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COVID-19 lgM-lgG Combo
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Absoludy COVID-19 IgM/ IgG Combo
- Absoludy COVID-19 IgM/IgG Combo for ABSOL use gives clinical decision-making for patients suspected of COVID-19 (coronavirus) infection. Absoludy COVID-19 IgM/IgG Combo for ABSOL use is a Fluorescence immunoassay detecting antibodies against the SARS-CoV-2 Virus.
· Performance
Total Results for IgM & IgG Clinical Agreement
| Method | 'A' 2019-nCoV Assay | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Absoludy COVID-19 IgM/IgG Combo | Positive | 55 | 0 | 55 |
| Negative | 5 | 92 | 97 | |
| Total | 60 | 92 | 152 | |
|
Clinical Sensitivity: 90.24%
Clinical Specificity: 97.82% |
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·Procedure
· Result & Interpretation
The result of two CH. is determined by ABSOL Cut-off Index (COI)
Test result is negative if COI is< 1.0 and positive if COI is ≥1.0 (Negative <1.0, Positive ≥1.0)
Test result is negative if COI is< 1.0 and positive if COI is ≥1.0 (Negative <1.0, Positive ≥1.0)
· Spectification
| Performance | Sensitivity: 91.67%, Specificity: 100% |
| Test time | 5 minutes |
| Sample type / Volume | Serum, Plasma(heparin, K2 -EDTA)/ 10 μL |
| Storage | 2~8°C |
· Components
| Cartridge(s) | 20ea |
| Pretreatment Tube(s) | 20ea |
| Disposable micropipette tips | 24ea |
| Code chip | 1ea |
| Instructions for Use | 1ea |
