scholarly journals Performance of Serology Assays for Diagnosing Celiac Disease in a Clinical Setting

2009 ◽  
Vol 16 (11) ◽  
pp. 1576-1582 ◽  
Author(s):  
Miriam Parizade ◽  
Yoram Bujanover ◽  
Batya Weiss ◽  
Vered Nachmias ◽  
Bracha Shainberg

ABSTRACT Diagnosis of celiac disease frequently depends upon serology assays. We set out to prospectively assess the diagnostic value of five serology tests: an enzyme-linked immunosorbent assay (ELISA) for tissue transglutaminase (tTG)-immunoglobulin A (IgA) and tTG-IgG, a chemiluminescence assay for tTG-IgA, an ELISA for deamidated gliadin peptide (DGP) IgG and IgA screening, and detection of endomysial antibodies (Abs) by indirect immunofluorescence. One hundred sixteen children at high risk for developing celiac disease were evaluated clinically and underwent small bowel biopsies and blood serology tests. We examined differences between younger and older children in terms of clinical presentation, test performance, and the ability of high Ab levels to correctly predict diagnosis of celiac disease. Celiac disease was diagnosed for 85 (73%) children. No significant clinical differences were observed between the biopsy-positive and biopsy-negative groups. Children ≤3 years of age revealed higher concentrations of tTG-IgA and DGP Abs than children >3 years old (P = 0.017 and 0.007, respectively). High Ab concentrations were predictive of villous atrophies, with sensitivities ranging from 92.8% to 97.9%, depending on the assay and the cutoff points applied. Sensitivities, specificities, positive predictive values, and negative predictive values varied among assays and improved after correction for best cutoff points. Assay specificities obtained in the clinical setting were lower than expected. The new tTG-IgA chemiluminescence assay demonstrated high throughput but low specificity (74.2%). The tTG-IgA ELISA exhibited the highest test efficiency, and the tTG-IgA chemiluminescence assay was suitable for large-scale screening, with reduced specificity. High concentrations of celiac disease-specific Abs bring into question the need for performance of biopsies on children at high risk.

2012 ◽  
Vol 49 (3) ◽  
pp. 204-207 ◽  
Author(s):  
Andreia Oliveira ◽  
Eunice Trindade ◽  
Marta Tavares ◽  
Rosa Lima ◽  
Mariana Terra ◽  
...  

CONTEXT - The first degree relatives of celiac patients represent a high risk group for the development of this disorder, so their screening may be crucial in the prevention of long-term complications. OBJECTIVE - In order to determine the prevalence of celiac disease in a group of first degree relatives of children with proven gluten intolerance, we conducted a prospective study that consisted in the screening of celiac disease, using a capillary immunoassay rapid test that allows a qualitative detection of IgA antibody to human recombinant tissue transglutaminase (IgA-TTG). METHODS - When the screening test was positive subjects were advised to proceed with further investigation. The screening test was performed in 268 first degree relatives (143 mothers, 89 fathers, 36 siblings) corresponding to 163 children with celiac disease. RESULTS - Screening test was positive in 12 relatives (4.5%), of which 1 refused to continue the investigation. In the remaining 11 relatives celiac disease was diagnosed in 7 cases (2.6%, 5 mothers, 2 fathers) who had a median age of 39 years (27-56 years), mild gastrointestinal symptoms, high titre of IgA-TTG and histology abnormalities confirming the diagnosis. All these patients are currently on a gluten-free diet. CONCLUSION - The prevalence of celiac disease among first degree relatives (2.6%) was 5 times higher than that in the general population. Although the recommendations for screening asymptomatic high risk groups, such as first degree relatives, are not unanimous the early diagnosis is crucial in preventing complications, including nutritional deficiency and cancer.


Parasitology ◽  
2007 ◽  
Vol 134 (14) ◽  
pp. 2021-2026 ◽  
Author(s):  
C. TANTRAWATPAN ◽  
W. MALEEWONG ◽  
C. WONGKHAM ◽  
S. WONGKHAM ◽  
P. M. INTAPAN ◽  
...  

SUMMARYTo improve the diagnosis of human fascioliasis caused byFasciola gigantica, we developed a peptide-based enzyme-linked immunosorbent assay (peptide-based ELISA) based on the detection of specific IgG4 subclass antibody. Two identified B-cell epitopes ofF. giganticacathepsin L1 were synthesized as single synthetic peptides, acetyl-DKIDWRESGYVTELKDQGNC-carboxamide (peptide L) and acetyl-DKIDWRESGYVTEVKDQGNC-carboxamide (peptide V), and their diagnostic potential was evaluated. The sera of 25 patients infected withF. gigantica, 212 patients with other parasitic infections, 32 cholangiocarcinoma patients and 57 healthy controls were analysed. The sensitivity, specificity, accuracy, and positive and negative predictive values of this assay were the same with both peptides at 100%, 99·7%, 99·7%, 96·2% and 100%, respectively. These highly sensitive and specific peptide-based ELISAs for the detection of specific IgG4 antibody could be useful for laboratory diagnosis of human fascioliasis in future large-scale surveys throughout Southeast Asia where this disease is prevalent.


