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Performance of HemosIL ReadiPlasTin, a Liquid Reagent for Prothrombin Time Measurement
J Lab Med Qual Assur 2019;41:9-12
Published online March 31, 2019
© 2019 Korean Association of External Quality Assessment Service.

Saeam Shin, Yunjung Jung, Wonkeun Song, Min-Jeong Park

Department of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
Correspondence to: Min-Jeong Park Department of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1 Singil-ro, Yeongdeungpo-gu, Seoul 07441, Korea Tel: +82-2-829-5258 Fax: +82-2-847-5260 E-mail: mjpark@hallym.or.kr
Received January 14, 2019; Revised February 13, 2019; Accepted February 26, 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:

Prothrombin time (PT) measurement is an important test for screening blood coagulation disorders and monitoring anticoagulant therapy. In this study, we evaluated the analytical performance of HemosIL ReadiPlasTin (Instrumentation Laboratory, USA), a liquid reagent for PT measurement.

Methods:

The precision of HemosIL ReadiPlasTin was evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP5-A3 guidelines. Further, comparison with HemosIL RecombiPlasTin 2G (Instrumentation Laboratory, USA) was made according to the CLSI EP9-A3 guidelines. The reference intervals were established according to the CLSI C28-A3 guidelines.

Results:

The coefficient of variation values for repeatability and total imprecision at two levels of control materials were lower than 1.1% and 3.4%, respectively. The performance of HemosIL ReadiPlasTin was comparable to that of HemosIL RecombiPlasTin 2G, with a high correlation (r=0.996). The reference interval for normal subjects was 10.4–13.3 seconds.

Conclusions:

HemosIL ReadiPlasTin showed an acceptable degree of imprecision and its performance showed high correlation with that of a conventional reagent. Therefore, it is expected to be useful for PT measurement in clinical laboratories.

Keywords : Blood coagulation tests, Prothrombin time, Thromboplastin
꽌 濡

Prothrombin time (PT)뒗 삁븸쓳怨좎쭏솚쓽 꽑蹂 諛 빆쓳怨좎젣 移섎즺쓽 異붿쟻愿李 紐⑹쟻쑝濡 엫긽寃궗떎뿉꽌 媛옣 쓷엳 궗슜릺뒗 寃궗씠떎. PT뒗 쇅씤꽦 諛 怨듯넻 寃쎈줈뿉 愿뿬븯뒗 삁븸쓳怨좎씤옄(I, II, V, VII, X)쓽 寃고븤 샊 뼲젣젣쓽 쑀臾대 꽑蹂꾪븯硫, 삁쟾利 솚옄뿉꽌 寃쎄뎄슜 빆쓳怨좎젣쓽 슜웾쓣 議곗젅븯뒗뜲 湲곗씠 릺誘濡 젙솗븳 寃궗寃곌낵瑜 蹂닿퀬븯뒗 寃껋씠 以묒슂븯떎. PT뒗 궗슜븯뒗 옣鍮꾩 떆빟씠 寃곌낵뿉 겙 쁺뼢쓣 誘몄튌 닔 엳뼱 媛 寃궗떎뿉꽌 궗슜븯뒗 떆빟쓽 듅꽦쓣 뙆븙븯怨 遺꾩꽍꽦뒫쓣 룊媛븯硫, 李멸퀬踰붿쐞瑜 꽕젙븯뒗 寃껋씠 떊猶곗꽦 엳뒗 寃궗寃곌낵瑜 蹂닿퀬븯뒗 뜲 以묒슂븯떎[1].

