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COVID-19 Ag
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Absoludy COVID-19 Ag
- Absoludy COVID-19 Ag for ABSOL use gives clinical decision-making for patients suspected of COVID-19 (coronavirus) infection. Absoludy COVID-19 Ag for ABSOL use is a Fluorescence immunoassay detect- ing antibodies against the SARS-CoV-2 Virus.
· Performance
Total Results for COVID-19 Ag Clinical Agreement
| Results | 'A' 2019-nCoV Assay | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Absoludy COVID-19 Ag | Positive | 49 | 1 | 50 |
| Negative | 1 | 91 | 92 | |
| Total | 50 | 92 | 142 | |
|
Clinical Sensitivity: 98%
Clinical Specificity: 99% |
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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: 98%, Specificity: 99% |
| Test time | 5 min |
| Sample type | Nasopharyngeal or oropharyngeal swab |
| Storage | 2~8 °C |
· Spectification
| Cartridge | 20ea |
| Pretreatment Tube | 20ea |
| Drop cap | 20ea |
| Sterile swab for specimen collection | 20ea |
| Code chip | 1ea |
| Instructions for Use | 1ea |
