Developed by several institutes under a DBT sponsored collaborative program
Globally, there has been an increase in number of patients diagnosed with celiac disease. The inner lining of the small intestine (where food is digested and absorbed) gets damaged and food is not absorbed properly which leads to weight loss, failure to gain weight, prolonged diarrhea, abdominal fullness, bulky stools, and anemia (lack of blood).
Correct diagnosis of celiac disease is essential because it requires lifelong adherence to gluten-free diet and helps prevent long term complications like diabetes, thryoiditis, osteoporosis (thin bones) etc. The diesease is genetic and can be caused by ingestion of a protein called gluten which is present in cereals such as wheat and barley. When someone genetically susceptibile eats food containing gluten the body’s immune system gets activated and the inner lining of small intestine gets damaged. The disease continues till the person keeps taking gluten containing food.
2.2 million children under the age of 5 are affected by Celiac Disease and 42000 of them die (2011).Prevalence rate is 0.4-0.75 percent in Europe and 0.6 to 0.8 percent in Latin America, North Africa and Middle East. Saharawi (people living in western part of Sahara Desert) tribe has a high prevalence of 5.6 percent (2005). The disease is more common than is recognized in India. A recent study has shown that the prevalence of celiac disease in the north Indian community is ~1 percent.
The activated immune system also produces some specific antibodies such as anti-tissue transglutaminase antibody and anti-endomysial antibody. The detection of these antibodies is the first step in both screening and diagnosis of this disease. Patients, in whom the antibody levels are found to be positive, the diagnosis of celiac disease can be confirmed by taking biopsies from the small intestinal lining using endoscopy. Avoidance of food and food products containing gluten is the treatment of celiac disease.
Some new therapies which may be useful for treatment include, oral enzyme therapy, tissue transglutaminase inhibitor, HLA-DQ peptide presentation blocker, T-cell silencing agent and cytokine therapy. A number of new drugs are now also being developed, none of them are presently available. Celiac disease is a relatively new disease in India and only a handful of patients are diagnosed, the majority are still undiagnosed. After a clinical suspicion, the first test done is a blood test based on serology such as estimation of anti-tissue transglutaminase antibody.
There are two types of diagnostic kits in this regards: An ELISA based test, which requires processing of blood in the laboratory. It requires sophisticated equipment and trained laboratory personnel. Many hospitals, especially small centres across our country do not have access to the conventional expensive laboratory-based tests for identifying antibodies in the blood. Once individuals identified in small hospitals can be referred to larger hospitals where facilities for conducting confirmatory intestinal biopsies are available.
It is, therefore, imperative to have easily available, affordable, rapid, sensitive and specific tests that can identify celiac disease correctly and also decrease the time required for the diagnosis of the disease. This can be done by a simple point of care (PoC) test that give rapid results and shorten the time between diagnosis and therapeutic intervention. Diagnostic kits which are used presently are all imported from Europe and America. The Department of Biotechnology, Ministry of Science & Technology, Government of India perceived a need to develop an indigenous diagnostic kit for this disease.
Accordingly, DBT sponsored a collaborative program between Translational Health Science and Technology Institute (THSTI), Gurgaon, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, All India Institute of Medical Sciences (AIIMS),New Delhi with an industrial partner, M/s J. Mitra and Co., New Delhi for the development of affordable, indigenous, rapid sensitive and specific diagnostic tests for celiac disease. The whole programme was co-ordinated by THSTI, Gurgaon.
The Diagnostic Assays thus developed by the above mentioned laboratories are affordable, rapid, sensitive and specific to identify Celiac Disease which helps quicker therapeutic interventions. The Assays comprise of two tests:
(i) Celiac Microlisa, which is based on indirect Elisa; and
(ii) Celiac Card which is a point-of-care test giving result in 20 minutes time. These tests are thus very useful in the screening of patients suspected to have this disease and can be done at any part of the country since it does not require sophisticated laboratory and highly skilled personnel.
EP News Bureau-Mumbai
