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Sensitivity and Specificity of Immunological Methods for the Detection of Anti-Topoisomerase I (Scl70) Autoantibodies: Results of a Multicenter Study

¹ Laboratorio di Patologia Clinica, Ospedale Civile, 30027 S. Donà di Piave (VE), Italy.

² Istituto di Chimica Clinica and
³ Divisione 4 Medica, Azienda Ospedaliera "S. Maria della Misericordia", 33100 Udine, Italy.

⁴ Servizio di Immunologia e Microbiologia, Azienda Ospedaliera S. Maria degli Angeli, 33170 Pordenone, Italy.

⁵ Patologia Clinica II, Ospedale S. Chiara, 38100 Trento, Italy.

⁶ Laboratorio Analisi Chimico-Cliniche e Microbiologia, Ospedale Civile, 33053 Latisana (UD), Italy.

⁷ Dipartimento di Medicina di Laboratorio, Ospedale Civile, 30015 Chioggia (VE), Italy.

⁸ Laboratorio Analisi Chimico-Cliniche, Ospedale Geriatrico, 35100 Padova, Italy.

⁹ Laboratorio Analisi Chimico-Cliniche e Microbiologiche, Ospedale Civile, 31033 Castelfranco, Veneto (TV), Italy.
^a Author for correspondence. Fax 39-0421-227571; e-mail nbizzaro{at}dacos.it

Background: The ability of immunometric methods to identify anti-topoisomerase I (Scl70) antibodies is controversial. We wished to quantify the performance of the currently available commercial systems for the assay of anti-topoisomerase I antibodies in a large multicenter study.

Methods: Fifty Italian clinical laboratories analyzed 36 serum samples: 27 from individuals with scleroderma/systemic sclerosis, and 9 from a control group. The scleroderma/systemic sclerosis samples were positive in our laboratories by both ELISA and immunoblot (IB), and the control samples were negative. The laboratories used 42 immunoenzymatic (ELISA), 21 IB, 3 counterimmunoelectrophoresis, and 2 dot-blot methods, produced by 23 different manufacturers.

Results: We obtained 2389 results. The ELISA methods showed 99.2% specificity and 97.2% sensitivity for detection of anti-Scl70 antibodies. For IB methods, specificity was 97.6% and sensitivity was 96.1%. The Western-blot method had poor analytical specificity (27% false positives for anti-extractable nuclear antigen antibodies other than anti-Scl70).

Conclusions: Excluding Western blots, commercial ELISA and IB reagents as used in clinical laboratories have a sensitivity and a specificity >95% for determination of anti-Scl70 antibodies.

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