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Annual Report of the Korean Association of External Quality Assessment Service on Urinalysis and Fecal Occult Blood Testing (2018)
J Lab Med Qual Assur 2019;41:75-81
Published online June 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Chang-Ho Jeon, A-Jin Lee, Sang-Gyung Kim, Hun-Seok Suh, and Young-Cheol Bae

Department of Laboratory Medicine, School of Medicine, Catholic University of Daegu, Daegu, Korea
Correspondence to: Chang-Ho Jeon, Department of Laboratory Medicine, Daegu Catholic University Medical Center, School of Medicine, Catholic University of Daegu, 33 Duryugongwon-ro 17-gil, Namgu, Daegu 42472, Korea, Tel: +82-53-650-4144 Fax: +82-53-653-8672 E-mail: chjeon@cu.ac.kr
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract

In 2018, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed using 1,590 participants. Urine chemistry tests were performed thrice while urine sediment and FOB tests twice. Urine chemistry tests comprised of pH, protein, glucose, ketone body, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of urine chemistry and specific gravity tests showed accuracy rates >95%, except for the pH test. The accuracy rate of urine sediments was low, especially for atypical calcium oxalate crystal and red blood cell cast. In the FOB quality test, reagents showed accuracy rates >90%, except for SD and GC Genedia FOB reagents. In the FOB quantitative test, Alfresa NS-Plus C instrument showed falsely high values in the FOB negative specimens.

Keywords : Quality control, Urinalysis, Occult blood, Accuracy
꽌濡

슂寃쎄븰遺꾧낵쓽 2018뀈룄 쇅遺젙룄愿由ъ궗뾽쓣 쐞븯뿬 슂솕븰寃궗뒗 3쉶 떆뻾븯怨 珥 12媛쒖쓽 愿由щЪ吏덉쓣 궗슜븯떎. 슂移⑥궗寃궗뒗 2쉶 떆뻾븯쑝硫 珥 8媛쒖쓽 궗吏꾩쓣 寃뚯떆븯뿬 뙋룆븯룄濡 븯떎. 蹂옞삁寃궗(fecal occult blood, FOB) 삉 븳 2쉶 떆뻾븯쑝硫 珥 6媛쒖쓽 愿由щЪ吏덉쓣 궗슜븯떎. 슂솕븰寃궗 諛 FOB 떊鍮숇룄議곗궗뿉뒗 援궡뿉꽌 젣議곕맂 愿由щЪ吏덉쓣 궗슜븯떎.

2018뀈 떊鍮숇룄議곗궗궗뾽 寃곌낵뙋젙뿉꽌 諛섏젙웾寃곌낵瑜 굹궡뒗 寃궗빆紐⑹ 寃곌낵媛믪씠 理쒕퉰룄媛±1떒怨꾨 蹂댁씠뒗 쟾泥 湲곌 닔媛 쟾泥 李몄뿬湲곌 닔쓽 80%瑜 꽆쑝硫 젙떟쑝濡 뙋젙븯떎. 2018뀈룄 씠쟾뿉뒗 듅젙 옣鍮꾩쓽 寃곌낵遺꾪룷媛 쟾泥 寃곌낵 遺꾪룷 긽씠븯寃 굹궇 寃쎌슦 떎鍮덈룄 寃곌낵뒗 젙떟쑝濡 諛섏쁺븯 쑝굹 씪愿맂 洹쒖젙쓣 쟻슜븯湲 뼱젮썱떎. 뵲씪꽌 2018뀈뿉뒗 긽湲곗 媛숈씠 쟾泥 李몄뿬湲곌 닔쓽 80%瑜 꽆쑝硫 젙떟쑝濡 뙋젙븯떎. 李몄뿬湲곌 1李 1,490, 2李 1,559, 3李 1,590湲곌씠 媛곴컖 李몄뿬븯뿬 2017뀈뿉 鍮꾪븯뿬 利앷븯떎.

옱猷 諛 諛⑸쾿

1. 긽

슂寃쎄븰遺꾧낵뿉꽌뒗 븳엫긽寃궗젙룄愿由ы삊쉶뿉 벑濡앸맂 湲곌쓣 긽쑝濡 2018뀈룄 2썡, 4썡, 8썡 3李⑥뿉 嫄몄퀜 젙룄愿由 臾쇱쭏쓣 諛쒖넚븯떎. 李몄뿬湲곌 닔뒗 3李 議곗궗뿉꽌 1,590湲곌쑝濡 2017뀈룄 룞씪 李⑥닔쓽 1,450湲곌뿉 鍮꾪븯뿬 9.6% 利앷릺뿀떎.

