Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit
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 s...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | Biosafety and Health |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S259005362300126X |
| _version_ | 1797378603426512896 |
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| author | Tingting Ma Donglai Liu Keliang Lyu Tingting Gao Dawei Shi Lanqing Zhao Shu Shen Yabin Tian Sihong Xu Haiwei Zhou |
| author_facet | Tingting Ma Donglai Liu Keliang Lyu Tingting Gao Dawei Shi Lanqing Zhao Shu Shen Yabin Tian Sihong Xu Haiwei Zhou |
| author_sort | Tingting Ma |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T20:10:08Z |
| format | Article |
| id | doaj.art-74ce845da62c4c59a086d53d25c3e6e8 |
| institution | Directory Open Access Journal |
| issn | 2590-0536 |
| language | English |
| last_indexed | 2024-03-08T20:10:08Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Biosafety and Health |
| spelling | doaj.art-74ce845da62c4c59a086d53d25c3e6e82023-12-23T05:22:33ZengElsevierBiosafety and Health2590-05362023-12-0156326330Establishment and application of national reference panels for SARS-CoV-2 antigen detection kitTingting Ma0Donglai Liu1Keliang Lyu2Tingting Gao3Dawei Shi4Lanqing Zhao5Shu Shen6Yabin Tian7Sihong Xu8Haiwei Zhou9Division II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, China; School of Life Sciences and Medicine, Shandong University of Technology, Zibo 255049, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, China; School of Life Sciences and Medicine, Shandong University of Technology, Zibo 255049, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, China; Corresponding authors: No. 2 Tiantan Xili, Dongcheng District, Beijing 100050, China (S. Xu and H. Zhou).Division II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, China; Corresponding authors: No. 2 Tiantan Xili, Dongcheng District, Beijing 100050, China (S. Xu and H. Zhou).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.http://www.sciencedirect.com/science/article/pii/S259005362300126XSARS-CoV-2Antigen detection kitNational reference panelQuality standard |
| spellingShingle | Tingting Ma Donglai Liu Keliang Lyu Tingting Gao Dawei Shi Lanqing Zhao Shu Shen Yabin Tian Sihong Xu Haiwei Zhou Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit Biosafety and Health SARS-CoV-2 Antigen detection kit National reference panel Quality standard |
| title | Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit |
| title_full | Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit |
| title_fullStr | Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit |
| title_full_unstemmed | Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit |
| title_short | Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit |
| title_sort | establishment and application of national reference panels for sars cov 2 antigen detection kit |
| topic | SARS-CoV-2 Antigen detection kit National reference panel Quality standard |
| url | http://www.sciencedirect.com/science/article/pii/S259005362300126X |
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