| Number of wells | 96 |
| Principle | IgM Capture |
| Assay format | Qualitative |
| Total incubation time | 150 minutes |
| Sample type | Serum / Plasma |
| Sample volume | 5 μL |
| Reading wavelength | 450nm |
| Storage | 2-8°C |
| Certification | TFDA / CE marked ✱ |
✱Notified body: 0344
1541 hospitalized patients were tested. The results are as follows:
| PERFORMANCE | Test Positive | Test Negative |
| Confirmed Positive | 551 | 1 |
| Confirmed Negative | 5 | 984 |
| Inter-assay precision CV | < 25% | Intra-assay precision CV | < 20% |
The diagnostic sensitivity is 96.1%;The diagnostic specificity is 100%
| Catalogue No. | Product |
| 4CME3 | ANTICORASE MB-96 (TMB) |