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Chapter 58 : Laboratory Controls and Standards

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Abstract:

Growing numbers of microbiology laboratories are turning to the wide array of molecular technologies and platforms that are becoming available. With these new systems comes the need for effective ways to gauge their accuracy and reproducibility. This chapter describes different types of controls, along with their design and their potential utility in molecular microbiology applications. Control materials may take the form of run controls, calibrators, or standards. Run controls are used in a number of different embodiments to monitor overall assay performance and to estimate analytical uncertainty. Regardless of the type of control or the final application, an ideal control, calibrator, or standard would be composed of a matrix that is similar to the specimen matrix being tested, and it would contain the agent being targeted in the intact, biological form in which it naturally occurs. While assay-ready control materials can be purchased from a number of vendors, the number of organisms and assays for which they are available is limited. Raw-material components for control construction are available for many analytes, but to use these materials, each laboratory performing a test would have to manufacture its own controls and design reaction specifications to detect the control targets. The concept of a range would imply use for quantitative assays only; however, even qualitative molecular detection methodologies often provide results that lend themselves to some type of quantitative or semiquantitative analysis.

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58

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Figures

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FIGURE 1

Effects of inhibition on target quantitation. All of the panels represent PCR amplification plots from samples that contain 1,000 copies of target DNA and 100 copies of internal control DNA. Panels A and C show the target and internal control results for an uninhibited sample, while panels B and D represent results from the same sample assayed in the presence of inhibitors. When compared to the uninhibited target amplification curve in panel A, the amplification curve in panel B is shifted to the right because the reaction is inhibited. Without the use of an internal control for normalization, this sample would be underquantitated by a factor of 10. Inhibition of the control reaction is observed in panel D, which shows a 10-fold decrease in the expected amount of internal control DNA (10 copies instead of the 100 copies shown in panel C). If the internal controls were used to normalize the target results, the inhibited sample quantity would be increased by a factor of 10 (because the internal control concentration is 10-fold lower than expected), and this would produce a correct target quantity determination of 1,000 copies.

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58
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References

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Tables

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TABLE 1

Scope of molecular microbiology technologies and applicable controls

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58
Generic image for table
TABLE 2

Control materials and representative suppliers

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58
Generic image for table
TABLE 3

Methods for quantification of control materials

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58
Generic image for table
TABLE 4

Calibrator dilution series and corresponding AMR percentage

Citation: Exner M. 2011. Laboratory Controls and Standards, p 899-909. 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.ch58

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