| Autor: |
Tingting Ma, Donglai Liu, Keliang Lyu, Tingting Gao, Dawei Shi, Lanqing Zhao, Shu Shen, Yabin Tian, Sihong Xu, Haiwei Zhou |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Biosafety and Health, Vol 5, Iss 6, Pp 326-330 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2590-0536 |
| DOI: |
10.1016/j.bsheal.2023.10.002 |
| Popis: |
To develop a national reference panel for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit and establish a quality standard. The cultures of SARS-CoV-2 and other pathogens were collected to establish a national reference panel for SARS-CoV-2 antigen detection. The stability and homogeneity of the reference panel were evaluated. Based on World Health Organization (WHO) guidance and nucleic acid quantitative results, a quality standard reference panel was established. Currently, three generations of SARS-CoV-2 antigen national reference materials with batch numbers 370095–202001, 370095–202202, and 370095–202203 have been successfully established. These national reference panels comprised 8 positive samples, 20 negative samples, 1 repetitive sample, and 1 lower detection limit sample. The stability and homogeneity of the reference panel meet the requirements. The quality standards are as follows: the positive and negative coincidence rates are 8/8 and 20/20, respectively. The 10 test results of the medium and low-concentration repetitive reference materials should be positive, and the color rendering should be uniform (or the coefficient of variance should not be higher than 20.0%). The lower detection limit should be at least 5 × 105 U/mL (equivalent to copies/mL), and higher concentrations above the lower detection limit must be positive. A national reference panel for the SARS-CoV-2 antigen detection kit has been established. As the standard of SARS-CoV-2 antigen reagents, the reference panel has played a crucial role in the pre-marketing quality evaluation and post-marketing quality supervision in China. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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