COVID-19 lgM-lgG Combo > ABSOL

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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.
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· 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
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· 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)
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· 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
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· Components
Cartridge(s) 20ea
Pretreatment Tube(s) 20ea
Disposable micropipette tips 24ea
Code chip 1ea
Instructions for Use 1ea
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