Author(s):  
Karsten Conrad ◽  
Dirk Roggenbuck ◽  
Annelore Ittenson ◽  
Dirk Reinhold ◽  
Thomas Buettner ◽  
...  

AbstractThis study investigated whether a dot immunoassay (DIA) can provide simultaneous detection of anti-tissue transglutaminase (tTG), anti-deamidated gliadin (DG) and total IgA antibodies, as required in the work-up of celiac disease (CD) patients.Celiac disease patients (n=111) consecutively diagnosed from 2001 to 2011 at the Children’s Hospital and Institute of Immunology (Technical University Dresden) were tested for anti-tTG, anti-DG and total IgA by enzyme-linked immunosorbent assay (ELISA) and DIA retrospectively. Blood donors (n=45) and non-CD individuals with low IgA serum levels (n=8) were included as controls. Antibodies to endomysial antigens (EmA) were assessed by indirect immunofluorescence (IIF).Four (3.6%) of 111 CD patients demonstrated an IgA deficiency with total IgA below 50 mg/L by ELISA. Total IgA of the 107 IgA-non-deficient CD patients varied from 70 to 6000 mg/L. All four IgA-deficient CD patients were detected by a reduced reaction control of DIA and demonstrated positive anti-tTG or anti-DG IgG by DIA or ELISA. Detection of anti-tTG and anti-DG by DIA and ELISA showed a very good agreement (IgA: κ=0.972, 0.856, respectively; IgG: 0.921, 0.895, respectively).Immunodot assay is a reliable and easy-to-use technique for the detection of IgA-deficient CD patients. Simultaneous assessment of anti-tTG and anti-DG IgA antibodies, and IgA deficiency by DIA can improve the efficacy of CD serology.


2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Mwemezi L. Kabululu ◽  
Maria V. Johansen ◽  
James E. D. Mlangwa ◽  
Ernatus M. Mkupasi ◽  
Uffe C. Braae ◽  
...  

Abstract Background Taenia solium is a zoonotic parasite responsible for neurocysticercosis—a major cause of late-onset acquired epilepsy in humans. Lack of affordable, specific and sensitive diagnostic tools hampers control of the parasite. This study assessed the performance of an antigen detection enzyme-linked immunosorbent assay (Ag-ELISA) in the diagnosis of viable T. solium cysticercosis in naturally infected slaughter-age pigs in an endemic area in Tanzania. Methods A total of 350 pigs were bled before they were slaughtered and their carcases examined. Serum was analyzed for circulating antigens by using a monoclonal antibody-based B158/B60 Ag-ELISA. Each carcase was examined for the presence of Taenia hydatigena cysticerci and half carcase musculature together with the whole brain, head muscles, tongue, heart and diaphragm were sliced with fine cuts (< 0.5 cm) to reveal and enumerate T. solium cysticerci. Half carcase dissection can detect at least 84% of infected pigs. Prevalence and their 95% confidence intervals (CI) were calculated in Stata 12. Sensitivity, specificity, predictive values and likelihood ratios were determined. Results Twenty–nine pigs (8.3%, 95% CI: 5.6–11.7%) had viable T. solium cysticerci while 11 pigs had T. hydatigena cysticerci (3.1%, 95% CI: 1.6–5.5%). No co-infection was observed. Sixty-eight pigs (19.4%, 95% CI: 15.4–20%) tested positive on Ag-ELISA; of these, 24 had T. solium cysticerci and 7 had T. hydatigena cysticerci. Sensitivity and specificity were determined to be 82.7% and 86.3%, respectively. Positive and negative predictive values were 35.2% and 98.2%, respectively. Likelihood ratios for positive and negative Ag-ELISA test results were 6.0 and 0.2, respectively. There was a significant positive correlation between the titre of circulating antigens and intensity of T. solium cysticerci (r(348) = 0.63, P < 0.001). Conclusions The Ag-ELISA test characteristics reported in this study indicate that the test is more reliable in ruling out T. solium cysticercosis in pigs, than in confirming it. Hence, a negative result will almost certainly indicate that a pig has no infection, but a positive result should always be interpreted with caution. Estimates of T. solium prevalence based on Ag-ELISA results should, therefore, be adjusted for test performance characteristics and occurrence of T. hydatigena.