HemosIL ReadiPlasTin (Instrumentation Laboratory, Bedford, MA, USA) 2016뀈 11썡뿉 援궡뿉꽌 떇빟泥 듅씤쓣 諛쏆 듃濡щ낫뵆씪뒪떞 떆빟쑝濡, 湲곗〈뿉 룞씪 젣議곗궗쓽 떆빟씤 HemosIL RecombiPlasTin 2G媛 룞寃곌굔議고삎깭씤뜲 鍮꾪빐 븸긽삎깭씪뒗 李⑥씠젏씠 엳떎. 씠뿉 옄뱾 떆빟쓽 遺꾩꽍꽦뒫쓣 룊媛븯怨, 寃궗옄媛 떆빟쓣 궗슜븿뿉 엳뼱 뼱뼚븳 옣젏씠 엳뒗吏 븣븘遊꾩쑝濡쒖뜥 엫긽寃궗떎뿉꽌 삁븸쓳怨좉궗 떆빟쓣 꽑깮븯뒗 뜲 룄쓣 二쇨퀬옄 븯떎.

옱猷 諛 諛⑸쾿

1. 옱猷

긽愿꽦 룊媛 諛 李멸퀬踰붿쐞 꽕젙쓣 쐞븯뿬 븳由쇰븰援 媛뺣궓꽦떖蹂묒썝 삁븸쓳怨좉궗떎뿉 PT寃궗媛 쓽猶곕릺뼱 寃궗 썑 궓 옍뿬 寃泥대 궗슜븯떎. 삁븸 0.109 M (3.2%) 援ъ뿰궛굹듃瑜 슜븸 0.3 mL씠 뱾뼱 엳뒗 BD Vacutainer Plus Citrate Tube (Becton Dickinson, Franklin Lakes, NJ, USA)뿉 빆쓳怨좎젣 1:9쓽 鍮꾩쑉濡 梨꾪삁븳 썑 梨꾪삁愿쓣 빟 5쉶 꽎뼱二쇱뼱 삁븸怨 빆쓳怨좎젣瑜 샎빀븯떎. 梨꾪삁 썑 4떆媛 씠궡뿉 2,500 g쑝濡 15遺꾧컙 썝떖遺꾨━瑜 떆뻾븯뿬 삁냼뙋寃고븤삁옣쓣 遺꾨━븳 썑 ACL TOP 550 CTS (Instrumentation Laboratory) 옣鍮꾨줈 利됱떆 PT寃궗瑜 떆뻾븯떎. 슜삁 諛 吏吏덊삁 寃泥대뒗 룊媛뿉꽌 젣쇅븯떎.

2. 寃궗 諛 룊媛

1) 젙諛룄 룊媛

HemosIL ReadiPlasTin쑝濡 痢≪젙릺뒗 PT쓽 젙諛룄瑜 룊媛븯湲 쐞븯뿬 젙긽怨 鍮꾩젙긽 몢 媛吏쓽 긽뭹솕맂 젙룄愿由щЪ吏(HemosIL Normal Control, HemosIL Low Abnormal Control; Instrumentation Laboratory)쓣 궗슜븯떎. Clinical and Laboratory Standards Institute (CLSI) EP5-A3 吏移⑥쓽 諛⑸쾿쓣 寃궗떎 떎젙뿉 留욊쾶 蹂삎븯뿬[2], 5씪뿉 嫄몄퀜 삤쟾怨 삤썑 2李⑤뵫 諛섎났 寃궗븳 썑 젙룄愿由щЪ吏덉쓽 寃곌낵媛믪쓽 룊洹 諛 諛섎났젙諛룄(repeatability), 珥 鍮꾩젙諛룄(total imprecision)瑜 怨꾩궛븯떎.

