Absoludy COVID-19 IgM/ IgG Combo
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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%
|
·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)
· 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 |