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Performance Evaluation of the Total ProstateSpecific Antigen (PSA), Free PSA, and [–2]proPSA Assay for Calculation of the Prostate Health Index Using the UniCel DxI 800 Analyzer
J Lab Med Qual Assur 2019;41:207-213
Published online December 31, 2019
© 2019 Korean Association of External Quality Assessment Service.

Won-Kyu Choi, Hyun-Ki Kim, Woochang Lee, Sail Chun, and Won-Ki Min

Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence to: Woochang Lee
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
Tel: +82-2-3010-4516 Fax: +82-2-478-0884 E-mail: wlee1@amc.seoul.kr
Received October 14, 2019; Revised November 4, 2019; Accepted November 14, 2019.
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

Background:

Prostate-specific antigen (PSA) is widely used as a tumor marker of prostate cancer, but it is not specific for cancer. Numerous efforts have been made to find another tumor marker that can replace PSA. Recently, the Prostate Health Index (PHI) has been introduced, which shows higher diagnostic performance for prostate cancer than PSA. In this study, we evaluated the performance of the UniCel DxI 800 (Beckman Coulter, USA) for quantitative measurement of total PSA (tPSA), free PSA (fPSA), and [-2]proPSA used for calculating the PHI.

Methods:

The precision, linearity, and limit of detection of the three items, as well as the correlation between the UniCel DxI 800 (Beckman, USA) and a comparable instrument in the Asan Medical Center, the Alinity i (Abbott, USA), were evaluated in accordance with the Clinical Laboratory Standards Institute guidelines.

Results:

The total coefficient of variation for the three items was less than 5%. Linearity was observed for each manufacturer-claimed analytical measurement range, with R2=0.99. The claimed limit of blank and limit of detection were verified. The results of the UniCel DxI 800 showed good correlation with those of the Alinity i (tPSA, r=0.995; fPSA, r=0.994).

Conclusions:

The UniCel DxI 800 showed good analytical performance. Therefore, it will be useful to use the UniCel DxI 800 in the clinical laboratory to measure the diagnostic markers of prostate cancer.

Keywords : Prostate Health Index, Prostate-specific antigen, Free prostate-specific antigen, [-2]Pro-prostate-specific antigen
꽌 濡

쟾由쎌꽑븫 쟾 꽭怨꾩쟻쑝濡 궓꽦뿉寃뚯꽌 2踰덉㎏濡 쓷븯寃 吏꾨떒릺硫 븫쑝濡 씤븳 궗留앹썝씤 以 5踰덉㎏濡 쓷븳 븫씠硫[1], 븳援뿉꽌룄 2009뀈源뚯 쟾由쎌꽑븫쓽 뿰졊몴以솕諛쒖깮瑜좎씠 留ㅻ뀈 吏냽쟻쑝濡 利앷븯뿬 쁽옱 4踰덉㎏濡 留롮씠 諛쒖깮븯뒗 븫醫낆씠떎[2]. 쟾由쎌꽑븫쓽 吏꾨떒쓣 쐞빐 쟾由쎌꽑 듅씠빆썝(prostate-specific antigen, PSA)怨 吏곸옣닔吏寃궗(digital rectal examination, DRE)濡 씠猷⑥뼱吏 꽑蹂꾧궗 깮寃쓣 넻븳 솗吏꾧궗瑜 떆뻾븯怨 엳떎. PSA뒗 遺꾩옄웾 34,000쓽 떦떒諛깆쑝濡, 쟾由쎌꽑쓽 긽뵾꽭룷뿉꽌 二쇰줈 깮꽦릺뼱 怨좊냽룄濡 젙븸 궡뿉 遺꾨퉬릺吏留 씪諛섏쟻쑝濡 삁以묒뿉룄 4 ng/mL 씠궡쓽 냼웾쑝濡쒕룄 議댁옱븳떎[3]. 쟾由쎌꽑븫씠 엳쓣 寃쎌슦 PSA쓽 遺꾨퉬媛 利앷븯湲 븣臾몄뿉 븫쓽 吏꾨떒몴吏옄濡 꼸由 궗슜릺怨 엳뒗뜲, 씠뒗 珥덇린 吏꾨떒뿉 룄쓣 二쇱뼱 븫쑝濡 씤븳 궗留앸쪧쓣 궙異붾뒗 뜲 룄쓣 二쇱뿀떎[4]. 븯吏留 PSA뒗 쟾由쎌꽑鍮꾨利, 쟾由쎌꽑뿼怨 媛숈 뼇꽦吏덊솚怨 뿰졊 뿉 뵲씪꽌룄 遺꾨퉬媛 利앷빐 쟾由쎌꽑븫뿉 듅씠쟻씠吏 븡떎. 쟾由 꽑븫쓽 꽑蹂꾧궗濡 PSA瑜 씠슜븯硫 븫씠 븘땶 寃쎌슦뿉룄 鍮꾪듅씠쟻쑝濡 利앷븳 PSA濡 씤빐 遺덊븘슂븳 깮寃씠 利앷븷 닔 엳떎[5]. 삉븳 쟾由쎌꽑븫쓣 삁痢≫븷 닔 엳뒗 PSA쓽 젙솗븳 吏꾨떒쟻 湲곗移섍 뾾뼱 씪諛섏쟻 李멸퀬踰붿쐞 긽븳씤 4 ng/mL 씠븯쓽 PSA 닔移섎 蹂댁씤 궓꽦쓽 15%뿉꽌 쟾由쎌꽑븫씠 諛쒓껄릺湲곕룄 븳떎 [6].

