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Clinical comparison of QUANTA Flash dsDNA chemiluminescent immunoassay with four current assays for the detection of anti-dsDNA autoantibodies.

Infantino M, Meacci F, Bentow C, Martis P, Benucci M, Afeltra A, Rigon A, Atzeni F, Sarzi-Puttini P, Manfredi M, Mahler M - J Immunol Res (2015)

Bottom Line: Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT.Significant variations among dsDNA methods were observed.QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.

View Article: PubMed Central - PubMed

Affiliation: Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy.

ABSTRACT

Introduction: The objective of the present study was to compare QUANTA Flash dsDNA, a chemiluminescent immunoassay (CIA) on the BIO-FLASH, a rapid-response chemiluminescent analyzer, to three other anti-dsDNA antibody assays and to Crithidia luciliae indirect immunofluorescence test (CLIFT).

Methods: In the first part of the study, 161 samples, 61 from patients suffering from systemic lupus erythematosus (SLE) and 100 from a disease control group, were tested by QUANTA Flash dsDNA CIA, QUANTA Lite dsDNA SC ELISA, BioPlex 2200 multiplex flow immunoassay (MFI), ImmuLisa dsDNA ELISA, and NOVA Lite CLIFT. A second cohort of 69 SLE patients was then tested by QUANTA Flash dsDNA and CLIFT to expand the study.

Results: The overall qualitative agreements varied between 77.0% (NOVA Lite CLIFT versus QUANTA Lite) and 89.4% (ImmuLisa versus NOVA Lite CLIFT). The clinical sensitivities for the anti-dsDNA antibody tests varied from 8.2% (NOVA Lite CLIFT) to 54.1% (QUANTA Lite), while the clinical specificities varied from 88.0% (BioPlex 2200) to 100.0% (NOVA Lite CLIFT). Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT.

Conclusion: Significant variations among dsDNA methods were observed. QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.

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Related in: MedlinePlus

Receiver operating characteristics (ROC) analysis of QUANTA Flash dsDNA compared to CLIFT positive (n = 35) and negative (n = 195) samples. Different cut-offs are shown to demonstrate the optimal agreements. Note: equivocal range determined by the manufacturer is along the 80.0% positive agreement (green highlight). PPA: positive percent agreement; TPA: total percent agreement.
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fig4: Receiver operating characteristics (ROC) analysis of QUANTA Flash dsDNA compared to CLIFT positive (n = 35) and negative (n = 195) samples. Different cut-offs are shown to demonstrate the optimal agreements. Note: equivocal range determined by the manufacturer is along the 80.0% positive agreement (green highlight). PPA: positive percent agreement; TPA: total percent agreement.

Mentions: The CLIFT is often used as a confirmatory assay. Consequently, we used the CLIFT results (positive versus negative) as the reference and analyzed the utility of the other assays to match the sensitivity and specificity of the CLIFT. All CLIFT positive samples were also positive by all four methods, except for one sample that was missed by the ImmuLisa. ROC analysis (ROC curve not shown) of the four anti-dsDNA antibody assays compared to CLIFT resulted in AUC values of 0.93 (95% CI 0.85–1.00) for BioPlex, 0.94 (95% CI 0.88–1.00) for ImmuLisa, 0.95 (95% CI 0.91–0.99) for QUANTA Lite, and 0.97 (95% CI 0.94–0.99) for QUANTA Flash. A cut-off of 106.7 IU/mL for QUANTA Flash dsDNA would result in an optimal agreement to CLIFT, with a positive agreement of 100.0% (95% CI 47.8–100.0%), negative agreement of 95.5% (95% CI 91.0–98.2%), total agreement of 95.7% (95% CI 91.2–98.2%), and kappa = 0.57 (95% CI 0.29–0.85). To further validate the good agreement between QUANTA Flash dsDNA and CLIFT, additional SLE patients (n = 69, Inova Diagnostics serum bank) tested by both methods were added to the study population. ROC analysis of the clinical performance for NOVA Lite CLIFT and QUANTA Flash dsDNA among the new study population (SLE = 130, controls = 100) can be found in Figure 3. ROC analysis for the agreement of QUANTA Flash dsDNA results to NOVA Lite CLIFT results can be found in Figure 4.