2. 옱猷

슂솕븰寃궗瑜 쐞븳 愿由щЪ吏덉 1李(CU-18-01–04), 2李 (CU-18-05–08), 3李(CU-18-09–12) 寃泥 紐⑤몢 援궡뿉꽌 젣議고븳 븸긽愿由щЪ吏 4醫낆뵫쓣 媛 쉶썝湲곌뿉 깋옣 룷옣븯뿬 諛쒖넚븯떎. 씠 以 1李 諛 3李⑥뿉뒗 蹂 삊쉶 솃럹씠吏뿉 寃뚯떆븳 슂移⑥궗 궗吏 8留 벑 紐⑤몢 20醫낆쓽 寃泥대 슦넚 諛 寃뚯떆븯뿬 젙룄愿由 떊鍮숇룄議곗궗瑜 떆뻾븯떎. 寃곌낵移섏쓽 엯젰 蹂 삊쉶뿉꽌 援ъ텞븳 떊鍮숇룄議곗궗궗뾽 솃럹씠吏뿉꽌 吏곸젒 엯젰븯뒗 諛⑹떇쓣 궗슜븯떎. FOB瑜 쐞븳 愿由щЪ吏덈룄 1李 諛 2李 寃泥 紐⑤몢 援궡뿉꽌 젣議고븳 젏븸꽦 遺꾨쭚愿由щЪ吏 3醫(CS-17-01–06) 쓣 媛 쉶썝湲곌뿉 깋옣 룷옣븯뿬 諛쒖넚븯떎.

3. 젙룄愿由щЪ吏덉쓽 뿀슜移

슂솕븰 諛 FOB 寃궗쓽 寃쎌슦 遺꾧낵쐞썝쉶뿉꽌 떎뿕븳 李멸퀬移, 媛 湲곌뿉꽌 쉶떊븳 寃곌낵쓽 씪移섎룄瑜 怨좊젮븯쑝硫, 젙꽦 寃곌낵뒗 젙떟씠嫄곕굹 李몄뿬湲곌쓽 80% 씪移섎 蹂댁씠뒗 寃곌낵濡 븯떎. 諛섏젙웾寃곌낵뒗 寃곌낵媛믪씠 理쒕퉰룄媛±1떒怨꾨 蹂댁씠뒗 쟾泥 湲곌 닔媛 쟾泥 李몄뿬湲곌 닔쓽 80%瑜 꽆쑝硫 젙떟쑝濡 뙋젙븯떎. 젙웾寃곌낵瑜 蹂댁씠뒗 寃궗빆紐⑹ 寃곌낵媛믪씠 湲곗遺꾨쪟뿉 빐 3 몴以렪李⑥닔(standard deviation index) 씠궡씪 寃쎌슦 젙떟쑝濡 뙋젙븯떎.

寃곌낵

1. 슂솕븰寃궗 9醫낆쓽 떊鍮숇룄議곗궗 꽦쟻

슂솕븰寃궗 9醫(pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte)쓽 떊鍮숇룄議곗궗 꽦쟻 Table 1뿉 슂빟븯떎. 紐⑤뱺 빆紐⑹뿉꽌 95% 씠긽쓽 젙떟瑜좎쓣 굹궡뿀쑝굹 pH 빆紐⑹ 1-3李 紐⑤몢 95% 씠븯쓽 젙떟瑜좎쓣 굹 궡뿀떎.

Table 1 . Number of participants and acceptable rates in urine chemistry quality control.

Tests1st QC2nd QC3rd QC



ParticipantsAcceptable (%)ParticipantsAcceptable (%)ParticipantsAcceptable (%)
pH1,49094.01,55893.21,58990.4
Protein1,49596.51,56494.71,59597.9
Glucose1,49098.21,55998.11,59099.2
Ketone1,45199.51,51699.61,54597.4
Bilirubin1,44998.91,51499.31,54398.3
Blood1,49098.21,55997.31,59095.1
Urobilinogen1,45199.01,51697.61,54594.2
Nitrite1,42799.61,48499.61,50999.3
Leukocyte1,41897.01,47398.91,49799.0

Abbreviation: QC, quality control..


2. 슂솕븰 遺꾩꽍湲곗뿉 뵲瑜 슂솕븰寃궗 떊鍮숇룄議곗궗 꽦쟻

媛 쉶궗蹂 슂솕븰 遺꾩꽍湲곗뿉 뵲瑜 슂솕븰寃궗쓽 떊鍮숇룄議곗궗 꽦쟻 Table 2 媛숇떎. YD (YD Diagnostics, Yongin, Korea)媛 39.8%濡 媛옣 留롮씠 궗슜븯怨 엳쑝硫, SD (Standard Diagnostics, Seoul, Korea) 21.8%, Roche (Roche Diagnostics, Mannheim, Germany) 14.8%, DFI (DFI Co. Ltd., Gimhae, Korea) 9.6% 닚씠뿀떎.

