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identify allergens which may be responsible for allergic disease and/or anaphylactic episode, to confirm
sensitization to particular allergens prior to beginning immunotherapy, and to investigate the specificity of
allergic reactions to insect venom allergens, drugs, or chemical allergens.
Interpretation: Detection of IgE antibodies in serum (Class 1 or greater) indicates an increased
likelihood of allergic disease as opposed to other etiologies and defines the allergens that may be
responsible for eliciting signs and symptoms. The level of IgE antibodies in serum varies directly with the
concentration of IgE antibodies expressed as a class score or kU/L.
Reference Values:
Class IgE kU/L Interpretation
0 Negative
1 0.35-0.69 Equivocal
2 0.70-3.49 Positive
3 3.50-17.4 Positive
4 17.5-49.9 Strongly positive
5 50.0-99.9 Strongly positive
6 > or =100 Strongly positive Reference values
apply to all ages.
Clinical References: Homburger HA: Allergic diseases. In Clinical Diagnosis and Management by
Laboratory Methods. 21st edition. Edited by McPherson RA, Pincus MR. WB Saunders, Publ, New York,
Chapter 53, Part VI, pp. 961-971, 2007
Barrett's-Associated Neoplasia, Cytology and FISH
Clinical Information: Barrett's esophagus is a preneoplastic condition that results in the
transformation of benign squamous epithelium of the esophagus into specialized glandular intestinal
mucosa. Patients with Barrett's esophagus are at a significantly increased risk for developing esophageal
adenocarcinoma and, therefore, require close monitoring. Guidelines recommend periodic endoscopic
examination of the esophagus with 4-quadrant biopsies taken every 1 cm to 2 cm of affected esophagus.
Currently, histology results are considered the gold standard for diagnosing esophageal dysplasia and
adenocarcinoma. However, there are many limitations of biopsy including limited sampling of the
affected area, lengthy procedure time for biopsy collection, poor interobserver reproducibility of
pathologists to diagnose dysplasia or adenocarcinoma, and an inability of histologic findings to predict
patient progression from Barrett's esophagus to esophageal adenocarcinoma.(1) FISH, a technique that
utilizes fluorescently labeled DNA probes to examine cells for chromosomal alterations, can be used to
detect cells with chromosomal changes (eg, polysomy) that are indicative of neoplasia (dysplasia or
adenocarcinoma). Studies indicate that a multicolor, multitarget FISH assay that utilizes probes to 8q24
(MYC), 9p21 (CDKN2A), 17q12 (ERBB2; alias HER-2), and 20q13.2 (ZNF217), is able to detect
dysplasia and adenocarcinoma in endoscopic esophageal brushing specimens collected from patients with
Barrett's esophagus.(1,2)
Useful For: Aid to identifying dysplasia and adenocarcinoma in patients with Barrett's esophagus
Interpretation: An interpretive report is provided based on the combination of routine cytology and
FISH results.
Reference Values:
An interpretive report will be provided.
Clinical References: 1. Brankley SM, Wang KK, Harwood AR, et al: The development of a
fluorescence in situ hybridization assay for the detection of dysplasia and adenocarcinoma in Barrett's
esophagus. J Mol Diagn 2006 May;8(2):260-267 2. Rygiel AM, Milano F, Ten Kate FJ, et al: Gains and
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