REFERENCES AND LINKS

THE VITAMIN B12 AND FOLATE PATHOLOGY INVESTIGATION

THE INVESTIGATION OF ERRORS IN PATHOLOGY TESTS

FOR VITAMIN B12 AND FOLATE DEFICIENCY

BY MEANS OF MEDICAL EXPERIMENTS

INTRODUCTION	THE SERUM VITAMIN B12 INVESTIGATION	THE METHYLMALONIC ACID INVESTIGATION
THE HOMOCYSTEINE INVESTIGATION	THE HOLOTRANSCOBALAMIN INVESTIGATION	THE FOLATE INVESTIGATION
REFERENCES AND LINKS	B12 AND FOLATE INFORMATION	RESPONSES TO INVESTIGATION

VITAMIN B12 REFERENCES

FOLATE REFERENCES

VITAMIN B12 LINKS

FOLATE LINKS

B12 Deficiency References

Part A - Errors in Pathology

Part B - Causes

Part C - Consequences

Part D - Diagnosis - General

Part E - Diagnosis - HoloTC

Part F - Treatment

Part G - Miscellaneous

Index

This page contains the following sections:

A - Errors in Pathology

AA - Errors and Quality Assurance - Australian Labs
AB - Errors and Quality Assurance - General
AC - Errors and Quality Assurance - Immunoassays - Reports
AD - Errors and Quality Assurance - Immunoassays - Package Inserts
AE - Methylmalonic Acid and Homocysteine - Analytical Methods and Errors
AF - Methylmalonic Acid and Homocysteine - Lab Reference Intervals and Limits
AG - Examples of Erroneous Publications
AH - Errors in Pathology - Legal

You can go to a section by selecting the link.

Errors and Quality Assurance - Australian Labs

Number	Article Link
AA01	Error rates in Australian chemical pathology laboratories, Khoury et al, MJA 1996; 165: 128-130
AA02	Ensuring quality in all phases of the pathology cycle, Bryant, MJA 1996; 165: 125-126
AA03	Alarm Bells Ring, RCPA News, Vince Caruso

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Errors and Quality Assurance - General

Number	Article Link
AB01	The control of analytical accuracy and day to day precision helps for the follow-up of patients and is essential when using biochemical data from the literature, ERNDIM
AB02	Quality Control in Inherited Disorders of Metabolism (IDM) Laboratories ERNDIM Schemes and Theoretical Aspects, ERNDIM
AB03	Errors, mistakes, blunders, outliers, or unacceptable results: how many?, Witte et al, Clinical Chemistry. 1997;43:1352-1356
AB04	How good are clinical laboratories? An assessment of current performance [published erratum appears in Clin Chem 1993 Mar;39(3):558], Robert Rej and Richard W Jenny, Clinical Chemistry, Vol 38, 1210-1217
AB05	Laboratory tests: proper communication reduces error, Sanjay A Pai, student BMJ 2005;13:397- 440 November ISSN 0966-6494
AB06	System to Monitor a Portion of the Total Testing Process in Medical Clinics and Laboratories: Evaluation of a Split-Specimen Design, Shahangian et al, Clinical Chemistry. 1999;45:269-280
AB07	Uncertainty of Measurement, RCPA
AB08	Setting analytical goals for random analytical error in specific clinical monitoring situations, Fraser et al, Clinical Chemistry, Vol 36, 1625-1628
AB09	Information on Uncertainty of Measurement Dept. of Chemical Pathology, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.
AB10	Uncertainty of Measurement Budget Procedure, weblabstats.com
AB11	How to improve estimates of imprecision, Jan S. Krouwer and Robin Rabinowitz, Clinical Chemistry, Vol 30, 290-292
AB12	Blunders, Bandolier, 47-6
AB13	Key Incident Monitoring & Management Systems (KIMMS), RCPAQAP
AB14	Hear, Hear, Hear! Hearings on untruth and unquality! Part I. Cracks in the Healthcare Quality System?, James O. Westgard, PhD, FACB
AB15	DESIRABLE SPECIFICATIONS FOR TOTAL ERROR, IMPRECISION, AND BIAS, DERIVED FROM BIOLOGIC VARIATION, James O. Westgard, PhD, FACB
AB16	Uncertainty of Measurement in Clinical Laboratory Sciences, Xavier Fuentes-Arderiu, Clinical Chemistry. 2000;46:1437-1438
AB17	Accuracy in Clinical Chemistry, Caraway, Clinical Chemistry 17: 63-71, 1971
AB18	Setting Performance Goals and Evaluating Total Analytical Error for Diagnostic Assays, Jan S. Krouwer, Clinical Chemistry. 2002;48:919-927
AB19	The Specialist Pathology Workforce in Australia, AMWAC Report 2003.5
AB20	Comparison of quality-control rules used in clinical chemistry laboratories, J Bishop and AB Nix, Clinical Chemistry, Vol 39, 1638-1649
AB21	Desirable standards for laboratory tests if they are to fulfill medical needs, CG Fraser and PH Petersen, Clinical Chemistry, Vol 39, 1447-1453
AB22	Graphical interpretation of analytical data from comparison of a field method with a Reference Method by use of difference plots, Per Hyltoft Petersen et al, Clinical Chemistry. 1997;43:2039-2046
AB23	Thoughts on quality-control systems: a laboratorian's perspective, George S. Cembrowski, Clinical Chemistry. 1997;43:886-892
AB24	Reference Intervals for New Methods, Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB25	Statistical Techniques for Reference Intervals, , Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB26	Interferences - are some methods better than others?, Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB27	So How good are your results?, Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB28	Quantifying the Effects of Setting Quality Control Standard Deviations Greater than Actual Standard Deviations on Westgard Rules, Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB29	Evaluation of Beckton- Dickinson PST II and SST II Blood Collection Tubes, Dr Graham Jones, Department of Chemical Pathology, St Vincent's Hospital, Sydney
AB30	Confidence Interval, Wolfram Math World
AB31	Analytical Performance Characteristics Should Be Judged against Objective Quality Specifications, Fraset et al, Clinical Chemistry. 1999;45:321-323
AB32	Quality Control: Introduction, Pawan Angra, Division of Laboratory Systems. Public Health Practice Program Office. Centers for Disease Control and Prevention
AB33	Uncertainty of Measurement in Quantitative Medical Testing - A Laboratory Implementation Guide, G.H. White and I. Farrance, AACB Uncertainty of Measurement Working Group
AB34	Evidence for Common Reference Intervals, Dr Ken Sikaris
AB35	Standardisation of Reference Intervals: An Australasian View, Graham Jones and Antony Barker, Clin Biochem Rev. 2007 November; 28(4): 169–173.
AB36	Traceability in Laboratory Medicine, Vesper HW and Thienpont LM, Clin Chem 2009;55:1067–75.