Table 2 . Acceptable rates based on urine analyzers of different companies.

InstrumentpHProteinGlucoseKetoneBilirubinBloodUrobilinogenNitriteLeukocyteTotal
YD92.797.498.499.599.598.799.699.797.8580 (39.8)
SD95.697.698.799.599.597.398.999.399.0318 (21.8)
Roche81.898.099.999.299.796.695.499.299.4216 (14.8)
DFI91.387.297.199.099.299.499.499.899.2140 (9.6)
Siemens88.797.999.299.493.399.498.899.499.289 (6.1)
Eiken87.393.898.892.393.091.998.199.799.149 (3.4)
Sysmex99.694.510089.098.389.299.199.895.532 (2.2)
Arkray95.199.310099.310083.110099.398.624 (1.6)
Beckman99.093.393.399.083.793.399.099.089.79 (0.6)

Values are presented as % or number (%)..

The instruments were from the following companies: YD (YD Diagnostics, Yongin, Korea), SD (Standard Diagnostics, Seoul, Korea), Roche (Roche Diagnostics, Mannheim, Germany), DFI (DFI Co. Ltd., Gimhae, Korea), Siemens (Siemens Healthcare, Erlangen, Germany), Eiken (Eiken Chemical Co., Tokyo, Japan), Symex (Symex Co., Kobe, Japan), Arkray (Arkray Inc., Kyoto, Japan), and Beckman (Beckman Coulter Inc., Brea, CA, USA)..


遺遺꾩쓽 옣鍮꾩뿉꽌 90% 씠긽쓽 젙떟瑜좎쓣 蹂댁쑝굹 쉶궗蹂 옣鍮꾩뿉 뵲씪 젙떟瑜좎뿉 떎냼 李⑥씠瑜 굹궡뼱 씪遺 寃궗빆 紐⑹뿉꽌뒗 90% 씠븯쓽 젙떟瑜좎쓣 蹂댁떎. pH 빆紐⑹ Roche, Siemens (Siemens Healthcare, Erlangen, Germany), 諛 Eiken (Eiken Chemical Co., Tokyo, Japan) 젣뭹씠 90% 씠븯쓽 젙떟瑜좎쓣 굹궡뿀怨, protein DFI궗, ketone Sysmex궗, bilirubin Beckman궗(Beckman Coulter Inc., Brea, CA, USA), blood뒗 Sysmex 諛 Arkray궗(Arkray Inc., Kyoto, Japan), leukocyte Beckman궗뿉꽌 媛곴컖 90% 씠븯쓽 젙떟瑜좎쓣 굹궡뿀떎.

pH 빆紐⑹뿉꽌 90% 씠븯瑜 蹂댁씠뒗 떆빟뱾씠 留롮븘꽌 1-3쉶李 寃泥 以 媛옣 젙떟瑜좎씠 궙 寃泥대 긽쑝濡 寃곌낵遺꾪룷瑜 遺꾩꽍븯떎(Table 3). 理쒕퉰룄媛±1떒怨 媛믪씠 寃泥 CU-18-01뿉꽌뒗 90.5%, 寃泥대챸 CU-18-05뿉꽌뒗 89.7%, 寃泥 CU-18-11 뿉꽌뒗 84.5%濡 굹궗떎. CU-18-01 諛 CU-18-05 寃泥대뒗 理쒕퉰룄媛±1떒怨꾨 踰쀬뼱굹뒗 湲곌쓽 鍮꾩쑉씠 떎瑜 寃泥댁뿉 鍮꾪빐 긽쟻쑝濡 留롮븯떎. CU-18-11 寃泥대뒗 理쒕퉰룄媛믪씠 5.0쑝濡 5.5源뚯留 젙떟쑝濡 씤젙릺뼱 媛옣 궙 젙떟瑜좎쓣 굹궡뿀떎. 젙떟瑜좎씠 궙븯뜕 3媛 쉶궗쓽 寃곌낵瑜 遺꾩꽍븳 寃곌낵 CU-18-01 諛 CU-18-05 寃泥댁뿉꽌 Eiken궗뒗 궙 履쎌쑝濡 Roche 젣뭹 넂 寃곌낵媛 留롮븯떎. 諛섎㈃ Siemens궗뒗 CU-18-11 寃泥 뿉꽌 넂 寃곌낵媛 留롮븯떎.

