Table 2. Comparison of 15 commercial immunoassays for detection of CA15.3 (MUC1) in serum [54].

Antibody assays	Manufacturer	Manufacturer cutoff (U/mL)	FN Group 1 (expected to be LOW)	FP in Group 2 (expected to be HIGH)	FP in Group 3 (expected to be HIGH)	AUC*	Optimum cut-off (U/ml) §
Architect CA15-3	Biomira	23.4	7	-	1	0.99 9	31
Axsym CA 15-3	CanAg	38	-	-	1	0.99 8	39
CA15-3 Kryptor	Centocor/Fujirebio	31.3	-	2	1	1	25¥
Advia Centaur CA 15-3	Centocor/Fujirebio	25	1	-	-	1	29
Advia Centaur BR CA15-3	Centocor/Fujirebio	30	-	-	-	1	23¥
Acess BR monitor	Centocor/Fujirebio	30	-	-	-	1	25.1¥
Vidas CA15-3	CanAg	31.3	-	6	3	0.99 4	25.6
ELSA CA15-3	Centocor/Fujirebio	30	-	3	2	0.99 4	24.7
Liaison CA15-3	Centocor/Fujirebio	35	-	-	-	1	31.5¥
CA15-3 IRMA	Centocor/Fujrebio	30	-	2	-	0.99 9	25
Immulite 2000/2500 BR-MA	Centocor/Fujirebio	28	-	6	-	0.98 6	25
IRMA MUC1 CA15-3	CanAg	35	-	-	1	1	34
Vitros CA 15-3	Biomira	38.6	-	-	1	1	30.2¥
Elecys CA 15-3 II	Centocor/Fujirebio	32.4	-	2	1	1	23
AIA Pack 27.29	Centocor/Fujirebio	31.3	-	-	-	1	27¥
Overall			FPR= 1.5%	FNR: 3.1%	FNR: 1.9%

False negative rate (FNR); False positive rate (FPR); Area under the curve (AUC)

^*AUC was used as a method to distinguish between patients without recurrence (Group 1) from those with recurrent breast cancer (Groups 2 and 3).

^§Achieves 100% specificity;

^¥Achieves 100% sensitivity

Group 1: Breast cancer (BC) patients undergoing follow-up after treatment who showed no recurrence during observation for a period of at least 4 years after initial diagnosis.

Group 2: BC patients who had blood sample drawn between 0-90 days before the first diagnosis of metastasis.

Group 3: BC patients who had blood sample drawn ≥90 days after the detection of metastasis.