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CLSI C59

Revision A, September 1997

Complete Document

Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline



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VOL 17; NO 12
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Description / Abstract:

This document will address several issues which require particular attention. These include the following:

(1) Qualification and assessment of immunogen— Section 3.

(2) Polymorphism— Section 3.1.1.

(3) Antiserum specificity and titer— Sections 4, and 5.

(4) Storage conditions for patient samples— Section 6.3.

(5) Detergent requirements and effects—Section 6.5.

(6) Patient preparation— Section 7.

(7) Immunochemical methods— Section 8.

(8) Particle size effects— Section 8.1, and Section 8.3.

(9) Comparability of assay results among methods— Section 8.8.

(10) Storage conditions for reference materials— Section 9.

(11) Value assignment and transfer to reference materials— Section 9.

(12) Data management— Section 10 through Section 10.6.

(13) Interpretation of values— Section 12.