Table 4.
Performance of whole blood measurement by SH-SAW biosensor.
| Test Item | Marker | |||
|---|---|---|---|---|
| CRP | Lp(a) | apoB | SARS-CoV-2 S Protein | |
| Detection Method |
Pre-mix with secondary antibody |
Directly measurement | Dilution measurement | Directly measurement |
| Test time | 3 min | 3 min | 30 s | 40 s |
| Linearity range | 1.9–118 μg/mL | 83–1402 μg/mL | 51–2022 μg/mL | 50–1500 BAU/mL |
| Sensitivity | LoQ = 1000 ng/mL LoD = 390 ng/mL LoB = 170 ng/mL | LoD = 58.3 g/mL LoB = 14.5 g/mL |
LoD = 80.1 g/mL LoB = 54.7 g/mL |
LoD = 41.91 BAU/mL LoB = 27.48 BAU/mL |
| Comparison | R = 0.986/ Slope = 1.003 (n = 170) * |
R = 0.9698/ Slope = 1.0598 (n = 55) # |
R = 0.9287/ Slope = 0.9741 (n = 55) % |
NPA = 98.7% (n = 79)/PPA = 94.3% (n = 35) @ |
* Compared with Beckman Coulter CRP Latex; # Compared with Abbot Lp(a) Reagent Kit; % Compared with Advia Chemistry—Apolipoprotein B; @ Compared with cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit; Positive percentage agreement (PPA); Negative percentage agreement (NPA); Limit of quantification (LoQ); limit of blank (LoB); and limit of detection (LoD).