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Appendix A: Reviewers of Draft the Manuscript

 

Manfred Blum, M.D.
New York University Medical Center,
New York, NY, USA

Pierre Carayon, M.D.
Department of Biochemistry & Molecular Biology,
Marseille, France

Lawrence M. Demers, M.D.
Pennsylvania State School of Medicine,
Hershey PA, USA

John Dunn, M.D.
University of Virginia Health Sciences Center,
Charlottesville, VA, USA

David Endres, Ph.D.,F.A.C.B
University of Southern California,
Los Angeles, CA,USA

Shireen Fatemi, M.D.
Kaiser Permanente of Southern California,
Los Angeles, CA, USA

Timothy Greaves, M.D., F.A.C.P.
LAC-USC Medical Center,
Los Angeles, CA, USA

Tien-Shang Huang, M.D.
College of Medicine, National Taiwan University,
Taiwan

Annie Kung, M.D.
The University of Hong Kong,
Hong Kong

John Lazarus, M.A. M.D., F.R.C.P.
University of Wales College of Medicine,
Cardiff, Wales, UK

Charles Lewis, Jr., Ph.D.
Abbott Laboratories,
Abbott Park, IL, USA

Jon LoPresti, M.D., Ph.D.
University of Southern California,
Los Angeles, CA, USA

Rui Maciel, M.D.
Laboratorio de Endocrinologia Molecular Disciplina de Endocrinologia,
Sao Paulo, Brasil

Marvin Mitchell, M.D.
University Massachusetts Medical Center, Jamaica Plain, MA, USA

Jean Ruf, M.D.

Department of Biochemistry & Molecular Biology,
Marseille, France

Gerardo Sartorio, M.D.
Hospital J.M. Ramos Mejia,
Buenos Aires, Argentina

Peter Singer, M.D.
University of Southern California,
Los Angeles, CA, USA

Brad Therrell, Ph.D.
National Newborn Screening and Genetics Resource Center,
Austin, TX, USA

Hidemasa Uchimura, M.D.
Department of Clinical Pathology
Kyorin University, Japan

 

 

Appendix B. Calculation of the Goals for Bias and Imprecision.

 

Bias and imprecision is calculated as percent coefficient of variation [%CV], from the biological variation of the analyte in question (16-18).

W= Suggested goal for maximum bias in diagnostic testing is:

(CV2[within-subject] + CV2 [between-subject])1/2

_______________________________________________

4

 

X= Suggested goal for maximum bias in monitoring an individual is:

CV [within-subject]

_______________

4

 

Y= Suggested goal for maximum imprecision in diagnostic testing is:

(CV2 [within-subject] + CV2 [between-subject])1/2

____________________________________________

2

 

Z= Suggested goal for maximum imprecision for monitoring an individual is:

(CV [within-subject])

__________________

2

 

Table 4. Bias and Precision Targets for Thyroid Tests
Test Within- person
%CV
Between-person
%CV
W X Y Z
TT4 5.3 13 3.5 1.3 7.0 2.7
FT4 9.5 12.1 3.8 2.4 7.7 4.8
TT3 5.6 14.8 4.0 1.4 7.9 2.8
FT3 7.9 22.5 6.0 2.0 11.9 4.0
Tg 8.7 66.6 16.8 2.2 33.6 4.4
TSH 20.6 53.3 14.3 5.2 28.6 10.3

 

Appendix C. - Newborn Screening Quality Assurance Programs by Region:

 

Australasia -- Australasian Quality Assurance Program, National Testing Center 2nd Floor, National Women's Hospital, Claude Road, Epson, Auckland, New Zealand.

Europe -- Deutsche Genellschaft fur Klinische Chemie eV, Im Muhlenbach 52a, D-53127 Bonn, Germany.

UK -- United Kingdom External Quality Assurance, Wolfson EQA laboratory, PO Box 3909, Birmingham, B15 2UE, UK.

USA -- Centers for Disease Control and Prevention (CDC), 4770 Burford Highway NE, Atlanta, GA 30341-3724, USA.

(The UK NEQAS program has a charge to participants, but for the other two programs there is no charge).

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