New Reference Range
Compendium Summarizes
IMMULITE^® and IMMULITE^® 2000 Data

The first English edition of the IMMULITE® and IMMULITE® 2000 Reference Range Compendium (catalog number ZB197-A) is now available from DPC. This booklet, prepared by Dr. Werner Kühnel, Marketing Manager for Scientific Affairs at DPC Biermann in Germany, represents an attempt to assemble all known reference limits for the entire spectrum of DPC's IMMULITE and IMMULITE 2000 immunoassays. Originally a German- language publication, the document has been substantially updated in the English edition. It draws not only from material in package inserts, technical reports and other DPC publications, but also from IMMULITE and IMMULITE 2000 reference range studies summarized in journal articles and scientific presentations throughout the world.

The correct interpretation of laboratory results often depends critically on the availability of reference values generated with a compatible assay system and appropriate to the patient's sex, age, developmental stage and other characteristics. This is particularly true for infants and children. Accordingly, a notable feature of this booklet is its inclusion of extensive pediatric data, much of which has not yet been published elsewhere: in particular, a recent multivariate pediatric reference range study involving 700 subjects and more than a dozen analytes. As pediatric reference ranges are not yet available for all IMMULITE assays, published values obtained with other immunoassays are included for orientation in some instances.

So far as possible, reference range information has been summarized in a uniform manner throughout the booklet, using percentiles and interpercentile ranges. Also included are other types of information used in the interpretation of certain types of assays: therapeutic and toxic ranges, for assays used in therapeutic drug monitoring (TDM); cutoffs, for drugs of abuse (DOA) assays; and Classes, for allergen-specific IgE assays.

Results from the "real-world" studies tabulated in this publication—even when they disagree (often, because of "demographic differences")—will make the IMMULITE and IMMULITE 2000 systems still more useful to laboratories and physicians around the world.

The IMMULITE and IMMULITE 2000 Reference Range Compendium is available electronically as well, on DPC's Web site, under Technical Documents, Technical Reports.