Intended Use
Clinical Evaluation
BZ COVID-19 IgM/IgG | Allplex™ 2019-nCoV Assay | |||
Positive | Negative | Total | ||
Positive | IgG+/IgM+ | 22 | 0 | 22 |
IgG+/IgM- | 1 | 0 | 1 | |
IgG-/IgM+ | 5 | 0 | 5 | |
Negative | IgG-/IgM- | 2 | 30 | 32 |
Sub Total | 30 | 30 | 60 |
Days from symptom onset to blood collection | Number of RT-PCR positive samples | BZ COVID-19 IgM/IgG performance against days from sympton onset to blood collection | |||||||
IgM-/IgG- | IgM+/IgG- | IgM+/IgG+ | IgM-/IgG+ | ||||||
% | Count | % | Count | % | Count | % | Count | ||
≤7 days | 8 | 25% | 2/8 | 0% | 0/8 | 62.5% | 5/8 | 12.5% | 1/8 |
8-14 days | 5 | 0% | 0/5 | 0% | 0/5 | 60% | 3/5 | 40% | 2/5 |
15-21 days | 10 | 0% | 0/10 | 10% | 1/10 | 90% | 9/10 | 0% | 0/10 |
22-28 days | 4 | 0% | 0/4 | 0% | 0/4 | 75% | 3/4 | 25% | 1/4 |
29-32 days | 3 | 0% | 0/3 | 33.3% | 1/3 | 66.7% | 2/3 | 0% | 0/3 |
Total | 30 | - | 2 | - | 2 | - | 22 | - | 4 |