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IgG | IgM | ||||||
---|---|---|---|---|---|---|---|
Tage nach Auftreten der Symptome | Zu jeder Zeit PCR positiv | Proben mit positiven Ergebnissen (Serum) | PPA* | 95% CI | Proben mit positiven Ergebnissen (Serum) | PPA* | 95% CI |
≦7 | 12 | 0 | 0 | 4 | 33,33 | 13,81%-60,93% | |
8-14 | 53 | 30 | 56,6% | 43,26%-69,05% | 44 | 83,02% | 70,78%-90,80% |
≦15 | 132 | 127 | 96,21 | 91,43%-98,37% | 129 | 97,73% | 93,53%-99,22% |
Total | 197 |
No | Content | Quantity |
---|---|---|
1 | Instructions for use | 1 Exemplar |
2 | Test Cassette | 25 |
3 | Sample Diluent ( Phospate buffer containing casein) | 1 Fläschchen |
4 | Mini-Pipetten | 25 |
Produktname | Probentpy | Lager-Temperatur | Packungseinheit |
---|---|---|---|
SARS COV-2 IgG / IgM Antibody Rapid Test Kit | Serum, Plasma, Whole Blood | 2°C – 30°C | 25 Tests / Kit |
A | IgM(-) & IgG(+) | Positiver Hinweis auf eine frühere Infektion bzw. positiver Antikörper-Impfstatus |
---|---|---|
B | IgM(+) & IgG(-) | Positiver Hinweis auf eine akute Infektion |
C | IgM(+) & IgG(+) | Positiver Hinweis auf eine anhaltende Infektion |
D | IgM(-) & IgG(-) | Negativ |
E | No Control | Ungültig |
SARS-CoV2 Positive Samples | ||||
---|---|---|---|---|
Clinical site(s) | Hefei CDC, Fuyang CDC, Anhui Province CDC, China | Yale New Haven Hospital, New Haven, CT, USA | ||
Infection time | 1-14 days | >14 days | 1-14 days | >14 days |
Sample quantity | 294 | 118 | 31 | 9 |
IgM/IgG positive | 134 | 111 | 24 | 9 |
IgM positive | 133 | 111 | 24 | 9 |
IgG positive | 103 | 109 | 24 | 9 |
None | 160 | 7 | 7 | 0 |
Sensitivity-IgM/IgG [95%CI] | 45.6% [39.8-51.46] | 94.1% [88.2-97.6%] | 77.4% [59.9%-90.4%] | 100% [66.4-100%] |
Sensitivity-IgM[95%CI] | 45.2% [39.5-51.1] | 94.1% [88.2-97.6%] | 77.4% [59.9%-90.4%] | 100% [66.4-100%] |
Sensitivity-IgG[95%CI] | 35.0% [29.6-40.8] | 94.4% [86.0-96.5%] | 77.4% [59.9%-90.4%] | 100% [66.4-100%] |
SARS-CoV2 Negative Samples | ||||||
---|---|---|---|---|---|---|
Clinical site(s) | Hefei CDC, Fuyang CDC, Anhui Province CDC, China | Hefei, Fuyang, Anhui Province, CHINA | New Haven, CT, USA | |||
Sample Type | Other respiratory samples | Pregnant woman | Inpatient’s in other departments | Physical Examination | Healthy controls | Healthy controls |
Sample quantity | 281 | 416 | 252 | 112 | 336 | 41 |
IgM positive | 6 | 2 | 0 | 0 | 3 | 1 |
IgG positive | 0 | 0 | 0 | 0 | 1 | 0 |
None | 275 | 414 | 252 | 112 | 333 | 40 |
Specificity – IgM [95%CI] | 97.9% [95.4-99.2%] | 99.5% [98.3-99.9%] | 100% [98.6-100%] | 100% [96.8-100%] | 99.1% [97.4-99.8%] | 97.6% [87.1-99.9%] |
Specificity – IgG [95%CI] | 100.0% [98.7-100%] | 100% [99.1-100%] | 100% [98.6-100%] | 100% [96.8-100%] | 99.7% [98.4-99.9%] | 100% [91.4.4-100%] |
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