Assessing precision, bias and sigma-metrics of 53 measurands of the Alinity ci system.

Assay performance is dependent on the accuracy and precision of a given method. These attributes can be combined into an analytical Sigma-metric, providing a simple value for laboratorians to use in evaluating a test method's capability to meet its analytical quality requirements. Sigma-metrics were determined for 37 clinical chemistry assays, 13 immunoassays, and 3 ICT methods on the Alinity ci system. METHODS: Analytical Performance Specifications were defined for the assays, following a rationale of using CLIA goals first, then Ricos Desirable goals when CLIA did not regulate the method, and then other sources if the Ricos Desirable goal was unrealistic. A precision study was conducted at Abbott on each assay using the Alinity ci system following the CLSI EP05-A2 protocol. Bias was estimated following the CLSI EP09-A3 protocol using samples with concentrations spanning the assay's measuring interval tested in duplicate on the Alinity ci system and ARCHITECT c8000 and i2000SR systems, where testing was also performed at Abbott. Using the regression model, the %bias was estimated at an important medical decisions point. Then the Sigma-metric was estimated for each assay and was plotted on a method decision chart. The Sigma-metric was calculated using the equation: Sigma-metric=(%TEa-|%bias|)/%CV. RESULTS: The Sigma-metrics and Normalized Method Decision charts demonstrate that a majority of the Alinity assays perform at least at five Sigma or higher, at or near critical medical decision levels. CONCLUSION: More than 90% of the assays performed at Five and Six Sigma. None performed below Three Sigma. Sigma-metrics plotted on Normalized Method Decision charts provide useful evaluations of performance. The majority of Alinity ci system assays had sigma values >5 and thus laboratories can expect excellent or world class performance. Laboratorians can use these tools as aids in choosing high-quality products, further contributing to the delivery of excellent quality healthcare for patients.

Evaluation of the Abbott ARCHITECT Chagas prototype assay.

Serologic tests are established tools for the diagnosis of Chagas disease applied to support a safe blood supply in endemic countries. However, sensitivity and specificity of most commercially available enzyme-linked immunosorbent assays (ELISAs) are not regarded as adequate enough to rely on a single assay to determine the Trypanosoma cruzi infection status of a blood donor or a patient. The overall assay performance is driven by the general choice of antigens and the actual antigen cocktail provided in the test. In this report we describe key performance data of the Abbott ARCHITECT Chagas prototype assay in comparison to the well-recognized bioMérieux ELISA cruzi assay. The ARCHITECT assay demonstrated superior specificity (99.99% versus 99.93%) and sensitivity (99.85% versus 98.38%), along with excellent precision, thus showing the potential to serve as single assay to determine the T. cruzi status of a given blood unit or diagnostic specimen on a fully automated instrument platform.

Development of fully automated determination of marker-specific immunoglobulin G (IgG) avidity based on the avidity competition assay format: application for Abbott Architect cytomegalovirus and Toxo IgG Avidity assays.

Determination of the avidity of immunoglobulin G (IgG) directed against a specific marker has become an established diagnostic tool for identifying or excluding acute infections with pathogens. A novel assay format termed AVIcomp (avidity competition based on mass action) circumventing the conventional chaotropic format has been developed for determination of the avidity of marker-specific IgG in patient specimens. Its applications for cytomegalovirus (CMV) and Toxoplasma gondii are presented. Specific high-avidity IgG from the patient specimen is selectively blocked using a soluble antigen in a sample pretreatment reagent, and the amount of remaining specific low-avidity IgG is determined relative to that in an untreated control. The comparison of the conventional chaotropic format, represented by the Radim CMV IgG Avidity assay, and the newly developed AVIcomp method, as exemplified by the Architect CMV IgG Avidity assay, on blood drawn within 4 months after seroconversion revealed a sensitivity of 100% (97.3% by an alternative calculation) for the AVIcomp format versus 87.5% (75.7% by an alternative calculation) for the chaotropic avidity assay. The specificity on 312 CMV IgG reactive and CMV IgM nonreactive specimens from pregnant women was 100% for the AVIcomp assay and 99.7% for the conventional avidity assay. The Architect Toxo IgG Avidity assay showed an agreement of 97.2% with the bioMérieux Vidas Toxo IgG Avidity Assay employing chaotropic reagents. These performance data suggest that the AVIcomp format shows superior sensitivity and equivalent specificity for the determination of IgG avidity to assays based on the chaotropic method and that the AVIcomp format may also be applicable to other disease states.