SEA-HLM-328 Distribution: General Guidelines on Standard Operating Procedures for Clinical Chemistry Dr A.S. Kanagasabapathy Professor and Head, Department of Clinical Biochemistry Christian Medical College, Vellore Dr Sudarshan Kumari Regional Advisor, Blood Safety and Clinical Technology WHO, SEARO World Health Organization Regional Office for South-East Asia New Delhi September 2000 © Word Health Organization 2000 This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, by freely reviewed, abstracted, reproduced or translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors Contents Page Foreword......................................................................................................................................................................vii Acknowledgements......................................................................................................................................................ix Preface .........................................................................................................................................................................xi SECTION A: GENERAL INTRODUCTION 1. Introduction........................................................................................................................................................1 Quality manual......................................................................................................................... 1 Standard operating procedures.................................................................................................. 2 Laboratory errors ...................................................................................................................... 3 Preparation of QC pool............................................................................................................. 5 Construction of Levey Jennings chart.......................................................................................... 7 External quality assessment...................................................................................................... 10 2. Introduction to SOP..........................................................................................................................................12 Specifications ..................................................................................................................................... 12 SECTION B: BIOCHEMICAL MEASUREMENTS IN PLASMA/SERUM 3. Glucose – Glucose Oxidase Method ...............................................................................................................15 Introduction ........................................................................................................................... 15 Principle of the method .......................................................................................................... 15 Specimen type, collection and storage ..................................................................................... 15 Reagents ................................................................................................................................ 16 Equipment, glassware and other accessories ............................................................................. 17 Procedure .............................................................................................................................. 17 Calculation and calibration graph............................................................................................. 18 Analytical reliabilities............................................................................................................... 18 Hazardous materials ............................................................................................................... 19 Reference range and clinical interpretation............................................................................... 19 Limitations ............................................................................................................................. 19 References ............................................................................................................................. 19 4. Urea – Diacetyl Monoxime Method................................................................................................................21 Introduction ........................................................................................................................... 21 Principle of the method .......................................................................................................... 21 Specimen types, collection and storage .................................................................................... 21 Reagents ................................................................................................................................ 21 Page i Equipment, glassware and other accessories ............................................................................. 22 Procedure .............................................................................................................................. 22 Calculation and calibration graph............................................................................................. 23 Analytical reliabilities............................................................................................................... 24 Hazardous materials ............................................................................................................... 24 Reference range and clinical interpretation............................................................................... 24 Limitations ............................................................................................................................. 24 References ............................................................................................................................. 25 5. Creatinine – Jaffe’s Method..............................................................................................................................26 Introduction ........................................................................................................................... 26 Principle of the method .......................................................................................................... 26 Specimen type, collection and storage ..................................................................................... 26 Reagents ................................................................................................................................ 26 Equipment, glassware and other accessories ............................................................................. 27 Procedure .............................................................................................................................. 27 Calculation and calibration graph............................................................................................. 28 Analytical reliabilities............................................................................................................... 29 Hazardous materials ............................................................................................................... 29 Reference range and clinical interpretation............................................................................... 29 Limitations ............................................................................................................................. 29 References ............................................................................................................................. 30 6. Cholesterol – Cholesterol Oxidase Method.....................................................................................................31 Introduction ........................................................................................................................... 31 Principle of the method .......................................................................................................... 31 Specimen type, collection and storage ..................................................................................... 31 Reagents ................................................................................................................................ 31 Equipment, glassware and other accessories ............................................................................. 32 Procedure .............................................................................................................................. 32 Calculation and calibration graph............................................................................................. 32 Anaytical reliabilities ............................................................................................................... 33 Hazardous materials ............................................................................................................... 33 Reference range and clinical interpretation............................................................................... 33 Limitations ............................................................................................................................