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CE mared COVID-19 Antigen Rapid Test Device
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- 25 tests/kit
| Brand Name : | GENEDIAN |
|---|
Product description
The GENEDIAN COVID-19 Antigen Test cassette is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens directly from individuals suspected of COVID-19 by their healthcare provider within the first 7 days of the onset of symptoms. The COVID-19 Antigen Test cassette can also test specimens from asymptomatic individuals.
Highlights
n Saliva specimens
n Results to read at 15 min
n Easier and faster compared to molecular methods
n Room temperature storage
n Easy operation, no need of equipment
Clinical Performance Clinical Sensitivity and Specificity
The COVID-19 Antigen Test Cassette (saliva) has high sensitivity and specificity when compared with PCR products on the market. Positive results break-down by days since symptom onset:
The clinical sensitivity is 93.6%:95%Cl（87.7%-96.9%）
|
Days Post Symptom Onset |
Number of Samples |
PCR Positive |
COVID-19 Antigen Test Cassette |
95% Confidence Interval |
|
1 |
8 |
8 |
8（100%） |
62.8%-100% |
|
2 |
11 |
11 |
11（100%） |
70.0%-100% |
|
3 |
25 |
25 |
25（100%） |
84.2%-100% |
|
4 |
20 |
20 |
20（100%） |
81.0%-100% |
|
5 |
23 |
23 |
22（95.7%） |
77.3%-99.9% |
|
6 |
22 |
22 |
19（86.4%） |
65.8%-96.1% |
|
7 |
16 |
16 |
12（75.0%） |
50.0%-90.3% |
|
Total |
125 |
125 |
117（93.6%） |
87.7%-96.9% |
The clinical specificity is 99.6%:95%Cl（97.5%-99.9%）
|
Number of Samples PCR |
PCR Negative Results |
COVID-19 Antigen Test Cassette |
|
250 |
250 |
249/250=99.6% |
|
Total |
N/A |
99.6%；95%Cl: (97.5%-99.9%) |
We also provide a series of COVID-19 Antigen Rapid Test, including Covid-19 Antigen Test home test, please visit our COVID-19 Antigen Rapid Test page.
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