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Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients.
Clin Chim Acta. 2005 Sep; 359(1-2):109-14.CC

Abstract

BACKGROUND

The measurement of antinuclear antibodies (ANA) is used in the autoimmune laboratory for the screening of connective tissue diseases (CTD). ANA measurements are mainly performed by indirect immunofluorescence (IIF) on HEp-2 cells or by enzyme immunoassay (EIA). The objective of this study was to clinically evaluate an automated EIA for extractable nuclear antigens (ENA) which lacks anti-dsDNA for the screening of CTD.

METHODS

The study involved a total of 170 serum samples, 54 from patients with CTD, 26 from patients with other autoimmune diseases, and 90 from patients with non-autoimmune diseases. For all sera, ANA detection was performed by IIF and by EliA Symphony (Pharmacia Diagnostics, Freiburg, Germany), an ENA screening which detects the following autoantibodies: SSA/Ro, SSB/La, U1RNP (70 kDa, A, C), Scl-70, JO-1, centromere B and Sm. Also, anti-dsDNA (EliA dsDNA, Pharmacia Diagnostics, Freiburg, Germany) was measured on all samples. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), efficiency, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated.

RESULTS

Diagnostic efficiency was similar for IIF (82.6%) and EliA Symphony (82.3%), as well as PLR (6.5 for IIF, and 7.3 for Eli Symphony), and NLR (0.35 for IIF, and 0.41 for EliA Symphony). The combined measurement of EliA Symphony and dsDNA increased sensitivity but not PLR. Area under receiver operator characteristic (ROC) curve was similar for IIF (0.847) and EliA Symphony (0.823).

CONCLUSIONS

The results of the study demonstrate that EliA Symphony solely or combined with anti-dsDNA detection has an efficiency similar to HEp-2 cells IIF with a cut-off of 1:160 for the diagnosis of CTD.

Authors+Show Affiliations

González C
Laboratorio de Autoinmunidad, Servicio de Bioquímica, Hospital Universitario, 37007 Salamanca, Spain.
García-Berrocal B
No affiliation info available
Pérez M
No affiliation info available
Navajo JA
No affiliation info available
Herraez O
No affiliation info available
González-Buitrago JM
No affiliation info available

MeSH

Antibodies, AntinuclearConnective Tissue DiseasesEnzyme-Linked Immunosorbent AssayFluorescent Antibody Technique, IndirectHumansROC CurveSensitivity and Specificity

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15894301

Citation

González, Concepción, et al. "Laboratory Screening of Connective Tissue Diseases By a New Automated ENA Screening Assay (EliA Symphony) in Clinically Defined Patients." Clinica Chimica Acta; International Journal of Clinical Chemistry, vol. 359, no. 1-2, 2005, pp. 109-14.
González C, García-Berrocal B, Pérez M, et al. Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients. Clin Chim Acta. 2005;359(1-2):109-14.
González, C., García-Berrocal, B., Pérez, M., Navajo, J. A., Herraez, O., & González-Buitrago, J. M. (2005). Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients. Clinica Chimica Acta; International Journal of Clinical Chemistry, 359(1-2), 109-14.
González C, et al. Laboratory Screening of Connective Tissue Diseases By a New Automated ENA Screening Assay (EliA Symphony) in Clinically Defined Patients. Clin Chim Acta. 2005;359(1-2):109-14. PubMed PMID: 15894301.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients. AU - González,Concepción, AU - García-Berrocal,Belén, AU - Pérez,Marta, AU - Navajo,José A, AU - Herraez,Oscar, AU - González-Buitrago,José M, PY - 2004/07/08/received PY - 2005/03/13/revised PY - 2005/03/14/accepted PY - 2005/5/17/pubmed PY - 2005/11/8/medline PY - 2005/5/17/entrez SP - 109 EP - 14 JF - Clinica chimica acta; international journal of clinical chemistry JO - Clin Chim Acta VL - 359 IS - 1-2 N2 - BACKGROUND: The measurement of antinuclear antibodies (ANA) is used in the autoimmune laboratory for the screening of connective tissue diseases (CTD). ANA measurements are mainly performed by indirect immunofluorescence (IIF) on HEp-2 cells or by enzyme immunoassay (EIA). The objective of this study was to clinically evaluate an automated EIA for extractable nuclear antigens (ENA) which lacks anti-dsDNA for the screening of CTD. METHODS: The study involved a total of 170 serum samples, 54 from patients with CTD, 26 from patients with other autoimmune diseases, and 90 from patients with non-autoimmune diseases. For all sera, ANA detection was performed by IIF and by EliA Symphony (Pharmacia Diagnostics, Freiburg, Germany), an ENA screening which detects the following autoantibodies: SSA/Ro, SSB/La, U1RNP (70 kDa, A, C), Scl-70, JO-1, centromere B and Sm. Also, anti-dsDNA (EliA dsDNA, Pharmacia Diagnostics, Freiburg, Germany) was measured on all samples. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), efficiency, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated. RESULTS: Diagnostic efficiency was similar for IIF (82.6%) and EliA Symphony (82.3%), as well as PLR (6.5 for IIF, and 7.3 for Eli Symphony), and NLR (0.35 for IIF, and 0.41 for EliA Symphony). The combined measurement of EliA Symphony and dsDNA increased sensitivity but not PLR. Area under receiver operator characteristic (ROC) curve was similar for IIF (0.847) and EliA Symphony (0.823). CONCLUSIONS: The results of the study demonstrate that EliA Symphony solely or combined with anti-dsDNA detection has an efficiency similar to HEp-2 cells IIF with a cut-off of 1:160 for the diagnosis of CTD. SN - 0009-8981 UR - https://www.unboundmedicine.com/medline/citation/15894301/Laboratory_screening_of_connective_tissue_diseases_by_a_new_automated_ENA_screening_assay__EliA_Symphony__in_clinically_defined_patients_ DB - PRIME DP - Unbound Medicine ER -