One Step IVD Novel Coronavirus Rapid Test Cassette
(2022年06月21日)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 and Anterior Nasal Specimen
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
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