Table 3 . Distribution of pH across specimens and instruments.

SpecimenIntended responseResultNo. of allNo. of EikenNo. of RocheNo. of Siemens
CU-18-01Unacceptable<5.525100
Unacceptable6621101
Acceptable6.52351221
Acceptable79662416532
Acceptable7.51481547
Unacceptable>8540440
CU-18-05Unacceptable<5.532011
Unacceptable6541101
Acceptable6.52301201
Acceptable710132514534
Acceptable7.51551844
Unacceptable>8740631
CU-18-11Acceptable59744320210
Acceptable5.53683346
Unacceptable62111233
Unacceptable>6.536080

The instruments were from the following companies: Eiken (Eiken Chemical Co., Tokyo, Japan), Roche (Roche Diagnostics, Mannheim, Germany), and Siemens (Siemens Healthcare, Erlangen, Germany)..


3. 슂솕븰 遺꾩꽍湲곕줈 떆뻾븳 슂鍮꾩쨷寃궗 떊鍮숇룄議곗궗 꽦쟻

슂鍮꾩쨷寃궗뒗 援댁젅怨 寃궗뒗 떆뻾븯吏 븡怨 슂솕븰 遺꾩꽍옣鍮꾨줈 痢≪젙븯떎. Table 4뿉꽌 媛숈씠 紐⑤뱺 寃泥댁뿉꽌 95% 씠긽쓽 젙떟瑜좎쓣 굹궡뿀떎. 洹몃윭굹 寃곌낵엯젰 떆 옒紐삳맂 媛믪씠 엯젰릺뒗 寃쎌슦媛 諛쒖깮븯뿬 0.02, 6.5 벑쓽 寃곌낵媛 엯젰릺뿀떎. 媛 湲곌뿉꽌 寃곌낵엯젰 떆 二쇱쓽媛 븘슂븯떎.

Table 4 . Acceptable rates in the urine specific gravity test.

SpecimenParticipantsMean±standard deviation95% Confidence intervalAcceptable (%)
CU-18-011,4171.006±0.0031.000 to 1.01599.6
CU-18-021,4181.008±0.0031.005 to 1.01597.6
CU-18-031,4171.008±0.0031.005 to 1.01596.3
CU-18-041,4181.02±0.0051.010 to 1.03097.9
CU-18-051,4761.006±0.0031.000 to 1.01599.9
CU-18-061,4781.007±0.0031.005 to 1.01496.2
CU-18-071,4781.007±0.0261.005 to 1.01596.8
CU-18-081,4781.02±0.0051.010 to 1.03097.7
CU-18-091,5021.006±0.0031.000 to 1.01097.5
CU-18-101,5021.007±0.0371.005 to 1.01597.7
CU-18-111,5021.003±0.0361.000 to 1.01099.2
CU-18-121,5021.02±0.0371.010 to 1.03098.1

4. 궗吏 寃泥대 씠슜븳 슂移⑥궗臾 寃궗寃곌낵

궗吏 寃泥대 궗슜븯뿬 떆뻾븳 슂移⑥궗臾 떊鍮숇룄議곗궗쓽 룊洹 젙떟瑜좎 52.9%뿉꽌 99.6%쓽 젙떟瑜좎쓣 蹂댁떎(Figs. 1, 2 and Table 5). Cholesterol 寃곗젙(CUI-18-03), 젙옄(CUI-18-04), bilirubin 寃곗젙(CUI-18-06) 諛 諛깊삁援(CUI-18-07)뒗 紐⑤몢 90% 씠긽쓽 젙떟瑜좎쓣 굹궡뿀떎.

Table 5 . Acceptable rates in the urine sediment examination.

Specimen no.No. of participantsResultsNo. of answersAcceptable (%)Unacceptable (%)
CUI-18-01924Calcium oxalate48952.9
CUI-18-01924Ammonium magnesium phosphate40944.3
CUI-18-02924Cellular cast (RTE and/or neutrophil)56160.7
CUI-18-02924Granular cast coarsely19521.1
CUI-18-02924RBC/pigmented/muddy brown casts828.9
CUI-18-03924Cholesterol87294.4
CUI-18-03924Uric acid505.4
CUI-18-04924Spermatozoa92099.6
CUI-18-05901Granular cast coarsely38342.5
CUI-18-05901RBC/pigmented/muddy brown casts31635.1
CUI-18-05901Granular cast finely778.5
CUI-18-06901Bilirubin83892.9
CUI-18-07901Leukocyte (eosinophil, lymphocyte)88498.1
CUI-18-08901Transitional epithelial cell (urothelial)49755.2
CUI-18-08901Renal tubular epithelial cell (RTE)32936.5
CUI-18-08901Squamous epithelial cell424.7

Abbreviations: RTE, renal tubular epithelial; RBC, red blood cell. .


