Cholestech LDX^® System Procedural Documentation

• Cholestech LDX System User Manual
• Cholestech LDX System Procedure Manual
• Cholestech LDX Quick Reference Guide
• All Lipids/Glucose Cassettes Package Insert
• Lipid Profile•ALT Cassette Package Insert
• ALT•AST Cassette Package Insert
• hs-CRP Cassette Package Insert
• Running ALT•AST and Lipid Profile on the Same Patient
• Running Lipid Profile and hs-CRP on the Same Patient
• Running ALT•AST, Lipid Profile and hs-CRP on the Same Patient
• Running Lipid and A1C on the Same Patient
• Calculated Results on the Cholestech LDX Analyzer

Cholestech GDX™ System Procedural Documentation

• Cholestech GDX Analyzer User Manual
• Cholestech GDX System Procedure Manual
• Cholestech GDX Quick Reference Guide
• A1C Test Cartridges Package Insert
• A1C Controls Package Insert
• A1C Cartridge Transport and Storage
• Cholestech GDX System (Technical Focus)

LDX System Accuracy and Reproducibility

• CRMLN Certificate
• The Accuracy and Reproducibility of a Rapid, Fingerstick Method for Measuring a Complete Lipid Profile With ALT is Comparable to Reference Laboratory Methods
• Accuracy and Reproducibility of Point-of-Care Lipid Test Methods Are Certified by the Cholesterol Reference Method Laboratory Network
• Accuracy of a Rapid, Fingerstick Lipid Profile Method Is Comparable to Commercial Laboratory Methods
• Accuracy of a Rapid, Fingerstick Method for High Sensitivity CRP is Comparable to a Commercial Laboratory Method
• The Accuracy and Reproducibility of a Rapid, Fingerstick Method for Measuring a Complete Lipid Profile is Comparable to a Reference Laboratory Method
• Clinical Performance of the CardioChek P.A™ and the Cholestech LDX System Compared to a Clinical Diagnostic Laboratory Reference Method for the Determination of Lipid Profiles
• Accuracy of Two Rapid, Fingerstick Methods for Measuring LDL Cholesterol
• The Accuracy and Reproducibility of a Rapid, Fingerstick Method for Measuring Alanine Aminotransferase is Comparable to Reference Laboratory Methods
• The Accuracy and Reproducibility of a Rapid, Point-of-Care Method for Measuring Alanine Aminotransferase and Aspartate Aminotransferase Is Comparable to Clinical Laboratory Methods
• Performance Evaluations on the Cholestech LDX System
• Precision, Accuracy, and Total Analytical Error

GDX System Accuracy and Reproducibility

• NGSP Certificate
• Accuracy and Reproducibility of a Rapid, Fingerstick Method for Measuring A1C Certified by the NGSP
• Comparison of Two Rapid Methods for Determining A1C
• Multi-method Comparison of Point of Care A1C Testing Analyzers

Test Information

• A1C (hemoglobin A1C)
• ALT and AST
• High Sensitivity C-Reactive Protein (hs-CRP)
• Glucose and Diabetes
• Patient Variables in Lipid Testing
• Standardization of Lipid Tests
• Hemoglobin Variants and Derivatives on A1C Measurement

Data Logs

• Cholestech LDX Patient Result Log
• Cholestech LDX Quality Control Log
• Cholestech LDX Quality Control Log #2
• Cholestech LDX Optics check log
• A1C Result log (.xls)

Material Safety Data Sheets

• Controls : Lipids, glucose, ALT, AST
• Cassettes : Lipids, glucose, ALT, AST
• Controls : hs-CRP
• Cassettes : hs-CRP
• Controls : A1C
• Cholestech GDX : Optics Check Cartridge
• Cholestech GDX Test Cartridge

Quality Control Assay Sheets

A1C

• Lot 071V19 (Expiration Date: 17 January 2009)
• Lot 071V18 (Expiration Date: 11 December 2008)
• Lot 071V17 (Expiration Date: 16 November 2008)
• Lot 071V16 (Expiration Date: 18 September 2008)
• Lot 071V15 (Expiration Date: 06 March 2008)

hs-CRP

• Lot 0802R (for C17 7161 only)
• Lot 0802 (for C17 7148 only)
• Lot 0802 (for C17 6854 only)
• Lot 0802 (for C17 6772B only)
• Lot 0802 (for C17 6741 only)
• Lot 0802 (for C17 6615B only)
• Lot 0802 (for C17 6548B only)
• Lot 0802 (for C17 6539 only)
• Lot 0802 (for C17 6456 only)
• Lot 0802 (for C17 6470B only)

Lipid Controls (Lipids and Glucose)

• Lot 8021 (Expiration Date: 21 January 2009)
• Lot 7311 (Expiration Date: 7 November 2008)
• Lot 7207A (Expiration Date: 26 July 2008)

Lipid Profile•ALT Controls

• Lot 7190 (Expiration Date: 8 April 2008)

Multi-Analyte Controls (Lipids, Glucose, ALT, and AST)

• Lot 8021 (Expiration Date: 21 October 2008)
• Lot 7311 (Expiration Date: 7 August 2008)
• Lot 7207A (Expiration Date: 26 April 2008)

Calibration Verification Materials (Lipids, Glucose)

• Lot 8049 (Expiration Date: 18 February 2009)
• Lot 7235 (Expiration Date: 23 August 2008)
• Lot 7088 (Expiration Date: 29 March 2008)

Miscellaneous

• Achieving Successful Proficiency Testing
• CLIA 88

CardioChek is a trademark of Polymer Technology Systems Inc.