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Chapter 56 : Molecular Test Validation, Monitoring, and Quality Control

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Abstract:

Test validation is the ongoing process of ensuring that the expected performance of an assay is consistently met in testing clinical specimens. Test (or assay) validation is an integral part of quality assessment (QA), which includes quality control, quality improvement, and method validation. QA encompasses routine quality control, proficiency testing, technical staff competency, instrument calibration, and clinical correlation. Quality management of molecular testing begins with the test request and continues through specimen collection, transport, processing, analytical testing, result generation, result review, test interpretation, and reporting. This chapter focuses mainly on the analytical phase of testing. The types of molecular testing included in the chapter are qualitative, quantitative, multiplex, and microarray methods. Quantitative molecular testing consists of numeric values with defined units in the test result. Quality assurance includes quality control, quality improvement, and method validation. Validation of the analytical phase not only includes ensuring adequate and acceptable training on the test but also relies upon evaluation by actual observation of the technologist performing the test on a recurrent basis (operator competency assessment). This should include validation of staff adherence to the standard operating procedure (SOP) exactly as stated, biosafety, patient confidentiality, result interpretation, reporting, and quality control documentation. The use of quality controls, proficiency testing, and monitoring of technical staff competency and equipment and instrument performance are all essential parts of this process.

Citation: Bankowski M. 2011. Molecular Test Validation, Monitoring, and Quality Control, p 885-890. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch56

Key Concept Ranking

Herpes simplex virus 1
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Hepatitis C virus
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West nile virus
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Hepatitis C virus
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West nile virus
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Hepatitis C virus
0.4270833
0.5006866
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Figures

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FIGURE 1

Internal PT documentation report.

Citation: Bankowski M. 2011. Molecular Test Validation, Monitoring, and Quality Control, p 885-890. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch56
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Image of FIGURE 2
FIGURE 2

PT investigation and corrective action of failed testing.

Citation: Bankowski M. 2011. Molecular Test Validation, Monitoring, and Quality Control, p 885-890. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch56
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References

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1. Bachner, P.,, and W. Hamlin. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988. Part I. Clin. Lab. Med. 13:739752; discussion 737–738.
2. Bachner, P.,, and W. Hamlin. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988. Part II. Clin. Lab. Med. 13:987994.
3. Forbes, B. A. 2003. Introducing a molecular test into the clinical microbiology laboratory: development, evaluation, and validation. Arch. Pathol. Lab. Med. 127:11061111.
4. Fryer, J. F.,, S. A. Baylis,, A. L. Gottlieb,, M. Ferguson,, G. A. Vincini,, V. M. Bevan,, W. F. Carman, and, P. D. Minor. 2008. Development of working reference materials for clinical virology. J. Clin. Virol. 43:367371.
5. Hsieh, E.,, and J. P. Liu. 2008. On statistical evaluation of the linearity in assay validation. J. Biopharm. Stat. 18:677690.
6. Schewe, C.,, T. Goldmann,, M. Grosser,, A. Zink,, K. Schluns,, S. Pahl,, T. Ulrichs,, S. H. Kaufmann,, A. Nerlich,, G. B. Baretton,, M. Dietel,, E. Vollmer, and, I. Petersen. 2005. Inter-laboratory validation of PCR-based detection of Mycobacterium tuberculosis in formalin-fixed, paraffin-embedded tissues. Virchows Arch. 447:573585.
7. Schmitt, Y. 2001. Performance characteristics of quantification assays for human immunodeficiency virus type 1 RNA. J. Clin. Virol. 20:3133.

Tables

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TABLE 1

Molecular infectious disease testing validation controls

Citation: Bankowski M. 2011. Molecular Test Validation, Monitoring, and Quality Control, p 885-890. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch56
Generic image for table
TABLE 2

FDA-cleared panels for molecular infectious disease testing

Citation: Bankowski M. 2011. Molecular Test Validation, Monitoring, and Quality Control, p 885-890. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch56

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