Figure 1.

Images of urine sediments (arrow) for external quality assessment. (A) CUI-18-01 calcium oxalate crystal (original magnification×400). (B) CUI-18-02 cellular cast (original magnification×200). (C) CUI-18-03 cholesterol crystal (original magnification×400). (D) CUI-18-04 spermatozoa (original magnification×400).


Figure 2.

Images of urine sediments for external quality assessment. (A) CUI-18-05 red blood cell cast (original magnification×400). (B) CUI-18-06 bilirubin crystal (original magnification×100). (C) CUI-18-07 white blood cells (original magnification×200). (D) CUI-18-08 renal tubular epithelial cells (original magnification×400).


Calcium oxalate (CUI-18-01)瑜 44.3%뿉꽌 triple phosphate 寃곗젙쑝濡 蹂닿퀬븯뒗뜲, 鍮꾩젙삎 calcium oxalate 寃곗젙씠씪 뙋룆씠 슜씠븯湲 븡븯떎. 꽭룷썝二(CUI-18-02)瑜 21.1%뿉꽌 怨쇰┰썝二쇰줈, 쟻삁援 썝二(CUI-18-05)瑜 42.5%뿉꽌 援듭 怨쇰┰썝二쇰줈 뙋젙븯뿬 紐⑤몢 젙떟쑝濡 梨꾪깮븯떎. 꽭눊愿긽뵾꽭룷(CUI-18-08)뒗 55.2%뿉꽌 씠뻾긽뵾꽭룷濡 蹂닿퀬븯뿬 젙떟쑝濡 梨꾪깮븯떎. 몢 꽭룷뒗 留ㅻ뀈 異쒖젣릺吏留 援щ퀎씠 슜씠븯吏 븡븯떎. 븳 옣쓽 궗吏꾩쑝濡 뙋룆씠 뼱졄吏留 슂移⑥궗臾쇱쓽 젙솗븳 뙋룆쓣 쐞븯뿬 媛 湲곌쓽 吏냽쟻씤 愿떖怨 끂젰씠 븘슂븯떎.

5. FOB 떆빟뿉 뵲瑜 FOB 젙꽦寃궗쓽 젙떟瑜 諛 떆빟쓽 遺꾪룷

FOB 떆빟뿉 뵲瑜 FOB 젙꽦寃궗쓽 젙떟瑜좎 Table 6 뿉 굹궡뿀떎. 떆빟 SD FOB rapid test (335湲곌), YD FOB test (145湲곌), Asan FOB easy test (Asan Pharmaceutical, Seoul, Korea; 63湲곌), Eiken homocatch light (Eiken Chemical Co., Tokyo, Japan; 59湲곌) 닚쑝濡 궗슜븯떎.

紐⑤뱺 떆빟뿉꽌 뼇샇븳 젙떟瑜좎쓣 굹궡뿀쑝굹, FOB 쓬꽦 3寃泥 以 2寃泥댁뿉꽌 SD FOB 諛 GC Genedia FOB (Green Cross Medial Science Co., Yongin, Korea) 떆빟 90% 씠븯쓽 궙 젙떟瑜좎쓣 굹궡뿀떎. Humasis궗 떆빟 2017뀈뿉뒗 쓬꽦 寃泥 2媛쒖뿉꽌 紐⑤몢 90% 씠븯쓽 젙떟瑜좎쓣 굹궡뿀쑝굹 2018뀈뿉뒗 90% 씠긽쓽 젙떟瑜좎쓣 굹궡뿀떎.

Table 6 . Acceptable rates in the fecal occult blood quality test.

ReagentsNo.CS-18-01CS-18-02CS-18-03CS-18-04CS-18-05CS-18-06






Negative (%)Negative (%)Positive (%)Positive (%)Negative (%)Positive (%)
SD FOB rapid test33584.797.199.8100.076.4100.0
YD Occult Tech FOB test14594.9100.0100.0100.093.898.6
ASAN easy test FOB6398.2100.0100.0100.092.198.4
Eiken Hemocatch light59100.0100.0100.0100.0100.0100.0
Humasis FOB test4292.597.5100.0100.090.597.6
HBI HiSens FOB NCard34100.0100.0100.0100.091.297.1
GC Genedia FOB2889.392.9100.0100.085.7100.0
Bio focus FOB rapid test2692.696.3100.0100.092.3100.0

Abbreviation: FOB, faecal occult blood..