遺덊븘슂븳 寃궗濡 씤븳 遺옉슜쓣 궙異붾㈃꽌 쟾由쎌꽑븫쓣 듅씠쟻쑝濡 吏꾨떒븯湲 쐞빐 PSA瑜 泥댄븷 닔 엳뒗 吏꾨떒몴吏옄瑜 李얘린 쐞븳 留롮 뿰援щ뱾씠 엳뿀怨 洹쇰옒 뱾뼱 PSA쓽 룞삎 떒諛깆쭏뿉 븳 뿰援ш 留롮씠 吏꾪뻾릺怨 엳떎. PSA뒗 삁븸 냽뿉꽌 떒諛깅텇빐슚냼 뼲젣젣 蹂듯빀泥대 씠猷 蹂듯빀삎(complex form, complex PSA)怨 洹몃젃吏 븡 쑀由ы삎(free form, fPSA)쑝濡 議댁옱븯硫 쑀由ы삎 proPSA, benign PSA, intact PSA濡 遺꾨쪟븷 닔 엳떎. Total PSA (tPSA) 寃궗뒗 삁븸 궡 蹂듯빀삎怨 쑀由ы삎쓽 빀쓣 痢≪젙븯뒗 寃껋쑝濡 쟾由쎌꽑븫쓣 꽑蹂꾪븯湲 쐞빐 媛옣 쓷븯寃 씠슜릺뒗 寃궗씠硫, fPSA 寃궗뒗 PSA쓽 쑀由ы삎留 痢≪젙븳떎. fPSA쓽 tPSA뿉 븳 遺꾩쑉(% free PSA, %fPSA)씠 쟾由쎌꽑뿉 븙꽦吏덊솚씠 엳쓣 寃쎌슦 媛먯냼븯怨 뼇꽦吏덊솚씠 엳쓣 寃쎌슦 利앷븳떎怨 븣젮졇 엳떎. ProPSA뒗 떎떆 븘誘몃끂궛쓽 寃고빀삎깭뿉 뵲씪 [-7]proPSA, [-5]proPSA, [-2]proPSA (p2PSA) 벑쑝濡 援щ퀎븷 닔 엳쑝硫, 씠 以 p2PSA媛 媛옣 븞젙븳 삎깭씠硫 쟾由쎌꽑븫뿉 듅씠쟻씠떎[7-9]. College of American Pathologists뿉꽌 떆뻾븳 2019뀈 1李 쇅遺젙룄 愿由ы봽濡쒓렇옩뿉 뵲瑜대㈃ tPSA쓽 痢≪젙쓣 쐞빐 궗슜븳 젣議곗궗 蹂 寃궗옣鍮꾩쓽 鍮덈룄뒗 Siemens (27.20%), Roche (23.75%), Beckman Coulter (21.12%), Abbott (18.4%) 닚씠怨, fPSA 痢≪젙쓣 쐞빐 궗슜븳 젣議곗궗蹂 寃궗옣鍮꾩쓽 鍮덈룄뒗 Roche (31.40%), Beckman Coulter (29.05%), Abbott (22.74%), Siemens (16.81%) 닚씠떎. 븳엫긽寃궗젙룄愿由ы삊쉶뿉꽌 떆뻾븳 2019뀈 1李 떊鍮숇룄議곗궗뿉 뵲瑜대㈃ PSA 痢≪젙쓣 쐞빐 궗슜븳 젣議곗궗蹂 寃궗옣鍮꾩쓽 鍮덈룄뒗 Roche (45.50%), Abbott (27.70%), Siemens (14.21%), Beckman Coulter (7.74%) 닚씠떎.

