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Establishing a quality assurance plan for nucleic acid-based diagnostic laboratories: from planning to implementation

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Abstract

Nucleic acid-based technologies have opened new perspectives in diagnosis, prognosis, and treatment in clinical medicine. To maintain patient confidence in this rapidly expanding field and to provide the highest standard of analysis, strict laboratory quality assurance procedures must be followed. While impressive break-through are taking place in this field, the need for an appropriate and suitable quality assurance (QA) plan for nucleic acid-based diagnostic laboratories must be a top priority. In this study, we developed a systematic QA plan for this kind of diagnostic laboratories that would enable us to assure the highest quality standards of their services. We focus on those labs that would like to start introducing a quality system for the first time and discuss the most appropriate ways to pave the way to implement a QA plan from the beginning. This QA plan is suitable for any nucleic acid-based techniques laboratory regardless of the field or services provided.

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Acknowledgments

We acknowledge support by the International Atomic Energy Agency, through Consultant Meeting “Establish Guidelines of a Quality Assurance and Quality Control Network for Molecular Diagnosis and Genotype Identification of Insect-borne Diseases” and ARCAL LXXXII and RAS 6034 programs. We acknowledge anonymous reviewers of this manuscript for invaluable help in improving the quality of this work.

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Authors and Affiliations

  1. Brazilian Society of Clinical Pathology, Rua dois de dezembro No. 78, salas 909/910, Flamengo, Rio de Janeiro, 22220-040, Brazil

    Derliane Oliveira

  2. Faculty of Information Science and Technology Multimedia University, ITB First Floor, Jalan Ayer Keroh Lama, 75450, Malaka, Malaysia

    Sook Fan Yap

  3. Department of Medical Sciences, Bureau of Quality Laboratory Standards, Ministry of Public Health (MOPH), Tiwanond Road, Muang, Nonthaburi, 11000, Thailand

    Siripan Wongwanich

  4. Division of Human Health, International Atomic Energy Agency, Wagramer Strasse 5, 1400, Vienna, Austria

    Baldip Khan

  5. Laboratorio de Virología Molecular, Facultad de Ciencias, Centro de Investigaciones Nucleares, Igua 4225, 11400, Montevideo, Uruguay

    Juan Cristina

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  1. Derliane Oliveira
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  2. Sook Fan Yap
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  5. Juan Cristina
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Correspondence to Juan Cristina.

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Oliveira, D., Yap, S.F., Wongwanich, S. et al. Establishing a quality assurance plan for nucleic acid-based diagnostic laboratories: from planning to implementation. Accred Qual Assur 15, 89–97 (2010). https://doi.org/10.1007/s00769-009-0598-4

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  • DOI: https://doi.org/10.1007/s00769-009-0598-4

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