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Chapter 122 : Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory

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Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, Page 1 of 2

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Abstract:

Clinical laboratories provide vital services to physicians and patients, public health agencies, and medicolegal entities. Because laboratory test results influence patient care and medical decisions rely on accurate and timely laboratory results, clinical laboratories must ensure that the results are obtained at the time and for the patient. The ability to ensure accuracy of patient results rests on developing a quality program that governs all functional aspects of the clinical laboratory.

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122
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Figures

Image of FIGURE 1
FIGURE 1

Stages in assay development and validation. The flowchart illustrates the four stages of assay development required to scientifically evaluate a potential diagnostic assay, develop and validate the method, and implement continuous quality monitoring of the assay.

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122
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Image of FIGURE 2
FIGURE 2

Tracking control performance using a Levey-Jennings chart. The chart shows daily values of a hypothetical control with a mean value of 30.0. The upper limit and lower limit of the control are set at +3 SD and −3 SD from the mean value, respectively. The positions of 1 and 2 SD from the mean are indicated. The chart illustrates several instances of out-of-control analytical runs as described by the Westgard rules, indicated by letters A through E: A, violation of 1 rule (control value exceeds mean + 2 SD); B and C, violation of 2 rule (two consecutive control values are either plus or minus 2 SD from the mean); D, violation of 4 rule (four consecutive measurements exceed the mean by 1 SD); E, violation of 7 rule (seven consecutive measurements trend upwards). CL, control limit; UCL, upper control limit; LCL, lower control limit.

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122
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Image of FIGURE 3
FIGURE 3

Monthly trending of assay results. Assay results were trended over the course of 12 months. The shaded region spanning months March through June shows an abnormally elevated percentage of positive results, which require further investigation.

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122
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References

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Tables

Generic image for table
TABLE 1

Assay validation or verification requirements per CLIA standard 493.1253

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122
Generic image for table
TABLE 2

Considerations prior to development or validation studies

Citation: Knight V, Lebo T. 2016. Validation and Quality Control: General Principles and Application to the Clinical Immunology Laboratory, p 1180-1192. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch122

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