Tests Covering the Spectrum

Natural Killer Cell Function
Test Code: 2108

This test evaluates the functional capacity of patients’ natural killer cells (NK) by assessing the
ability of NK cells present in peripheral blood mononuclear cells (PBMC) to lyse K562 cells. As a critical part of the innate immune system, NK cells mediate killing of virally infected cells and tumor cells. The determination of NK cell function can be useful in elucidating how a disease develops. Conditions associated with natural killer cell dysfunction include: acute and chronic viral infections; chronic fatigue immune dysfunction syndrome (CFIDS);
hemophagocytic lymphohistiocytosis (HLH); juvenile rheumatoid arthritis (JRA); macrophage activation syndrome (MAS); chronic myelogenous leukemia (CML); metastatic melanoma (MM); Sjogren’s syndrome; and systemic lupus erythematosus (SLE).

Other testing related, which may be appropriate for some patients are: T-B-NK Immunophenotyping (403106) and Toll-Like Receptor Pathway Function (403091).

Mannan-Binding Lectin Pathway Function
Test Code: 34

Mannan-binding lectin (MBL) deficiencies occur in approximately 10-20% of the population. As part
of the innate immune system, MBL is crucial in targeting microbial pathogens for destruction via opsonization, enhancement of phagocytosis and complement activation. Deficient quantities of MBL results in predisposition to serious infections and autoimmune diseases, such as pneumonitis, sepsis, osteomyelitis, gastroenteritis, cystic fibrosis, and meningitis (when the adaptive immune system is immature such as in early childhood or when suppressed such as during chemotherapy or after organ transplantation). Structurally MBL is a C1q-like molecule that in association with MBL-associated
serine proteases (MASPs) bind to surface carbohydrates on bacteria, fungi, viruses and protozoa. This Enzyme Immunoassay (EIA) allows MBL pathway function to be indirectly monitored by determining the specific C4b-depositing capacity of patient sera with an anti-human C4 monoclonal antibody. Individuals suffering from recurrent infection should be considered for testing as a

prognostic indicator alerting to the need for heightened therapeutic or prophylactic measures.

Other testing related, which may be appropriate for some patients are: Mannan-Binding Lectin Protein (33), Mannan-Binding Lectin ProGenotyper™ (402857) and MASP-2 Polymorphism ProGenotyper™ (402856).

Free-IgE (Xolair®) Test
Coming Soon

This test is intended to allow physicians to monitor Xolair® effectiveness in reducing IgE levels for patients with moderate to severe allergic asthma. IBT’s Free IgE testing only measures the amount of IgE unbound by Xolair® (free-IgE); thus allowing physicians to evaluate the drug’s effectiveness in binding IgE and aid in determining dosage. Other testing methods currently available can only measure total IgE levels — these tests cannot differentiate between IgE bound or unbound to Xolair®. To minimize variables and establish an ideal comparison point, it is recommended that a baseline IgE be measured using Free-IgE testing before initial dosing with Xolair®.

Another key test currently available
which may be appropriate for some patients is: Xolair® Perennial Allergy Panel (402786).

In the News

IBT Laboratories would like to thank all new and existing clients for visiting us at our ACAAI booth last month in Miami. We heard your requests and wanted to address a few of the frequently asked questions regarding CU Index™ Testing Services and BasoFunction testing.

Sample Insurance Support Letter
For those with insurance billing issues, please visit:
CU Indexwww.ibtlabs.com/cu
BasoFunction — www.ibtlabs.com/baso


CU Index Testing Services
Test Code: 2103

Chronic Urticaria has been demonstrated by Kaplan and others to have an autoimmune

etiology in 30-50% of chronic urticaria patients. Patients who test positive (≥10) with the CU Index™ have an autoimmune basis for their disease. The treatment course for autoimmune positive patients is often different than for acute and transient urticaria or idiopathic chronic urticaria. Drugs that modulate the basic immunological aspects of the disease (methotrexate, calcineurin inhibitors, etc.) may be considered if an autoimmune etiology is established.

New Autoimmune Chronic Urticaria Testing
We are currently working on an additional chronic urticaria test, which will measure IgG autoantibodies against the high affinity IgE receptor (FcεRIα). We expect this test to be available early 2010.

BasoFunction Testing
Basophil Activation Test — Test Code: 501250
BasoFunction Histamine Release Test (HRT) — Test Code: Allergen Specific; Call Client Services

These tests, Basophil Activation Test and BasoFunction HRT, complement each other in assessing histamine response in vitro following challenge with a non-specific stimulus and suspected allergens, respectfully. Initially a baseline measurement of basophil activation is assessed by measuring the amount of histamine released (ng/mL) when basophils are activated by a non-specific stimulus (fMLP). This baseline measurement is then compared to histamine released following a specific allergen stimulation. The BasoFunction testing may be useful with patients who have a suggestive history of a specific allergy and for who skin testing and/or in vitro specific IgE testing is not appropriate or available. Currently, IBT has the ability to test for various analgesics, anesthetics, antibiotics and food additives; totaling over 40 antigens.

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