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Internal quality control of a turbidimetric immunoassay for canine serum C-reactive protein based on pooled patient
Mad Kjelgaard-Hansen1, Asger Lundorff Jensen, Annemarie T Kristensen
1Central Laboratory, Department of Small Animal Clinical Scienes, The Royal Veterinary and Agricultural University, Frederiksberg, Denmark. mjkh@kvl.dk
Insights
A new internal quality control (IQC) method using pooled canine serum for C-reactive protein (CRP) turbidimetric immunoassay (TIA) ensures accurate results. This simple IQC procedure demonstrates excellent analytical performance and reliability for canine CRP testing.
Area of Science:
- Veterinary diagnostics
- Clinical chemistry
- Immunochemistry
Background:
- Optimized internal quality control (IQC) is crucial for reliable medical decision-making.
- IQC ensures accurate analytical results and prevents unnecessary rejection of valid tests.
- Alternative control materials, like patient samples, require investigation when species-specific standards are unavailable.
Purpose of the Study:
- To implement a straightforward IQC procedure for canine C-reactive protein (CRP) determination using turbidimetric immunoassay (TIA).
- To utilize pooled canine serum as control material for the CRP-TIA assay.
- To evaluate the clinical analytical performance of the assay with the developed IQC method.
Main Methods:
- Adherence to proposed guidelines for IQC planning and implementation using two control materials.
- Objective quality requirements defined by biological variation data.
- IQC performance goals set for high error detection (P(ed) >.90) and low false rejection (P(fr) <.05).
Main Results:
- The 1(2.5s) control rule met performance criteria (P(ed) =.94-1.00, P(fr) =.03).
- Successful implementation of the IQC method over a 14-week period.
- Observed coefficients of variation of 3.8% (low) and 2.9% (high) indicate excellent analytical performance.
Conclusions:
- A simple IQC procedure for CRP-TIA using canine serum control materials was successfully developed and implemented.
- The IQC method achieved high error detection and low false rejection rates.
- The assay demonstrated excellent long-term analytical performance over 14 weeks.
Background:
Optimized internal quality control (IQC) procedures are important to ensure that only results without medically important errors are used for medical decision-making and to ensure that unnecessary rejection of valid analytical runs is avoided. Additionally, estimates of the analytical performance can be derived from IQC data. In the absence of available species-specific standards of a compound, the use of alternative control materials based on patient samples is a possibility, although investigations on the suitability of this approach are needed.
Objectives:
The objective of the study was to plan and implement a simple IQC procedure with control material based on pooled canine serum samples for a turbidimetric immunoassay (TIA) for the determination of human C-reactive protein (CRP) that recently was validated for the determination of canine serum CRP, and to assess the clinical analytical performance of the assay.
Methods:
Proposed guidelines for the planning and implementation of IQC procedures were followed by using 2 control materials. Quality requirements of the assay were defined objectively by means of available data on biological variation, and goals for IQC performance were defined according to recommendations (probability of error detection [P(ed)] >.90 and of false rejection [P(fr)] <.05). Analytical performance was evaluated by means of medical decision charts.
Results:
The control rule of 1(2.5s) (ie, rejection of the analytical run if at least 1 of 2 control materials deviates from the mean by more than 2.5 SD) fulfilled the criteria of predicted IQC performance (P(ed) =.94-1.00, P(fr) =.03). The IQC method was successfully implemented over a 14-week period. The observed coefficient of variation in the period of monitoring was 3.8% (low) and 2.9% (high), which equals excellent analytical performance.
Conclusions:
It was possible to plan and implement a simple IQC procedure for the CRP-TIA with control materials based on canine serum samples that fulfilled the criteria of high error detection and low false rejection of valid analytical runs. The assay showed excellent long-term analytical performance over a 14-week period.
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