Giriprasad Venugopal1,2, John Mechenro1,2, Govind Makharia3, Alka Singh3, Srinivasan Pugazhendhi4, Ramadass Balamurugan5, Balakrishnan S Ramakrishna6,7. 1. SRM Institutes for Medical Science, 1, Jawaharlal Nehru Salai, Vadapalani, Chennai, 600 026, India. 2. SRM Medical College Hospital and Research Centre, Kattankulathur, India. 3. All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110 029, India. 4. Kansas University Medical Center, Kansas City, KA, USA. 5. Indian Institute of Technology, Samantapuri, Bhubaneswar, 751 013, India. 6. SRM Institutes for Medical Science, 1, Jawaharlal Nehru Salai, Vadapalani, Chennai, 600 026, India. wurama@hotmail.com. 7. SRM Medical College Hospital and Research Centre, Kattankulathur, India. wurama@hotmail.com.
Abstract
BACKGROUND: The diagnosis of celiac disease (CeD) in clinical practice relies on serological testing for IgA antibodies to human tissue transglutaminase (anti-tTG) which diagnose CeD autoimmunity. We compared three kits for their performance in diagnosis of the disease and evaluated the point prevalence of CeD autoimmunity in a South Indian urban population. METHODS: In the first part of the study, sera from 90 patients with documented CeD and 92 healthy controls were tested for anti-tTG using three different kits. One thousand nine hundred and seventeen healthy adults residing in urban areas of Vellore and Kancheepuram districts were tested for CeD autoimmunity using a sequential two-test strategy. RESULTS: The sensitivity, specificity, false positivity, false negativity, positive predictive value, and negative predictive value for the three assays respectively were as follows: 95.5%, 82.6%, 17.3%, 4.4%, 84.3%, and 95% for the Aeskulisa New Generation Assay; 85.5%, 100%, 0%, 14.4%, 100%, and 87.6% for Quanta Lite; and 71.1%, 100%, 0%, 28.8%, 100%, and 71% for Celiac Microlisa. The ROC curves showed good discrimination for all three ELISAs with an AUC of 0.947, 0.950, and 0.886 for the Aeskulisa, Quanta Lite, and Celiac Microlisa, respectively. Of 1917 (males 908, females 1009) healthy adults, 113 (5.89%) were seropositive for IgA anti-htTG in the Aeskulisa test. Two of the latter tested positive in the Quanta Lite assay and/or the Celiac Microlisa assay. The CeD autoimmunity prevalence in this urban population was 1.0 per thousand (95% confidence interval 0.3 to 3.7 per thousand). CONCLUSION: Sequential testing for anti-tTG using first a highly sensitive assay followed by a very specific assay is a new strategy for screening for CeD in clinical practice.
BACKGROUND: The diagnosis of celiac disease (CeD) in clinical practice relies on serological testing for IgA antibodies to humantissue transglutaminase (anti-tTG) which diagnose CeD autoimmunity. We compared three kits for their performance in diagnosis of the disease and evaluated the point prevalence of CeD autoimmunity in a South Indian urban population. METHODS: In the first part of the study, sera from 90 patients with documented CeD and 92 healthy controls were tested for anti-tTG using three different kits. One thousand nine hundred and seventeen healthy adults residing in urban areas of Vellore and Kancheepuram districts were tested for CeD autoimmunity using a sequential two-test strategy. RESULTS: The sensitivity, specificity, false positivity, false negativity, positive predictive value, and negative predictive value for the three assays respectively were as follows: 95.5%, 82.6%, 17.3%, 4.4%, 84.3%, and 95% for the Aeskulisa New Generation Assay; 85.5%, 100%, 0%, 14.4%, 100%, and 87.6% for Quanta Lite; and 71.1%, 100%, 0%, 28.8%, 100%, and 71% for Celiac Microlisa. The ROC curves showed good discrimination for all three ELISAs with an AUC of 0.947, 0.950, and 0.886 for the Aeskulisa, Quanta Lite, and Celiac Microlisa, respectively. Of 1917 (males 908, females 1009) healthy adults, 113 (5.89%) were seropositive for IgA anti-htTG in the Aeskulisa test. Two of the latter tested positive in the Quanta Lite assay and/or the Celiac Microlisa assay. The CeD autoimmunity prevalence in this urban population was 1.0 per thousand (95% confidence interval 0.3 to 3.7 per thousand). CONCLUSION: Sequential testing for anti-tTG using first a highly sensitive assay followed by a very specific assay is a new strategy for screening for CeD in clinical practice.
Authors: Kirsten Bibbins-Domingo; David C Grossman; Susan J Curry; Michael J Barry; Karina W Davidson; Chyke A Doubeni; Mark Ebell; John W Epling; Jessica Herzstein; Alex R Kemper; Alex H Krist; Ann E Kurth; C Seth Landefeld; Carol M Mangione; Maureen G Phipps; Michael Silverstein; Melissa A Simon; Chien-Wen Tseng Journal: JAMA Date: 2017-03-28 Impact factor: 56.272