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Evaluation of an automated chemiluminescent immunoassay kit for antinuclear antibodies in autoimmune diseases

  • Diagnosis of Autoimmunity
  • Published:
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Abstract

The identification of antinuclear antibodies (ANA) is an essential step in the diagnosis of different autoimmune diseases. The gold standard method for their detection is immunofluorescence assay. However, this is a subjective and laborious method, thus a need for simplified objective methods has aroused. In the current work, we evaluated such automated method, the LIAISON® (DiaSorin, Italy) for the detection of ANA. A total of 242 sera were analyzed including 67 from healthy subjects, 107 from primary biliary cirrhosis (PBC) patients, 20 from scleroderma patients and 48 from patients with Sjögren’s syndrome. All sera were analyzed using the automated chemiluminescent immunoassays, LIAISON® for the presence of ANA (kit No. 310300). Positive samples were further analyzed for the presence of antidouble-stranded DNA (dsDNA) and autoantibodies to 6 extractable nuclear antigens (ENA) of the LIAISON® (kits No. 310330 and 310331). Negative samples were further analyzed by Blueblot ANA assay (D-TEK, Belgium) or BlueDot Liver (D-TEK, Belgium) as appropriate. The LIAISON® specificity for ANA screening was 97 %. ANA positivity was determined in 80 % of all patients. The sensitivity was 95.5 % in scleroderma, 83 % in PBC and 72.9 % in Sjogren’s syndrome. ENA was positive in all ANA-positive scleroderma and Sjögren’s sera and in 27 % of ANA-positive PBC sera. Among scleroderma or Sjögren patients that were ANA negative, 4 samples were positive for anti-SSA and 2 for RNP-68 utilizing Blueblot assays. M2 protein was found in 1 out of the ANA-negative PBC patients. The LIAISON® ANA screen is specific and sensitive for the evaluation of ANA in patients with primary biliary cirrhosis, scleroderma and Sjögren’s syndrome.

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Abbreviations

RNP:

Ribonucleoprotein particles

Sm:

Smith

CENP:

Centromere protein

PM:

Polymyositis

PCNA:

Proliferating cell nuclear antigen, gp210—nuclear envelope glycoprotein, sp100—nuclear body protein

LKM1:

Liver kidney microsome

LC1:

Liver cytosol

SLA:

Soluble liver antigen, SS-A (Ro), SS-B (La), Jo-1 (histidyl-t-RNA synthetase), Scl-70 (DNA topoisomerase I)

Scl:

Scleroderma

M2:

Mitochondrial protein 2

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Authors and Affiliations

  1. The Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center (affiliated to Sackler Faculty of Medicine, Tel-Aviv University), 52621, Tel-Hashomer, Israel

    Yaron Zafrir, Boris Gilburd, Marina Garcia Carrasco, Shaye Kivity, Yehuda Shoenfeld & Nancy Agmon-Levin

  2. Department of Rheumatology, Clinical Hospital Buenos Aires University, Buenos Aires, Argentina

    Marina Garcia Carrasco

  3. Department of Medicine ‘A & C’, Sheba Medical Center, Tel-Hashomer, Israel

    Shaye Kivity

  4. Servicio Inmunología, Hospital Universitario Marqués de Valdecilla-IFIMAV, 39008, Santander, Spain

    María Sánchez-Castañón & Marcos López-Hoyos

  5. Blood Centre, Sheba Medical Center, Tel-Hashomer, Israel

    Mathilda Mandel

  6. Department of Rheumatology and Internal Diseases, Wroclaw Medical University, Wrocław, Poland

    Magdalena Szmyrka

  7. Incumbent of the Laura Schwarz-Kip Chair for Research of Autoimmune Diseases, Tel-Aviv University, Tel-Aviv, Israel

    Yehuda Shoenfeld

Authors
  1. Yaron Zafrir
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  2. Boris Gilburd
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  3. Marina Garcia Carrasco
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  4. Shaye Kivity
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  5. María Sánchez-Castañón
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  6. Marcos López-Hoyos
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  7. Mathilda Mandel
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  8. Magdalena Szmyrka
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  9. Yehuda Shoenfeld
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  10. Nancy Agmon-Levin
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Correspondence to Nancy Agmon-Levin.

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Zafrir, Y., Gilburd, B., Carrasco, M.G. et al. Evaluation of an automated chemiluminescent immunoassay kit for antinuclear antibodies in autoimmune diseases. Immunol Res 56, 451–456 (2013). https://doi.org/10.1007/s12026-013-8416-9

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  • DOI: https://doi.org/10.1007/s12026-013-8416-9

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