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

https://www.dianbiotech.com/covid-19-antigen-rapid-test/

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