Diagnostic accuracy of a fully automated multiplex celiac disease antibody panel for serum and plasma

Terryberry, Jeff; Tuomi, Jani; Perampalam, Subo; Peloquin, Russ; Brouwer, Eric; Schuppan, Detlef; Guandalini, Stefano

doi:10.1515/cclm-2019-0088

Cited by 5 publications

(5 citation statements)

References 44 publications

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“…This study also demonstrated equivalent SARS-CoV-2 IgG assay results using plasma collected by fingerstick or by venipuncture. Fingerstick plasma has been used to detect IgG for the confirmation of celiac disease diagnosis [19] and to detect both IgG and IgM after suspected measles or Rubella infection [7,20]. Collection of fingerstick plasma in Microtainer tubes is quick and easy and does not require a trained phlebotomist, making it a feasible alternative to venipuncture for use in SARS-CoV-2 curbside testing or drive-through testing sites.…”

Section: Discussionmentioning

confidence: 99%

Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

Anderson

Holzmayer

Vallari

et al. 2021

Preprint

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Serologic testing for SARS-CoV-2 antibodies can be used to confirm diagnosis, estimate seroprevalence, screen convalescent plasma donors, and assess vaccine efficacy. Several logistical and infrastructure challenges limit access to SARS-CoV-2 serologic testing. Dried blood spot (DBS) samples have been used for serology testing of various diseases in resource-limited settings. We examined the use of DBS samples and capillary blood (fingerstick) plasma collected in Microtainer tubes for SARS-CoV-2 testing with the automated Abbott ARCHITECT SARS-CoV-2 IgG (List 6R86) and IgM assays and use of venous whole blood with a prototype PANBIO rapid point-of-care lateral flow SARS-CoV-2 IgG assay. The ARCHITECT SARS-CoV-2 IgG assay was initially optimized for use with DBS, venous and capillary plasma, and venous whole blood collected from patients with symptoms and PCR-confirmed COVID-19 and negative asymptomatic controls. Assay linearity and reproducibility was confirmed with 3 contrived DBS samples, with sample stability and signal recovery after 14 days at room temperature. ARCHITECT SARS-CoV-2 IgG and IgM assay results showed high concordance between fingerstick DBS and venous DBS samples, and between fingerstick DBS and venous whole blood samples (n=61). Discordant results were seen in 3 participants (2 IgG, 1 IgM) who were in the process of seroreversion at the time of sample collection and had results near the assay cutoff. Use of fingerstick plasma collected in Microtainer tubes (n=109) showed 100% concordant results (R2=0.997) with matched patient venous plasma on the ARCHITECT SARS-CoV-2 IgG assay. High concordance of assay results (92.9% positive, 100% negative) was also observed for the PANBIO SARS-CoV-2 IgG assay compared to the ARCHITECT SARS-CoV-2 IgG assay run with matched venous plasma (n=61). Fingerstick DBS and plasma samples are easy and inexpensive to collect and, along with the use of rapid point-of-care testing platforms, will expand access to SARS-CoV-2 serology testing, particularly in resource-limited areas.

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Section: Discussionmentioning

confidence: 99%

Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

Anderson

Holzmayer

Vallari

et al. 2021

Preprint

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“…This is important for patients who initially test negative for the IgA tTG and IgA antibodies used for screening but have positive DGP antibodies. The accuracy of venous to capillary plasma samples was proven with 100% agreement analysis for results using the Ig_plex 9…”

Section: Diagnosismentioning

confidence: 99%

“…The accuracy of venous to capillary plasma samples was proven with 100% agreement analysis for results using the Ig_plex. 9 Gluten challenge Patients who do not have a confi rmed celiac disease diagnosis and who are restricting or avoiding gluten in their diet can undergo a gluten challenge. This test lets serum antibody levels rise to a detectable range before screening.…”