理쒓렐뿉뒗 쟾由쎌꽑븫뿉 빐 뜑 넂 吏꾨떒쟻 꽦뒫쓣 蹂댁뿬二쇰뒗 Prostate Health Index (PHI)媛 媛쒕컻릱뒗뜲, tPSA, fPSA, 洹몃━怨 p2PSA瑜 痢≪젙빐 닔移섎 援ы븳떎(PHI=p2PSA/fPSA × √tPSA). PHI뒗 50 씠긽 궓꽦뿉꽌 젙긽냼寃ъ쓽 DRE 4-10 ng/mL쓽 PSA 닔移섎 蹂댁씪 븣 깮寃쓣 떆뻾븯湲 쟾 쟾由쎌꽑븫쓣 삁痢≫븷 닔 엳뒗 寃궗씠怨[10], 2012뀈 誘멸뎅 Food and Drug Administration (FDA)뿉 듅씤맂 씠썑濡 쁽옱 50뿬 媛 援媛뿉꽌 씠슜릺怨 엳떎[7]. 蹂 뿰援ъ뿉꽌뒗 tPSA, fPSA, 洹몃━怨 p2PSA쓣 젙웾쟻쑝濡 痢≪젙븷 닔 엳뒗 UniCel DxI 800 (Beckman Coulter, Brea, CA, USA)쓣 긽쑝濡 젙諛룄, 吏곸꽑꽦, 寃異쒗븳怨 諛 긽愿꽦 벑쓽 닔뻾뒫쓣 룊媛븯떎.

옱猷 諛 諛⑸쾿

1. 긽

긽愿꽦 룊媛瑜 쐞빐 2018뀈 11썡遺꽣 2018뀈 12썡源뚯 湲곗〈뿉 꽌슱븘궛蹂묒썝 寃궗떎뿉꽌 궗슜븯怨 엳뒗 옣鍮꾩씠硫 援궡뿉꽌 쓷엳 궗슜릺怨 엳뒗 옣鍮 以 븯굹씤 Alinity i (Abbott, Chicago, IL, USA)濡 tPSA fPSA 寃궗媛 쓽猶곕릺뿀뜕 寃泥 以묒뿉꽌 痢≪젙媛믪씠 엫긽쟻쑝濡 以묒슂븳 냽룄踰붿쐞 궡뿉 異⑸텇엳 遺꾪룷븯뒗 123媛쒖쓽 옍뿬 삁泥 寃泥대 궗슜븯쑝硫, 寃궗 떆뻾 쟾 源뚯 -70°C 씠븯뿉꽌 깋룞蹂닿쓣 븯떎. 蹂 뿰援щ뒗 꽌슱븘궛 蹂묒썝 엫긽떆뿕떖궗쐞썝쉶(institutional review board)쓽 떖쓽 硫댁젣瑜 諛쏆븯떎(S2019-2043-0001).

2. 寃궗諛⑸쾿

UniCel DxI 800 옣鍮꾨줈 Access Hybritech PSA (Beckman Coulter), Access Hybritech free PSA (Beckman Coulter) Access Hybritech p2PSA (Beckman Coulter) 떆빟쓣 씠슜빐 tPSA, fPSA, p2PSA瑜 痢≪젙븯떎. Alinity i 옣鍮꾨줈 Alinity i Total PSA (Abbott) Alinity i Free PSA (Abbott) 떆빟쓣 씠슜빐 tPSA, fPSA瑜 痢≪젙븯떎.