2) 긽愿꽦 룊媛

긽愿꽦 룊媛뒗 CLSI EP9-A3뿉 뵲씪 떆뻾븯떎[3]. 寃궗떎뿉 PT寃궗媛 쓽猶곕맂 寃泥 以 젙긽怨 鍮꾩젙긽 寃곌낵媛 怨④퀬猷 룷븿릺룄濡 148寃泥대 꽑蹂꾪븯떎. 湲곗諛⑸쾿쑝濡쒕뒗 븳由쇰븰援 媛뺣궓꽦떖蹂묒썝 삁븸쓳怨좉궗떎뿉꽌 湲곗〈뿉 궗슜븯뜕 떆빟씤 HemosIL RecombiPlasTin 2G (international sensitivity index [ISI]=0.98; Instrumentation Laboratory)濡 痢≪젙븳 媛믪쓣 궗슜븯쑝硫 룊媛諛⑸쾿쑝濡쒕뒗 HemosIL ReadiPlasTin 떆빟(ISI=0.99)쑝濡 痢≪젙븳 媛믪쓣 궗슜븯떎. 寃궗踰 媛꾩쓽 긽愿꽦怨 씪移섎룄瑜 룊媛븯湲 쐞븳 Pearson 긽愿遺꾩꽍 諛 Deming 쉶洹遺꾩꽍, Bland-Altman 遺꾩꽍쓣 떆뻾븯떎.

3) 李멸퀬踰붿쐞 꽕젙

CLSI C28-A3 吏移⑥뿉 洹쇨굅븯뿬 嫄닿컯寃吏 솚옄 136紐낆쓽 삁옣쑝濡 PT쓽 젙긽李멸퀬踰붿쐞瑜 꽕젙븯떎[4]. 李멸퀬踰붿쐞뒗 鍮꾨え닔쟻 諛⑸쾿쓣 넻빐 寃곌낵媛믪쓽 2.5遺꽣 97.5 諛깅텇쐞닔濡 젙븯떎.

3. 넻怨꾨텇꽍

넻怨꾨텇꽍 EP evaluator (Data Innovations LLC, South Burlington, VT, USA) GraphPad Prism (GraphPad Software, San Diego, CA, USA) 봽濡쒓렇옩쓣 궗슜븯떎. 넻怨꾩쟻쑝濡 P媛믪씠 0.05 씠븯씤 寃쎌슦瑜 쑀쓽븳 寃껋쑝濡 媛꾩<븯떎.

寃 怨

1. 젙諛룄 룊媛

젙긽怨 鍮꾩젙긽 몢 媛吏쓽 젙룄愿由щЪ吏덉쓣 궗슜븯뿬 痢≪젙븳 寃곌낵媛믪쓽 룊洹 諛 諛섎났젙諛룄, 珥 鍮꾩젙諛룄瑜 Table 1뿉 젙由ы븯떎. 젙긽 젙룄愿由щЪ吏덉쓽 룊洹 PT 媛믪 11.67珥덉쑝硫 諛섎났젙諛룄 諛 珥 鍮꾩젙諛룄뒗 媛곴컖 1.1%, 2.1%濡 젣議곗궗쓽 鍮꾩젙諛룄 湲곗(諛섎났젙諛룄 諛 珥 鍮꾩젙諛룄媛 媛곴컖 2.0%, 3.0% 誘몃쭔)蹂대떎 궙븯떎. 鍮꾩젙긽 젙룄愿由щЪ吏덉쓽 룊洹 PT 媛믪 21.56珥덉쑝硫 諛섎났젙諛룄 諛 珥 鍮꾩젙諛룄뒗 媛곴컖 0.9%, 3.4%濡 젣議곗궗쓽 鍮꾩젙諛룄 湲곗(諛섎났젙諛룄 諛 珥 鍮꾩젙諛룄媛 媛곴컖 3.0%, 4.0% 誘몃쭔)蹂대떎 궙븯떎.

Table 1 . Repeatability and total imprecisions of prothrombin time measured using HemosIL ReadiPlasTin.

MaterialUnitMeanRepeatabilityTotal imprecision


SDCV (%)SDCV (%)
Normal control (HemosIL Normal Control)Sec11.670.131.10.252.1
Abnormal control (HemosIL Low Abnormal Control)Sec21.560.190.90.743.4

Abbreviations: SD, standard deviation; CV, coefficient of variation..


