Proceedings of the International Cyanide Detection Testing Workshop

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Vocabulary, 1994 4.5 Foundations of Clinical Research, Applications to Practice, Leslie Gross Portney, Mary Watkins, Appleton & Lange, 1993 4.6 Validation and Peer Review of U.S. Environmental Protection Agency Chemical Methods of Analysis”, Forum on Environmental Measurements, October 14, 2005 4.7 Protocol for the Design, Conduct, and Interpretation of Method-Performance Studies, Pure and Applied Chemistry, 67, No. 2, 1995, 331-343. 4.8 Harmonized Guidelines for Single-laboratory Validation of Methods of Analysis, Pure and Applied Chemistry, 2002, 74, 835 - 855.” 5. Specifi c Procedure(s): 5.1 Prior to submitting methods to the network: 5.1.1 The intended use of the method should be defi ned 5.1.2 The intended use should be aligned with network capabilities 5.1.3 A study plan for method validation should be submitted to and approved by the involved network for review before starting the validation. 5.1.4 A written procedure which includes all the following elements must be prepared: • Intended use and criteria for use • Assay principle and safety precautions • Acceptable sample types, sample collection method, preparation, preservation, storage and transportation conditions • Description of reagents supplied or directions for preparation and QC • Description of quality controls to be used. • Detailed instructions on how to perform the method. • Detailed instructions on how to interpret and report the result. , • Any limitations of the method that are known or suspected • A summary of the performance characteristics of the method 5.1.5 Written directions (specifi cations) for the production and QC of the reagents, if provided for the method 5.2 Methods should be validated whenever any of the following occur: 5.2.1 Submission of a new method to the network for inclusion as an offi cial method. 5.2.2 Expansion of the scope of an existing network method to include additional analytes 66
or new matrices. 5.2.3 Modifi cation of a network method’s range beyond validated levels. 5.2.4 Modifi cation of a network method that may alter its performance specifi cations. This includes: changes to the fundamental science of an existing method, equivalence issues such as substitutions of reagents/apparatus, or changes to some instrumental parameters. Since it is diffi cult to predict the results of any change, all but the most trivial of changes should be evaluated for effects on method performance. 5.3 Performance specifi cations required to validate a method. 5.3.1 Performance specifi cations that should be determined to validate a method will vary depending on the intended use, the type of method being validated, and the degree to which it has previously been validated. All methods submitted must have all the proper controls and the parameters for calibrating and operating the method instrumentation included in the written procedure. 5.3.1.1 Typical validation characteristics which should be considered are the following: (See Glossary for defi nitions of these characteristics in Appendix 1) Characteristics of quantitative methods • Method uncertainty • Minimum quantifi able concentration • Detection limit (See MDL and MDC) • Applicable analyte concentration range • Accuracy • Precision • Analytical specifi city • Linearity • Ruggedness/robustness • Clinical sensitivity • Clinical specifi city 5.3.1.2 Validation tools (Ref ORA-LAB SOP# 5.4.5) The following tools should be used to demonstrate the ability to meet method specifi cations of performance: • Blanks: Use of various types of blanks enables assessment of how much of the result is attributable to the analyte and to other causes. • Reference materials and certifi ed reference materials with typical interferences expected. Use of known materials can be incorporated to assess the accuracy of the method, as well as for obtaining information on interferences. • Fortifi ed (spiked) materials and solutions: Recovery determinations can be estimated from fortifi cation or spiking with a known amount of analyte. (Note: Understanding that spiked recovery may not be truly representative of recovery from naturally incurred analytes.) • Replication: Replicate analyses provide a means of checking for changes in precision in an analytical process which could adversely affect the results. 67
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Proceedings of the International Cy
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Proceedings of the Cyanide Detectio
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ACKNOWLEDGEMENTS The Proceedings of
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PREFACE The International Cyanide D
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EXECUTIVE SUMMARY The International
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ATCA) in homogenized fi sh tissue m
