uncut sheet for COVID-19 IgGIgM Antibody Rapid Test Device CE
certificate
For professional and in vitro diagnostic use only.
| Product Name | Professional COVID-19 Antibody Rapid Test Device CE certificate |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow
chromatographic immunoassay for the qualitative detection of
antibodies (IgG and IgM) to Novel coronavirus in human Whole
Blood/Serum/Plasma. It provides an aid in the diagnosis of
infection with Novel coronavirus.
[PERFORMANCE CHARACTERISTICS]
Accuracy
If a person suffered the novel coronaviruses, there are several
stages before recovery, like window period, early stage, initial
stage, mid-term, and later period. The window period continues 14
days, 3-7days mostly, and no antibody produced at this time. Early
stage is about 1-7 days after onset, and the IgM antibody appears,
but the concentration is too low to be detected. Initial stage is
about 8-14 days after onset, the
IgM antibody increases and the IgG antibody appears. Mid-term is
about 15-39 days after onset, the IgM antibody decreases gradually
and the IgG antibody peaks. The later period is about 1-2 months
after onset, and IgM antibody could be detected hardly.
Also, everyone is different because of the difference of people’s
immune response. For example, the antibody concentration of older
people is higher than younger significantly, and the antibody
levels in Asymptomatic infected human body are low
generally. A side-by-side comparison was conducted using the Novel
coronavirus IgG/IgM Rapid Test and RT-PCR. 200 clinical specimens
from Professional Point of Care site were evaluated, 57 were
positive and 143 negative. In order to consider the difference of
antibody production in people after infection as much as possible,
we conducted 10 trails respectively. Base on the results from the
clinical studies, the statistical analysis was made as follows:
COVID-19 IgM: the average sensitivity is 81.38% (95% CI:
70.18%~92.58%), the average specificity is 93.93% (95% CI:
88.23%~99.62%) and the total accuracy is 90.67% (95% CI:
87.07%~94.26%).
COVID-19 IgG: the average sensitivity is 92.50% (95% CI:
87.65%~97.35%), the average specificity is 95.53% (95% CI:
92.01%~99.06%) and the total accuracy is 94.67% (95% CI:
91.57%~97.77%).