The instruments used were from the following companies: SD (Standard Diagnostics, Seoul, Korea), YD (YD Diagnostics, Yongin, Korea), Asan Pharmaceutical (Seoul, Korea), Eiken Chemical Co. (Tokyo, Japan), Humasis Co. (Anyang, Korea), HBI Co. (Anyang, Korea), GC (Green Cross Medial Science Co., Yongin, Korea), and Bio Focus Co. (Uiwang, Korea)..


6. FOB 떆빟뿉 뵲瑜 FOB 젙웾寃궗쓽 젙떟瑜 諛 떆빟쓽 遺꾪룷

FOB 젙웾寃궗寃곌낵 遺꾪룷뒗 Table 7뿉 슂빟븯떎. 옣鍮 蹂꾨줈 寃궗뿉 궗슜븯뒗 蹂웾씠 떖씪꽌 옣鍮 媛 鍮꾧탳媛 뼱젮썙 蹂댁젙븳 媛믪쓣 븿猿 鍮꾧탳븯떎. 궗슜옣鍮꾨뒗 Eiken (161湲 愿), Alfresa (Alfresa Pharma Co., Osaka, Japan; 64湲곌), Kyowa (Kyowa Chemical Industry Co., Kagawa, Japan; 36湲곌) 닚쑝濡 遺꾪룷븯떎. Alfresa 옣鍮꾨뒗 옣鍮꾩뿉 뵲씪 寃곌낵移섍 꼫臾대굹 긽씠븯뿬 NS-Plus C NS-Prime쑝濡 굹늻뼱 遺꾩꽍븯떎. Eiken, Kyowa, Alfresa NS-Prime 옣鍮꾨뒗 Kyowa 옣鍮꾧 FOB 뼇꽦 寃泥(CS-18-03, CS-18-04)뿉꽌 떎냼 넂 媛믪쓣 蹂댁쑝굹 쑀궗븳 寃곌낵瑜 굹궡뿀떎. 洹몃윭굹 Alfresa NS-Plus C 옣鍮꾨뒗 CS-18-01, CS-18-02 諛 CS-18-05 寃泥댁뿉꽌 留ㅼ슦 넂 닔移섎 蹂댁떎. 蹂 寃泥대뱾 紐⑤몢 쓬꽦 寃泥대줈꽌 Alfresa NS-Plus C瑜 궗슜븯뒗 湲곌뿉꽌뒗 뼇꽦쑝濡 蹂닿퀬븷 닔 엳뿀 떎.

Table 7 . Result distribution of the fecal occult blood quantitative test.

InstrumentSpecimen no.No.ng/mLμg/g stool


MedianAverageMinimumMaximumMedianAverageMinimumMaximum
EikenCS-18-011614.06.01.0118.00.81.20.223.6
KyowaCS-18-01361.02.01.09.01.02.01.09.0
NS-Plus CCS-18-012772.072.025.0126.013.713.74.823.9
NS-PrimeCS-18-01375.06.01.017.01.01.10.23.2
EikenCS-18-021612.04.01.029.00.40.80.25.8
KyowaCS-18-02361.02.01.010.01.02.01.010.0
NS-Plus CCS-18-022788.089.060.0136.016.716.911.425.8
NS-PrimeCS-18-02376.07.01.031.01.11.30.25.9
EikenCS-18-03161380.0377.0221.0516.076.075.444.2103.2
KyowaCS-18-0336113.0106.043.0141.0113.0106.043.0141.0
NS-Plus CCS-18-0327273.0281.0210.0423.051.953.439.980.4
NS-PrimeCS-18-0337274.0272.089.0426.052.151.716.980.9
EikenCS-18-04163414.0411.0153.0543.082.882.230.6108.6
KyowaCS-18-0440115.0104.342.0148.0115.0104.342.0148.0
NS-Plus CCS-18-0426333.0337.4123.0459.063.364.123.487.2
NS-PrimeCS-18-0441322.0316.5184.0387.061.260.135.073.5
EikenCS-18-051631.02.70.053.00.20.50.010.6
KyowaCS-18-05401.01.20.07.01.01.20.07.0
NS-Plus CCS-18-052684.078.61.0117.016.014.90.222.2
NS-PrimeCS-18-054112.011.80.036.02.32.20.06.8
EikenCS-18-06163191.0194.340.01037.038.238.98.0207.4
KyowaCS-18-064056.049.310.076.056.049.310.076.0
NS-Plus CCS-18-0626171.0174.792.0263.032.533.217.550.0
NS-PrimeCS-18-0641157.0152.240.0206.029.828.97.639.1

The instruments used were from the following companies: Eiken Chemical Co. (Tokyo, Japan), Kyowa (Kyowa Chemical Industry Co., Kagawa, Japan), NS-Plus C & NS-Prime (Alfresa Pharma Co., Osaka, Japan)..


