Performance Evaluation of Automated Clinical Chemistry Analyzer for Indocyanine Green (ICG) R15 Test.
- Author:
Ju Heon PARK
1
;
Eun Jeong WON
;
Hyun Jung CHOI
;
Seung Jung KEE
;
Soon Pal SUH
Author Information
- Publication Type:Original Article
- Keywords: Indocyanine green retention rate at 15 minutes; Automation; AU5832
- MeSH: Automation; Chemistry, Clinical*; Humans; Indocyanine Green*; Methods; Spectrophotometry
- From:Laboratory Medicine Online 2016;6(3):140-146
- CountryRepublic of Korea
- Language:Korean
- 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.