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Errors and Quality Assurance - Immunoassays - Reports

Number	Article Link
AC01	Interference in Immunoassay, Colin Selby, Ann Clin Biochem 1999; 36: 704-721
AC02	Interferences in Immunoassay—Still a Threat, Larry J. Kricka, Clinical Chemistry. 2000;46:1037-1038
AC03	Interferences in Immunoassay, Jill Tate and Greg Ward, Clin Biochem Rev 2004;25(ii):105-20,
AC04	Unusual Results From Immunoassays and the Role of the Clinical Endocrinologist, Alison M. Jones; John W. Honour, Clin Endocrinol. 2006;64(3):234-244.
AC05	Human Anti-Animal Antibody Interferences in Immunological Assays, Larry J. Kricka, Clinical Chemistry. 1999;45:942-956
AC06	QP 1: A Wake-up call for Quality Management, James O. Westgard, PhD, FACAB
AC07	Failure of Assay to Identify Low Cobalamin Concentrations, Ralph Carmel et al, Clinical Chemistry. 2000;46:2017-2018
AC08	Failure of Assay to Identify Low Cobalamin Concentrations, Representatives of Bayer Diagnostics respond, Clinical Chemistry. 2000;46:2018-2019
AC09	Antibody interference in thyroid assays: a potential for clinical misinformation, Normand Després, and Andrew M. Granta, Clinical Chemistry. 1998;44:440-454
AC10	False-Positive Immunoassay Results, Vincent Marks, Clinical Chemistry. 2002;48:2008-2016.
AC11	Heteroantibody: Phantom of the Immunoassay, Moon W Nahm and Joseph W. Hoffmann, CLIN.CHEM.36/6, 829 (1990)
AC12	Heterophile Antibodies to Bovine and Caprine Proteins Causing False-Positive Human Immunodeficiency Virus Type 1 and Other Enzyme-Linked Immunosorbent Assay Results, Joseph H. Willman et al, Clinical and Diagnostic Laboratory Immunology, July 1999, p. 615-616, Vol. 6, No. 4 1071-412X/99/$04.00+0
AC13	HeterophilicAntibodies:a Problem for All Immunoassays, Lynette M. Boscato andMargaret C. Stuart, CLIN. CHEM. 34/1, 27-33 (1988)
AC14	Falsely Increased Thyroid-stimulating Hormone Concentrations attributable to Interference from Human Antimouse Antibodies, Francoise Flourie et al, Clinical Chemistry 48, No. 12, 2002
AC15	Immunometric Assay Interference, Johan Bjerner et al, Clinical Chemistry. 2002;48:613-621

