with plunger in it. Allow blood to flow into capillary tube, filling tube to the black mark. Do not allow air bubbles in tube.
D. Add sample to the test cassette sample well by pushing the plunger down on the capillary tube.
8. Venous/Control sample:
A. Firmly attach a disposable pipette tip to the end of the Mini-Pet pipette.
B. To fill the pipette, push the plunger down as far as you can.
C. Place the pipette tip into the sample and slowly release the plunger. Do not allow air to be drawn into the tip.
D. Apply sample to the test cassette sample well by pressing the plunger again. Move the pipette tip out of the sample well before releasing the plunger again.
E. Remove the pipette tip and place in a biohazard container.
9. Keep the cassette level after the sample has been applied. Immediately place the cassette into the drawer of the Analyzer. The black reaction bar must face toward the Analyzer. The brown magnetic strip must be on the right.
10. Press RUN. The drawer will close.
11. When the test is complete, the Analyzer will beep. The test results will be displayed.
12. Press DATA to view the calculated results.
13. To obtain the patient’s Risk Assessment, reply to the Risk Assessment questions as prompted by the analyzer.
14. When complete the results will be printed.
15. Place the patient results on the patient’s Screening Form.
16. When the drawer opens, remove the cassette and place in a biohazard container.
17. To run another cassette, press RUN. Repeat the test procedure.
Note: After 4 minutes a beep will sound and the system will timeout.
18. Leave the Analyzer drawer empty and closed, when not in use. If the RUN button is not pushed within 15 seconds, the drawer will close and the screen will go blank.
Mercy Family Pharmacy:
1. During the patient visit, the patient will be educated about the significance of their lipid profile and their Coronary Heart Disease (CHD) risk (steps 1-5)(See ATP III Guidelines for Cholesterol Quick Desk Reference). The patient will be counseled on what they can do related to modifiable CHD risk factors such as smoking, diet, exercise, compliance with medications.
2. CHOLESTEROL MANAGEMENT PROGRAM VISITS
At each follow-up appointment, in addition to measurement of the patient’s lipid panel, the pharmacist will review modifiable risk factors and potential or actual drug therapy problems including compliance with meds.
3. LIPID PROFILE MONITORING
General lipid profile monitoring guidelines follow:
A. Inquire about a recheck at 8 - 12 weeks with a new lipid medication or dose adjustment.
B. Inquire about liver profile testing as required for HMG-CoA medications.
C. When an unusual reading is obtained, causes may include:
a. Inaccurate testing results.
b. Alteration in response due to drug-drug/diet interactions, change in nutritional status, or altered seasonal response.
c. Alteration in drug administration or patient compliance.
d. Abnormal product performance or use of products from various manufacturers.
1. Performance of the Cholestech LDX System has not been tested on newborns.
2. Blood collection tubes with glycerol should not be used for Triglyceride test.
3. Hand creams and soaps with glycerol may cause falsely elevated Triglyceride results.
1. Cholesterol analytical range is 100-500 mg/dl. Results less than 100 will appear as “less than 100”. Results greater than 500 will appear as "greater than 500".
2. Triglyceride analytical range is 45 - 650 mg/dl. Results less than 45 will appear as “less than 45”. Results greater than 650 will appear as "greater than 650".
3. HDL Cholesterol analytical range is 15-100 mg/dl. Results less than 15 will appear as “less than 15”. Results greater than 100 will appear as "greater than 100".
4. Glucose analytical range is 50 - 500 mg/dl. Results less than 50 will appear as “less than 50 mg/dl”. Results greater than will appear as “greater than 500 mg/dl”.
5. If the Cholesterol, HDL or Triglyceride result is outside of the analytical range, the LDL will appear as N/A.
6. If the Triglyceride result is greater than 650, the HDL result may not be accurate and will appear as N/A.
7. If the Triglyceride result is greater than 400, the LDL will not be calculated.
1. Total Cholesterol less than 200 mg/dl
2. HDL Cholesterol greater than 40 mg/dl
3. Triglyceride less than 150 mg/dl
4. Glucose less than 100 mg/dl
1. An Optics Check must be performed once each day of use to verify instrument performance.
A. Press the RUN button. The drawer will open. “Load Cassette and Press Run” will be displayed.
B. Place the Optics Check Cassette into the cassette drawer.
C. Press the RUN button again and the Analyzer will automatically perform the Optics Check.
D. Optics Check and four numbers will be displayed, one for each optical channel.
E. Check to see that the numbers are within the acceptable range (80-105). This range is printed on the Optics Check Cassette.
