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
• 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
• Calculated Results on the Cholestech LDX Analyzer

LDX System Accuracy and Reproducibility

• CRMLN Certificate
• 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

Test Information

• ALT and AST
• High Sensitivity C-Reactive Protein (hs-CRP)
• Glucose and Diabetes
• Patient Variables in Lipid Testing
• Standardization of Lipid Tests

Data Logs

• Cholestech LDX Patient Result Log
• Cholestech LDX Quality Control Log
• Cholestech LDX Quality Control Log #2
• Cholestech LDX Optics check log

Material Safety Data Sheets

• Controls & Calibration Verification Materials : Lipids, glucose, ALT, AST
• Cassettes : Lipids, glucose, ALT, AST
• Controls : hsCRP
• Calibration Verification Materials : hsCRP
• Cassettes : hs-CRP

Quality Control Assay Sheets

hs-CRP

• Lot 0905108 (for C17 7959B only)
• Lot 0905019 (for C17 7996 only)
• Lot 0905108 (for C17 7841 only)
• Lot 0905108 (for C17 7794 only)
• Lot 0905108 (for C17 7656 only)
• Lot 0802R (for C17 7794 only)
• Lot 0802R (for C17 7656 only)
• Lot 0802R (for C17 7459 only)
• Lot 0802R (for C17 7321 only)
• Lot 0802R (for C17 7260 only)
• Lot 0802R (for C17 7212 only)
• Lot 0802R (for C17 7161 only)

Lipid Controls (Lipids and Glucose)

• Lot 0034 (Expiration Date: 03 February 2011)
• Lot 9175 (Expiration Date: 24 June 2010)
• Lot 9063 (Expiration Date: 4 March 2010)
• Lot 8317 (Expiration Date: 12 November 2009)

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

• Lot 0034 (Expiration Date: 03 November 2010)
• Lot 9287 (Expiration Date: 14 July 2010)
• Lot 9175 (Expiration Date: 24 March 2010)
• Lot 9063 (Expiration Date: 4 December 2009)
• Lot 8317 (Expiration Date: 12 August 2009)

Calibration Verification Materials

Lipids and Glucose

• Lot 9063 (Expiration Date: 4 December 2009)
• Lot 8317 (Expiration Date: 12 August 2009)

hsCRP

• Lot 0905019 (for C17 7959B)
• Lot 0905019 (for C17 7996)
• Lot 0905108 (for C17 7841)
• Lot 0905105 (for C17 7794)
• Lot 0905105 (for C17 7656)

Miscellaneous

• Achieving Successful Proficiency Testing
• CLIA 88

CardioChek is a trademark of Polymer Technology Systems Inc.