3. 젙諛룄

젙諛룄(precision) 룊媛뒗 Clinical and Laboratory Standards Institute (CLSI) EP05-A3뿉 뵲씪 냽룄, 以묎컙냽룄, 怨좊냽룄쓽 긽뭹솕맂 젙룄愿由щЪ吏덉씤 Liquicheck Tumor Marker Control (Bio-Rad Laboratories, Irvine, CA, USA), Access Hybritech p2PSA Quality Conrtol (Beckman Coulter)쓣 20씪 룞븞 留ㅼ씪 2踰, 寃궗留덈떎 2踰덉뵫 諛섎났 痢≪젙븯뿬 닔뻾븯떎[11]. 痢≪젙맂 媛믪쑝濡 냽룄뿉 뵲씪 룊洹, 諛섎났젙 諛룄(repeatability) 諛 寃궗떎 궡 젙諛룄(within-laboratory precision) 蹂씠怨꾩닔瑜 怨꾩궛븯떎.

4. 吏곸꽑꽦

吏곸꽑꽦(linearity) 룊媛뒗 CLSI EP06-A뿉 뵲씪 젣議곗궗媛 젣떆븯뒗 痢≪젙媛뒫踰붿쐞(tPSA, 0.008-150.0 ng/mL; fPSA, 0.005-20.0 ng/mL; p2PSA, 0.69-5,000.0 pg/mL)瑜 怨좊젮빐 媛 빆紐⑹쓽 Access Hybritech Calibrators 以 理쒓퀬냽룄臾 吏(tPSA, 150 ng/mL; fPSA, 20 ng/mL; p2PSA, 5,000 pg/ mL)쓣 냽룄遺꽣 怨좊냽룄源뚯 떎꽢 媛吏 냽룄濡 怨꾨 씗꽍븳 썑 媛곴컖 4踰덉뵫 諛섎났 痢≪젙븯뿬 닔뻾븯떎. 5媛 냽룄蹂꾨줈 痢≪젙맂 媛믪쓽 룊洹좉낵 湲곕媛믪쓣 鍮꾧탳븯떎[12].

5. 寃異쒗븳怨

寃異쒗븳怨(detection limit)뒗 CLSI EP17-A2뿉 뵲씪 limit of blank (LoB) limit of detection (LoD)쓣 寃利앺븯떎. LoB 寃利앹쓣 쐞빐 怨듬갚 寃泥대 20쉶 痢≪젙 썑 痢≪젙媛믪씠 젣議곗궗뿉꽌 젣떆븳 LoB (tPSA, 0.004 ng/mL; fPSA, 0.0006 ng/ mL; p2PSA, 0.50 pg/mL)蹂대떎 궙 寃泥댁쓽 鍮꾩쑉씠 85% (95% 떊猶곌뎄媛) 誘몃쭔씤吏 솗씤븯떎. LoD쓽 寃利앹쓣 쐞빐 媛 빆紐⑸퀎濡 123紐낆쓽 솚옄 옍뿬 寃泥 以묒뿉꽌 媛옣 궙 냽룄 寃泥대 20쉶 痢≪젙 썑 痢≪젙媛믪씠 젣議곗궗뿉꽌 젣떆븳 LoB蹂대떎 넂 寃泥댁쓽 鍮꾩쑉씠 理쒖냼 85% (95% 떊猶곌뎄媛) 씠긽씤吏 솗씤븯떎[13].

6. 긽愿꽦

긽愿꽦(comparison) 룊媛뒗 CLSI EP09-A3뿉 뵲씪 湲곗〈 궗슜옣鍮꾩씤 Alinity i 룊媛옣鍮꾩씤 UniCel DxI 800뿉 123媛쒖쓽 솚옄 寃泥대 씠슜빐 tPSA, fPSA瑜 媛곴컖 2踰덉뵫 諛섎났 痢≪젙븯뿬 닔뻾븯떎[14]. p2PSA UniCel Dxl 800 옣鍮꾩뿉꽌留 떆뻾릺뒗 寃궗빆紐⑹씠뼱꽌 Alinity i 옣鍮꾩 긽愿꽦 룊媛瑜 吏꾪뻾븯吏 紐삵뻽떎. 옣鍮꾨퀎 痢≪젙맂 媛믪쓽 긽愿꽦쓣 븣븘蹂닿린 쐞빐 Deming 쉶洹遺꾩꽍怨 Bland-Altman plot쓣 씠슜븯떎. 긽愿 怨꾩닔(coefficient of correlation, r)媛 0.975 씠긽씤 寃쎌슦 긽愿 꽦씠 엳떎怨 뙋떒븯떎.