怨좎같

2018뀈 2017뀈룄뿉 씠뼱꽌 李몄뿬湲곌씠 吏냽쟻쑝濡 利앷븯떎. 2017뀈 2016뀈룄뿉 鍮꾪빐 10.7%, 2018뀈 2017뀈룄뿉 鍮꾪빐 9.6%쓽 利앷瑜 媛곴컖 蹂댁떎.

떊鍮숇룄議곗궗 寃곌낵瑜 遺꾩꽍빐 蹂 븣 2017뀈뒗 슂솕븰寃궗 쟾 빆紐⑹뿉꽌 95% 씠긽쓽 젙떟瑜좎쓣 굹궡뿀쑝굹[1], 2018뀈뿉뒗pH 빆紐⑹씠 90.4%쓽 젙떟瑜좎쓣 蹂댁뿬 떎냼 궙븘吏 젙떟瑜좎쓣 굹궡뿀떎. 옣鍮꾨퀎濡 遺꾩꽍븳 슂솕븰寃궗쓽 젙떟瑜좎뿉꽌뒗 pH, protein, ketone, bilirubin, blood 諛 leukocyte뿉꽌 90% 씠븯쓽 젙떟瑜좎쓣 굹궡뒗 옣鍮꾧 諛쒓껄릺뿀떎. 씠 媛숈씠 떎닔쓽 빆紐⑹뿉꽌 젙떟瑜좎씠 궙븘吏 寃껋 諛섏젙웾 媛믪쓽 젙떟 뿀슜踰붿쐞瑜 쟾泥 李몄뿬湲곌쓽 80%源뚯 쟻슜븯湲 븣臾몄씠떎. Table 3뿉꽌 媛숈씠 듅젙 옣鍮꾩쓽 寃곌낵遺꾪룷媛 쟾泥 湲곌쓽 젙떟遺꾪룷 떎瑜닿쾶 굹굹뒗 寃쎌슦媛 諛쒖깮븯뿬 젙떟瑜좎씠 떎냼 븯씫븯떎. 씠뒗 젙룄愿由 寃泥댁뿉 뵲씪 옣鍮꾨퀎濡 湲곗쭏슚怨쇨 諛쒖깮븯뒗 寃껋쑝濡 蹂댁씠硫 씠뿉 븳 異붽쟻씤 뿰援ш 븘슂븯떎.

슂鍮꾩쨷寃궗뒗 2017뀈怨 꽦쟻怨 룞씪븯寃 李몄뿬湲곌쓽 젙떟瑜좎씠 뼇샇븯쑝굹 븘吏곷룄 寃곌낵 엯젰삤瑜섍 諛쒓껄릺뿀떎. 留ㅼ씪 솚옄쓽 寃곌낵瑜 엯젰븯뒗 寃껋쿂읆 젙룄愿由 寃곌낵 엯젰룄 젙룄愿由ъ쓽 븳 遺遺꾩씠떎. 뵲씪꽌 鍮꾩젙긽쟻씤 寃곌낵媛 엯젰릺吏 븡룄濡 媛 湲곌뿉꽌뒗 媛곷퀎븳 二쇱쓽瑜 湲곗슱뿬빞 븷 寃껋씠떎.

슂移⑥궗 떊鍮숇룄議곗궗뿉꽌룄 2017뀈 젙떟瑜 78.8%-99.3%蹂대떎 議곌툑 븯뼢맂 꽦쟻쓣 蹂댁떎. 2018뀈뿉뒗 鍮꾩젙삎 calcium oxalate, 쟻삁援 썝二 벑 떎냼 궃씠룄媛 넂 寃곗젙泥대뱾씠 젣떆 릺뼱 떎냼 젙떟瑜좎씠 궙븘吏 寃껋쑝濡 깮媛곷릺뿀떎. 쟻삁援 썝二쇰뒗 엫긽 寃泥댁뿉꽌 옄二 굹굹뒗 移⑥궗臾쇱씠誘濡 媛 湲곌뿉꽌 醫 뜑 二쇱쓽瑜 湲곗슱뿬 옒 뙋룆븷 닔 엳뼱빞 븷 寃껋씠떎. Calcium oxalate 寃곗젙 젙긽 눊뿉꽌 諛쒓껄릺뒗 寃곗젙쑝濡 蹂닿퀬瑜 옒 븞 븯뒗 寃쏀뼢씠 엳떎. 븯吏留 냼蹂뿉꽌 鍮덈쾲븯寃 굹궇 寃쎌슦 슂寃곗꽍쓣 삎꽦븷 닔 엳쑝誘濡 寃쎄怨쇱젙뿉꽌 諛쒓껄릺硫 鍮좎쭚뾾씠 蹂닿퀬빐빞 븳떎[2,3]. 꽭눊愿 긽뵾꽭룷 씠뻾긽뵾꽭룷쓽 援щ퀎 留ㅻ뀈 異쒖젣븯怨 엳吏留 븳 옣쓽 궗吏꾩쑝濡 뙋룆씠 슜씠븯吏 븡 떎젙씠떎.

