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Chapter 51 : Molecular Microbiology Test Quality Assurance and Monitoring

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Abstract:

This chapter will provide a discussion on test quality assurance and the ongoing process of monitoring test performance, including documentation, instrumentation, and testing personnel. Historically, the definition of either validation or verification has been complicated by the different verbiage used by the different regulatory organizations. For example, the College of American Pathologists (CAP) defines validation as “a defined process by which a laboratory confirms that a laboratory-developed or modified FDA-cleared/approved test performs as intended or claimed.” The ISO 9000 definition states that validation is the “confirmation through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled” and includes the determination of performance characteristics such as accuracy, precision, sensitivity, and specificity. Likewise, CAP defines verification as “the process by which a laboratory determines that an FDA-cleared/approved test performs according to the specifications set forth by the manufacturer.” The ISO 9000 definition states that verification is the “confirmation through the provision of objective evidence that specified requirements have been fulfilled” and that it is “the ongoing process that confirms specified requirements (predetermined by validation) are fulfilled.” For purposes of this chapter, the discussion of the ongoing process of assuring that the expected performance of a test (or assay) is consistently met in the testing of clinical specimens will be called verification/validation. A recent article by Halling et al. brings the issue to light with verification and validation (1).

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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Figures

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FIGURE 1

Internal proficiency testing (I-PT) documentation report for PT when PT samples are not available from a qualified commercial source.

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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FIGURE 2

Proficiency testing investigation and corrective action report for failed testing.

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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References

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1. Halling KC, Schrijver I, Persons DL. 2012. Test verification and validation for molecular diagnostic assays. Arch Pathol Lab Med 136:1113[CrossRef].[PubMed]
2. Schmitt Y. 2001. Performance characteristics of quantification assays for human immunodeficiency virus type 1 RNA. J Clin Virol 20:3133[CrossRef].[PubMed]
3. Bachner P, Hamlin W. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988. Part II. Clin Lab Med 13:987994.[PubMed]
4. Bachner P, Hamlin W. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988. Part I. Clin Lab Med 13:739752, discussion 737–738.[PubMed]
5. Versalovic J. 2011. Manual of Clinical Microbiology, 10th ed. ASM Press, Washington, DC.
6. Specter S. 2009. Clinical Virology Manual, 4th ed. ASM Press, Washington, DC.
7. Bruns DE, Ashwood ER, Burtis CA. 2007. Fundamentals of Molecular Diagnostics. Saunders/Elsevier, St. Louis, MO.
8. Isenberg HD. 2004. Clinical Microbiology Procedures Handbook, 2nd ed. ASM Press, Washington, DC.
9. Larone DH. 2011. Medically Important Fungi, 5th ed. ASM Press, Washington, DC.
10. Tille PM. 2014. Bailey & Scott's Diagnostic Microbiology, 13th ed. Saunders Elsevier, Philadelphia, PA.
11. McPherson RA, Pincus MR. 2011. Henry's Clinical Diagnosis and Management by Laboratory Methods, 22nd ed. Saunders Elsevier, Philadelphia, PA.
12. Hsieh E, Liu JP. 2008. On statistical evaluation of the linearity in assay validation. J Biopharm Stat 18:677690[CrossRef].[PubMed]
13. Fryer JF, Baylis SA, Gottlieb AL, Ferguson M, Vincini GA, Bevan VM, Carman WF, Minor PD. 2008. Development of working reference materials for clinical virology. J Clin Virol 43:367371[CrossRef].[PubMed]
14. Schewe C, Goldmann T, Grosser M, Zink A, Schlüns K, Pahl S, Ulrichs T, Kaufmann SH, Nerlich A, Baretton GB, Dietel M, Vollmer E, Petersen I. 2005. Inter-laboratory validation of PCR-based detection of Mycobacterium tuberculosis in formalin-fixed, paraffin-embedded tissues. Virchows Arch 447:573585[CrossRef].[PubMed]
15. Forbes BA. 2003. Introducing a molecular test into the clinical microbiology laboratory: development, evaluation, and validation. Arch Pathol Lab Med 127:11061111.[PubMed]

Tables

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TABLE 1

Guideline documents from the CLSI

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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TABLE 2

—Cumulative Techniques and Procedures in Clinical Microbiology

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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TABLE 3

Molecular microbiology and infectious disease testing controls and calibrators

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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TABLE 4

Molecular microbiology and infectious disease testing quality control sources

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51
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TABLE 5

Guide to verification/validation of test performance for various levels of FDA categories

Citation: Bankowski M. 2016. Molecular Microbiology Test Quality Assurance and Monitoring, p 745-753. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch51

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