2. 긽愿꽦 룊媛

湲곗諛⑸쾿씤 HemosIL RecombiPlasTin 2G 룊媛諛⑸쾿씤 HemosIL ReadiPlasTin쓽 痢≪젙媛믪쓽 踰붿쐞뒗 媛곴컖 9.7-44.8珥덉 10.0-43.1珥덉떎. HemosIL ReadiPlasTin 떆빟 湲곗諛⑸쾿怨 Pearson 긽愿怨꾩닔(r)씠 0.996쑝濡 넻怨꾪븰쟻쑝濡 쑀쓽븳 긽愿꽦쓣 蹂댁떎(P<0.05). Deming 쉶洹遺꾩꽍쓣 넻빐 援ы븳 쉶洹諛⑹젙떇 Y(룊媛諛⑸쾿)=0.9985 (95% confidence interval [CI], 0.9732-1.024)×X(湲곗諛⑸쾿)+0.3110 (95% CI, –0.05613 to 0.6782)씠뿀떎(Fig. 1A). HemosIL Readi理탅asTin 떆빟쓽 HemosIL RecombiPlasTin 2G뿉 븳 bias뒗 2.126±3.412 (mean±1.96 SD)떎(Fig. 1B). Bland-Altman plot뿉꽌 PT 15珥 씠븯쓽 寃곌낵뿉꽌 HemosIL ReadiPlasTin 痢≪젙媛믪씠 넂 寃쏀뼢쓣 愿李고븯怨 PT 15珥 씠븯쓽 寃곌낵瑜 媛吏怨 긽愿꽦쓣 옱룊媛븯떎. PT 15珥 씠븯쓽 媛(n=85)뿉꽌 r=0.968 (P<0.05)씠뿀쑝硫, Deming 쉶洹諛⑹젙떇 Y(룊媛諛⑸쾿)=0.9977 (95% CI, 0.9026 to 1.093)×X(湲곗諛⑸쾿)+0.4233 (95% CI, –0.6213 to 1.468)씠뿀떎(Fig. 1C). Bland-Altman 遺꾩꽍뿉꽌 HemosIL RecombiPlasTin 2G뿉 븳 bias뒗 3.499±2.442 (mean±1.96 SD)씠뿀떎(Fig. 1D).

Figure 1.

Comparison between PT measurements using HemosIL RecombiPlasTin 2G and HemosIL ReadiPlasTin. (A, C) Deming regression plots using a total of 148 samples (A) and 48 samples with PT below 15 seconds (C). X-axis represents the PT measured using HemosIL RecombiPlasTin 2G as a reference method. Y-axis represents the PT measured using HemosIL ReadiPlasTin, as a comparative method. (B, D) Bland-Altman difference plots using a total of 148 samples (B) and 48 samples with PT below 15 seconds (D). X-axis represents the average PT measured using HemosIL RecombiPlasTin 2G and HemosIL ReadiPlasTin. Y-axis represents the percent difference in PT measured using HemosIL RecombiPlasTin 2G and HemosIL ReadiPlasTin. Abbreviations: PT, prothrombin time; SD, standard deviation.


3. 李멸퀬踰붿쐞 꽕젙

젙긽씤 136紐낆쓽 PT 以묒븰媛믪 11.7珥(궗遺꾩쐞 踰붿쐞, 11.1-12.2)쑝硫, 諛깅텇쐞닔 2.5% 97.5% 媛믪쓣 援ы븯뿬 꽕젙븳 李멸퀬踰붿쐞뒗 10.4-13.3珥덉떎. 젣議곗궗뿉꽌 젣떆븳 李멸퀬踰붿쐞뒗 10.2-12.9珥덉떎.

