• Title/Summary/Keyword: the evaluation of kit validation

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Evaluation of the Kit's Efficiency of Alpha Fetoprotein (AFP) Test (Alpha feto protein(AFP)검사 키트의 유효성 평가실험)

  • Cho, Hyun-su;Noh, Gyeong-woon;You, Tae-min
    • The Korean Journal of Nuclear Medicine Technology
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    • v.22 no.2
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    • pp.101-104
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    • 2018
  • Purpose Alpha fetoprotein(AFP) is a fetal serum protein that increases in germ cell tumors derived from liver cancer or egg yolk. AFP test has been used for screening of liver cancer, determination of tumor stage, determination of therapeutic effect, and fetal congenital malformations. The purpose of this study was to compare the results of the four kits, identify the advantages and disadvantages of each kit, and select the appropriate kits for our laboratory. Materials and Methods Blood samples were obtained from 89 patients attending the Seoul national university hospital. Experiments were carried out in accordance with manufacturer's instructions of four companies(A, B, C, D). The precision, recovery, linearity, and sensitivity test were performed for each kit. Results In case of the precision within the measurement, the CV value of the C kit was less than 5% at the low, middle, and high concentrations. The A, B and D kit's the CV value was less than 5% at the concentrations except the low concentration. The recovery rates of the A, B, C, and D kits were $100{\pm}15%$, $100{\pm}30%$, $100{\pm}16%$ and $100{\pm}14%$, respectively. All kits showed good linearity. Sensitivity was measured as 0.5 IU/mL for A, 0.4 IU/mL for B, 0.98 IU/mL for C, and 0.3 IU/mL for D. Conclusion The CV values of the four kits were within 10%, and the correlation coefficients were close to 1 for $R^2=0.978$, $R^2=0.992$ and $R^2=0.8957$. As a result, they are clinically available. Therefore, each laboratory should select the appropriate kit for their experiment's environment.

The Validation of a Commercial Testosterone RIA Test Kits (Testosterone RIA 검사 kit 별 유효성 비교평가)

  • Ryu, Hwa-jin;Shin, Seon-yeong;Cho, Seong-uk
    • The Korean Journal of Nuclear Medicine Technology
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    • v.26 no.1
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    • pp.38-41
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    • 2022
  • Purpose Testosterone is a steroid hormone synthesized by the Leydig cells of the testes in men, and by the adrenal cortex and ovaries in women. Testosterone production is regulated by luteinzing hormone secreted by the anterior pituitary gland. In this experiment, the effectiveness of testosterone radioimmunoassay (RIA) kits produced by three companies was evaluated and compared in case the production of testosterone kits was stopped or supply problems occurred. Materials and Methods In October 2021, samples were collected from the patients (n=49) who requested the testosterone RIA test. The experiment was conducted by dividing the patient's sample into low concentration (1.0 ng/mL or less), medium concentration (2.0-4.0 ng/mL) and high concentration (6.0 ng/mL or more). The Testosterone RIA test compared and evaluated the validity of Company A kits used in this hospital and those of Company B and C used in other hospitals. The precision, sensitivity, recovery, linearity and correlation were evaluated for each kit. The testosterone RIA test was carried out in accordance with the insert kit manual for each manufacturer. Results As a result of measuring the precision of the intra assay, the Coefficient of Variation (CV) value of the company A kit was high at 11.4% only in the low concentration sample, and in the case of the company B and C kits, the CV value was less than 10% at low, medium, and high concentrations. In the inter-assay precision measurement, the CV value was less than 15% in both A and C kits, but in the case of the B kit, the CV value exceeded 15% at low and medium concentrations. Sensitivity was 0.13 ng/mL for company A, 0.01 ng/mL for company B, and 0.01 ng/mL for company C, and the linearity of all three kits showed excellent linearity. In the case of recovery rate, all of the A, B, and C company kits showed results that were out of 90-110%. In the case of correlation test, when compared with the company A kit currently use in here, the correlation coefficient (R2) value for the company B kit was 0.9508, and for the company C kit was 0.9352 Conclusion As a result, there was a slight difference in precision at the low concentration sample. The correlation test showed an excellent correlation coefficient. However, it was difficult to secure samples of various concentrations because there were not many tests of testosterone requested at this hospital. So, additional experiments should be carried out by acquiring samples of various concentrations on each laboratory later.

Evaluation of the cost-effectiveness of ASF detection with or without the use of on-field tests in different scenarios, in Sardinia

  • Cappai, Stefano;Loi, Federica;Rolesu, Sandro;Coccollone, Annamaria;Laddomada, Alberto;Sgarangella, Francesco;Masala, Sergio;Bitti, Giuseppe;Floris, Vincenzo;Desini, Pietro
    • Journal of Veterinary Science
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    • v.21 no.2
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    • pp.14.1-14.10
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    • 2020
  • African swine fever (ASF) is a highly contagious disease of domestic pigs and wild boars (WBs). Without a vaccine, early antibody and antigen detection and rapid diagnosis are crucial for the effective prevention of the disease and the employment of control measures. In Sardinia, where 3 different suid populations coexisted closely for a long time, the disease persists since 1978. The recent ASF eradication plan involves more stringent measures to combat free-ranging pigs and any kind of illegality in the pig industry. However, critical issues such as the low level of hunter cooperation with veterinary services and the time required for ASF detection in the WBs killed during the hunting season still remain. Considering the need to deliver true ASF negative carcasses as early as possible, this study focuses on the evaluation and validation of a duplex pen-side test that simultaneously detects antibodies and antigens specific to ASF virus, to improve molecular diagnosis under field conditions. The main goal was to establish the specificity of the two pen-side tests performed simultaneously and to determine their ability to detect the true ASF negative carcasses among the hunted WBs. Blood and organ samples of the WBs hunted during the 2018/2019 hunting seasons were obtained. A total of 160 animals were tested using the pen-side kit test; samples were collected for virological and serological analyses. A specificity of 98% was observed considering the official laboratory tests as gold standards. The new diagnostic techniques could facilitate faster and cost-effective control of the disease.

RGB-Depth Camera for Dynamic Measurement of Liquid Sloshing (RGB-Depth 카메라를 활용한 유체 표면의 거동 계측분석)

  • Kim, Junhee;Yoo, Sae-Woung;Min, Kyung-Won
    • Journal of the Computational Structural Engineering Institute of Korea
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    • v.32 no.1
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    • pp.29-35
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    • 2019
  • In this paper, a low-cost dynamic measurement system using the RGB-depth camera, Microsoft $Kinect^{(R)}$ v2, is proposed for measuring time-varying free surface motion of liquid dampers used in building vibration mitigation. Various experimental studies are conducted consecutively: performance evaluation and validation of the $Kinect^{(R)}$ v2, real-time monitoring using the $Kinect^{(R)}$ v2 SDK(software development kits), point cloud acquisition of liquid free surface in the 3D space, comparison with the existing video sensing technology. Utilizing the proposed $Kinect^{(R)}$ v2-based measurement system in this study, dynamic behavior of liquid in a laboratory-scaled small tank under a wide frequency range of input excitation is experimentally analyzed.