Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Apr;26(3):115-118.
doi: 10.1097/RHU.0000000000000971.

Performance of Anti-Topoisomerase I Antibody Testing by Multiple-Bead, Enzyme-Linked Immunosorbent Assay and Immunodiffusion in a University Setting

Kate LaRiviere Homer  1 , Jeffrey Warren  2 , Dmitry Karayev  3 , Puja P Khanna  4 , Amber Young, Vivek Nagaraja, Allan L Metzger  3 , Dinesh Khanna
Affiliations

Performance of Anti-Topoisomerase I Antibody Testing by Multiple-Bead, Enzyme-Linked Immunosorbent Assay and Immunodiffusion in a University Setting

Kate LaRiviere Homer et al. J Clin Rheumatol. 2020 Apr.

Abstract

Background/objective: The criterion standard for anti-topoisomerase I antibody (anti-topo I antibody) testing in systemic sclerosis (SSc) uses immunodiffusion (ID) techniques, but enzyme-linked immunosorbent assay (ELISA) and multiple-bead technology are often used in current settings to save time and cost. Our aim was to assess the performance of the multiple-bead assay, ELISA, and ID testing methods.

Methods: We conducted a retrospective study of patients at the University of Michigan whose extractable nuclear antigen 10 autoantibody panel tested positive for the anti-topo I antibody by multiple-bead technology during a 1-year period. All samples positive by multiple-bead assay were sent to the RDL Laboratories and reflexed for ELISA, and all anti-topo I antibodies positive by ELISA were further tested by ID. Clinical data were reviewed by a rheumatologist and assessed for presence of SSc. Data were analyzed via frequency tables.

Results: Approximately 9500 extractable nuclear antigen 10 panels were ordered by physicians at the University of Michigan. Of these, 129 patients were positive for the anti-topo I antibody by multiple-bead assay, 51 were positive by multiple-bead assay and ELISA, and 21 were positive by multiple-bead assay, ELISA, and ID. We found that 26.4% of patients positive by multiple-bead assay, 47.1% positive by multiple-bead assay and ELISA, and 95.2% positive by multiple-bead assay, ELISA, and ID had SSc.

Conclusions: Multiple-bead assays have a high rate of false-positive results for the anti-topo I antibody in patients without clinical evidence of SSc. A stepwise approach of confirmation of positive multiple-bead assay results using both ELISA and ID improves the predictive value of antibody testing for the diagnosis of SSc.

PubMed Disclaimer

References

    1. Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017;390(10103):1685–99. - PubMed
    1. Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003;29(2):239–54. - PubMed
    1. van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis and rheumatism. 2013;65(11):2737–47. - PMC - PubMed
    1. Domsic RT, Medsger TA. Autoantibodies and Their Role in Scleroderma Clinical Care. Current treatment options in rheumatology. 2016;2(3):239–51.
    1. Mahler M, Silverman ED, Schulte-Pelkum J, et al. Anti-Scl-70 (topo-I) antibodies in SLE: Myth or reality? Autoimmunity reviews. 2010;9(11):756–60. - PubMed