Technical Support FAQs

Do patients need to be fasting for testing on the Cholestech LDX^® System?

Patients do not have to be fasting for total cholesterol and HDL cholesterol testing. Triglycerides and glucose can increase markedly after eating. For accurate triglyceride and glucose results patients should be fasting for 9-12 hours before blood is drawn for testing. The triglyceride result is used in calculating the LDL cholesterol result so for accurate LDL cholesterol results the patient should also be fasting.

Why am I getting N/A for my HDL cholesterol result?

Check to see what the triglyceride result is. If the triglycerides are >650 mg/dL (>7.34 mmol/L) the HDL cholesterol result will not be accurate and will be reported as N/A.

Why am I getting N/A for my LDL cholesterol result?

There may be several reasons for an LDL cholesterol result of N/A. The LDL cholesterol is calculated as follows: LDL=(TC-HDL-TRG/5).

• If the triglyceride result is >400 mg/dL (>4.51 mmol/L), the calculated LDL cholesterol will not be accurate and the LDL result will be reported as N/A.
• If the TC, HDL or TRG results are outside the measuring range of the instrument, the LDL will also not be calculated and will be reported as N/A.

How is the Lipid Profile•ALT test run on the Cholestech LDX System?

The Lipid Profile•ALT test is run using the same procedure as that for lipids and glucose with the following exception:

• There is a separate Cholestech control available for use with the Lipid Profile•ALT test cassette. You must use the Lipid Profile•ALT Control when running the Lipid Profile•ALT test.

How is the ALT•AST test run on Cholestech LDX System?

The ALT•AST test is run using the same procedure as that for lipids and glucose with the following exceptions:

• There is a separate Cholestech control available for use with the ALT•AST test cassette. Use the Multi-Analyte Controls, not the Lipid Controls, for ALT•AST.

Are there any other differences between the ALT•AST test and the lipid tests?

Assays for ALT and AST may be run at commercial clinical laboratories at different temperatures, typically 30°C or 37°C. The Cholestech LDX ALT•AST test is run at 37°C.

Why do I have to run the Optics Check Cassette and Controls?

The Optics Check Cassette checks the optical components and electronics of the Cholestech LDX System. It should be run each day you run patient samples and the results recorded on the Optics Check Log.

Cholestech Controls are run to assure that all parts of the Cholestech LDX System - the cassettes, the analyzer, the pipette and the operator - are functioning properly. Together the Optics Check Cassette and the controls give you assurance that your test results are accurate, precise and reliable.

How often do I have to run the controls?

• With each new shipment of cassettes (even if cassettes are from the same lot previously received)
• With each new lot of cassettes
• As otherwise required by your laboratory's standard Quality Control procedures
• If you are not running the Cholestech LDX System under CLIA waived status, or if your local or state regulations require more frequent testing of quality control material, then quality control must be performed in compliance with those regulations.

Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about test system integrity or operator technique (e.g., when reagents may have been stored or handled in a way that can degrade their performance or when operators have not performed a particular test in recent weeks).

The quality control results should be in range before testing patient samples. See the Cholestech LDX User Manual if they are not.

How do you run controls on the Cholestech LDX System?

Detailed information on how to run controls can be found on the Cholestech LDX Assay Sheet shipped with the product. Below is a brief summary of this information.

Controls should be run only when the material is at room temperature

Make certain that the lot number of the controls corresponds to the correct assay sheet when comparing expected results.

Mix each vial by gentle inversion 7-8 times

Use the appropriate MiniPet™ Pipette and tips to dispense the control material onto the test cassette. Use a new tip for each control level

Follow the direction for the test cassette procedure being used. Controls are to be tested in the same manner a patient's sample would be tested.

What is the expected range for the Cholestech LDX Optics Check Cassette?

The expected range for an Optics Check Cassette is listed on the cassette itself. Refer to your Optics Check Cassette for the specific standard range information.

How long can I use my cassettes? How long can I keep my cassettes at room temperature?

