Clinical Comparison of QUANTA Flash dsDNA Chemiluminescent Immunoassay with Four Current Assays for the Detection of Anti-dsDNA Autoantibodies

Table 3

Clinical performance characteristics for anti-dsDNA antibody assays.

	QUANTA Flash dsDNA	QUANTA Lite dsDNA SC	BioPlex 2200 dsDNA	ImmuLisa dsDNA	NOVA Lite dsDNA
Manufacturer’s cut-off used, where equivocal results are considered positive	35 IU/mL	30 IU/mL	5 IU/mL	50 IU/mL	N/A
Sensitivity in SLE%; (95% CI)	39.3 (27.2–52.7)	54.1 (40.8–66.9)	44.3 (31.5–57.6)	26.2 (15.8–39.1)	8.2 (2.7–18.1)
Specificity %; (95% CI)	96.0 (90.1–98.9)	91.0 (83.6–95.8)	88.0 (80.0–93.6)	96.0 (90.1–98.9)	100.0 (96.4–100.0)
LR+	9.84	6.01	3.69	6.56
LR−	0.63	0.50	0.63	0.77	0.92
Odds ratio	15.6	12.0	5.9	8.5	N/A
AUC (95% CI)	0.79 (0.72–0.87)	0.90 (0.86–0.95)	0.68 (0.60–0.77)	0.61 (0.52–0.71)	0.54 (0.51–0.58)
Cut-off used at 94.0% specificity	27.5 IU/mL	49.6 IU/mL	12 IU/mL	41.9 IU/mL	N/A
Sensitivity in SLE%; at 94.0% specificity (95% CI)	52.5 (39.3–65.4)	45.9 (33.1–59.2)	21.3 (11.9–33.7)	27.9 (17.1–40.8)	N/A

AUC: area under the curve; LR: likelihood ratio; CI: confidence interval.