Discussion and analysis of laboratory developed tests management model with the goal of product registration / 中华检验医学杂志

Currently, the management of domestic laboratory developed test (LDT) is still in the exploration stage, and new plans and ideas need to be investigated that are suitable for our national development. By analyzing encountered issues, combining the actual needs of the government, healthcare reform, and patients, this article proposes that "promoting healthy development of LDT projects and focusing on the organic combination of patients′ interest protection and innovation support" is an important direction for LDT management, around which the new idea for LDT project management is proposed, that is, LDT management model targeting product registration. The core of this management model is to target product registration and to ensure low service fees for patients and continuous real-time data monitoring. Benefit and risk analysis demonstrate that this management model can to a larger extent balance the realistic demands of patients, medical institutions, in vitro diagnostics companies, and government management departments, which benefits promoting the perfection and development of LDT projects in our country.

Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance / 中国医疗器械杂志

Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.

Review of the development history of in vitro diagnostics(IVD)industry in China / 国际检验医学杂志

The process of industrialization and its experience were precious assets of society,the research of industrial history was an important development direction of science,technology and economic and social histo-ry discipline.The research on the industrial history of Chinese in vitro diagnostics industry which had a direct and practical reference and guidance on the development of industrial economy and the improvement of in vitro diagnostics industry benign cycle,and which was also the key to promote healthy and comprehensive develop-ment of Chinese in vitro diagnostics industry.The study reviewed the development of over 30 years of Chinese in vitro diagnostics industry,and showed the whole process of industrial structure upgrading from scratch, weak to strong and germination to high speed development.

Expression level and clinical significance of FSTL1 in serum of patients with acute coronary syndrome / 国际检验医学杂志

Objective To observe the level changes and clinical diagnostic value of follicular statin -1 (FSTL1)in the serum of patients with different types of acute coronary syndrome(ACS).Methods Collected the clinical diagnosis of acute coronary syndrome patients 98 cases,which contained ST segment elevation my-ocardial infarction(STEMI)in 34 cases,non ST elevation myocardial infarction(NSTEMI)in 28 cases,unsta-ble angina pectoris(UA)in 36 cases,while the examination resuLts of healthy people as a control group of 20 cases.The Venous blood was collected and the FSTL1 levels of the 4 groups were detected by ELISA.Results The levels of Serum FSTL1 in ACS group was significantly higher than that in normal control group(P<0.05).Serum FSTL1 of the ACS group were significant correlated with Gensini score,cTNT,hs-CRP(related coefficient:0.210,0.236,0.219 separately).The AUC of FSTL1 was 0.910(95% CI:0.832 -0.988),which was lower than cTNT.The best cut-off value of FSTL1 as a biomarker was 5.65 μg/L(specificity:84.2% and sensitivity:77.5%).Moreover the combination of FSTL1,HDL and cTNT exhibited significantly higher AUC=0.945(95% CI:0.909 -0.981)than did other biomarkers alone or pair combinations.Conclusion In pa-tients with acute coronary syndrome,serum FSTL1 levels has a positive correlation with the degree of coro-nary stenosis and inflammation reaction,and has certain value in the diagnosis of acute coronary syndrome.

Common Problems and Suggestions on Full Life-cycle Supervision and Administration of Diagnostics / 中国医疗器械杂志

This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.

Allergen Microarrays for In Vitro Diagnostics of Allergies: Comparison with ImmunoCAP and AdvanSure

BACKGROUND: In vitro detection of the allergen-specific IgE antibody (sIgE) is a useful tool for the diagnosis and treatment of allergies. Although multiple simultaneous allergen tests offer simple and low-cost screening methods, these platforms also have limitations with respect to multiplexibility and analytical performance. As an alternative assay platform, we developed and validated a microarray using allergen extracts that we termed “GOLD” chip. METHODS: Serum samples of 150 allergic rhinitis patients were used in the study, and the diagnostic performance of the microarray was compared with that of AdvanSure (LG Life Sciences, Daejun, Korea) and ImmunoCAP (Phadia, Uppsala, Sweden). Standard IgE samples were used for the quantitative measurement of sIgEs. RESULTS: The microarray-based assay showed excellent performance in the quantitative measurement of sIgEs, demonstrating a linear correlation within the range of sIgE concentrations tested. The limit of detection (LOD) was lower than 0.35 IU/mL, which is the current standard for the LOD cut-off. The assay also provided highly reproducible sets of data. The total agreement percentage of positive and negative calls was 92.2% compared with ImmunoCAP. Moreover, an outstanding correlation was observed between the microarray and the ImmunoCAP results, with Cohen's kappa and Pearson correlation coefficient values of 0.80 and 0.79, respectively. CONCLUSIONS: The microarray-based in vitro diagnostic platform offers a sensitive, reproducible, and highly quantitative method to detect sIgEs. The results showed strong correlations with that of ImmunoCAP. These results suggest that the new allergen microarray can serve as a useful alternative to current screening platforms, ultimately becoming a first-line screening method.

Development of a Web-based Program to Calculate Sample Size for Evaluating the Performance of In Vitro Diagnostic Kits / 대한진단검사의학회지

BACKGROUND: Many studies evaluating the performance of in vitro diagnostic kits have been criticized for the lack of reliability. To attain reliability those evaluation studies should be preceded by sample size calculation ensuring statistical power. This study was intended to develop a web-based system to estimate the sample size, which was often neglected because it would require expert knowledge in statistics. METHODS: For sample size calculation, we extracted essential parameters from the performance studies on the 3rd generation anti-hepatitis C virus (HCV) kits reported in the literature. We developed a system with PHP web-script language and MySQL. The statistical models used in this system were as follows; one sample without power consideration (model 1), one sample with power consideration (model 2), and two samples with power consideration (model 3). RESULTS: Among the articles published between 1989 and 2005, 13 articles that evaluated the performance of anti-HCV kits were identified by searching with Medical Subject Headings (MeSH). The diagnostic sensitivity was 83-100% with a median of 145 samples (range; 12-1,091) and the specificity was 97-100% with a median of 1,025 samples (range; 33-4,381). The estimated sample size would be 280 in the model 1, 817 in the model 2, and 1,510 in the model 3, when we set 2% prevalence of HCV infection, 95% sensitivity of a conventional kit, 97% sensitivity of a new kit , 95% significance level (two-sided test), 2% allowable error, and 80% power. CONCLUSIONS: Our study indicates that an insufficient sample size is still a problem in performance evaluation. Our system should be helpful in increasing the reliability of performance evaluation by providing an appropriate sample size.