怨 李

蹂 뿰援ъ뿉꽌뒗 PT 痢≪젙쓣 쐞븳 HemosIL ReadiPlasTin 떆빟쓽 젙諛룄 湲곗〈 떆빟怨쇱쓽 긽愿꽦쓣 룊媛븯怨 李멸퀬踰붿쐞瑜 꽕젙븯떎. 젙諛룄 룊媛뿉꽌뒗 젙긽, 鍮꾩젙긽쓽 긽뭹솕맂 젙룄愿由щЪ吏덉쓣 궗슜븯뿬 PT 痢≪젙뿉 븳 諛섎났젙諛룄 珥 鍮꾩젙諛룄瑜 遺꾩꽍븯떎. 젙諛룄 룊媛寃곌낵 젙긽, 鍮꾩젙긽 젙룄愿由щЪ吏 紐⑤몢뿉꽌 1.1% 씠븯쓽 諛섎났젙諛룄 3.4% 씠븯쓽 珥 鍮꾩젙諛룄瑜 蹂댁뿬二쇱뼱 젣議곗궗媛 젣떆븯뒗 湲곗쓣 留뚯”븯떎.

긽愿꽦 룊媛뿉꽌뒗 湲곗〈뿉 룞씪젣議곗궗쓽 젣뭹씤 HemosIL RecombiPlasTin 2G濡 痢≪젙븳 PT 寃곌낵 鍮꾧탳븳 寃곌낵 긽愿怨꾩닔媛 0.996쑝濡 留ㅼ슦 슦닔븯떎. Bland-Altman 遺꾩꽍뿉꽌 HemosIL ReadiPlasTin뿉 쓽븳 痢≪젙媛믪씠 HemosIL RecombiPlasTin 2G뿉 쓽븳 痢≪젙媛믪뿉 鍮꾪빐 넂 寃쏀뼢쓣 蹂댁뿬 二쇱뿀뒗뜲, 씠뒗 PT媛 15珥 씠븯濡 궙 媛믪뿉꽌 李⑥씠媛 醫 뜑 슌졆븳 뼇긽쓣 굹궡뿀떎. 씠 媛숈 寃곌낵쓽 李⑥씠媛 엫긽쟻 쓽궗寃곗젙뿉 誘몄튂뒗 쁺뼢쓣 異붿젙븯湲 쐞븯뿬, 10珥 諛 13珥, 15珥덉쓽 PT 媛믪뿉꽌 HemosIL RecombiPlasTin 2G뿉 鍮꾧탳븳 HemosIL ReadiPlasTin쓽 寃곌낵瑜 Deming 쉶洹떇쑝濡 異붿젙븯뿬 蹂댁븯쓣 븣 寃곌낵媛 媛곴컖 10.3珥(95% CI, 10.15 to 10.44; % bias, 2.9) 諛 13.3珥(95% CI, 13.25 to 13.33; % bias, 2.2), 15.3珥(95% CI, 15.25 to 15.33; % bias, 1.9)떎. 씠뒗 Westgard 쎒궗씠듃뿉꽌 젣떆븯怨 엳뒗 뿀슜 媛뒫븳 珥 삤李⑥씤 5.3%瑜 湲곗쑝濡 븯쓣 븣 뿀슜 媛뒫븳 踰붿쐞쑝誘濡 엫긽쟻 以묒슂 쓽궗寃곗젙뿉 誘몄튂뒗 쁺뼢 겕吏 븡쓣 寃껋쑝濡 깮媛곷릺뿀떎[5] (https://www.westgard.com/biodatabase1.htm, assessed Jan 11, 2019). 湲곗〈뿉 HemosIL RecombiPlasTin 2G HemosIL ReadiPlasTin쓣 鍮꾧탳븳 臾명뿄씠 뾾뼱 몢 떆빟 媛꾩쓽 긽愿愿怨꾨 떒젙븯湲곕뒗 븘吏 씠瑜 寃껋쑝濡 깮媛곷릺硫, 뼢썑 異붽 룊媛뿰援щ 넻븳 젙솗븳 긽愿愿怨꾨텇꽍씠 븘슂븷 寃껋쑝濡 뙋떒맂떎.