2000 ◽  
Vol 14 (8) ◽  
pp. 668-671 ◽  
Author(s):  
Helen R Gillett ◽  
Hugh J Freeman

The antigen for immunoglobulin (Ig)Aendomysium antibody (EmA), a sensitive and specific serological marker for celiac disease, has recently been described as tissue transglutaminase (tTG). The aim of this study was to compare the assays used to measure IgAEmAand IgA tTG antibody in patients with celiac disease and disease control subjects. Sera from 21 patients with untreated celiac disease, 48 patients with treated celiac disease and 128 disease control subjects were tested both for IgA EmA with the use of indirect immunofluorescence against human umbilical cord and for IgA tTG antibody with the use of ELISA. Titres of IgA tTG antibody were significantly higher in both the untreated and treated celiac groups than in the disease control group. Titres in the treated group were, however, significantly lower than in the untreated group. A reference range was calculated to include 99.8% of the disease control group in whom small bowel biopsy showed no evidence of celiac disease. One patient from the disease control group with raised IgA tTG antibody titres and positive IgA EmA was found to have celiac disease on small bowel biopsy. The sensitivity, specificity, and positive and negative predictive values of the IgA EmA assay were all 100%. The sensitivity of the IgA tTG antibody assay was 95%, specificity 100%, positive predictive value 100% and negative predictive value 97.7%. An ELISA used to measure IgA tTG antibody is an excellent tool to screen for celiac disease and may prove useful for monitoring response to treatment.


1998 ◽  
Vol 114 ◽  
pp. A420 ◽  
Author(s):  
S. Sulkanen ◽  
T. Halttunen ◽  
I. Korponay-Szabo ◽  
K. Laurila ◽  
P. Collin ◽  
...  

2021 ◽  
Vol 8 ◽  
Author(s):  
Diyora Abdukhakimova ◽  
Kuanysh Dossybayeva ◽  
Anna Grechka ◽  
Zhaina Almukhamedova ◽  
Alyona Boltanova ◽  
...  

Background and Objective: The diagnosis of Celiac Disease (CD) is first based on the positivity for specific serological markers. The CytoBead CeliAK immunoassay simultaneously measures antibodies (IgA) directed to tissue transglutaminase (tTG), endomysium (EMA), and deamidated gliadin (DG), in addition to providing a control for total IgA levels. The aim of this study is to assess the reliability of this multiplex assay to detect anti-tTG IgA positive patients, compared with a conventional single-parameter enzyme-linked immunosorbent assay (ELISA).Methods: Serum samples from 149 pediatric patients were assessed by both CytoBead CeliAK immunoassay and ELISA, in order to evaluate their concordance for the measurement of anti-tTG IgA.Results: The measurement of anti-tTG IgA by CytoBead CeliAK immunoassay basically showed a complete concordance rate with the conventional and single-parameter ELISA, according to the respective cutoff values (3 U/ml and 10 U/ml).Conclusions: Our comparative analysis demonstrates a substantial equivalency between multiplex CytoBead CeliAK assay and the single-parameter conventional ELISA to assess anti-tTG IgA antibody in the context of the screening for CD in children. Importantly, CytoBead CeliAK assay could present some preanalytic, analytic, and economic advantages.


Author(s):  
Е. Шубина ◽  
И.Ю. Барков ◽  
А.Ю. Гольцов ◽  
И.С. Мукосей ◽  
Т.О. Кочеткова ◽  
...  

Неинвазивный пренатальный ДНК-скрининг (НИПС) начал использоваться в клинической практике в 2011г. и в настоящее время широко применяется, как и в мире, так и в России. Проанализирована встречаемость «редких» анеуплоидий при проведении полногеномного НИПС у 2061 пациенток и исходы беременностей при наличии таких результатов. Показано, что при анализе всего генома для полногеномного варианта НИПС можно получить дополнительную информацию, важную как для прогноза течения беременности, так и для прогноза плода. Это позволяет выделить дополнительную небольшую группу беременных, которым может быть рекомендовано более пристальное наблюдение в течение беременности или проведение дополнительных диагностических процедур. Однако для определения чувствительности и специфичности определения «редких» анеуплодий и CNV в настоящий момент недостаточно данных. Noninvasive prenatal DNA screening (NIPS) is getting more widespread in clinical practice in Russia and all around the world. The use of shallow whole-genome sequencing for NIPS allows analysis of all chromosome aneuploidies; hence there are large-scale studies only on test performance on common trisomies. This study aimed to analyze the prevalence of «rare» aneuploidies using whole-genome NIPS and pregnancy outcomes in case of a high risk of «rare» aneuploidy. Noninvasive prenatal DNA screening was performed using in house developed protocol. We have analyzed 2061 samples. In 8 cases (0.4%) high-risk of rare trisomy was detected (3 - trisomy 7, 2 - trisomy 8, 1 - trisomy 10, 2 - trisomy 15). We have identified two cases of a high risk of large copy number variations (CNV). For all of the high-risk cases, we have information about pregnancy outcomes. Thereby whole-genome analysis will enable us to get the additional information and reveal pregnancies in need of further observation or testing. Hence there is not enough data for the estimation of sensitivity and specificity of detection of «rare» aneuploidies.


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