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9.8. Immunoassay development on different platforms

Chapter 9

IgG, IgA and IgM Hevylite assays were initially launched in 2009/2010, and are available on the Binding Site SPAPLUS and Siemens BN™II instruments. Hevylite assays for the Binding Site Optilite® instrument are also in development. A summary of the features of Hevylite IgM assays is shown in Table 9.2. A full description of Binding Site instruments is present in Chapter 37. A general discussion of Hevylite assay implementation and interpretation is in Chapter 11.

The Binding Site SPAPLUSSiemens BNII
IgMκ IgMλ IgMκ IgMλ
Sensitivity (g/L)
[Dilution]
0.020
[1/1]
0.018
[1/1]
0.010
[1/5]
0.009
[1/5]
Precision (within run, %CV)1.5 - 2.4% 1.7 - 2.0% 2.8 - 5.6% 1.7 - 4.2%
Precision (between run, %CV)1.3 - 4.9% 0.5 - 5.4% 2.7 - 4.8% 1.1 - 9.3%
Prozone parametersYes Yes Yes Yes
Analytical time (min)15 15 12 12
Higher dilutions1 Automatic
then off-line
1 Automatic
then off-line
Automatic Automatic

Table 9.2. Comparison of features for IgM HLC assays on the BNII and SPAPLUS.

Questions

  1. How is the specificity of HLC antisera tested?
  2. How are internal reference preparations for HLC assays standardised?

Answers

  1. Using a panel of antigens (including monoclonal immunoglobulins of each class, subclass, and light chain type) using RID and turbidimetric/nephelometric techniques (Section 9.3).
  2. Using international serum protein reference materials (CRM470 and DA 470k; Section 9.4).
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