ArticleAnnals of translational medicine2020
Performance verification of a new domestic chemiluminescence detection system.
Article in Annals of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed, 5 citations in OpenAlex.
- Analytical evaluation of the performances of point-of-care and benchtop procalcitonin assays in comparison with the B⋅R⋅A⋅H⋅M⋅S PCT sensitive KRYPTOR assay.Frontiers in medicine · 2025Article
- Article
- Comparison on the consistency of Mindray and Siemens chemiluminescence analyzers for detecting FT3, FT4 and TSH in patients with hyper- and hypothyroidism.Annals of translational medicine · 2022Article
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProcalcitonin (PCT) is an acute phase response protein, which can be used as an indicator for early diagnosis of infection. At present, the main detection methods for PCT are electrochemiluminescence and enzyme-linked immunofluorescence. We aimed to explore the accuracy of PCT determination in a domestic chemiluminescence detection system and its correlation with other systems.
methodsClinical specimens were collected, and the precision, linearity, biological reference interval, contamination rate, Clinical reportable scope, and methodological comparison of the determination of PCT in a Chinese chemiluminescence detection system were evaluated and preliminarily verified by referring to Clinical and Laboratory Standards Institute (CLSI) documents or industry standards.
resultsThe results of precision verification showed that the coefficient of variation (CV) values of the variation coefficient of precision in the samples of low and high values were 2.07% and 0.83% respectively, while the CV values of the total variation coefficient of precision were 3.05% and 1.81% respectively; these findings all met the experimental requirements. The results of linear verification test showed that the linear range was 0.006-96.96 ng/mL, and the linear relationship was well within the detection range (R2 =0.9891). The biological reference interval and the carrying contamination rate were also verified. The clinical reportable range was 0.02-369.585 ng/mL. The results showed that the correlation coefficient between the Mindray CL900I and the Roche E602 was 0.9986, and that between the Mindray CL900I and the Snibe 2000 was 0.983. Meanwhile, when the PCT was higher than 0.1 ng/mL, the correlation coefficient was 100%.
conclusionsThe domestic chemiluminescence detection system has a good performance in the determination of calcitonin, as indicated by the measures of precision, linearity, biological reference interval, carrying contamination rate, and Clinical reportable scope, and can thus be used for clinical specimen detection. The results of methodological comparison showed that the correlation coefficient between the Mindray CL900I and Roche E602 was 0.9986, while the correlation coefficient between the Mindray CL900I and the Snibe 2000 was 0.983. The test results were consistent with the experimental requirements.
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