CE –marked
﹒BfArM Test-ID: AT981/21
﹒Specimen: Nasopharyngeal/nasal specimen
﹒Sensitivity(NP): 96.3%
﹒Specificity(NP): 100%
﹒Sensitivity(N): 95.5%
﹒Specificity(N): 99.6%
INTENDED USE
The Rapid SARS-CoV-2Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimens. It can be used as the aid in the diagnosis of SARS-CoV-2 infection by healthcare professionals and trained health care workers.
PRODUCT PARAMETERS
﹒CE –marked
﹒BfArM Test-ID: AT981/21
﹒Specimen: Nasopharyngeal/nasal specimen
﹒Storage temperature: 2-30℃
﹒Shelf life: 24 months
﹒Sensitivity(NP): 96.3%
﹒Specificity(NP): 100%
﹒Sensitivity(N): 95.5%
﹒Specificity(N): 99.6%
ORDERING INFORMATION
Product
Cat. No.
Format
Pack Size
Specimen*
Certificate
SARS-CoV-2 Ag
Rapid Test
ITP16010-TC1
Cassette
1T/Kit
NP/N
CE
ITP16010-TC5
Cassette
5T/Kit
NP/N
CE
ITP16010-TC25
Cassette
25T/Kit
NP/N
CE
*Specimen:
NP=Nasopharyngeal swab, N=Nasal swab
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