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COVID-19 NAb
본문
Absoludy COVID-19 Neutralizing Antibody
- · Absoludy COVID-19 Neutralizing Antibody for ABSOL use is based on the principle of Fluorescence immunoassay detecting semi-quantita- tive value of SARS-CoV-2 Virus's neutralizing antibody.
- · Measuring the level of COVID-19 Neutralizing Antibody is to help check the overall vaccine efficacy, compare efficacy of different vac- cine candidates, monitor longevity of protective immunity and lead to herd immunity.
· Performance
Total Results for COVID-19 NAb Clinical Agreement
| Result | 'A' 2019-nCoV Assay | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Absoludy COVID-19 NAb | Positive | 27 | 0 | 27 |
| Negative | 0 | 10 | 10 | |
| Total | 27 | 10 | 37 | |
|
Clinical Sensitivity: 98%
Clinical Specificity: 99% |
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·Procedure
Sample: Serum or Plasma(heparin, K2 -EDTA), 40μL
· 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
| AMR | 60~300 IU/mL |
| Performance | Sensitivity: 100%, Specificity: 100% |
| Test time | 5 min |
| Sample type | Serum and Plasma(Li-heparin or K2-EDTA) |
| Sample Volume | 40µL |
| Storage | 2~8 °C |
· Spectification
| Cartridge | 20ea |
| Pretreatment Tube | 20ea |
| Disposable tip | 24ea |
| Code chip | 1ea |
| Package Insert sheet | 1ea |
