Guidance on the development and validation of diagnostic tests that depend on nucleic acid amplification and detection

被引：24

作者：

Saunders, Nick ^{[1
]}

Zambon, Maria ^{[1
]}

Sharp, Ian ^{[1
]}

Siddiqui, Ruhi ^{[1
]}

Bermingham, Alison ^{[1
]}

Ellis, Joanna ^{[1
]}

Vipond, Barry ^{[2
]}

Sails, Andrew ^{[3
]}

Moran-Gilad, Jacob ^{[4
]}

Marsh, Peter ^{[5
]}

Guiver, Malcolm ^{[6
]}

机构：

[1] HPA Microbiol Serv Div, London NW9 5HT, England

[2] Microbiol Serv Bristol Virol, Dept Microbiol, Bristol BS2 8EL, Avon, England

[3] Royal Victoria Infirm, Leazes Wing, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England

[4] Minist Hlth, Publ Hlth Serv, IL-91010 Jerusalem, Israel

[5] Southampton Gen Hosp, Publ Hlth Lab Southampton, Hlth Protect Agcy, Southampton SO16 6YD, Hants, England

[6] Manchester Royal Infirm, Manchester Med Microbiol Partnership, Manchester M13 9WL, Lancs, England

来源：

JOURNAL OF CLINICAL VIROLOGY | 2013年 / 56卷 / 03期

关键词：

Guidance; Validation; Verification; PCR; Diagnostics; Development; MULTIPLE SEQUENCE ALIGNMENT; ACCURACY;

D O I：

10.1016/j.jcv.2012.11.013

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

In order to comply with national and international clinical laboratory accreditation standards (e. g. the ISO 15189, Clinical Pathology Accreditation standards) and with the joint code of practice for research, there must be a method of assessing that test methods are "fit for purpose". This document gives guidance on development and describes how a validation file is produced. A test method may be a commercial kit, an in-house assay or reagent or a set of reagents bought separately and used to prepare an in house assay. A validation file is needed for both current and new test procedures. The file may refer to data recorded in workbooks, papers and reports. Modifications to assays (including commercially available assays) necessitate either an update to the validation file or creation of a new file. This paper is intended to provide a generic framework for in-house assay development and validation of new nucleic acid amplification assays including real-time polymerase chain reaction (PCR). (C) 2012 Elsevier B.V. All rights reserved.

引用

页码：260 / 270

页数：11

共 16 条

[1] Gapped BLAST and PSI-BLAST: a new generation of protein database search programs
Altschul, SF
Madden, TL
Schaffer, AA
Zhang, JH
Zhang, Z
Miller, W
Lipman, DJ
[J]. NUCLEIC ACIDS RESEARCH, 1997, 25 (17) : 3389 - 3402
[2] [Anonymous], 2011, B MHRA, V18
[3] Banoo S, 2006, NAT REV MICROBIOL, pS21, DOI [10.1038/nrmico1523, 10.1038/nrmicro1523]
[4] Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative
Bossuyt, PM
Reitsma, JB
Bruns, DE
Gatsonis, CA
Glasziou, PP
Irwig, LM
Lijmer, JG
Moher, D
Rennie, D
de Vet, HCW
[J]. CLINICAL CHEMISTRY, 2003, 49 (01) : 1 - 6
[5] Validation of Laboratory-Developed Molecular Assays for Infectious Diseases
Burd, Eileen M.
[J]. CLINICAL MICROBIOLOGY REVIEWS, 2010, 23 (03) : 550 - +
[6] The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments
Bustin, Stephen A.
Benes, Vladimir
Garson, Jeremy A.
Hellemans, Jan
Huggett, Jim
Kubista, Mikael
Mueller, Reinhold
Nolan, Tania
Pfaffl, Michael W.
Shipley, Gregory L.
Vandesompele, Jo
Wittwer, Carl T.
[J]. CLINICAL CHEMISTRY, 2009, 55 (04) : 611 - 622
[7] MUSCLE: multiple sequence alignment with high accuracy and high throughput
Edgar, RC
[J]. NUCLEIC ACIDS RESEARCH, 2004, 32 (05) : 1792 - 1797
[8] Edwards Kirstin J., 2009, P85
[9] In vitro diagnostic medical devices, 236402011 ISO
[10] MAFFT: a novel method for rapid multiple sequence alignment based on fast Fourier transform
Katoh, K
Misawa, K
Kuma, K
Miyata, T
[J]. NUCLEIC ACIDS RESEARCH, 2002, 30 (14) : 3059 - 3066

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