Relationship between SARS-CoV-2 nucleocapsid protein and N gene and its application in antigen testing kits evaluation

	Relationship between SARS-CoV-2 nucleocapsid protein and N gene and its application in antigen testing kits evaluation
	Peng, T; Dong, LH; Feng, XL; Yang, Y; Wang, X; Niu, CY; Liang, ZW; Qu, W; Zou, QC; Dai, XH; Li, MH; Fang, X
	2023
发表期刊	TALANTA
ISSN	0039-9140
卷号	258
摘要	More than forty antigen testing kits have been approved to response the prevalence of SARS-CoV-2 and its variant strains. However, the approved antigen testing kits are not capable of quantitative detection. Here, we successfully developed a lateral flow immunoassay based on colloidal gold nanoparticles (CGNP-based LFIA) for nucleocapsid (N) protein of SARS-CoV-2 quantitative detection. Delta strain (NMDC60042793) of SARS-CoV-2 have been cultured and analyzed by our developed digital PCR and LFIA methods to explore the relationship between N protein amount and N gene level. It indicated that the linear relationship (y = 47 x) between N protein molecule number and N gene copy number exhibited very well (R2 = 0.995), the virus titers and N protein amount can be roughly estimated according to nucleic acid testing. Additionally, detection limits (LODs) of nine approved antigen testing kits also have been evaluated according to the Guidelines for the registration review of 2019-nCoV antigen testing reagents. Only three antigen testing kits had LODs as stated in the instructions, the LODs of Kits have been converted into the N gene and N protein levels, according to the established relationships among virus titer vers. N gene and antigen. Results demonstrated that the sensitivity of nucleic acid testing is at least 1835 times higher than that of antigen testing. We expect that the relationship investigation and testing kits evaluation have the important directive significance to precise epidemic prevention.
收录类别	SCI
语种	英语
文献类型	期刊论文
条目标识符	http://ir.kiz.ac.cn/handle/152453/14386
专题	管理、支撑部门_高等级生物安全灵长类动物实验中心
推荐引用方式 GB/T 7714	Peng, T,Dong, LH,Feng, XL,et al. Relationship between SARS-CoV-2 nucleocapsid protein and N gene and its application in antigen testing kits evaluation[J]. TALANTA,2023,258.
APA	Peng, T.,Dong, LH.,Feng, XL.,Yang, Y.,Wang, X.,...&Fang, X.(2023).Relationship between SARS-CoV-2 nucleocapsid protein and N gene and its application in antigen testing kits evaluation.TALANTA,258.
MLA	Peng, T,et al."Relationship between SARS-CoV-2 nucleocapsid protein and N gene and its application in antigen testing kits evaluation".TALANTA 258(2023).

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