F. Record the result in the Optics Check Log.
G. If the Optics Check Fails, repeat the test once. If the Optics Check continues to fail, call UCL Instrument Specialist Dept. 556-2010 ext. 150.
2. The bilevel Cholestech Lipid controls must be run with each new shipment and each new lot number of Cholestech LDX Lipid cassettes. The acceptable control ranges will be determined as listed below. Record controls on the Cholestech QC Log.
A. Determine the manufacturers expected range for each test on the control lot number to be used. These are located in the Cholestech Control package inserts.
B. Calculate the expected control mean for each test using a calculator.
(Lower Limit + Upper Limit) ÷ 2)
C. Apply the stated range for each test to determine the acceptable range.
C. Stated ranges are:
a. Level 1 Control:
Triglycerides ± 20
Cholesterol ± 16
Glucose ± 18
HDL ± 8
b. Level 2 Control:
Triglycerides ± 40
Cholesterol ± 22
Glucose ± 34
HDL ± 14
a. Cholesterol Control Level 1 expected range listed in Cholestech Control package insert is 141-198 mg/dl.
b. Determine the mean (141 + 198) ÷ 2 = 169.5 mg/dl
c. 169.5 - 16 = 153.5 lower acceptable limit
d. 169.5 + 16 = 185.5 upper acceptable limit
a. Acceptable range for Cholestech Level 1 Control is 153.5 - 185.5 mg/dl.
3. If a control result “FAILS”:
A. The operator repeats the control one time.
B. If the repeat “PASSES”, proceed with patient testing.
C. If the control repeat “FAILS”, instrument function verification is necessary.
a. Call the United Clinical Laboratories’ (UCL) Instrument Specialists Dept. 556-2010 ext. 150.
b. UCL will notify the site once the nature of the problem has been determined. If operator technique is identified as the problem, the operator will not perform any more tests until their technique has been re-evaluated.
c. Recertification will be managed by an operator/trainer and documented on the certification record, which will be maintained by the testing site.
1. Staff will wash their hands before and after the procedure using proper technique and will wear a fresh pair of latex or vinyl gloves while performing the capillary stick and the Lipid test.
2. Patients having a fingerstick are also to wash their hands with soap and water, when possible. If hand washing is not possible, their hands or the puncture site is to be cleansed with a prepackaged towelette containing alcohol.
3. Dispose of all lancets in a sharps container. All other soiled materials used in the testing are disposed in accordance with the hospital approved waste management policy.
4. If the instrument becomes visibly soiled during use, it will be cleaned with a disposable washcloth dampened with the site’s approved germicide. Do not allow any liquid to run down into the instrument when cleaning.
1. Cholestech LDX Procedure Manual. Cholestech Corporation. Hayward, CA. 1996
2. Cholestech LDX Lipid Profile II package insert. Cholestech Corporation. Hayward, CA. 1999 40201497 Rev.B
3. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 Hay 16; 285(19): 2486-2497.
4. Cholestech LDX Lipid Profile-Glu package insert. Cholestech Corporation. Hayward, CA., 2003; 40212314 Rev. C.
i. August 2002 L. McGovern
ii. May 2004 L. McGovern (Revised: for Finley Business Health)
iii. April 2006 S. Raymond, L. McGovern (Revised: XI.2.)
iv. February 2007 L. McGovern (Revised: I.)
v. November 2007 L. McGovern (Revised: VII.MFP.4.; FOH.1.)
vi. October 2009 L. McGovern, S. Raymond (Revised: II.1. added)
vii. September 2010 L. McGovern (Revised: IV.2.)
Representative: MMC-Family Pharmacy
Interim Review: September 2011 L. McGovern (Revised: Finley Occ. Health removed)