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GB SARS-CoV-2 Ab

Semi-quantitative ELISA for SARS-CoV-2 Spike/N antibodies (IgG/IgM) with 100% sensitivity & specificity. 10 µL sample, 105-minute assay.

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PRODUCT DESCRIPTION

This product is a semi-quantitative ELISA reagent designed for detection of IgG and IgM antibodies to SARS-CoV-2 Spike or N protein in human serum or plasma. It uses a direct sandwich ELISA format on a 96-well plate. The test requires only 10 µL of sample and has a 105-minute incubation time with a 450 nm readout. Clinical validation shows 100% sensitivity and 100% specificity. Non-Reactive results indicate no detectable anti-SARS-CoV-2 antibodies; Reactive results signify presence of antibodies, to be interpreted alongside vaccination or infection history.

SPECIFICATION

Number of wells	96
Principle	Direct Sandwich
Assay format	Semi-Quantitative
Total incubation time	105 minutes
Sample type	Serum or Plasma
Sample volume	10 μL
Reading wavelength	450nm
Storage	2-8°C
Certification	RUO

PERFORMANCE

5 serum samples collected from RT-PCR confirmed COVID-19 patients were tested. 139 normal healthy patients with samples collected before COVID-19 outbreak were tested. The results are as follows：

PERFORMANCE	Test Positive	Test Negative
Confirmed Positive	5	0
Confirmed Negative	0	139

Inter-assay precision CV

< 10%

Inter-assay precision CV

< 20%

The diagnostic sensitivity is 100%；The diagnostic specificity is 100%

COMPARISON

		Negative (n=89)			Positive (n=5)
		Company A			Company A
		Pos	Neg	total	Pos	Neg	total
GBC	Pos	0	0	0	4	1	5
	Neg	2	87	89	0	0	0
	total	2	87	89	4	1	5
Sensitivity	GBC	100%
Sensitivity	Company A	80%
Specificity	GBC	100%
Specificity	Company A	97.7%

ORDERING INFORMATION

Catalogue No.	Product
4ECO001	GB SARS-COV-2 Ab ELISA - 96T
4ECO002	GB SARS-COV-2 Ab ELISA - 480T