Clinical comparison of QUANTA Flash dsDNA chemiluminescent immunoassay with four current assays for the detection of anti-dsDNA autoantibodies.

Infantino M, Meacci F, Bentow C, Martis P, Benucci M, Afeltra A, Rigon A, Atzeni F, Sarzi-Puttini P, Manfredi M, Mahler M - J Immunol Res (2015)

Receiver operating characteristics (ROC) analysis of QUANTA Flash dsDNA compared to CLIFT positive (n = 35) and negative (n = 195) samples. Different cut-offs are shown to demonstrate the optimal agreements. Note: equivocal range determined by the manufacturer is along the 80.0% positive agreement (green highlight). PPA: positive percent agreement; TPA: total percent agreement.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4352420&req=5

fig4: Receiver operating characteristics (ROC) analysis of QUANTA Flash dsDNA compared to CLIFT positive (n = 35) and negative (n = 195) samples. Different cut-offs are shown to demonstrate the optimal agreements. Note: equivocal range determined by the manufacturer is along the 80.0% positive agreement (green highlight). PPA: positive percent agreement; TPA: total percent agreement.
Mentions: The CLIFT is often used as a confirmatory assay. Consequently, we used the CLIFT results (positive versus negative) as the reference and analyzed the utility of the other assays to match the sensitivity and specificity of the CLIFT. All CLIFT positive samples were also positive by all four methods, except for one sample that was missed by the ImmuLisa. ROC analysis (ROC curve not shown) of the four anti-dsDNA antibody assays compared to CLIFT resulted in AUC values of 0.93 (95% CI 0.85–1.00) for BioPlex, 0.94 (95% CI 0.88–1.00) for ImmuLisa, 0.95 (95% CI 0.91–0.99) for QUANTA Lite, and 0.97 (95% CI 0.94–0.99) for QUANTA Flash. A cut-off of 106.7 IU/mL for QUANTA Flash dsDNA would result in an optimal agreement to CLIFT, with a positive agreement of 100.0% (95% CI 47.8–100.0%), negative agreement of 95.5% (95% CI 91.0–98.2%), total agreement of 95.7% (95% CI 91.2–98.2%), and kappa = 0.57 (95% CI 0.29–0.85). To further validate the good agreement between QUANTA Flash dsDNA and CLIFT, additional SLE patients (n = 69, Inova Diagnostics serum bank) tested by both methods were added to the study population. ROC analysis of the clinical performance for NOVA Lite CLIFT and QUANTA Flash dsDNA among the new study population (SLE = 130, controls = 100) can be found in Figure 3. ROC analysis for the agreement of QUANTA Flash dsDNA results to NOVA Lite CLIFT results can be found in Figure 4.

Bottom Line: Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT.Significant variations among dsDNA methods were observed.QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.

View Article: PubMed Central - PubMed

Affiliation: Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy.

ABSTRACT

Introduction: The objective of the present study was to compare QUANTA Flash dsDNA, a chemiluminescent immunoassay (CIA) on the BIO-FLASH, a rapid-response chemiluminescent analyzer, to three other anti-dsDNA antibody assays and to Crithidia luciliae indirect immunofluorescence test (CLIFT).

Methods: In the first part of the study, 161 samples, 61 from patients suffering from systemic lupus erythematosus (SLE) and 100 from a disease control group, were tested by QUANTA Flash dsDNA CIA, QUANTA Lite dsDNA SC ELISA, BioPlex 2200 multiplex flow immunoassay (MFI), ImmuLisa dsDNA ELISA, and NOVA Lite CLIFT. A second cohort of 69 SLE patients was then tested by QUANTA Flash dsDNA and CLIFT to expand the study.

Results: The overall qualitative agreements varied between 77.0% (NOVA Lite CLIFT versus QUANTA Lite) and 89.4% (ImmuLisa versus NOVA Lite CLIFT). The clinical sensitivities for the anti-dsDNA antibody tests varied from 8.2% (NOVA Lite CLIFT) to 54.1% (QUANTA Lite), while the clinical specificities varied from 88.0% (BioPlex 2200) to 100.0% (NOVA Lite CLIFT). Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT.

Conclusion: Significant variations among dsDNA methods were observed. QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.

Show MeSH
Related in: MedlinePlus