As soon as you receive your cassettes they should be placed in the refrigerator. When stored refrigerated at 2-8°C (36°-46°F) the cassettes are stable and can be used until the expiration date printed on the cassette pouch and box. Cassettes can be taken out of the refrigerator and stored at room temperature for thirty (30) days. Once the cassettes have been removed from the refrigerator, and have reached room temperature, the room temperature timing starts. The cassettes cannot be returned to the refrigerator to extend the dating to the expiration date on the label once they have reached room temperature.

Can I use capillary tubes which are not Cholestech Capillary Tubes?

You should use only Cholestech Capillary Tubes when collecting blood for testing on the Cholestech LDX System. Cholestech Capillary Tubes are calibrated to hold the appropriate sample volume for each test. They also contain a lithium heparin anticoagulant which keeps the blood from clotting. Any other capillary tubes may not measure the correct amount or have the proper anticoagulant.

Can plasma or serum be used on the LDX System?

Yes, make certain that the Cholestech LDX is set to the sample type "SERUM" when running serum or plasma. See Cholestech LDX User Manual to set the sample type within the Configuration Menu of the Cholestech LDX.

What are the basic supplies every LDX System user should have?

View Product Catalogue for specific part numbers for these items

• Optics Check Cassette
• Validated control material for test(s) desired
• Appropriate MiniPet pipette/tips for running controls
• Cholestech LDX test cassette specific for the test(s) desired to be performed
• Appropriate blood collection supplies indicated for sample type to be used by end-user (e.g. lancets, capillary tubes and plungers, venous blood collection tubes and accessories)
• Alcohol pads, gauze, bandages, gloves, biohazard waste container

How closely should the Cholestech LDX System results agree with my current lab results?

The LDX System gives you the same level of accuracy and precision that you would get from a clinical lab. Results for total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides meet the total error guidelines set by the National Cholesterol Education Program (NCEP).

The total error guidelines are as follows:

Total cholesterol	±8.9%
HDL cholesterol	±13%
Triglycerides	±15%
LDL cholesterol	±12%

This means that you can expect 95% (95 out of 100) of the individual test results in normal individuals to be within these total error guidelines when you compare the LDX System results to a method which also meets NCEP total error guidelines.

Although there are no nationally accepted guidelines for glucose total error, the Cholestech LDX System provides test results which are consistent with good patient care. Total error for glucose = ±11%.

Do I need to calibrate my Cholestech LDX System?

The LDX System requires no user calibration. The calibration information for running a test is encoded on the brown magnetic stripe on each cassette and is read each time a cassette is run. Since calibration differences between methods can play a role in the variation in results between methods, the NCEP established the Lipid Standardization Program (LSP) to look at improving the accuracy and precision of lipid methods. To make it easier for vendors, such as Cholestech, to standardize their methods, a national network of laboratories (the National Cholesterol Reference Method Laboratory Network [CRMLN]) was set up with lipid methods standardized to the CDC (Centers for Disease Control and Prevention) reference methods for lipids. The Cholestech total cholesterol, HDL cholesterol and triglyceride methods on the test cassettes are standardized to the CDC through one of the CRMLN laboratories. The glucose method is standardized to a hexokinase method at a reference laboratory. The ALT and AST tests are standardized to a validated reference method. The hs-CRP test is standardized using an internationally accepted reference material.

What is the measuring range of the Cholestech LDX System tests?

The measuring range for each analyte is as follows:

• Total cholesterol 100 -500 mg/dL or 2.59 - 12.93 mmol/L
• HDL cholesterol 15-100 mg/dL or 0.39-2.59 mmol/L
• Triglycerides 45-650 mg/dL or 0.51 - 7.34 mmol/L
• Glucose 50-500 mg/dL or 2.78 - 27.75 mmol/L
• ALT 10-400 U/L, 37°C
• AST 10-400 U/L, 37°C
• hs-CRP 0.30 - 10.0 mg/L (whole blood), 0.03-8.00 mg/L (serum)

Results outside these ranges will be reported as less than (<) the lower limit or greater than (>) the upper limit. If repeat testing gives the same < or > result the sample should be sent to a clinical lab for testing.

What are the expected values for the different tests?

