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Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines
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Kangwei XU1, Junzhen GUO2, Xiaoming GAO1, Xu LU1, Yaru QUAN1, Xinhua XIANG1, Changgui LI1, *
Chinese Pharmaceutical Journal | 2024, 59(6) : 555 - 558
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Chinese Pharmaceutical Journal | 2024, 59(6): 555-558
Original article
Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines
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Kangwei XU1, Junzhen GUO2, Xiaoming GAO1, Xu LU1, Yaru QUAN1, Xinhua XIANG1, Changgui LI1, *
Affiliations
  • 1 National Institutes for Food and Drug Control, Beijing 102629, China
  • 2 Shandong Institute for Food and Drug Control, Jinan 250101, China
Published: 2024-03-22
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OBJECTIVE To evaluate the capacity of laboratories which participate in the proficiency testing of antigen content inactived COVID-19 vaccines. METHODS Samples of inactived COVID-19 vaccines for proficiency testing were tested for uniformity and stability, and was distributed together with reference and test kits to participating laboratories by cold chain transportation. Three indexes were evaluated: differential test, antigen content detection and laboratory variation. RESULTS The uniformity and stability of the proficiency test samples met the requirements. A total of 14 laboratories participated in this proficiency test and reported the results as required, and the assessment results of three indicators by each laboratory all satisfactory. CONCLUSION China's provincial drug testing institutions and inactivated vaccine manufacturers participating in this proficiency test have good detection capabilities and quality control levels for inactived COVID-19 vaccines.

inactived COVID-19 vaccine  /  ELISA  /  proficiency testing
Kangwei XU, Junzhen GUO, Xiaoming GAO, Xu LU, Yaru QUAN, Xinhua XIANG, Changgui LI. Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines[J]. Chinese Pharmaceutical Journal, 2024 , 59 (6) : 555 -558 .
Year 2024 volume 59 Issue 6
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Article Info
  • Receive Date:2023-05-04
  • Online Date:2026-04-08
  • Published:2024-03-22
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  • Received:2023-05-04
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    1 National Institutes for Food and Drug Control, Beijing 102629, China
    2 Shandong Institute for Food and Drug Control, Jinan 250101, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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