Quality Monitoring Approach for Optimizing Antinuclear Antibody Screening Cutoffs and Testing Work Flow.
J Appl Lab Med
; 1(6): 678-689, 2017 May 01.
Article
em En
| MEDLINE
| ID: mdl-33379827
ABSTRACT
BACKGROUND:
An antinuclear antibody (ANA) testing strategy involving enzyme immunoassay (EIA) screening that reflexed to immunofluorescence assay (IFA) was implemented, monitored, and optimized for clinical utility.METHODS:
The clinical utility, test performance, and workload implications of various ANA testing strategies were compared during the following study phases (a) Preimplementation (n = 469) when IFA was used for all ANA screening, (b) Verification (n = 58) when EIA performance was confirmed, (c) Implementation (n = 433) when a reflexive strategy (EIA screen/IFA confirmation) was implemented, and (d) Postimplementation (n = 528) after the reflexive strategy was optimized. Sequential samples were captured in the Preimplementation, Implementation, and Postimplementation phases for clinical performance evaluation.RESULTS:
Clinical performance of the EIA screen, per ROC analysis yielded area under the curve (AUC) of 0.846 in the Implementation phase and increased to 0.934 Postimplementation (P < 0.01); AUC for IFA similarly increased, from 0.678 to 0.808 (P = 0.05). The reflexive testing strategy increased screening sensitivity from 61% Preimplementation (IFA) to 98% (EIA) at Implementation and was maintained after optimization (98%, Postimplementation). Optimization decreased the false-positive rates for both EIA (from 40% to 18%) and IFA (18% to 8%) and was associated with reductions in daily full-time equivalent (by 33%) and IFA slide use (by 50%).CONCLUSIONS:
Continuous quality monitoring approaches that incorporate sequential data sets can be used to evaluate, deploy, and optimize sensitive EIA-based ANA screening methods that can reduce manual IFA work without sacrificing clinically utility.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
/
Screening_studies
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article