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Brand Name : | GENEDIAN |
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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 nasopharyngeal and anterior nasal swab specimens directly from individuals suspected of COVID-19 by their healthcare provider within the first 7 days of the onset of symptoms. The GENEDIAN COVID-19 Antigen Test Cassette can also test specimens from asymptomatic individuals.
Highlights
n Nasopharyngeal swab specimens
n Results to read at 15 min
n Easier and faster compared to molecular methods
n Room temperature storage
n Easy use, no need of equipment
Clinical Performance
Clinical Sensitivity and specificity
The COVID-19 Antigen Test Cassette (nasopharyngeal swab specimen) 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 97.6%:95%Cl(92.9%-99.5%)
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 |
21(95.5%) |
76.5%-99.9% |
7 |
16 |
16 |
15(93.8%) |
69.7%-99.9% |
|
125 |
125 |
122(97.6%) |
92.9%-99.5% |
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%) |
Test Procedure and Interpretation
Ordering Information
P/N |
Product Name |
Package |
G0400050* |
COVID-19 Antigen Test Cassette |
25 tests/kit |
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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