CELIAC DISEASEDEFINITIVE DIAGNOSES AND SIGNIFICANT COST REDUCTION WITH CASCADING TEST APPROACHES

G A S T R O E N T E R O L O G Y A T M A Y O C L I N I C

M A Y O C L I N I C L A B S . C O M / C E L I A C

CASCADING APPROACHES: A SIMPLIFIED SOLUTION

Working closely with our clinical GI colleagues, we have established several cascading algorithms to aid in the diagnosis of celiac disease. These algorithms, each with a specific utility, use automatic reflexing to perform the necessary tests and are available as orderable clinical tests.

Knowledge about the patient’s clinical presentation, past treatment, and previous laboratory testing is critical to selecting the most appropriate algorithm.

WHICH CASCADE SHOULD I ORDER?} Celiac Disease Serology Cascade

(Mayo Test ID: CDSP)

BENEFITS OF THIS CASCADE} Available when HLA DQ typing is not desired

or has been performed previously} Interpretive report includes recommendations

on the need for confirmatory biopsy

Note: If HLA DQ typing is desired, order Mayo ID: CDCOM.

A CHALLENGING DIAGNOSISCeliac disease is a chronic inflammatory condition that primarily affects the small intestine. It is caused by an inflammatory response mounted by the patient’s own immune system against dietary gluten, which ultimately results in damage and atrophy of the villae within the small intestine.

While the diagnostic criteria of celiac disease are well-defined, symptoms are generally nonspecific. This fact, combined with the variety of available tests—each with a specific utility and interpretation—can make a diagnosis quite challenging.

PRESUMPTIVE DIAGNOSTIC CRITERIA} Positive serology} Intestinal biopsy that demonstrates villous atrophy

DEFINITIVE DIAGNOSTIC CRITERIA} Resolution of clinical symptoms after initiation of a

gluten-free diet} Generally accompanied by: – Conversion to a negative serology – Reconstitution of the villae in the small intestine

ADDITIONAL CELIAC CASCADES

} Celiac Disease Comprehensive Cascade (Mayo Test ID: CDCOM)

– Includes both serologic and genetic testing (HLA DQ typing)

– Can completely rule out CD in about 50% of patients based on HLA typing

– Includes individual test results, clinical interpretation, and recommendations on whether to proceed to biopsy or pursue another diagnosis

} Celiac Disease Gluten-Free Cascade (Mayo Test ID: CDGF) – Developed to assist in evaluating patients who

have already reduced gluten in their diets – Includes HLA DQ typing as the initial test

2.2MApproximate number of people in the U.S. estimated to have celiac disease.1

6–10Average number of years until a correct diagnosis is achieved.2

83Estimated percentage of Americans who have celiac disease who are undiagnosed or misdiagnosed with other conditions.2

CELIAC DISEASE BY THE

NUMBERS

C U S T O M E R S E R V I C E F O R C L I N I C A L S P E C I A L I S T S / 8 5 5 - 5 1 6 - 8 4 0 4 O R + 1 - 8 5 5 - 3 7 9 - 3 1 1 5 ( I N T ’ L )

C E L I A C D I S E A S E

87% of patients diagnosed with only two tests instead of the standard five3.4

150Serology cascades performed

25Comprehensive cascades performed

Total Cost Savings over 12 months using cascade versus standard panel

$39,527

Celiac Disease Serology Cascade (Mayo Test ID: CDSP)Testing begins with Immunoglobulin A (IgA), Serum

Y Normal or Elevated IgA ES Deficient IgA (<1 mg/dL)

Tissue Transglutaminase (tTG), Antibody, IgA, Serum Low IgA (>1 mg/dL but below the age-matched reference values)

Selective IgA Deficiency

• Tissue Transglutaminase (tTG) Antibody, IgG, Serum

• Gliadin (Deamidated) Antibody, IgG, Serum

Interpretive report includes:• Serum IgA• Tissue Transglutaminase Antibody, IgG• Gliadin (Deamidated) Antibody, IgG• Interpretive comments

• Tissue Transglutaminase (tTG) Antibodies, IgA and IgG Profile, Serum

• Gliadin (Deamidated) Antibodies Evaluation, IgG and IgA, Serum

Interpretive report includes:• Serum IgA• Tissue Transglutaminase Antibody, IgA and IgG• Gliadin (Deamidated) Antibodies, IgA and IgG• Interpretive comments

Weak Positive(4.0–10.0 U/mL)

Positive or Negative(>10.0 U/mL or <4.0 U/mL)

Interpretive report includes:• Serum IgA• Tissue transglutaminase

antibody, IgA• Interpretive comments

• Endomysial Antibodies (IgA), Serum

• Gliadin (Deamidated) Antibody, IgA, Serum

Interpretive report includes:• Serum IgA• Tissue Transglutaminase Antibody, IgA• Endomysial Antibody, IgA• Gliadin (Deamidated) Antibody, IgA• Interpretive comments

SIGNIFICANTLY REDUCING COSTS: A CASE STUDY

CELIAC DISEASE SEROLOGY CASCADE: A DETAILED VIEW

100Hospital beds

MC2775-116rev0219

COLLEGIAL ACCESS TO MAYO CLINIC CLINICIANS, LABORATORIANS, AND GENETIC COUNSELORS

When you partner with Mayo Clinic Laboratories,

you extend your network to include some of

the world’s leading gastroenterology experts.

Mayo Clinic clinicians, laboratorians, and genetic

counselors are available to discuss testing

options, interpret results, or help with case

review and coordination.

CITATIONS

1. Rubio-Tapia A, Ludviggson JF, Brantner TL, et al. The prevalence of celiac disease in the United States. Am J Gastroenterol. 2012; Oct;107(10):1538-1544.

2. Celiac Disease Fast Facts. Available from: http://www.beyondceliac.org/celiac-disease/facts-and-figures/. Retrieved June 5, 2016.

3. Unpublished Mayo Clinic data. Snyder MR. April 2012.

4. PROMETHEUS® Celiac Serology Test Description. Available from: http://www.prometheuslabs.com/Resources/Celiac/Celiac_Serology_Product_Detail_CEL16003_Feb_1_2016.pdf. Retrieved June 5, 2016.

FOR MORE INFORMATION ABOUT CELIAC DISEASE, VISIT US AT:

mayocliniclabs.com/celiac