대한임상검사과학회지 (Korean Journal of Clinical Laboratory Science)

  • 제53권1호
  • /
  • Pages.19-31
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  • 2021
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  • 1738-3544(pISSN)
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  • 2288-1662(eISSN)
대한임상검사과학회 (Korean Society for Clinical Laboratory Science)
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OC Sensor PLEDIA를 이용한 LX Detergent Cleaning Solution과 OC Detergent Cleaning Solution의 동등성 평가

Analysis of a Comparability Test between LX Detergent Cleaning Solution and OC Detergent Cleaning Solution Using OC Sensor PLEDIA

  • Cha, Kyung Jae (Department of Field Application Scientist Team, Shinyang Chemical Co.,Ltd.)
  • 투고 : 2020.11.17
  • 심사 : 2021.02.01
  • 발행 : 2021.03.31
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초록

이 연구의 목적은 기능적, 정량적 분석을 바탕으로 수입 LX 세정액(LX-CS)과 자가제조 OC 세정액(OC-CS)의 성능을 비교하였다. 기능적 분석은 ADC값을 사용하여 평가하였다. 정량적 분석을 위해 CLSI 지침에 따라 정도 관리 물질을 이용하여 정밀도, 직선성 및 오염률을 평가하였다. OC-Sensor PLEDIA(Eiken Chemical, Japan)를 이용한 모든 cuvette의 ADC값은 허용기준을 만족하였다. 정량적 분석의 경우 두 제품의 정밀도는 5.0% 미만이었고, 오염율은 ±1.00% 이하였다. 직선성 기울기와 r2 값은 LX-CS에서 각각 1.0017와 0.9982였으며, OC-CS에서 0.9924와 0.9996이였다. 상관계수(r)는 0.9997이였다. 또한 40개의 가변을 이용한 % difference는 10% 미만, P값은 0.1 미만이였다. 각 각 차이: 표준 편차 비(D: ±1 SD 비)에 기초한 두 제품 모두 유사한 결과를 보였다. 결론적으로 두 제품의 기능적, 정량적 분석을 비교한 결과 유사하였다. 향후 자가제조한 OC세정액은 수입 LX세정액보다 훨씬 더 안정적이고 빠른 공급을 제공할 수 있을 것이라 기대된다.

This study aimed at comparing the performance of imported LX detergent cleaning solution (LX-CS) and the self-manufactured OC cleaning solution (OC-CS), based on functional and quantitative analysis. The functional analysis was carried out using apparent diffusion coefficient (ADC) values. For quantitative analysis, precision, linearity, and carry-over rates were measured with commercial control materials according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. Using OC-Sensor PLEDIA (Eiken Chemical, Japan), the ADC value of all cuvettes satisfied the acceptance criteria. For quantitative analysis, precision was less than 5.0% for the two products, and carry-over rates were less than ±1.00%. The linearity slopes and r2 values were 1.0017 and 0.9982 in the LX-CS, and 0.9924 and 0.9996 in the OC-CS, respectively. The correlation coefficient (r) was found to be 0.9997. Also, the percent difference in correlation with 40 artificial-stool specimens was less than 10% and the p-value was less than 0.1. The result of standard deviation ratio (D: ±1 SD ratio) was similar for both products. In conclusion, the functional and quantitative analyses of the two products were compared and showed similar results. In the future, the self-manufactured OC-CS will be able to provide a much more stable and faster supply than the imported LX-CS.

