COVID-19

The COVID-19 Tests are in vitro immunochromatographic assay for the rapid, qualitative detection of nucleocapsid protein antigen, IgG/IgM antibodies, neutralizing antibody from SARS-CoV-2 in human Whole blood, serum, plasma, nasopharyngeal swab, nasal swab and oral fluid specimens.

Key Benefits:

Qualitative, visually read results in 10 to 15 minutes
Detect COVID-19 Infection with a simple and rapid procedure
Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
All necessary reagents provided & no equipment needed.
High sensitivity and specificity
Specifications:

Clinical Evaluation: Sensitivity 97.25% / Specificity >99% / Accuracy 98.73%
Specimen: Nasal swab, Nasopharyngeal swab, Oral Fluid, Whole blood, serum, plasma
Time to Results: 10 to 15 minutes
Shelf Life: 24 months from the date of manufacture

Ordering Information

Product Description	Specimen	Catalog No.	Format	Cut-off Value	Kit Size	Regulatory Clearance
COVID-19 IgG/IgM Test	WB/S/P	GCCOV-402a	Cassette	/	25 Tests/Kit	CE-IVDD
SARS-CoV-2 NAb Test	WB/S/P	GCCOV(NAb)-402b	Cassette	/	25 Tests/Kit	CE-IVDD
COVID-19 Ag Test	NP	GCCOV-502a	Cassette	/	20 Tests/Kit	CE-IVDD
COVID-19 Ag Test (External Control included)	NP	GCCOV-502Ca	Cassette	/	1/2/3/5/7/20 Tests/Kit	CE-IVDD
COVID-19 Ag Test	NA	GCCOV-502a-NA	Cassette	/	1/2/3/5/7/10/15/20 Tests/Kit	CE-IVDD
COVID-19 Ag Test	NA	GCCOV-502Ua	Cassette	/	20 Tests/Kit	CE-IVDD
COVID-19 Ag Test	NA	GCCOV-503a	Device	/	1/2/5/10 Tests/Kit	FDA 510(k) CLIA WAIVED
COVID-19 Ag Test	NA/NP	GCCOV-502NN	Cassette	/	20 Tests/Kit	CE-IVDD
COVID-19 Ag Test	Oral Fluid	GCCOV-702a	Cassette	/	20 Tests/Kit	CE-IVDD
COVID-19 Ag Self-Test	NA	GCCOV-502a-Hxx	Cassette	/	1/2/3/5/7/8/10/15/20/25 Tests/Kit	CE-IVDD
COVID-19 Ag Self-Test	Oral Fluid	GCCOV-702a-Hxx	Cassette	/	1/2/3/5/7/10/15/20 Tests/Kit	CE-IVDD
Digital COVID-19 Ag Test	NA	GCCOV-D503a	Digital Device	/	1/2/3/5/7/10/15/20 Tests/Kit	CE-IVDD

S: Serum, P: Plasma, WB: Whole Blood, NP: Nasopharyngeal Swab, NA: Nasal Swab