| |
Platform
|
ELISA colorimetric
|
SIMOA
|
|---|
|
Analyte
|
Aβ1–42
|
Aβ1–40
|
t-tau
|
Aβ1–42
|
Aβ1–40
|
|---|
|
Assay
|
Provider
|
EUROIMMUN
|
EUROIMMUN
|
ADx
|
ADx
|
ADx
|
|
Catalogue number
|
EQ 6521-9601
|
EQ 6511-9601
|
NA
|
NA
|
NA
|
|
Biofluid
|
EDTA plasma
|
EDTA plasma
|
EDTA plasma
|
EDTA plasma
|
EDTA plasma
|
|
Status
|
Commercial
|
Commercial
|
Prototype
|
Prototype
|
Prototype
|
|
Specificity
|
Aβ1–42
|
Aβ1–40
|
6 tau isoforms
|
Aβ1–42
|
Aβ1–40
|
|
Dilution
|
Pre-dilution factora
|
4
|
4
|
4
|
4
|
20
|
|
Final sample dilutionb
|
5
|
5
|
5
|
5.8
|
29
|
|
Calibrator
|
Type
|
Recombinant
|
Recombinant
|
Recombinant
|
Recombinant
|
Recombinant
|
|
No. of calibrator points
|
7
|
7
|
7
|
7
|
7
|
|
Range, pg/mL
|
1–40
|
1–75
|
1–100
|
1–64
|
1–64
|
|
Patient samples
|
Number
|
199
|
199
|
199
|
199
|
199
|
|
Range, pg/mL
|
8.1–57.1
|
22.4–311.8
|
15.0–102.1
|
7.9–44.0
|
60.7–160.0
|
|
Within cal. range, %
|
100%
|
100%
|
100%
|
100%
|
100%
|
|
CV%
|
Intra-assay conc
|
1.63
|
1.67
|
2.15
|
4.33
|
2.24
|
|
Inter-assay conc
|
4.82
|
2.58
|
13.55
|
8.59
|
5.95
|
|
Analytical sensitivity
|
LoD, pg/mL
|
2.4
|
5.7
|
Not determined
|
0.46
|
0.77
|
|
LoQ, pg/mL
|
3.5
|
12.5
|
Not determined
|
1.21
|
1.57
|
|
S/N ratio
|
7.60
|
65.4
|
Not determined
|
11.0
|
240
|
|
Antibodies [26, 27]
|
Name capture
|
ADx102 (21F12)
|
ADx103 (2G3)
|
ADx203
|
ADx102 (21F12)
|
ADx103 (2G3)
|
|
Epitope capture (AA)
|
Aβ34–42
|
Aβ33–40
|
Tau194–204
|
Aβ34–42
|
Aβ33–40
|
|
Name detector
|
2G3
|
2G3
|
ADx204
|
2G3
|
2G3
|
|
Epitope detector (AA)
|
Aβ1–5
|
Aβ1–5
|
TauN-terminus
|
Aβ1–5
|
Aβ1–5
|
|
Assay protocol
|
Incubation times, h
|
3–0.5–0.5
|
3–0.5–0.5
|
3–0.5–0.5
|
2–0.08
|
2–0.08
|
|
Incubation T, °C
|
18–25
|
18–25
|
18–25
|
18–25
|
18–25
|
|
Curve fit
|
4PL
|
4PL
|
4PL
|
4PL
|
4PL
|
|
QC panel, pg/mL
|
QC1: high
|
30.5
|
189.2
|
22.3
|
13.7
|
83.2
|
|
QC2: intermediate
|
26.6
|
149.1
|
18.9
|
19.7
|
75.9
|
|
QC3: intermediate
|
22.0
|
116.8
|
21.7
|
13.4
|
69.7
|
|
QC4: low
|
20.7
|
107.3
|
23.7
|
10.5
|
33.3
|
|
QC5: low spiked
|
14.4
|
0.0
|
NA
|
21.6
|
21.8
|
|
QC6: high spiked
|
117.9
|
125.6
|
NA
|
173.7
|
181.2
|
|
C1: low kit control
|
23.3
|
114.6
|
NA
|
NA
|
NA
|
|
C2: high kit control
|
45.1
|
186.9
|
NA
|
NA
|
NA
|
- AA amino acid, Aβ β-amyloid, CV coefficient of variation, LoD limit of detection, LoQ limit of quantification, S/N ratio signal to noise ratio, QC quality control, T temperature, t-tau total tau
- aSample pre-dilution was performed using assay diluent in polypropylene low-binding 96-well microplates
- bFinal sample dilution during sample incubation step in assay protocol