FOB 젙꽦寃궗뿉꽌뒗 2016뀈뿉 씠뼱 2017뀈뿉룄 쓬꽦 寃泥댁뿉 븳 쐞뼇꽦瑜좎씠 넂吏 븡븘 援궡떆빟쓽 吏 媛쒖꽑씠 씠猷⑥뼱 吏 寃껋쑝濡 蹂댁씤떎[1,4]. 洹몃윭굹 SD궗 諛 GC Genedia 떆빟뿉꽌뒗 븘吏곷룄 쓬꽦 寃泥댁뿉 븳 젙떟瑜좎씠 76.4%-89.3%瑜 굹궡뼱 떆빟 媛쒖꽑씠 븘슂븯떎. 몢 쉶궗뒗 2017뀈뿉룄 쓬꽦 寃泥댁뿉꽌 86.2% 諛 88.9%쓽 젙떟瑜좎쓣 굹궡뼱 쉶궗뿉 鍮꾪븯뿬 FOB 寃궗뿉 븳 쐞뼇꽦瑜좎씠 넂 寃껋쑝濡 굹궗떎. 듅엳 SD궗 젣뭹 떊鍮숇룄議곗궗 李몄뿬湲곌쓽 43.9%瑜 李⑥븯怨 엳뼱 떆빟 媛쒖꽑씠 떆湲됲븳 떎젙씠떎.

蹂옞삁 젙웾寃궗뿉꽌 Alfresa 옣鍮꾩쓽 몢 媛吏 紐⑤뜽쓽 냽룄李④ 쁽븯뿬 Alfresa 옣鍮꾨뒗 紐⑤뜽蹂꾨줈 遺꾨━븯뿬 젙떟遺꾪룷瑜 遺꾩꽍븯떎. Alfresa NS-Plus C 옣鍮꾨뒗 쓬꽦 寃泥댁뿉꽌 紐⑤몢 넂 닔移섎 굹궡뿀쑝굹, FOB 뼇꽦 寃泥댁뿉꽌뒗 Alfresa NS-Prime 옣鍮 諛 Eiken 옣鍮꾩 쑀궗븳 냽룄媛믪쓣 굹궡뿀떎. 뵲씪꽌 Alfresa NS-Plus C 옣鍮꾨뒗 蹂젙웾寃궗뿉꽌 쐞뼇꽦 寃곌낵瑜 룄異쒗븷 媛뒫꽦씠 넂떎. NS-Plus C뒗 2005뀈뿉, NS-Prime 2013뀈寃쎌뿉 媛쒕컻릺뿀쑝硫, 媛곴컖 27媛 湲곌怨 37媛 湲곌뿉꽌 궗슜릺怨 엳떎[5]. NS-Plus C 옣鍮꾨뒗 異쒖떆맂 吏 삤옒릺뿀怨 궗슜븯뒗 湲곌룄 留롮 븡쑝誘濡 씠 옣鍮꾨 궗슜븯뒗 湲곌 NS-Prime 옣鍮꾨줈 援먯껜븯뒗 寃껋씠 諛붾엺吏곹븯떎. Kyowa 옣鍮꾨뒗 2017뀈怨 쑀궗븯寃 뼇꽦 寃泥댁뿉꽌 떎냼 넂寃 痢≪젙릺뒗 寃쏀뼢쓣 蹂댁떎.

Table 7뿉 젣떆맂 μg/g stool뿉 쓽븳 닔移섎뒗 떎젣移섍 븘땲怨 옣鍮꾨퀎濡 二쇱엯릺뒗 蹂 뼇쓣 씪愿꾩쟻쑝濡 쟻슜븯뿬 궛닠쟻쑝濡 룄異쒕맂 닔移섏씠떎.

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