• Title/Summary/Keyword: 잔여검체

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Evaluation of Carryover Contamination on Autopipetting System (자동분주기의 이월오염 평가)

  • Lee, Hyun-Ju;Min, Gyung-Sun;Shin, Sun-Young;Woo, Jae-Ryong;Lee, Ho-Young
    • The Korean Journal of Nuclear Medicine Technology
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    • v.13 no.3
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    • pp.189-192
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    • 2009
  • Purpose: Autopipetting system is an efficient automated equipment pipetting patient samples and reagents for rapid and accurate test. However, it can cause carryover between high concentration sample and low concentration sample. We evaluated carryover contamination of TECAN freedom Evo 100 autopipetting system. Materials and Method: We studied carryover contamination of $\alpha$-fetoprotein (AFP) and carcinoembryonic antigen (CEA) test on TECAN freedom Evo 100 autopipetting system. Very low concentration control samples were pipetted for comparison to the contaminated very low concentration samples. Then, The contaminated very low concentration samples were pipetted following the high concentration samples were pipetted alternately. The difference of low concentration samples represents carryover. The target value to decide carryover was 1ppm (parts per million). Results: For AFP, the mean values of the uncontaminated control samples and the contaminated samples were less than 0.6 IU/mL (the l imit of detection (LoD)). Carryover did not occur even though the high concentration sample which value was 650000 IU/mL. For CEA, the values of the low concentration control samples and the contaminated samples were less than 0.2 ng/mL (LoD). Carryover did not occur even though the high concentration sample which value was 65,000 ng/mL. Conclusions: Sample carryover was not found on TECAN freedom Evo 100 autopipetting system for AFP, CEA. However, carryover is a potential problem with automated instruments and robotic pipetting systems. Therefore, Clinical laboratories must periodically verify carryover contamination for the accurate and confidential test results.

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Consent for using human biological material in research: based on the revised Bioethics and Safety Act (인체유래물연구에 대한 동의 소고(小考) - 개정 생명윤리법 제42조의2를 계기로 -)

  • Lee, Dongjin;Lee, Sun Goo
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.111-140
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    • 2019
  • The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

A Study on Heavy Metal Contents in Processed Foods and Their Safety Evaluations (가공식품 중 중금속 함량 및 안전성 평가)

  • Lee, Hyo-Jung;Shim, Jee-Youn;Oh, Hyun-Suk;Jang, Mi-Ran;Lee, Yoon-Ae;Lee, Ryun-Kyung;Kim, Min-A;Lee, Sang-Min;Cho, Tae-Yong;Kang, Ho-Il
    • Korean Journal of Food Science and Technology
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    • v.44 no.1
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    • pp.21-27
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    • 2012
  • This research was carried out as a survey on the contents of lead, cadmium, and arsenic in processed foods (milk, vegetable oil, and margarine) in Korea. The limits of quantification (LOQs) were Pb 0.3 ${\mu}g/kg$, Cd 0.15 ${\mu}g/kg$, and As 0.45 ${\mu}g/kg$ for milk and Pb 0.61 ${\mu}g/kg$, Cd 0.31 ${\mu}g/kg$, and As 0.91 ${\mu}g/kg$ for vegetable oil and margarine. The recoveries were 92.6-98.0% for Pb, 91.2-98.9% for Cd, and 97.9-104.7% for As. The average levels of Pb were 2.395 ${\mu}g/kg$ for milk, and 7.656 ${\mu}g/kg$ for vegetable oil. The average levels of Cd were 0.483 ${\mu}g/kg$ for milk, and 0.380 ${\mu}g/kg$ for vegetable oil, and levels of As were 0.781 ${\mu}g/kg$ for milk, and 1.241 ${\mu}g/kg$ for vegetable oil. The results of this study showed that Pb, Cd, and As contents in the whole samples were less than the maximum residual levels in the processed foods that were specified by the Codex standard.