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| Quality Evaluation of Three KRAS Gene Mutation Detection Kits |
| DONG Lian-hua1,WANG Shang-jun2,ZHANG Yu-jing1,WANG Jing1 |
1. National Institute of Metrology, Beijing 100029, China
2. Nanjing Institute of Measurement and Testing Technology, Nanjing, Jiangsu 210049, China |
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Abstract In order to understand the quality of the human KRAS gene mutation detection kit, and to guide the selection and use of the kit, three kits commonly available on the market (random numbered A, B and C) were used for quality evaluation. The accuracy, specificity, detection limit and repeatability of the kits were evaluated using standard materials. The positive rate of the seven mutants was 100%, which indicated the accuracy of the kits was good. The specific verification results of the three laboratories showed that the three kits could not meet the negative coincidence rate of 100% mutants, that is, each kit had a false positive result, and the number of mutants with a negative coincidence rate of 100%: 6 for kit A, 6 for kit B, and 3 for kit C. The results of the detection limit showed that the actual detection limits of the seven mutants were not exactly the same as the identified detection limits (1%). And the number of mutants in the three laboratories that were consistent and consistent with the detection limit: 0 for kit A, 3 for kit B, and 5 for kit C. The low level repeatability of all the kits were good (<5%).
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Received: 19 July 2022
Published: 08 March 2023
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2023, Vol. 44 
