CE-marked
Sensitivity: 94.4%
Specificity: 98%
ISO:13485
INTENDED USE
The Rapid SARS-CoV-2 Antibody (IgM/IgG) Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of IgG and/or IgM to SARS-CoV-2 in human whole blood (venous and fingerstick), serum or plasma specimens. This test is intended for use by healthcare professionals and trained healthcare workers as an aid in the diagnosis of SARS-CoV-2 infection.
PRODUCT PARAMETERS
· Sensitivity: 94.4%
· Specificity: 98%
· Specimen: whole blood, serum or plasma
· Test time: 15-20 minutes
· Storage temperature: 2-30℃
· Shelf life: 24 months
ORDERING INFORMATION
Product
Cat. No.
Type
Pack size
Specimen*
Cert.
SARS-CoV-2 IgM
& IgG
ITP16001-TC25
Cassette
25T/Kit
S/P/WB
CE
ITP16002-TC25
Cassette
25T/Kit
S/P/WB
CE
*Specimen:
WB=Whole Blood, S=Serum, P=Plasma
(with lancets and swabs)
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