蹂 뿰援ъ쓽 젣븳젏 긽愿꽦 遺꾩꽍뿉 궗슜븳 寃泥닿 寃쎄뎄슜 빆쓳怨좎젣瑜 蹂듭슜븳 솚옄쓽 寃껋씤吏 솗씤븯吏 紐삵뻽떎뒗 젏씠떎. International normalized ratio 怨꾩궛뿉 궗슜븯뒗 ISI 媛믪 뙆由곗쓣 蹂듭슜븯怨 엳뒗 솚옄뱾뿉꽌 PT 떆빟쓽 삁誘쇰룄瑜 蹂댁젙븳 寃껋씠誘濡 뙆由 移섎즺 異붿쟻寃궗뿉꽌쓽 떆빟 蹂寃쎌뿉 뵲瑜 bias媛 엫긽쟻 쓽궗寃곗젙뿉 誘몄튂뒗 쁺뼢뿉 빐꽌뒗 뼢썑 異붽뿰援ш 븘슂븷 寃껋씠떎.

蹂 뿰援ъ뿉꽌 꽕젙븳 李멸퀬踰붿쐞뒗 10.4-13.3珥덈줈 씠쟾뿉 媛숈 寃궗떎뿉꽌 HemosIL RecombiPlasTin 2G濡 꽕젙븳 9.2-13.3珥덉뿉 鍮꾪빐 李멸퀬移 븯븳씠 넂븘吏뒗 寃껋쓣 솗씤븷 닔 엳뿀떎. 씠 媛숈씠 PT쓽 寃곌낵뒗 媛숈 젣議곗궗쓽 젣뭹씠뜑씪룄 寃궗뿉 궗슜릺뒗 듃濡щ낫뵆씪뒪떞 떆빟쓽 꽦긽 諛 냽룄뿉 뵲씪 떖씪吏 닔 엳쑝誘濡 媛 寃궗떎뿉꽌 옄泥댁쟻쑝濡 李멸퀬踰붿쐞瑜 꽕젙 샊 寃利앺븯뒗 寃껋씠 以묒슂븯떎.

HemosIL ReadiPlasTin 떆빟씠 븸긽삎깭濡 릺뼱 엳뼱 湲곗〈뿉 룞씪 젣議곗궗뿉꽌 뙋留ㅽ븯뜕 룞寃곌굔議고삎깭쓽 HemosIL RecombiPlasTin 2G 떆빟뿉 鍮꾪빐 씗꽍 쟾냽썑뿉 떎삩솕 怨쇱젙씠 븘슂븯吏 븡븘꽌 떆빟 젣議곗뿉 珥 35遺꾧웾쓽 떆媛꾩씠 떒異뺣맂떎뒗 옣젏씠 엳뿀떎. 삉븳 씗꽍븸쓣 듃濡щ낫뵆씪뒪떞 떆빟뿉 遺꾩<븷 븣 뵾렖쑝濡 젙웾쓣 옱吏 븡怨, 1蹂묒뿉 떞湲 씗꽍븸쓣 紐⑤몢 떆빟뿉 꽔 썑 궗슜븷 닔 엳뼱꽌 異붽쟻쑝濡 떆빟 젣議곗떆媛 諛 닔湲곌낵젙쑝濡 씤븳 옉뾽웾씠 媛먯냼릺뿀떎. 닔湲곌낵젙쓽 媛먯냼뒗 寃궗삤瑜섏쓽 媛뒫꽦룄 궙異 닔 엳쓣 寃껋쑝濡 깮媛곷맂떎.

寃곕줎쟻쑝濡 HemosIL ReadiPlasTin쓽 遺꾩꽍꽦뒫 룊媛寃곌낵 留뚯”뒪윭슫 鍮꾩젙諛룄瑜 蹂댁쑝硫, 湲곗〈쓽 HemosIL RecombiPlasTin 2G룄 슦닔븳 긽愿꽦 諛 씪移섎룄瑜 蹂댁떎.

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