Comparison of the analytical and clinical performances of two different routine testing protocols for antinuclear antibody screening

Autor: Sandra Fuentes Cantero, Antonio Pérez Pérez, Antonio León Justel, Francisco Javier Vázquez Barbero, Concepción González Rodríguez
Přispěvatelé: Universidad de Sevilla. Departamento de Bioquímica Médica y Biología Molecular e Inmunología
Rok vydání: 2021
Předmět:
Male
Microbiology (medical)
medicine.medical_specialty
Routine testing
Anti-nuclear antibody
diagnosis
systemic autoimmune rheumatic diseases
Clinical Biochemistry
Enzyme-Linked Immunosorbent Assay
antinuclear antibodies
Gastroenterology
Autoimmune Diseases
Immunoenzyme Techniques
Rheumatic Diseases
Internal medicine
medicine
Screening method
Humans
Mass Screening
Immunology and Allergy
Line immunoassay
Fluorescent Antibody Technique
Indirect
Research Articles
Immunoassay
Indirect immunofluorescence
medicine.diagnostic_test
business.industry
Biochemistry (medical)
Public Health
Environmental and Occupational Health
IIf
Hematology
Middle Aged
enzyme‐linked immunosorbent assay
Medical Laboratory Technology
method comparison
Antibodies
Antinuclear
Female
Blood Coagulation Tests
CTD
EliA
business
Research Article
Zdroj: Journal of Clinical Laboratory Analysis
ISSN: 1098-2825
0887-8013
DOI: 10.1002/jcla.23914
Popis: Background The diagnosis of systemic autoimmune rheumatic diseases (SARD) is based on the detection of serum antinuclear antibodies (ANA) for which indirect immunofluorescence (IIF) is the golden standard. New solid‐phase immunoassays have been developed to be used alone or in combination with the detection of extractable antinuclear antibodies (ENA) to improve SARD diagnosis. The purpose of this study was to compare the clinical performances of different ANA screening methods alone or in combination with ENA screening methods for SARD diagnosis. Methods A total of 323 patients were screened for ANA by IIF, EliA™ CTD Screen, and ELISA methods. Agreements were calculated between the methods. Then, EliA™ CTD Screen positive samples were screened for ENA by line immunoassay (LIA) and fluorescence enzyme immunoassay (FEIA). Results The diagnostic accuracy of EliA™ CTD Screen (79% sensitivity and 91% specificity) was better than that of ELISA or IIF. The combination of EliA™ CTD plus IIF had the highest sensitivity (93%). ENA determination revealed that Ro52 and Ro60 were the most prevalent specificities. The use of IIF alone was not able of detecting up to 36% of samples positive for Ro52, and 41% for Ro60. Conclusions EliA™ CTD Screen has a better diagnostic performance when compared to IIF and ELISA. The combined use of EliA™ CTD Screen and IIF clearly improves the rate and accuracy of SARD diagnosis. The use of EliA™ CTD Screen as first‐line screening technique allows the detection of antibodies, which could not be detected by IIF alone.
There is still room for improvement in ANA screening testing. Currently there are different methods available for systemic autoimmune rheumathic disease sift, but the optimization of screening protocols does not only rely on the selection of the best method–there is no perfect test‐ but in the detection of the optimal combination for the specific laboratory routine. In our study we compared the performance of two protocols in our routine samples: solid phase test+IIF and ELISA+IIF. IIF together with EliA CTD Screen (solid phase test) resulted in the highest sensitivity, while EliA CTD Screen showed the best sensitivity/specificity balance.
Databáze: OpenAIRE
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