Theory and application of Microbiological Assay

Preface

Acknowledgments

Chapter 1 Microbiological Assay, An Overview


1.1 Introduction


1.2 General Principles of Biological Assay


1.3 Basic Techniques of Microbiological Assay


1.4 Capability and Limitations


1.5 Current Status of Antibiotic Assays


1.6 When to Use Microbiological Assays

References

Chapter 2 Test Organisms


2.1 Introduction


2.2 Safety


2.3 Culture Media


2.4 Freeze-Dried Assay Cultures


2.5 Culture Checks


2.6 Culture Maintenance


2.7 Preparation of the Inoculum


2.8 Preparation of Spore Suspensions


2.9 Preliminary Assay Considerations


2.10 Minimum Inhibitory Concentration

References

Chapter 3 Test Solutions


3.1 Introduction


3.2 Reference Standards: Principles and Problems


3.3 Reference Standards: Practical Approaches


3.4 Preparation of Test Solution

References

Chapter 4 The Agar Diffusion Assay


4.1 Essential Features of the Assay


4.2 Practical Methods of Zone Production


4.3 Factors Influencing Zone Size


4.4 Dose-Response Relationship


4.5 Practical Assay Designs


4 4. The Plate Method in Practice


5 References

Chapter 5 Tube Assays for Growth-Inhibiting Substances


5.1 Introduction


5.2 Outline of the Method


5.3 Nature of the Response


5.4 Critical Factors


5.5 The Tube Method in Practice


5.6 Automated Methods

References

Chapter 6 Tube Assays for Growth-Promoting Substances


6.1 Introduction


6.2 Outline of the Method


6.3 Nature of the Response


6.4 Critical Factors


6.5 The Tube Method in Practice

References

Chapter 7 Quality Control Procedures


7.1 Introduction


7.2 Media


7.3 Diluents


7.4 Stock Cultures


7.5 Inoculum


7.6 Spore Suspension


7.7 Working Standards


7.8 Standard Solutions


7.9 Dilutions


7.10 Plating-Out Pipettes


7.11 Miscellaneous Equipment


7.12 Designs Used in Microbiological Assays


7.13 Zone-Reading Performance


7.14 Washing Performance


7.15 Finding the Correct Dose Levels


7.16 Adjusting Zone Size


7.17 Testing Agar for Suitability in Diffusion Assays


7.18 Staff Selection and Training

References

Chapter 8 Assay Design and Evaluation


8.1 Definitions


8.2 Dose-Response Lines: Type 1


8.3 Dose-Response Lines: Type 2


8.4 Selection of Experimental Design

References

Chapter 9 Diffusion Assay Methods for Antibiotics


9.1 Introduction


9A Routine Methods


9.2 Amikacin


9.3 Amoxicillin


9.4 Ampicillin


9.5 Azlocillin


9.6 Bacitracin


9.7 Benzalkonium Chloride


9.8 Carbenicillin


9.9 Cefazolin


9.10 Cefotaxime


9.11 Ceftazidime


9.12 Cefuroxime


9.13 Cephalexin


9.14 Cephaloridine


9.15 Cephalothin


9.16 Chlortetracycline


9.17 Cloxacillin


9.18 Dihydro streptomycin


9.19 Gentamicin


9.20 Neomycin


9.21 Novobiocin


9.22 Nystatin


9.23 Oxytetracycline


9.24 Penicillin G


9.25 Penicillin V


9.26 Phenylmercuric Acetate


9.27 Streptomycin


9.28 Tetracycline


9.29 Thiomersal


9.30 Tobramycin


9B Code of Federal Regulations (21 CFR) Methods


9.31 Amoxicillin


9.32 Amphomycin


9.33 Amphotericin


9.34 Ampicillin


9.35 Bacitracin


9.36 Bleomycin


9.37 Carbenicillin


9.38 Cefactor


9.39 Cefadroxil


9.40 Cefamandole


9.41 Cefazolin


9.42 Cefotaxime


9.43 Cefoxitin


9.44 Cephalexin


9.45 Cephaloglycin


9.46 Cephaloridine


9.47 Cephalothin


9.48 Cephapirin


9.49 Cephradine


9.50 Clindamycin


9.51 Cloxacillin


9.52 Colistimethate Sodium


9.53 Colistin


9.54 Cyclacillin


9.55 Dactinomycin


9.56 Dicloxacillin


9.57 Dihydrostreptomycin


9.58 Erythromycin


9.59 Gentamicin


9.60 Kanamycin


9.61 Methicillin


9.62 Mitomycin


9.63 Nafcillin


9.64 Natamycin


9.65 Neomyci


9.66 Netilmicinn


9.67 Novobiocin


9.68 Nystatin


9.69 Oleandomycin


9.70 Oxacillin


9.71 Paromomycin


9.72 Penicillin


9.73 Penicillin


9.74 Plicamycin


9.75 Polymyxin


9.76 Rifampin


9.77 Sisomicin


9.78 Streptomycin


9.79 Ticarcillin


9.80 Vancomycin

References

Chapter 10 Diffusion Assay Methods for Vitamins


10.1 Introduction


10.2 Thiamine


10.3 Riboflavin


10.4 Pyridoxine


10.5 Cyanocobalamin


10.6 Biotin


10.7 Folic Acid


10.8 Nicotinic Acid


10.9 Pantothenate

References

Chapter 11 Practical Tube Assays


11A Antibiotics


11.1 Introduction


11.2 Amikacin


11.3 Candicidin


11.4 Capreomycin


11.5 Chloramphenicol


11.6 Chlortetracycline


11.7 Cycloserine


11.8 Demeclocycline


11.9 Dihydro streptomycin


11.10 Doxycycline


11.11 Erythromycin


11.12 Gramicidin


11.13 Kanamycin


11.14 Lincomycin


11.15 Meclocycline


11.16 Methacycline


11.17 Minocycline


11.18 Neomycin


11.19 Oxytetracycline


11.20 Rifamycin Sodium


11.21 Rolitetracycline


11.22 Spectinomycin


11.23 Streptomycin


11.24 Tetracycline


11.25 Tobramycin


11.26 Troleandomycin


11.27 Tyrothricin


11B Vitamins


11.28 Introduction


11.29 Common Techniques


11.30 Thiamine


11.31 Riboflavin


11.32 Pyridoxine


11.33 Cyanocobalamin


11.34 Folic Acid


11.35 Niacin


11.36 Pantothenate

References

Chapter 12 Assay Replication


12.1 Introduction


12.2 Replication for Routine Samples


12.3 Replication for Stability Samples


12.4 Replication for Raw Materials


12.5 Replication for Calibration of In-House Standards


12.6 Replication for Collaborative Assays

References

Appendix 1 Disinfectants and Detergents Suitable for Use in Microbiological Assay Laboratories

Appendix 2 Suppliers of Bacteriological Culture Media

Appendix 3 Formulas and Preparation of Bacteriological Culture Media

Appendix 4 List of Media and Diluents Used in Antibiotic Assays

Appendix 5 Sources of Reference Substances and Cultures

Appendix 6 Expressions for the Calculation of E and F for Potency Estimation from Parallel Line Assays

Appendix 7 Basic Bacteriological Staining Techniques

Appendix 8 Some Practical Assay Designs

Index