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Performance Evaluation of the Stat Profile pHOx Ultra Blood Gas Analyzer
J Lab Med Qual Assur 2019;41:47-49
Published online March 31, 2019
© 2019 Korean Association of External Quality Assessment Service.

Hye-Young Lee, Sunyoung Ahn, Hyun-Ki Kim, Woochang Lee, Sail Chun, Won-Ki Min

Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Correspondence to: Won-Ki Min Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea Tel: +82-2-3010-4503 Fax: +82-2-478-0884 E-mail: wonkmin@gmail.com
Received October 23, 2018; Revised February 28, 2019; Accepted March 4, 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

The objective of this study was to evaluate the analytical performance of the Stat Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical, USA), a new blood gas/chemistry analyser, including its precision and linearity, comparison studies, and the carry-over effect of commercial reagents and patient specimens. We assessed all the results on the basis of the Clinical and Laboratory Standards Institute guidelines. The following parameters were assessed: pH, partial pressure of carbon dioxide, partial pressure of oxygen, ionized calcium, ionized magnesium (iMg), and lactate concentration The total imprecision had a coefficient of variation of 0.0%–1.8%, and the linear measurement ranges for each parameter were all acceptable. In comparison with the Nova Critical Care Xpress Analyzer (Nova Biomedical, USA), the results indicated a good agreement, except for iMg. All carry-over ranges were between –0.5% and –1.4%. The Stat Profile pHOx Ultra Blood Gas Analyzer showed good analytical performance in terms of precision, linearity, comparison studies, and carry-over effect. The Stat Profile pHOx Ultra Blood Gas Analyzer can provide reliable measurements across a clinically relevant range and has potential use in laboratory tests.

Keywords : Stat Profile pHOx Ultra Blood Gas Analyzer, Performance, Evaluation
Body

삁븸媛뒪, 쟾빐吏 諛 궗궛臾 痢≪젙 遺꾩꽍湲곌린씤 Stat Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical, Waltham, MA, USA)쓽 遺꾩꽍꽦뒫쓣 룊媛븯떎. 룊媛뒗 pH, partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), ionized calcium (iCa), ionized magnesium (iMg), lactate濡 珥 6媛 寃궗빆紐⑹뿉 븯뿬 떎떆븯떎. 젙諛룄룊媛뿉꽌 pH, pCO2, pO2뒗 냽룄, 以묎컙냽룄, 怨좊냽룄濡 援ъ꽦맂 Stat Profile pHOx Ultra/CCX blood gas controls (Nova Biomedical) level 1-3쓣, iCa, iMg, lactate 냽룄, 怨좊냽룄濡 援ъ꽦맂 Stat Profile pHOx Ultra/CCX chemistry controls (Nova Biomedical) level 1-2瑜 씠슜븯떎. 珥 젙諛룄 寃궗씪 媛 젙諛룄뒗 Clinical and Laboratory Standards Institute (CLSI) EP05-A3뿉 뵲씪 媛곴컖쓽 젙룄愿由щЪ吏덉쓣 20씪 룞븞 留ㅼ씪 2쉶, 留ㅽ쉶 2쉶 諛섎났 痢≪젙븯뿬 援ы븯떎[1,2]. 吏곸꽑꽦 룊媛뒗 긽뭹솕맂 Calibration Verification Controls (RNA Medical, Devens, CA, USA)쓣 씠슜븯뿬 5媛吏 냽룄濡 룊媛븯뒗뜲, 씠뱾쓣 媛곴컖 4쉶뵫 諛섎났 痢≪젙븯뿬 CLSI EP06-A뿉 뵲씪 룊媛븯떎[1,3]. 긽愿꽦 룊媛뒗 異⑸텇븳 뼇쓽 솚옄 寃泥 40媛쒕 씠슜븯뿬 CLSI EP09-A3뿉 뵲씪 Nova Critical Care Xpress (CCX) Analyzer (Nova Biomedical) 룊媛湲곌린뿉꽌 李⑤濡 媛곴컖 2쉶뵫 諛섎났 痢≪젙븳 썑 洹 寃곌낵瑜 遺꾩꽍븯떎[4,5]. Nova Biomedical궗쓽 긽뭹솕맂 젙룄愿由щЪ吏 high/low level濡 寃泥 媛 긽샇삤뿼 諛깅텇쑉(carry-over percentage)쓣 怨꾩궛븯떎[1,6]. 媛 빆紐⑸퀎 젙諛룄 寃궗寃곌낵뿉꽌 珥 젙諛룄뒗 0.0%뿉꽌 1.8%씠뿀쑝硫 寃궗씪 媛 젙諛룄뒗 0.0%뿉꽌 1.3%떎(Table 1). 吏곸꽑꽦 룊媛寃곌낵瑜 쐞븳 쉶洹遺꾩꽍寃곌낵 紐⑤뱺 寃궗빆紐⑹뿉꽌 寃곗젙怨꾩닔(R2)媛 0.996-1.000쑝濡 굹궗떎(Fig. 1). Nova CCX Analyzer (Nova Biomedical) 鍮꾧탳룊媛뿉꽌 iMg (r=0.974)瑜 젣쇅븳 긽愿怨꾩닔(r)媛믪씠 0.976-0.999濡 긽愿꽦쓣 留뚯”븯怨, 6媛 빆紐⑹쓽 쉶洹怨≪꽑쓽 湲곗슱湲곕뒗 0.962-1.091, y젅렪 –0.630-0.630씠뿀떎(Fig. 2). 紐⑤뱺 긽샇삤뿼 諛깅텇쑉쓽 踰붿쐞뒗 –0.5%-1.4%씠뿀떎(Table 2). Stat Profile pHOx Ultra Blood Gas Analyzer뒗 紐⑤뱺 寃궗빆紐⑹뿉꽌 슦닔븳 젙諛룄 吏곸꽑꽦쓣 蹂댁뿬二쇱뿀怨, Nova CCX analyzer 쟾諛섏쟻쑝濡 긽愿꽦룄 넂븯쑝硫 긽샇삤뿼 슚怨(carry-over effect)룄 愿李곕릺吏 븡븯떎. 寃곕줎쟻쑝濡, Stat Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical)뒗 蹂 룊媛뿉꽌 슦닔븳 遺꾩꽍꽦뒫쓣 蹂댁뿬二쇱뼱 엫긽寃궗떎뿉꽌 쑀슜븯寃 궗슜븷 닔 엳쓣 寃껋쑝濡 깮媛곷맂떎.