Section: Key Pointsmentioning

confidence: 99%

“…1,7 A recent study highlighted the utility of the new Ig_plex celiac disease panel, which demonstrated equivalent or better performance for IgA tTG as that reported for the standard ELISA test. 9 This improvement to the screening process can shorten the time of diagnosis by testing for four celiac disease-related antibodies (IgA and IgG to tTG and DGP) in a simple sample and test. This is important for patients who initially test negative for the IgA tTG and IgA antibodies used for screening but have positive DGP antibodies.…”

Section: Key Pointsmentioning

confidence: 99%

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Updates on the diagnosis and management of celiac disease

Soltesz¹,

Mosebach²,

Paruch³

et al. 2022

Jaapa

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Celiac disease is a chronic autoimmune enteropathy affecting about 1% of the population. Gluten ingestion triggers an immune response in genetically susceptible patients, resulting in intestinal and extraintestinal disease manifestations. Current recommendations for diagnosis include serology for celiac-specific antibodies to transglutaminase, endomysium, and deamidated gliadin, and IgA serology. New highly accurate point-of-care tests can efficiently screen for celiac disease and improve the diagnostic timeframe. Definitive diagnosis is most commonly made via biopsy of the small bowel showing villous atrophy. A gluten-free diet with micronutrient supplementation is the only recommended treatment for celiac disease. Primary care providers must be able to recognize screening indications, refer patients appropriately, and provide proper patient education and follow-up.

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“…The accuracy of serologic testing is of tremendous importance, both in the biopsy and no-biopsy approach. Even though the sensitivity and specificity of TGA in the detection of CD is considered very high, it has been demonstrated in various studies that the diagnostic performance may vary depending on the different assays used (9)(10)(11)(12)(13). In this study, we aimed to investigate the real-life performance of a CD serology automated multiplex analyzer (Bioplex 2200, Bio-Rad Laboratories, CA), which is used as the CD serology test at Clalit Health Services, Israel's largest Health Maintenance Organization, and to explore the correlation between TGA levels and intestinal biopsies in children.…”

Section: What Is Newmentioning

confidence: 99%

Real‐life Performance of Multiplex Celiac Antibody Test in the Diagnosis of Pediatric Celiac Disease

Guz‐Mark

Kori

Topf-Olivestone

et al. 2022

J. pediatr. gastroenterol. nutr.

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Objective: Tissue-transglutaminase antibodies (TGA) may be used to diagnose celiac disease (CD) without biopsy in selected cases. We aimed to investigate real-life performance of a CD serology automated analyzer (Bioplex2200), and to explore the correlation between TGA levels and intestinal biopsies in children. Methods: A retrospective review was performed in 2 pediatric gastroenterological centers, between November 1, 2018 and April 1, 2020 and included patients with both TGA serology testing and duodenal biopsies. Retrieved data included patients' demographics, medical background, TGA levels, and biopsy results. Results: Overall, 538 children were evaluated, 256 with positive TGA (68.4% girls, median age 6.4 years), and 282 with negative TGA (53.9% girls, median age 13.4 years). Among patients with positive TGA, intestinal biopsies confirmed CD in 219 (85.5%). Overall, positive serology with normal histology was found in 14.5% of the cohort, with 52%; 21.6%; 21.1%; and 4.2% in TGA ranges of 1 to 3 times upper limit of normal (ULN); 3 to 5 ULN; 5 to 10 ULN; and above 10 times ULN, respectively, P < 0.001. Area under the receiver-operating characteristic curve (AUC) was 0.963 (95% CI 0.947-0.980). Among patients with positive TGA, 216 (84.4%) had positive antiendomysial antibodies. In this sub-group, the overall diagnostic performance was inferior, with AUC of 0.737 (95% CI 0.834-0.839). Conclusions: The Multiplex TGA assay had a very high diagnostic accuracy in real-life. Among patients with positive TGA, adding EMA did not improve the diagnostic performance of the test. False-positive rates differed between different ranges of TGA and were low with TGA above 10 times ULN.

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Diagnostic accuracy of a fully automated multiplex celiac disease antibody panel for serum and plasma

Cited by 5 publications

References 44 publications

Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

Updates on the diagnosis and management of celiac disease

Real‐life Performance of Multiplex Celiac Antibody Test in the Diagnosis of Pediatric Celiac Disease

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