CLSI C59
Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
| Organization: | CLSI |
| Publication Date: | 1 September 1997 |
| Status: | active |
| Page Count: | 52 |
scope:
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.
Document History
