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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

Comparison of different assays for the detection of anti-dsDNA antibodies using receiver operating characteristics (ROC) analysis. The ROC curves show the discrimination between SLE patients (n = 61) and controls (n = 100) using different assays. Note: the NOVA Lite CLIFT assay is a semiquantitative assay (grades 0 to 4 were given by operator).
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fig1: Comparison of different assays for the detection of anti-dsDNA antibodies using receiver operating characteristics (ROC) analysis. The ROC curves show the discrimination between SLE patients (n = 61) and controls (n = 100) using different assays. Note: the NOVA Lite CLIFT assay is a semiquantitative assay (grades 0 to 4 were given by operator).

Mentions: The clinical sensitivities at the recommended cut-off were 8.2% (95% confidence interval, CI 2.7–18.1%) for NOVA Lite CLIFT, 26.2% (95% CI 15.8–39.1%) for ImmuLisa, 39.3% (95% CI 27.2–52.7%) for QUANTA Flash, 44.3% (95% CI 31.5–57.6%) for BioPlex, and 54.1% (95% CI 40.8–66.9) for QUANTA Lite. The clinical specificities at the recommended cut-off were 100.0% (95% CI 96.4–100.0%) for NOVA Lite CLIFT, 96.0% (95% CI 90.1–98.9%) for ImmuLisa, 96.0% (95% CI 90.1–98.9%) for QUANTA Flash, 88.0% (95% CI 80.0–93.6%) for BioPlex, and 91.0% (95% CI 83.6–95.8%) for QUANTA Lite. When the sensitivities were compared at a specificity of 94.0%, the values ranged between 8.2% (95% CI 2.7–18.1%) for CLIFT and 52.5% (95% CI 39.3–65.4%) for QUANTA Flash dsDNA CIA. Sensitivities and specificities as well as positive and negative likelihoods ratios (LR) and area under the curve (AUC) values for all assays are shown in Table 3. The odds ratio (LR+/LR−) for dsDNA methods varied between 5.9 (BioPlex) and 15.6 (QUANTA Flash). Comparative ROC curve analysis among SLE patients (n = 61) and disease controls (n = 100) for five anti-dsDNA antibody assays showed significantly different AUC values. QUANTA Flash and QUANTA Lite had the highest AUC values which were significantly higher (P < 0.05) than the AUC values of the other assays (see Figure 1).


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)

Comparison of different assays for the detection of anti-dsDNA antibodies using receiver operating characteristics (ROC) analysis. The ROC curves show the discrimination between SLE patients (n = 61) and controls (n = 100) using different assays. Note: the NOVA Lite CLIFT assay is a semiquantitative assay (grades 0 to 4 were given by operator).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: Comparison of different assays for the detection of anti-dsDNA antibodies using receiver operating characteristics (ROC) analysis. The ROC curves show the discrimination between SLE patients (n = 61) and controls (n = 100) using different assays. Note: the NOVA Lite CLIFT assay is a semiquantitative assay (grades 0 to 4 were given by operator).
Mentions: The clinical sensitivities at the recommended cut-off were 8.2% (95% confidence interval, CI 2.7–18.1%) for NOVA Lite CLIFT, 26.2% (95% CI 15.8–39.1%) for ImmuLisa, 39.3% (95% CI 27.2–52.7%) for QUANTA Flash, 44.3% (95% CI 31.5–57.6%) for BioPlex, and 54.1% (95% CI 40.8–66.9) for QUANTA Lite. The clinical specificities at the recommended cut-off were 100.0% (95% CI 96.4–100.0%) for NOVA Lite CLIFT, 96.0% (95% CI 90.1–98.9%) for ImmuLisa, 96.0% (95% CI 90.1–98.9%) for QUANTA Flash, 88.0% (95% CI 80.0–93.6%) for BioPlex, and 91.0% (95% CI 83.6–95.8%) for QUANTA Lite. When the sensitivities were compared at a specificity of 94.0%, the values ranged between 8.2% (95% CI 2.7–18.1%) for CLIFT and 52.5% (95% CI 39.3–65.4%) for QUANTA Flash dsDNA CIA. Sensitivities and specificities as well as positive and negative likelihoods ratios (LR) and area under the curve (AUC) values for all assays are shown in Table 3. The odds ratio (LR+/LR−) for dsDNA methods varied between 5.9 (BioPlex) and 15.6 (QUANTA Flash). Comparative ROC curve analysis among SLE patients (n = 61) and disease controls (n = 100) for five anti-dsDNA antibody assays showed significantly different AUC values. QUANTA Flash and QUANTA Lite had the highest AUC values which were significantly higher (P < 0.05) than the AUC values of the other assays (see Figure 1).

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