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.