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Performance evaluation of a radioimmunoprecipitation assay for the detection of N-type voltage-gated calcium channel antibodies.
Lozier, Bucky K; Haven, Thomas R; Tebo, Anne E; Peterson, Lisa K.
Afiliación
  • Lozier BK; ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
  • Haven TR; ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
  • Tebo AE; ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, USA; Department of Pathology, University of Utah, 15 N Medical Dr. East Ste. 1100, Salt Lake City, UT 84112, USA.
  • Peterson LK; ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT 84108, USA; Department of Pathology, University of Utah, 15 N Medical Dr. East Ste. 1100, Salt Lake City, UT 84112, USA. Electronic address: lisa.k.peterson@aruplab.com.
J Immunol Methods ; 496: 113102, 2021 09.
Article en En | MEDLINE | ID: mdl-34298066
BACKGROUND: In this study, we assessed the performance characteristics of a laboratory-developed radioimmunoassay (RIA) to detect N-type voltage-gated calcium channel (N-VGCC) antibodies found in several autoimmune neurologic diseases. METHODS: Four hundred and forty-five (n = 445) sera were evaluated, including 156 sera (50 positive and 106 negative for N-VGCC antibodies) previously tested at Mayo Clinic Laboratories (MCL) and 289 controls (n = 187 disease and n = 102 healthy). Specimens were analyzed with the RIA using N-VGCC labeled with 125I-ω-conotoxin GVIA. The RIA was compared to the predicate MCL assay using a tiered positive predictive value (PPV) approach. Other performance characteristics evaluated included specificity, precision, interference, and stability. RESULTS: Qualitative inter-laboratory agreement based on tiered PPVs was 100% for results >1.00 nmol/L (71% PPV), 48% for results of 0.10-0.99 nmol/L (24% PPV) and 22% for results of 0.04-0.10 nmol/L (19% PPV). Negative results showed 90% agreement (n = 106). Specificity in controls positive for other neural autoantibodies and healthy controls were 87% and 100%, respectively. Acceptable results were observed for other performance characteristics. CONCLUSIONS: Inter-laboratory correlations demonstrate equivalence between assays with some discrepancies between low positive results. Collaborative efforts aimed at assessing the clinical spectrum associated with these antibodies and consensus for harmonizing test performance are required for optimal categorization of patients.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Autoanticuerpos / Radioinmunoensayo / Pruebas Serológicas / Autoinmunidad / Síndrome Miasténico de Lambert-Eaton / Canales de Calcio Tipo N Tipo de estudio: Diagnostic_studies / Evaluation_studies / Observational_studies / Prevalence_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Immunol Methods Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Autoanticuerpos / Radioinmunoensayo / Pruebas Serológicas / Autoinmunidad / Síndrome Miasténico de Lambert-Eaton / Canales de Calcio Tipo N Tipo de estudio: Diagnostic_studies / Evaluation_studies / Observational_studies / Prevalence_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Immunol Methods Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos