Stewart Green and Christopher Randell

CONTENTS

Introduction 158

1 Overview of "Traditional" Microbiological Methods 159

2 Rapid Microbiological Methods in Practice 161

2.1 Identification Methods 162

2.2 Miniaturized Detection Kits 162

2.3 Fatty Acid Analysis Using Gas Chromatography 163

2.4 Electrophoresis 163

2.5 Mass Spectroscopy (MALDI-TOF) 163

2.6 ELISA (Enzyme-Linked Immunosorbent Assay) 164

2.7 Nucleic Acid Technique 164

2.8 Fluorescent Probes 165

2.9 Fourier Transform Infrared Spectroscopy (FTIR) 165

3 Enumeration and Presence Methods 165

3.1 ATP (Adenosine Triphosphate)-Based Systems 166

3.2 Microcalorimetry 167

3.3 Impedance 167

3.4 Direct Epifluorescent Filtration Technique (DEFT) 168

4 The International Regulatory Position 169

5 Validation 170

6 Identification Methods 172

6.1 Accuracy 172

6.2 Precision 173

6.3 Ruggedness 173

6.4 Robustness 173

© 2004 by CRC Press LLC 157

6.5 Qualitative Methods (Presence or Absence) 173

7 Case Study 177

7.1 Precision 177

7.2 Specificity 178

7.3 Limit of Quantification 178

7.4 Linearity 178

7.5 Range 179

7.6 Ruggedness 179

7.7 Robustness 179

7.8 Equivalence 179

8 Ready Reckoner 180

References 180

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