키워드

참고문헌

  1. Lee ES. Health insurance corporation colorectal cancer screening guidelines. 2nd ed. Goyang: National Cancer Center; 2018. p40-48.
  2. Limin X. Clegg, Frederick P. Li, Benjamin F. Hankey, Kenneth Chu, Brenda K. Edwards. Cancer survival among US Whites and Minorities. Arch Intern Med. 2002;162:1985-1993. https://doi.org/10.1001/archinte.162.17.1985
  3. Allison JE. Colon cancer screening guidelines 2005: the fecal occult blood test option has become a better FIT. Gastroenterology. 2005;129:745-748. https://doi.org/10.1053/j.gastro.2005.06.034
  4. Allison JE, Tekawa IS, Ransom LJ, Adrain AL. A comparison of fecal occult blood tests for colorectal-cancer screening. N Engl J Med. 1996;334:155-159. https://doi.org/10.1056/NEJM199601183340304
  5. Jochim STD, Frank AO, Rene WMH, Henk AH, Rund JL, Sietze TT, et al. Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-Stage colorectal cancers. Cancer Epidemiol Biomarkers Prev. 2011;20:272-280. https://doi.org/10.1158/10559965
  6. Don C. Rockey. Occult gastrointestinal bleeding. N Engl J Med. 1999;341:38-46. https://doi.org/10.1056/NEJM199907013410107
  7. Jeon CH, Lee AJ, Kim KD. Annual report on external quality assessment scheme for urinalysis and faecal occult blood testing in Korea (2014). J Lab Med Qual Assur. 2015;37:179-189. https://doi.org/10.15263/jlmqa.2015.37.4.179
  8. Inger DB. Colorectal cancer screening. Prim Care. 1999;26:179-187. https://doi.org/10.1016/s0095-4543(05)70108-1
  9. Walter A. Kester. Characterizing and testing A/D and D/A converters for color video applications. IEEE Trans Circuits Sys I Regul Pap.1978;25:539-550. https://doi.org/10.1109/TCS.1978.1084492
  10. Shinichi Touzuka, Keiko Aoyama. OC sensor series PLEDIA service manual. 2nd ed. Tokyo: Eiken chemical and Hitachi, Ltd; 2019. p343-368.
  11. McEnroe R, Durham A, Goldford M, Kondratovich M, Lababidi S, Magari R, et al. Evaluation of precision of quantitative measurement procedures, approved guideline. CLSI document EP5-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
  12. Daniel W, Martin K, Astles J. Evaluation of the linearity of quantitative measurement procedures: a statistical approach, approved guideline. CLSI document EP6-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2003.
  13. Clinical and Laboratory Standards Institute. Verification of comparability of patient results within one health care system, approved guideline. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
  14. Krouwer JS, Cembrowski GS, Tholen DW. Preliminary evaluation of quantitative clinical laboratory measurement procedures, approved guideline. CLSI document EP10-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2006.
  15. Budd J, Durham A, Gwise T, Iriarte B, Kallner A, Linnet K, et al. Measurement procedure comparison and bias estimation using subject samples, approved guideline. CLSI document EP09-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.
  16. Jeon CH, Lee AJ, Kim SG. Suh HS, Bae YC. Annual report on external quality assessment scheme for urinalysis and faecal occult blood testing in Korea (2017). J Lab Med Qual Assur. 2018;40:128-139. https://doi.org/10.15263/jlmqa.2018.40.3.128
  17. Apolline A, Laure C, Johann-Francois O, Sebastien G, Nicolas C, Jean-Francois B. Comparison of decontamination efficacy of cleaning solutions on a biological safety cabinet workbench contaminated by cyclophosphamide. Can J Hosp Pharm. 2017;70:407-414. https://doi.org/10.4212/cjhp.v70i6.1708
  18. Nefise O, Filiz K, Dugu P. Comparison of steam technology and a two-step cleaning(water/detergent) and disinfecting(1,000 resp.5,000ppm hypochlorite) method using microfiber cloth for environmental control of multidrug-resistant organisms in an intensive care unit. GMS Hyg Infect Control. 2019;14:1-7. https://doi.org/10.3205/dgkh000330
  19. Kim JH, Kim HS, Chung HJ, Yoon NS, Pyo YJ, Bae HG, et al. Evaluation of the OC-SENSOR neo System for testing fecal occult blood. J Lab Med Qual Assur. 2007;27:210-215.
  20. Hong SB, Kim HS, Park HS, Lee DH. Evaluation of the HM-JACK automatic analyzer for fecal occult blood test. J Lab Med Qual Assur 2002;24:221-224.
  21. Kim DC, Cho SS, Song J, Kim EC, Kim JQ. Evaluation of the OC-SENSOR (Automatic Measuring Apparatus) for immunological fecal occult blood test. J Clin Pathol Qual Control. 1998;20:281-287.
  22. Kim JH, Chung HJ, Yoon NS, Pyo YJ, Bae HG. Evaluation of the OC-SENSOR neo System for testing fecal occult blood. Korean J Lab Med. 2007;27:210-215. https://doi.org/10.3343/kjlm.2007.27.3.210
  23. Park YM, Choi Q, Kwon GC, Koo SH. Performance evaluation of the HM-JACKarc analyser for fecal occult blood test. J Lab Med Qual Assur. 2016;38:137-142. https://doi.org/10.15263/jlmqa.2016.38.3.137
  24. Kim BH, Cha YJ. Verification of comparability among quantitative results obtained using multiple instruments within a health care system. Lab Med Online. 2014;4:65-70. https://doi.org/10.3343/lmo.2014.4.2.65