Table 1 . Precision profile of the Stat Profile pHOx Ultra Blood Gas Analyzer.

AnalyteLevelMean (mg/dL)CV (%)

Within runBetween runBetween dayTotal
pHLow7.20.00.00.00.0
Middle7.40.00.00.00.0
High7.60.00.00.00.0
pCO2 (mm Hg)Low23.20.70.90.70.5
Middle41.70.60.50.30.8
High54.90.70.30.31.3
pO2 (mm Hg)Low56.50.80.00.40.6
Middle117.70.20.20.20.4
High141.20.20.30.50.9
iCa (mg/dL)Low4.30.40.00.10.4
High6.40.30.20.00.3
iMg (mg/dL)Low1.61.60.00.81.8
High2.91.20.01.31.8
Lactate (mmol/L)Low2.00.60.00.00.6
High7.00.60.21.31.5

The instrument and quality control materials used in this study were from Stat Profile pHOx Ultra Blood Gas Analyzer (Nova Biomedical, Waltham, MA, USA) and Calibration Verification Controls (RNA Medical, Devens, CA, USA), respectively..

Abbreviations: CV, coefficient of variation; pCO2, partial pressure of carbon dioxide; pO2, partial pressure of oxygen; iCa, ionized calcium; iMg, ionized magnesium..


Figure 1.

Linearity profile on the Stat Profile pHOx Ultra Blood Gas Analyzer. (A) pH, (B) pCO2, (C) pO2, (D) iCa, (E) iMg, (F) lactate. Abbreviations: pCO2, partial pressure of carbon dioxide; pO2, partial pressure of oxygen; iCa, ionized calcium; iMg, ionized magnesium.


Figure 2.

Comparison of the Nova Critical Care Xpress Anlayzer and Nova pHOx Ultra Blood Gas Anlayzer. Scatter plot and bias plot are shown for each analyte. In scatter plots, solid lines indicate regression lines and dotted lines indicate identity lines. (A) pH, (B) pCO2, (C) pO2, (D) iCa, (E) iMg, (F) lactate. Abbreviations: pCO2, partial pressure of carbon dioxide; pO2, partial pressure of oxygen; iCa, ionized calcium; iMg, ionized magnesium.


Table 2 . Carry-over effect on the measurement of the Stat Profile pHOx Ultra Blood Gas Analyzer with quality control material.

AnalyteMean (%)
pH-1.3
PCO2 (mm Hg)-0.5
PO2 (mm Hg)-1.4
iCa (mg/dL)-1.1
iMg (mg/dL)-0.5
Lactate (mmol/L)-1.0

Abbreviations: pCO2, partial pressure of carbon dioxide; pO2, partial pressure of oxygen; iCa, ionized calcium; iMg, ionized magnesium..


References
  1. Nova Biomedical. Nova pHOx Ultra Blood Gas Analyzer instructions for use manual (ref 49795). Waltham (MA): Nova Biomedical, 2018.
  2. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods:approved guideline. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2014.
  3. Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures:a statistical approach:approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute, 2003.
  4. Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples: approved guideline. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2013.
  5. Nova Biomedical. Nova Critical Care Xpress (CCX) Analyzer instructions for use manual (ref 38343). Waltham (MA): Nova Biomedical, 2017.
  6. Pesce MA. Laboratory automation. In: Kaplan LA, Pesce AJ, editors. Clinical chemistry: theory, analysis, correlation. 5th ed. St. Louis (MO): Mosby, 2010:370.