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decreased respiratory activity by the new method. A false positive involves growth on the agar plate but decreased respiration in the new method. A true negative involves growth on agar, and no charge or an increase in respiration. Finally, a false negative result occurs if there is no observable growth around the lter paper disk by the agar plate method, while the new method shows no charge or an increase in respiratory activity. Table 16.1 summarizes the results obtained in this validation experiment. From the results shown in Table 16.1, three parameters may be calculated: selectivity, sensitivity and ef ciency, as de ned in Eqs. 16.31 16.33. In this example, all three parameters are equal to 100%. Prior to use in a clinical laboratory, this kind of test must undergo regulatory approval. Data are required from several hospital labs, from numerous control and sample organisms, as well as a range of antibiotics. 16.7.2. Measurement of Plasma Homocysteine by Fluorescence Polarization Immunoassay (FPIA) Methodology6 Elevated concentrations of plasma homocysteine (HCY) are related to an increased risk of cardiovascular disease, which exists in numerous forms in plasma, with the main form existing as a disul de with itself, cysteine, or albumin. Therefore, the rst step in the measurement involves treatment with a reducing agent, in this case dithiothreitol (DTT), to obtain HCY in its free form (Eq. 16.34). Some amino acids (e.g., L-cysteine and L-methionine) are present in human plasma at higher molar concentrations than HCY and may interfere with this assay. To avoid this possible interference, the highly selective enzymatic conversion of HCY to S-adenosyl-L-homocysteine (SAH), as shown in Eq. 16.34, is used. Both reactions (reduction and conjugation) are accomplished in 30 min at 34  C.
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16:34 A monoclonal antibody was raised against SAH, and used in a competitive reaction where the antibody binds either SAH or a uoresceinated SAH analogue (tracer),
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during 20 min at room temperature, as shown in Eq. 16.35.
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16:35 The uorescence polarization (P) was calculated from measured uorescence values according to Eq. 16.36, where Fk is the uorescence intensity parallel to the excitation plane, and F is the uorescence intensity perpendicular to the excitation plane. P Fk F Fk F 16:36
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A calibration curve was constructed using ve HCY concentration and a blank solution, and the nonlinear curve obtained (Fig. 16.9) was used to calculate the unknown concentrations.
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Figure 16.9. Calibration curve based on determinations of HCY standards. [Reprinted, with permission, from Mohammed T. Shipchandler, and Ewin G. Moore, Clinical Chem. 41:7, 1995, 991 994. Rapid, Fully Automated Measurement of Plasma Homocyst(e)ine with the Abbot Imx Analyzer . # Amer. Assos. for Clinical Chemistry.]
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TABLE 16.2. Intraassay and Interassay Variation Coef cients for Calibration Data from the Plasma Homocysteine Assaya Standard (mmol/L) 3.75 7.50 15.00 30.00 60.00 CV Intraassay n 3 Interassay n 3 8.0 3.6 3.4 2.7 1.8 9.1 4.5 6.5 3.0 2.6
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a Reprinted, with permission, from Mohammed T. Shipchandler and Ewin G. Moore. Clinical Chem. 41:7, 1995, 991 994. Rapid, Fully Automated Measurement of Plasma Homocyst(e)ine with the Abbot Imx Analyzer . # Amer. Assos. for Clinical Chemistry.
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Coef cients of variation for intraassay and interassay calibration data are shown in Table 16.2. Matrix effects were studied by dilution with buffer of two real plasma samples. Both parallelism tests (Table 16.3) show that matrix effects are not significant for this method, since the observed calculated results show apparently random scatter $ 100% Another method used to study matrix effects is the recovery experiment. Table 16.4 shown that recoveries are within acceptable limits, since the calculated values are again scattered $ 100%. Cross-reactivity was study for similar molecules expected to be present in plasma. L-Cysteine (hydrochloride) and L-methionine at 5 and 4.5 mmol/L, respectively, were assayed in buffer. The observed polarization values correspond to HCY concentrations of 0.0 and 0.1 mmol/L, respectively. Thus, the antibody-binding reaction is suf ciently selective in the presence of these potential interferents. Accuracy was assessed by comparison with established methods. Regression equations were determined for clinical samples analyzed by this new method and four established HCY quantitation methods. Results from this new method were plotted as x values and the established method results were plotted as y. Table 16.5 shows the regression equations and their statistical quality parameters. The correlation coef cients (r) obtained between the tested methods are good, although the differences in slopes are large, indicating either overestimation of HCY concentration by methods B D, or underestimation of HCY concentrations by method A and the new method. The authors believe that these differences can be attributed to different purities of commercial standards (HCY) used in the different laboratories. The use of standard reference materials, as indicated previously in this chapter, would allow a better assessment of the accuracy of the new method. However, for many biological analytes, these materials are not available. Under these conditions,
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