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Errors and Quality Assurance - Immunoassays - Package Inserts

Number	Article Link
AD01	Abbott AxSym Package Insert B12
AD02	Abbott AxSym Package Insert Homocysteine
AD03	Abbott AxSym Package Insert Folate
AD04	Abbott AxSym Package Insert Holotranscobalamin
AD05	Abbott Architect Package Insert B12
AD06	Axis Shield Homocysteine EIA Control Kit
AD07	ADVIA Centaur® and ACS:180® Vitamin B12 Assay

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Methylmalonic Acid and Homocysteine - Analytical Methods and Errors

Number	Article Link
AE01	Metabolic abnormalities in cobalamin (vitamin B12) and folate deficiency, Allen et al, The FASEB Journal, Vol 7, 1344-1353
AE02	Assay of Methylmalonic Acid in the Serum of Patients with Cobalamin Deficiency Using Capillary Gas Chromatography-Mass Spectrometry, Stabler et al, J Clin Invest. 1986 May; 77(5): 1606–1612.
AE03	Solid-Phase Sample Extraction for Rapid Determination of Methylmalonic Acid in Serum and Urine by a Stable-Isotope-Dilution Method, Rasmussen, Clinical Chemistry, Vol 35, 260-264
AE04	Methylmalonic Acid Measured in Plasma and Urine by Stable-Isotope Dilution and Electrospray Tandem Mass Spectrometry, Magera et al, Clinical Chemistry. 2000;46:1804-1810
AE05	Analysis of Dicarboxylic Acids by Tandem Mass Spectrometry. High-Throughput Quantitative Measurement of Methylmalonic Acid in Serum, Plasma, and Urine, Kushnir et al, Clinical Chemistry. 2001;47:1993-2002
AE06	Analysis of Methylmalonic Acid in Plasma by Liquid Chromatography–Tandem Mass Spectrometry, Anne Schmedes and Ivan Brandslund, Clinical Chemistry. 2006;52:754-757
AE07	Method for the Determination of Total Homocysteine in Plasma and Urine by Stable Isotope Dilution and Electrospray Tandem Mass Spectrometry, Mager et al, Clinical Chemistry. 1999;45:1517-1522
AE08	Total Plasma Homocysteine Measured by Liquid Chromatography–Tandem Mass Spectrometry with Use of 96-Well Plates, Torsten Arndt et al, Clinical Chemistry. 2004;50:755-757
AE09	Total homocysteine in plasma or serum: methods and clinical applications, Ueland et al, Clinical Chemistry, Vol 39, 1764-1779
AE10	Within-Person Variation of Plasma Homocysteine and Effects of Posture and Tourniquet Application, Rasmussen et al, Clinical Chemistry. 1999;45:1850-1855
AE11	Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion, Refsum et al, Clinical Chemistry. 2004;50:3-32
AE12	Consensus Paper on the Rational Clinical Use of Homocysteine, Folic Acid, and B-Vitamins in Cardiovascular and Thrombotic diseases - Guidelines and Recommendations, D.A.C.H. - Liga Homocystein
AE13	Comparison of Serum and Plasma Methylmalonic Acid Measurements in 13 Laboratories: An International Study, Pfeiffer et al, Clinical Chemistry. 1999;45:2236-2242
AE14	External Quality Assessment of Methylmalonic Acid and Total Homocysteine, Moller et al, Clinical Chemistry. 1999;45:1536-1542
AE15	Interlaboratory Variation of Plasma Total Homocysteine Measurements: Results of Three Successive Homocysteine Proficiency Testing Surveys, Hanson et al, Clinical Chemistry. 2002;48:1539-1545
AE16	Comparison of Plasma Total Homocysteine Measurements in 14 Laboratories: An International Study, Pfeiffer et al, Clinical Chemistry. 1999;45:1261-1268
AE17	Assessment of Laboratory Tests for Plasma Homocysteine -- Selected Laboratories, July-September 1998, MMWR Weekly, November 12, 1999 / 48(44);1013-1015
AE18	Comparison of Three Different Plasma Homocysteine Assays with Gas Chromatography–Mass Spectrometry, Ubbink et al, Clinical Chemistry. 1999;45:670-675
AE19	Evaluation of Novel Assays in Clinical Chemistry: Quantification of Plasma Total Homocysteine, Nexo et al, Clinical Chemistry. 2000;46:1150-1156
AE20	CDC Laboratory Procedure Manual - Methylmalonic Acid
AE21	CDC Laboratory Procedure Manual - Homocysteine
AE22	Development of a new standard reference material: SRM 1955 (homocysteine and folate in human serum), Satterfield et al, Anal Bioanal Chem. 2006 Jun;385(3):612-22. Epub 2006 Apr 29.
AE23	No longer available
AE24	Certificate of Analysis - Standard Reference Material 1955, NIST
AE25	Material Details - SRM 1955 - Homocysteine and Folate in Frozen Human Serum, NIST
AE26	Interlaboratory Variability for Total Homocysteine Analysis in Plasma, Eliason et al, Clinical Chemistry. 1999;45:315-316
AE27	The Quality of Diagnostic Samples, Chronolab - Homocysteine
AE28	Mass Spectrometric Applications for Diagnosing Metabolic and Endocrine Diseases, Kushnir, Mark M, Doctoral thesis, Uppsala University, Teknisk-naturvetenskapliga vetenskapsområdet, Chemistry, Department of Physical and Analytical Chemistry, Analytical Chemistry
AE29	Evaluation of blood collection tubes specific for homocysteine measurement on AxSYM, Immulite and LC-MS/MS systems, A.O. de Graaf, Ned Tijdschr Klin Chem Labgeneesk 2008; 33: 172-174
AE30	Results of B-Vitamin Supplementation Study Used in a Prediction Model to Define a Reference Range for Plasma Homocysteine, Johan B. Ubbink et al, CLIN. CHEM. 41/7, 1033-1037 (1995)

