Sysmex Journal International
2013Vol.23 No.1
RepublishedEvaluating the Analytical Performance of New Immunoassay System "HISCL-5000"
AUTHOR(S)
Eriko FUJIMAKI, Hiroya TANI, Takahiko KISHI, and Minehiro GOTOH
Department of Clinical Laboratory, Aichi Medical University Hospital
SUMMARY
Sysmex Corporation developed HISCL-5000 to enhance the lineup of its fully automated immunoassay systems, including HISCL-2000i . We evaluated the basic performance of the new system for HBs antigen ( HBsAg ) and prostate-specific antigen ( PSA ). The within-run reproducibility and between-day reproducibility of HISCL-5000 were both found to be good ; the coefficient of variation ( CV ) in within-run reproducibility was determined to be 1.61-1.72% for HBsAg and 1.59-1.78% for PSA, and that in between-day reproducibility as 0.920-2.06% for HBsAg and 1.02-3.59% for PSA. The limit of detection was determined to be 0.008 IU/mL for HBsAg and 0.001 ng/mL for PSA ; the requirements for limit of detection shown in the product's package insert were well satisfied. Regarding correlations of HBsAg assay values with those obtained using other products ( ARCHITECT i 2000, ABBOTT JAPAN Co., Ltd. ; LUMIPULSE G1200, Fujirebio Inc. ; AIA-1800ST, Tosoh Corporation ), the qualitative test results concordance rate was found to be 100% for all products, with the correlation with ARCHITECT i2000 determined to be y = 1.73x - 1061.4, r = 0.988. Likewise, the correlations of PSA assay values were determined to be y = 0.875x + 1.61, r = 0.999 with ARCHITECT i 1000 ( ABBOTT JAPAN Co., Ltd. ), y = 0.853x + 1.78, r = 0.995 with LUMIPULSE G1200, and y = 0.869x + 1.48, r = 0.999 with AIA-1800ST. These findings demonstrate good analytical performance and short measuring time; HISCL-5000 is useful in routine laboratory testing and pre-consultation examination.
KEY WORDS
HISCL-5000, Chemiluminescent enzyme immunoassay, HBsAg, PSA, High sensitivity
NOTE(S)
This article is translated and republished from Igaku-to-Yakugaku 2013; 69 (1): 179-187.