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Validation of the ISE method applie
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Importing countries should also req
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INTRODUCTION Cyanide fi shing is a
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through the implementation of a net
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Working Group 2 The Export Working
Page 25 and 26: o o o o Can the U.S. require verifi
Page 27 and 28: Polymeric membrane based ion select
Page 29 and 30: Goal 2: Provide recommendations on
Page 31 and 32: hands-on training that develops a d
Page 33 and 34: Goal 3: Identify research needs to
Page 35 and 36: Working Group 1 Participants Bob KO
Page 37 and 38: estimated at roughly 3 to 5 days. H
Page 39 and 40: Goal 2 : Identify steps, agreements
Page 41 and 42: 3) certifi cate, but tests positive
Page 43 and 44: Report from Working Group 3 The Par
Page 45 and 46: No. of Shipments 6,000 5,000 4,000
Page 47 and 48: Goal 3: Provide a recommendation wi
Page 49: Working Group 3 Participants Eric P
Page 53 and 54: Introduction Since the early 1960
Page 55 and 56: ainbow trout exposed to 40 mg SCN -
Page 57 and 58: Blennies, which were net-caught and
Page 59 and 60: electrical potential (similar to an
Page 61 and 62: in the Philippines under contract w
Page 63 and 64: endorsing the IMA’s use of the IS
Page 65 and 66: The intended products from the rese
Page 67 and 68: WPCF 1992, 1998). Both of these stu
Page 69 and 70: ASTM (1997) Standard test methods f
Page 71 and 72: Kuegsen, M., Kloock, J.P., Knobbe,
Page 73 and 74: Philippines. In Proceedings from th
Page 75: 3) 4) 5) 6) the metabolism of cyani
Page 79 and 80: Level Two: The method should be val
Page 81 and 82: of cyanide exposure and to identify
Page 83 and 84: Special considerations for the anal
Page 85 and 86: tissue samples indispensable. Altho
Page 87 and 88: y reduction and subsequent separati
Page 89 and 90: can also be used for analysis of cy
Page 91 and 92: thiocyanate in saliva and serum bas
Page 93 and 94: are many discrepancies in the liter
Page 95 and 96: Table 3. Analytical Methods to dete
Page 97 and 98: Poisoning, In Textbook of military
Page 99 and 100: (70) Odoul, M., Fouillet, B., Nouri
Page 101 and 102: V. (1975) Stable reagents for the c
Page 103 and 104: (159) Felscher, D. and Wulfmeyer, M
Page 105 and 106: Purpose of this Document The purpos
Page 107 and 108: day. One cyanide tablet (2 g) is mi
Page 109 and 110: 10-90% following exposure to cyanid
Page 111 and 112: existing cyanide detection methods
Page 113 and 114: - Plasma lactate — elevated plasm
Page 115 and 116: Method Advantages Disadvantages Hig
Page 117 and 118: Paper Method Matrix Detection Limit
Page 119 and 120: Table 4 lists experts identifi ed t
Page 121 and 122: X Jerry Thomas CDC Em Steve Borron
Page 123 and 124: References Barber, C. and Pratt, V.
Page 125 and 126: Rates of Recovery. Environmental Ma
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COUNTRY REPORTS
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The first three of these destructiv
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enforcement is minimal. There is an
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1. Management/guidance to the Minis
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in Vietnam now and requires more ef
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Figure 2: Administrative structure
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References Baquero, J. (1999) Marin
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Acronyms • CDT • Cyanide Detect
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Law/Ordinance/Decree /Decision 52/2
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of samples required for analysis. U
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Field test kit. BFAR recognizes the
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Political Will Having planted the s
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gravely by fi shing communities. Th
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ecome the partner and counterpart o
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Ion-Selective Electrodes for Cyanid
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References Alban, J., Manipula, B.E
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levels with mV readings recorded as
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Trends Determined by Cyanide Testin
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Implementing agencies: • Quaranti
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APPENDIX
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1:30 Overview of and Potential Cyan
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Kristine Johnson Director Kingfi sh
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Assessment of U.S. Role in Trade: U
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