Date: August 17, 2023

Product: Green Spring® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

We, Shenzhen Lvshiyuan Biotechnology Co. Ltd. as the manufacturer, hereby declare that the Green Springs SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) can detect the following SARS-CoV-2 virus variants which are listed as "variants of concern (VOC)", "variants of interest (VOI)" and "variants under monitoring (VUM)" by the World Health Organization. VOC refers to the large number and wide range of cases caused worldwide and data confirms the transmission ability, strong toxicity, or reduced effectiveness of vaccines and clinical treatments. VOI refers to a confirmed case of community transmission, or has been found in multiple countries, but has not yet formed a large-scale infection. VUM refers to a SARS-CoV-2 variant with genetic changes that are suspected to affect virus characteristics with some indication that it may pose a future risk, but the phenotypic or epidemiological impact is currently unclear, requiring enhanced monitoring and repeat assessment pending new evidence.
 

WHO Categories	WHO labeling	Pango Lineage	Date of designation
Variants of Concern (VOC)	Alpha	B.1.1.7	Sep 20
	Beta	B.1.351	Mai 20
	Gamma	P.1	Nov 20
	Delta	B.1.617.2	Okt 20
	Omicron	B.1.1.529	Nov 21
Variants of Interest (VOI)	Epsilon	B.1.427	Feb 21
		B.1.429	Jun 21
	Eta	B.1.525	Feb 21
	Iota	B.1.526	Feb 21
	Kappa	B.1.617.1	Mai 21
	N/A	B.1.617.3	Mai 21
	Zeta	P.2	Feb 21
	Mu	B.1.621, B.1.621.1	Sep 21
	IHU	B.1.640.2	Sep 21
Variants under monitoring (VUM)		BA.1 xAY.4 recombinant	Mrz 22
		B.1.640	Nov 21
		BA.1	Nov 21
		BA.2	Feb 22
		BA.2.12.1	Feb 22
		BA.3	Feb 22
		BA.4	Jan 22
		BA.5	Jan 22
		BF.7	Mrz 22
		BA.2.75	Mai 22
		BQ.1.1	Aug 22
		XBB	Sep 22
		BQ.1	Sep 22
		EG.5	Feb 23

The new coronavirus (SARS-CoV-2 or 2019-nCoV) is a non-segmented forward RNA virus. This is the cause of the new type of coronavirus pneumonia (COVID-19), which is highly contagious to humans. The SARS-CoV-2 virus has several structural proteins, including spikes (S), envelope (E), membrane (M), and nucleocapsid (N).

The SARS-CoV-2 virus has the characteristics of strong nucleocapsid (N) protein stability. The mutant virus strains that have been found worldwide are derived from the SARS-CoV-2 20B/GR evolutionary strain (lineage B.1.1.7), including many mutation, the mutation location is the spike (S) protein of the new coronavirus, which is the location where the SARS-CoV-2 virus uses to bind to the cell's ACE2 receptor.

The SARS-CoV-2 Antigen Rapid Test Kit, produced by Shenzhen Lvshiyuan Biotechnology Co., Ltd., is used for in vitro qualitative detection of the SARS-CoV-2 virus nucleocapsid (N) protein in human nasopharyngeal, oropharyngeal, anterior-nasal or saliva samples.

 

It can be seen that the mutation sites of mutated virus strains including EG.5 strain have no effect on the detection rate of the kits produced by our company. The kit is suitable for assay of the SARS-CoV-2 variant virus as listed in the table above.