7. 넻怨꾨텇꽍

넻怨꾨텇꽍쓣 쐞빐 EP Evaluator Release 10 (David G. Rhoade, Kennett Square, PA, USA) Microsoft office Excel 2016 (Microsoft Corp., Redmond, WA, USA) 냼봽듃썾뼱瑜 씠슜븯떎.

寃 怨

1. 젙諛룄

媛 寃궗빆紐⑸퀎 룊洹, 諛섎났젙諛룄 諛 寃궗떎 궡 젙諛룄 蹂씠 怨꾩닔瑜 Table 1뿉 슂빟븯떎. tPSA쓽 냽룄蹂 寃궗떎 궡 젙諛룄 蹂씠怨꾩닔뒗 3.5%, 2.8%, 2.6%씠뿀怨, fPSA쓽 냽룄蹂 寃궗떎 궡 젙諛룄 蹂씠怨꾩닔뒗 4.2%, 3.4%, 3.2%씠뿀怨, p2PSA쓽 寃궗떎 궡 젙諛룄 蹂씠怨꾩닔뒗 4.7%, 4.2%, 4.3%씠뿀떎.

Table 1 . Precision profile of the UniCel DxI 800.

Analyte (unit)LevelMeanCoefficients of variation (%)

Re­pea­tabi­lityWithinlabo­ra­tory preci­sion
Total PSA (ng/mL)Low0.1473.33.5
Middle3.6192.52.8
High16.1542.22.6
Free PSA (ng/mL)Low0.1623.54.2
Middle4.0452.53.4
High16.7872.53.2
[-2]ProPSA (pg/mL)Low20.7883.84.7
Middle185.9933.54.2
High1,014.8253.94.3

Abbreviation: PSA, prostate-specific antigen..


2. 吏곸꽑꽦

媛 寃궗빆紐⑸퀎 젣議곗궗쓽 痢≪젙媛뒫踰붿쐞쓽 냽룄援ш컙뿉꽌 씪李 꽑삎씠뿀怨 寃곗젙怨꾩닔(coef icient of determination, R2)뒗 0.99 씠긽쑝濡 吏곸꽑꽦쓣 굹궡뿀떎(Fig. 1).

Figure 1.

Linearity of total PSA, free PSA, and [-2]proPSA measured by UniCel Dxi 800. (A) Total PSA. (B) Free PSA. (C) [-2] ProPSA. Abbreviation: PSA, prostate-specific antigen.


3. 寃異쒗븳怨

LoB 寃利앹쓣 쐞븳 媛 빆紐⑸퀎 20媛쒖쓽 怨듬갚 寃泥댁쓽 寃곌낵移 (tPSA, 0.0022 ng/mL; fPSA, 0.0000 ng/mL; p2PSA, 0.3016 pg/mL)뒗 紐⑤몢 젣議곗궗뿉꽌 젣떆븳 LoB蹂대떎 궙븯 떎. LoD 寃利앹쓣 쐞븳 媛 빆紐⑸퀎 20媛쒖쓽 솚옄 寃泥댁쓽 寃곌낵移(tPSA, 0.0147 ng/mL; fPSA, 0.0753 ng/mL; p2PSA, 2.1855 pg/mL)뒗 紐⑤몢 젣議곗궗뿉꽌 젣떆븳 LoB蹂대떎 넂븯떎.

4. 긽愿꽦

湲곗〈 옣鍮꾩씤 Alinity i 긽愿꽦 룊媛뿉꽌 tPSA fPSA쓽 긽愿怨꾩닔뒗 媛곴컖 0.995, 0.994濡 0.975 씠긽쓽 醫뗭 긽愿꽦쓣 蹂댁뿬二쇱뿀떎. 湲곗〈 옣鍮꾩 UniCel DxI 800 궗씠뿉꽌 tPSA fPSA쓽 룊洹 %諛붿씠뼱뒪뒗 媛곴컖 10.28%, –17.24%씠뿀떎 (Fig. 2).

