Human Lactoferrin

•Lactoferrin is a glycoprotein secreted by mucosal membranes; it Lactoferrin is a glycoprotein secreted by mucosal membranes; it is a major protein in the secondary granules of leukocytesis a major protein in the secondary granules of leukocytes

•During intestinal inflammation, activated leukocytes infiltrate the During intestinal inflammation, activated leukocytes infiltrate the mucosa and lumen, increasing the level of fecal lactoferrinmucosa and lumen, increasing the level of fecal lactoferrin

•Fecal lactoferrin is elevated in patients suffering from active Fecal lactoferrin is elevated in patients suffering from active inflammatory bowel disease (IBD) but not in persons with irritable inflammatory bowel disease (IBD) but not in persons with irritable bowel syndrome (IBD) or healthy personsbowel syndrome (IBD) or healthy persons

Lactoferrin levels in disease

12001200

800800

400400

00

Lac

tofe

rrin

leve

ls

L

acto

ferr

in le

vels

(u

g/g

we

t we

ight

)

(ug

/g w

et w

eig

ht)

Crohn’sCrohn’sDiseaseDisease

N=78N=78

UlcerativeUlcerativeColitisColitisN=71N=71

Irritable Irritable Bowel Bowel

SyndromeSyndromeN=31N=31

HealthyHealthyPersonsPersons

N=56N=56

Two new non-invasive tests to detect intestinal inflammation

• IBD-CHEKIBD-CHEKTMTM – a qualitative ELISA for the clinical lab – a qualitative ELISA for the clinical lab

• IBD-QUIK CHEKIBD-QUIK CHEKTM TM – a qualitative lateral flow test for – a qualitative lateral flow test for the clinical lab or physician’s officethe clinical lab or physician’s office

Performance Characteristics of the IBD-CHEK™ Test

N=236N=236 TotalTotal IBD-CHEKIBD-CHEKTMTM IBD-CHEKIBD-CHEKTMTM

Crohn’s diseaseCrohn’s diseaseActiveActive 52 52 85% 85% 15% 15%InactiveInactive 26 26 62%62% 39% 39%

Ulcerative colitisUlcerative colitisActiveActive 40 40 88% 88% 13% 13%InactiveInactive 31 31 52%52% 48% 48%

Active IBSActive IBS 31 31 0% 0% 100% 100%

Healthy personsHealthy persons 56 56 0% 0% 100% 100%

(+) (-)

Clinical Results with theIBD-CHEK™

• When distinguishing active IBD from irritable When distinguishing active IBD from irritable bowel syndrome and healthy persons, the bowel syndrome and healthy persons, the IBD-CHEKIBD-CHEKTMTM test exhibited a sensitivity of test exhibited a sensitivity of 86% and specificity of 100%86% and specificity of 100%

• When distinguishing active Crohn’s disease When distinguishing active Crohn’s disease from irritable bowel syndrome and healthy from irritable bowel syndrome and healthy persons, the persons, the IBD-CHEKIBD-CHEKTMTM test exhibited a test exhibited a sensitivity of 85% and specificity of 100%sensitivity of 85% and specificity of 100%

IBD-CHEK™ Test

• Qualitative ELISA for detecting elevated fecal Qualitative ELISA for detecting elevated fecal lactoferrin as an indicator of intestinal inflammationlactoferrin as an indicator of intestinal inflammation

• Utilizes a four-step procedure with results in 75 Utilizes a four-step procedure with results in 75 minutesminutes

• A valuable noninvasive diagnostic aid to distinguish A valuable noninvasive diagnostic aid to distinguish active IBD from IBSactive IBD from IBS

• Available by direct order for hospital and reference Available by direct order for hospital and reference labslabs