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Methylmalonic Acid and Homocysteine - Lab Reference Intervals and Limits

Number	Article Link
AF01	Age- and gender-specific reference intervals for total homocysteine and methylmalonic acid in plasma before and after vitamin supplementation, Rasmussen et al, Clinical Chemistry, Vol 42, 630-636
AF02	Methylmalonic acid concentrations in serum of normal subjects: biological variability and effect of oral L-isoleucine loads before and after intramuscular administration of cobalamin, Rasmussen et al, Clinical Chemistry, Vol 36, 1295-1299
AF03	Royal Perth Hospital Division of Laboratory Medicine Diagnostic Test Directory
AF04	Central Sydney Laboratory Service Handbook Homocysteine
AF05	RCPA Manual Homocysteine - plasma
AF06	RCPA Manual - Vitamin B12 - serum
AF07	SYDPATH Specimen Handling Database
AF08	Eastern Health Pathology Online Handbook Homocysteine
AF09	St Vincent's Pathology Melbourne Test Collection Manual
AF10	Mayo Medical Laboratories Test Catalog
AF11	The Reference Laboratory at the Cleveland Clinic Test Directory
AF12	Sundhed Homocysteine
AF13	Sundhed Methylmalonate
AF14	Quest Diagnostics Homocysteine
AF15	Cedars Sinai Laboratory Services Onsite Test Menu
AF16	Calgary Laboratory Services Test Directory
AF17	KING JAMES MEDICAL LABORATORY, INC.
AF18	Labcorp Anemia Profile, Megaloblastic, Serum
AF19	MyLabQuality.com Reference Intervals
AF20	LipoScience Homocysteine
AF21	Massachusetts General Hospital Pathology Service Handbook Homocysteine
AF22	UCHSC Biochemical Genetics Laboratory Clinical Test Information Homocysteine

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Examples of Erroneous Publications

Number	Article Link
AG01	Anaemia - Pernicious, Ask me about nutrition, Darling Downs Health Unit
AG02	Investigation of Suspected Vitamin B12 Folic Acid Deficiency, Institute of Clinical Pathology and Medical Research
AG03	Appropriate use of tests for folate and vitamin B12 deficiency, Aust Prescr.1999;Volume 22 Number 1
AG04	Vitamin B12 - serum, RCPA Manual, 31 March 2004
AG05	Vitamin B12 deficiency , RCPA Manual, 19 May 2004 Note - Archived copy on this web site
AG06	Vitamin B12 deficiency , RCPA Manual, 27 June 2007
AG07	Homocysteine - plasma - RCPA Manual 21 March 2004

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Errors in Pathology - Legal

Number	Article Link
AH01	Health Quality and Complaints Commission Act
AH02	NATA Accredited Labs - Sullivan Nicolaides Pathology
AH03	NATA Accredited Labs - Mater Pathology
AH04	NATA Accredited Labs - Queensland Health Pathology Service (QHPS)
AH05	NATA Accredited Labs - Pacific Laboratory Medicine Service (PaLMS)
AH06	NATA Accredited Labs - Central Sydney Laboratory Service (RPAH)

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