ABSTRACT
In this study, the Search Your Mind (S.Y.M., 心) project aimed to collect prospective digital phenotypic data centered on mood and anxiety symptoms across psychiatric disorders through a smartphone application (app) platform while using both centralized and decentralized research designs: the centralized research design is a hybrid of a general prospective observational study and a digital platform-based study, and it includes face-to-face research such as informed written consent, clinical evaluation, and blood sampling. It also includes digital phenotypic assessment through an application-based platform using wearable devices. Meanwhile, the decentralized research design is a non-face-to-face study in which anonymous participants agree to electronic informed consent forms on the app. It also exclusively uses an application-based platform to acquire individualized digital phenotypic data. We expect to collect clinical, biological, and digital phenotypic data centered on mood and anxiety symptoms, and we propose a possible model of centralized and decentralized research design.
ABSTRACT
BACKGROUND: The ComboStick Reader 720(R)(DFI Co., Ltd. Korda) is a newly developed automated urine analyzer. The objective of this analysis was to evaluate the analytical performance of the Combostick Reader 720 and ComboStick 10 reagent strips and to compare the results using the Uriscan Pro II and Uriscan Gen 10 SGL strips (YD Diagnostics, Korea). METHODS: The Dipstick urinalyses were performed on a ComboStick Reader 720(R) using ComboStick 10 strips and on a Uriscan Pro II(R) using Uriscan 10 SGL strips. Precision was evaluated with commercial control materials. The sets of results were analyzed for concordance with weighted kappa values or intraclass correlation coefficients (ICCs). The microscopic urine analysis was carried out to confirm the results from both automated urine analyzers. Agreement between the dipstick methods and the microscopic method was evaluated by kappa values and the McNemar test. RESULTS: Within and between-run precisions of the ComboStick Reader 720(R) were 90.0% to 100%. A comparison of results from 1,700 urine samples using the ComboStick Reader 720(R) and Uriscan Pro II(R) revealed a very high concordance rate of > or = 91.0% on consideration of neighboring blocks for all analytes of the dipstick urinalysis. There was a good association between the microscopic method and the dipstick methods of the two automated urine analyzers. The ComboStick Reader 720(R) revealed a statistically higher degree of agreement for leukocytes. CONCLUSIONS: The ComboStick Reader 720(R) and ComboStick 10 strips showed good precisions and revealed a statistically significant agreement with the Uriscan Pro II(R) and Uriscan 10 SGL strips. For leukocytes, the ComboStick Reader 720(R) was superior to the Uriscan Pro II(R) in comparing the agreement between the microscopic and dipstick methods. The overall performance of the ComboStick Reader 720(R) and ComboStick 10 strips were satisfactory.
Subject(s)
Leukocytes , Reagent Strips , UrinalysisABSTRACT
BACKGROUND: The aim of the study was to establish a new syphilis test algorithm using Architect Syphilis TP (Abbott Japan, Japan: AST), a fully automated treponemal antibody test, as a screening test in a university hospital laboratory. We evaluated performance characteristics of AST in various patient groups. METHODS: A total of 1,357 serum samples obtained from patients at a university hospital from June to August, 2008 were categorized into checkup, preoperative, other diseases, diagnosis (clinically suspected of syphilis), and follow up groups. We compared the results of AST with those of RPR (N=1,276) or Treponema pallidum hemagglutination assay (TPHA, N=81). Samples with discrepant results between RPR or TPHA and AST were retested by fluorescent treponemal antibody absorption test (FTA-ABS) and all patients' clinical records were thoroughly reviewed. RESULTS: The positive rate of AST was significantly higher than that of RPR in preoperative and other diseases groups and was the same as that of RPR in diagnosis group. There were no significant differences in check up and follow up groups. The results of AST showed 97.4% (1,243/1,276) and 97.5% (79/81) concordance rates with those of RPR and TPHA, respectively. Among 26 RPR-AST discrepant and FTA-ABS confirmed cases, there were 20 RPR false-negatives, 4 RPR false-positives, 1 AST false-negative, and 1 AST false-positive. CONCLUSIONS: Based on the results and literature review, we established a new syphilis test algorithm using AST as a screening test, which would be helpful for detection of more syphilis patients including latent infections.