Figure 2.

Comparison of UniCel DxI 800 and Alinity i. Scatter plot, bias plot, and percent bias plot for each analyte are shown. (A–C) Total PSA. (D–F) Free PSA. Abbreviation: PSA, prostate-specific antigen.


怨 李

蹂 뿰援щ뒗 쟾由쎌꽑븫쓽 吏꾨떒怨 쐞뿕룄 삁痢≪뿉 룄씠 릺뒗 PHI瑜 궛異쒗븷 븣 븘슂븳 슂냼씤 PSA, fPSA, p2PSA瑜 痢≪젙븯뿬 UniCel DxI 800쓽 닔뻾뒫쓣 룊媛븯떎. 젙諛룄 룊媛뿉꽌 媛 빆紐⑹쓽 紐⑤뱺 냽룄쓽 寃궗떎 궡 젙諛룄 蹂씠怨꾩닔媛 5% 誘몃쭔씠뿀떎. 씠뒗 National Academy of Clinical Biochemistry뿉꽌 沅뚯옣븯뒗 醫낆뼇몴吏옄寃궗쓽 젙諛룄 뿀슜湲곗쓣 留뚯”뻽떎. 吏곸꽑꽦 룊媛뿉꽌 痢≪젙媛뒫踰붿쐞 궡뿉꽌 吏곸꽑꽦쓣 솗씤뻽떎. LoB LoD뿉 븳 룊媛뿉꽌 CLSI 吏移⑥쓽 議곌굔쓣 留뚯”븯떎. 湲곗〈 옣鍮꾩씤 Alinity i 鍮꾧탳븳 긽愿꽦 룊媛뿉꽌 tPSA fPSA뒗 룊媛湲곗쓣 留뚯”떆耳곗쑝굹 UniCel DxI 800 뿉꽌 tPSA뒗 룊洹 %諛붿씠뼱뒪媛 10.28%濡 湲곗〈 옣鍮꾨낫떎 넂寃 痢≪젙릺怨 fPSA뒗 룊洹 %諛붿씠뼱뒪媛 –17.24%濡 궙寃 痢≪젙릺뒗 寃쏀뼢쓣 蹂댁떎. 씠뒗 寃泥 痢≪젙쓣 쐞빐 媛 寃궗옣鍮꾩뿉 궗슜븳 蹂댁젙臾쇱쭏(calibrator) 醫낅쪟쓽 李⑥씠濡 빐꽍븷 닔 엳떎. 꽭怨꾨낫嫄닿린援(World Health Organization, WHO) 蹂댁젙臾쇱쭏쓣 궗슜븷 寃쎌슦 Hybritech 蹂댁젙臾쇱쭏쓣 궗슜븷 븣蹂대떎 tPSA媛 빟 20% 궙寃 痢≪젙맂떎怨 븣젮졇 엳떎[15-17]. 씠踰 뿰援ъ뿉꽌 tPSA fPSA쓽 痢≪젙쓣 쐞빐 UniCel DxI뿉 Hybritech 蹂댁젙 臾쇱쭏쓣 궗슜뻽怨 Alinity i뿉 WHO 蹂댁젙臾쇱쭏쓣 궗슜뻽湲 븣臾몄뿉 UniCel DxI 800 옣鍮꾩뿉꽌 tPSA媛 10.28% 궙寃 痢≪젙릺뿀쓣 寃껋쑝濡 異붿젙맂떎.