Cholesterol and Triglycerides:

The National Heart, Lung and Blood Institute issued 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) in May, 2001. The ATP III report presents NCEP's updated clinical guidelines for cholesterol testing and management and describes the following classifications for cholesterol and triglyceride testing:

Total Cholesterol:

• Desirable: Less than 200 mg/dL (<5.17 mmol/L)
• Borderline: 200-239 mg/dL (5.17-6.18 mmol/L)
• High: Equal to or greater than 240 mg/dL (≥6.21 mmol/L)

HDL Cholesterol:

• Low: less than 40 mg/dL (<1.03 mmol/L)
• High: equal to or greater than 60 mg/dL (≥1.55 mmol/L)

LDL Cholesterol:

• Optimal: less than 100 mg/dL (<2.59 mmol/L)
• Near optimal/above optimal: 100-129 mg/dL (2.59-3.34 mmol/L)
• Borderline high: 130-159 mg/dL (3.36-4.11 mmol/L)
• High: 160-189 mg/dL (4.14-4.89 mmol/L)
• Very high: equal to or greater than 190 mg/dL (≥4.91 mmol/L)

Triglycerides:

• Normal: Less than 150 mg/dL (<1.69 mol/L)
• Borderline high: 150-199 mg/dL (1.69-2.25 mmol/L)
• High: 200-499 mg/dL (2.26 - 5.64 mmol/L)
• Very high: equal to or greater then 500 mg/dL (≥ 5.65 mmol/L)

The ATP III identified HDL cholesterol levels below 40 mg/dL (1.03 mmol/L) as associated with increased risk of coronary heart disease (CHD) in men and women. A high HDL cholesterol level greater than or equal to 60 mg/dL (1.55 mmol/L) is protective and decreases CHD risk.

Glucose:

The American Diabetes Association criteria for fasting plasma glucose (FPG) and the diagnosis of diabetes mellitus:

• FPG ≤ 100 mg/dL (5.55 mmol/L) (normal fasting glucose)
• FPG ≥ 100 and less than 126 mg/dL (≥ 5.5 mmol/L and < 7.00 mmol/L) (impaired fasting glucose or impaired glucose tolerance)
• FPG ≥ 126 mg/dL (7.00 mmol/L) (provisional diagnosis of diabetes confirmed by one of the three methods below)

The criteria for diagnosis of diabetes:

• Symptoms of diabetes plus casual plasma glucose concentration ≥ 200 mg/dL (11.1 mmol/L). Casual is defined as any time of day without regard to time since last meal. (The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.)
• FPG = 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours.
• 2 hr. post glucose load ≥ 200 mg/dL during an oral glucose tolerance test. The test should be performed as described by WHO (World Health Organization) using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.

Any of the above abnormal glucose levels must be confirmed, on a subsequent day, by any one of the three methods listed above. When screening for diabetes, any abnormal glucose result should be referred to a physician for further follow up.

ALT:

• 10-40 U/L at 37°C

AST:

• 10-30 U/L at 37°C

hs-CRP:

• Low risk <1mg/L
• Average risk 1-3 mg/L
• High risk >3mg/L

What is CLIA '88?

CLIA '88, the Clinical Laboratory Improvement Amendments of 1988 is a series of federal laws regulating laboratory testing that were enacted to ensure high quality, reliable, safe and accurate testing in laboratories of all types and sizes throughout the United States. It established new standards for laboratory personnel, quality control and quality assurance based on the complexity and risk of the tests performed. Laboratory tests are classified into one of three categories based on the complexity: waived, moderate complexity, and high complexity. The Cholestech LDX System is in the waived category for all test except hs-CRP.

Distributor FAQs

Where can I find product part numbers?

Click here to view our complete product catalogue

What are the expiration dates of the Cholestech LDX cassettes?

The expiration date for Cholestech LDX test cassettes is between 6 and 12 months from the date of manufacture, depending on the type of test cassette. We strive to provide the longest dating possible to our customers.

Do Cholestech LDX test cassettes have to be shipped refrigerated to customers?

