Rapid SARS-CoV-2 Antibody (IgM/IgG) Test

CE-marked

Sensitivity: 94.4%

Specificity: 98%

ISO:13485

  • Product Detail

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
(with lancets and swabs)

25T/Kit

S/P/WB

CE

*Specimen: WB=Whole Blood, S=Serum, P=Plasma


Operation Guidance-SARS-CoV-2 IgM&IgG

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