삁泥 PSA뒗 쟾由쎌꽑쓽 듅씠쟻씤 吏꾨떒몴吏옄濡 吏꾨떒씠굹 移섎즺슚怨쇱쓽 뙋젙, 寃쎄낵愿李곗뿉 씠슜릺怨 엳떎. 븯吏留 삁泥 PSA뒗 쟾由쎌꽑븫뿉 듅씠쟻씠吏 븡븘 씠瑜 泥댄븷 닔 엳뒗 뿬윭 寃궗뱾쓣 媛쒕컻븯怨 엳떎. 쁽옱源뚯 媛쒕컻맂 寃궗踰 以묒뿉꽌 誘멸뎅 FDA쓽 듅씤쓣 諛쏆 寃궗踰뺤쑝濡 PHI prostate cancer antigen 3 (PCA3, 삉뒗 differential display code 3)媛 엳떎. PCA3뒗 쟾由쎌꽑븫씠 엳쓣 寃쎌슦 諛쒗쁽씠 利앷븯뒗 듅吏뺤씠 엳뼱 냼蹂 寃泥댁뿉꽌 PCA3 score (ratio of PCA3 RNA to PSA RNA)瑜 痢≪젙븯뿬 쟾由쎌꽑븫 吏꾨떒뿉 씠슜븷 닔 엳떎[3,7,8]. 븯吏留 PCA3뒗 珥덇린 吏꾨떒蹂대떎 二쇰줈 깮寃寃곌낵媛 쓬꽦씪 寃쎌슦 깮寃쓽 옱寃 뿬遺瑜 寃곗젙븯뒗 뜲 씠슜븯怨 엳뼱 쟾由쎌꽑븫쓽 珥덇린 吏꾨떒쓣 븯뒗 뜲 엳뼱 쑀슜꽦씠 뼥뼱吏꾨떎[18]. PHI뒗 PSA 굹 %fPSA蹂대떎 쟾由쎌꽑븫뿉 븳 듅씠룄媛 넂븘 吏덈퀝쓣 媛먮퀎 븷 븣 룄씠 릺뼱 遺덊븘슂븳 깮寃쓣 以꾩씠怨 怨쇰룄븳 移섎즺濡 씤븳 쑀빐瑜 以꾩씪 닔 엳떎[5,19-21]. 삉븳 怨좎쐞뿕룄쓽 쟾由쎌꽑븫 (Gleason score ≥7)씪 寃쎌슦 PHI쓽 닔移섍 利앷빐 移섎즺媛 諛섎뱶떆 븘슂븳 솚옄瑜 넃移섎뒗 寃쎌슦瑜 以꾩씪 닔 엳떎[22-25]. 븳援씤쓽 쟾由쎌꽑븫 諛쒖깮瑜좎 誘멸뎅蹂대떎 궙吏留 吏냽쟻쑝濡 利앷븳 뼇긽쓣 蹂댁떎. 삉븳 깮寃寃곌낵뿉꽌 誘몃텇솕맂 怨좎쐞뿕룄 뼇긽쓣 蹂댁씠嫄곕굹 궗留앸쪧씠 넂 삁썑媛 븞 醫뗭 듅꽦쓣 蹂댁씤떎 [26,27]. 理쒓렐 븳援씤쓣 긽쑝濡 븳 뿰援ъ뿉꽌 湲곗〈 寃곌낵 媛숈씠 PHI媛 쟾由쎌꽑븫쓽 媛먮퀎怨 쐞뿕룄 삁痢≪뿉 룄씠 맆 닔 엳떎뒗 蹂닿퀬媛 엳떎[28]. 씠윭븳 PHI쓽 엫긽쟻 쑀슜꽦쓣 怨좊젮븳떎硫 PHI 궛異쒖쓣 쐞븳 tPSA, fPSA, p2PSA쓽 젙솗븳 痢≪젙씠 以묒슂븯떎怨 븷 닔 엳떎.

寃곕줎쟻쑝濡, UniCel DxI 800瑜 씠슜븳 tPSA, fPSA, p2PSA 痢≪젙 슦닔븳 젙諛룄 吏곸꽑꽦쓣 蹂댁怨, tPSA fPSA뒗 긽愿꽦 湲곗쓣 留뚯”븯떎. 븯吏留 tPSA fPSA뒗 媛 寃궗옣鍮꾩뿉 꽌濡 떎瑜 蹂댁젙臾쇱쭏쓽 궗슜쑝濡 씤븳 寃곌낵媛믪쓽 李⑥씠媛 엳湲 븣臾몄뿉 痢≪젙諛⑸쾿쓽 씪移섑솕媛 븘슂븯떎. 뵲씪꽌 쟾由쎌꽑븫쓽 吏꾨떒몴吏옄瑜 痢≪젙븯湲 쐞븳 엫긽寃궗떎뿉꽌 UniCel DxI 800瑜 쑀슜븯寃 궗슜븷 닔 엳쓣 寃껋씠씪 깮媛곹븳떎.

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