Cholestech LDX test cassettes (except hs-CRP) do not require refrigeration when shipped to your customers. Shipments are stable when shipped over a three (3) day time frame without cold packs. Hs-CRP cassettes must be shipped with cold packs over a two (2) day frame. Refrigerate all cassettes upon arrival. All cassettes can be taken out of the refrigerator and stored at room temperature for thirty (30) days. Once the cassettes have been removed from the refrigerator, and have reached room temperature, the room temperature timing starts. The cassettes cannot be returned to the refrigerator to extend the dating to the expiration date on the label once they have reached room temperature.

Do controls have to be shipped refrigerated to end users?

Yes, controls should be shipped with cold packs overnight with "Refrigerate Upon Arrival" stickers.

What is the policy for same day shipments?

Our cutoff time for same day orders is 10am (PST). Depending on order volume being processed we may not always able to ship the same day. There may be an added charge of $25 for same day orders.

Where can I get training information for Cholestech Systems?

Visit the product training section to view training video and additional training resources

Does Cholestech provide in-service training to new customers?

Yes. Cholestech products are supported by a dedicated nationwide team of Technical Consultants. The Technical Consultant will assess the customer training needs. To locate a Tech Consultant in your geographic area call Customer Service at 800.733.0404 (510.732.7200)

What do I do if my customer has a complaint, a question or needs service?

All complaints must be reported to Technical Service for proper documentation. The caller should be prepared to provide a contact name and telephone number for the complainant.

General Questions

Where can I find information about reimbursement for Cholestech Products?

Visit the Billing and Coding section to get specific reimbursement information for your state

How accurate are Cholestech LDX and GDX Systems?

Click here to learn about certified accuracy of Cholestech Systems

Why do I need a Certificate of Waiver?

CLIA '88 applies to all laboratories, physician offices, pharmacies, or other entities that perform testing of materials derived from the human body for purposes of diagnosis, prevention, treatment or heath assessment. All users of waived tests are required to register with CMS (formerly HCFA) and obtain a CLIA Certificate of Waiver.

How do I get a CLIA Certificate of Waiver?

Visit the CLIA compliance central for more information on how to obtain a CLIA waiver

Frequently Used Acronyms

A1C	It is the major sub fraction of the glycated normal hemoglobin, also known as glycohemoglobin, or glycosylated hemoglobin (HbA1c)
ADA	American Diabetes Association
AHA	American Heart Association
ALT	Alanine Aminotransferase
API	American Proficiency Institute
AST	Aspartate Aminotransferase
CAP	College of American Pathologists
CDC	Centers for Disease Control and Prevention
CHC	Community Health Centers
CHD	Coronary Heart Disease
CLIA	Clinical Laboratory Improvement Amendments
CLIAC	Clinical Laboratory Improvement Advisory Committee
CMS	Centers for Medicare and Medicaid Services
COLA	Commission on Office Laboratory Accreditation
CPT	Current Procedural Terminology
CRMLN	Cholesterol Reference Method Laboratory Network
CVD	Cardiovascular Disease
DCCT	Diabetes Control and Complications Trial
E&M	Evaluation & Management Codes
EOB	Explanation of Benefits
FDA	Food and Drug Administration
GLU	Glucose
GPO	Group Purchasing Organization
HDL	High Density Lipoprotein
HIDA	Health Industry Distributors Association
HMO	Health Maintenance Organization
hs-CRP	High sensitivity C-reactive protein
ICD-9	International Classification of Disease, 9th Revision
IHPM	Institute for Health and Productivity Management
JCAHO	Joint Commission on Accreditation of Health Care Organizations
LDL	Low Density Lipoproteins
LSP	Lipid Standardization Program
MCO	Managed Care Organization
MMA	Medicare Prescription Drug/Improvement and Modernization Act
MSDS	Material Safety Data Sheet
NCD	National Coverage Determination
NCEP	National Cholesterol Education Program
NGSP	National Glycohemoglobin Standardization Program
NHLBI	National Heart, Lung, & Blood Institute
NIH	National Institutes of Health
POCT	Point-of-Care Testing
POC	Point-of-Care
POL	Physician Office Lab
ROM pack	Read Only Memory Package - Brains of the LDX
TC	Total Cholesterol
TRG	Triglycerides
UKPDS	United Kingdom Prospective Diabetes Study
510(k)	US FDA Premarket Notification
%CV	Coefficient of variation - precision