Performance Evaluation of Automated Clinical Chemistry Analyzer for Indocyanine Green (ICG) R15 Test

Ju-Heon Park; Eun Jeong Won; Hyun-Jung Choi; Seung-Jung Kee; Soon-Pal Suh

doi:10.3343/lmo.2016.6.3.140

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Park, Won, Choi, Kee, and Suh: Performance Evaluation of Automated Clinical Chemistry Analyzer for Indocyanine Green (ICG) R15 Test

Original Article

Laboratory Medicine Online 2016; 6(3): 140-146.

Published online: 1 July 2016

DOI: https://doi.org/10.3343/lmo.2016.6.3.140

Performance Evaluation of Automated Clinical Chemistry Analyzer for Indocyanine Green (ICG) R15 Test

Ju-Heon Park, M.D., Eun Jeong Won, M.D., Hyun-Jung Choi, M.D., Seung-Jung Kee, M.D., Soon-Pal Suh, M.D.

Department of Laboratory Medicine, Chonnam National University Medical School, Gwangju, Korea.

Corresponding author: Soon-Pal Suh. Department of Laboratory Medicine, Chonnam National University Medical School, 42 Jebong-ro, Dong-gu, Gwangju 61469, Korea. Tel: +82-62-220-5341, Fax: +82-62-224-2518, spsuh@jnu.ac.kr

Received 23 April 2015 Revised 29 December 2015 Accepted 31 December 2015

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

The conventional indocyanine green retention rate at 15 minutes (ICG R15) test is inefficient and inconvenient because it requires the use of a manual spectrophotometer and several samples per patient. This study aimed to establish the automation of the ICG R15 test using an automated clinical chemistry analyzer, and to evaluate the calculation of R15 with a small number of samples.

Methods

The performance of the AU5832 (Beckman Coulter, USA) for determining ICG concentration was evaluated in accordance with the Clinical Laboratory Standards Institute (CLSI) guidelines. The R15 results for 77 patients determined by spectrophotometry and AU5832 were compared. We evaluated the calculation of R15 with three samples, except for one sample in which the results had been obtained previously, at 5, 10, and 15 minutes after injection of ICG into the patients, and compared the results with those obtained with four samples.

Results

The automated ICG test using the AU5832 system showed proper performances according to CLSI. Although the difference in the R15 results between the two methods was within the 95% confidence interval, the R15 was adjusted by the regression equation because it was slightly lower according to the automated method compared with the manual method. The R15 with three samples (0, 5, and 15 minutes) showed the best correlation with conventional R15 with four samples (r²=0.996). Compared with the manual method, the R15 result using the AU5832 showed excellent agreement with four samples (kappa value 0.904) and with three samples (kappa value 0.880).

Conclusions

The ICG R15 test using the AU5832 system is comparable with the conventional method in clinical use.

Keywords: Indocyanine green retention rate at 15 minutes, Automation, AU5832

Figures and Tables

Fig. 1

Linear regression plots of the results of indocyanine green (ICG) concentrations gathered using spectrophotometry (800 nm and 805 nm). The results were also obtained via an automation method using Beckman Coulter AU5832 (800 nm). (A) A significant correlation was observed between ICG concentrations at 800 nm and 805 nm (r²=0.999, P value<0.001). (B) The ICG concentrations using AU5832 at 800 nm also showed significant correlations with those gathered using spectrophotometry at 805 nm (r²=0.957, P value<0.001).

Fig. 2

Bland-Altman plots comparing the retention rate at 15 minutes (R15) results obtained using spectrophotometry and AU5832. (A) A difference plot of the R15 results gathered using spectrophotometry at 805 nm and AU5832 at 800 nm. (B) A difference plot of the R15 results acquired using spectrophotometry at 805 nm and AU5832 at 800 nm. The results were corrected using a regression equation (Y=3.915+0.969X).

Fig. 3

Linear regression plots comparing the retention rates at 15 minutes (R15) results of AU5832 calculated with 3 or 4 samples obtained at 0, 5, 10, and 15 minutes. (A) A scatter plot of R15 with 3 samples obtained at 5, 10, and 15 minutes. (B) A scatter plot of R15 with 3 samples obtained at 0, 10, and 15 minutes. (C) A scatter plot of R15 with 3 samples obtained at 0, 5, and 15 minutes.

Table 1

Precision profiles for the automated measurement of indocyanine green (ICG) concentrations using Beckman Coulter AU5832

Level^*	Mean (mg/dL)	SD (mg/dL)	CV (%)
Level^*	Mean (mg/dL)	SD (mg/dL)	Within-run	Between-run	Between-day	Total
1	0.20	0.01	0.88	1.15	1.67	2.21
2	0.49	0.01	0.60	1.74	0.64	1.95

^*According to the Clinical Laboratory Standards Institute (CLSI) document EP-5A2, the tests were performed 80 times using two ICG concentration levels: 0.2 mg/dL for level 1 and 0.5 mg/dL for level 2.

Abbreviation: CV, coefficient of variation.

Table 2

Agreement between indocyanine green retention rates at 15 minutes (ICG R15) measured using manual spectrophotometry and AU5832 with 3 or 4 samples from 77 patients

R15 categories^† gathered using spectrophotometry	AU5832^* with 4 samples (0, 5, 10, 15 minutes)		AU5832^* with 3 samples (0, 5, 15 minutes)
R15 categories^† gathered using spectrophotometry	No. of agreements	No. of disagreements	No. of agreements	No. of disagreements
Category A^†	41	0	41	0
Category B^†	27	4	26	5
Category C^†	5	0	5	0
Total no. (%)	73 (94.8%)	4 (5.2%)	72 (93.5%)	5 (6.5%)
Kappa value	0.904		0.880

^*The R15 of AU5832 was corrected using the following regression equation: Y=3.915+0.969X; ^†The categories were divided as follows: category A: R15<15%; category B: 15%≤R15<30%; category C: R15≥30%.

Notes

This article is available from http://www.labmedonline.org

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