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Background@#In this study, the usefulness of within-subject biological coefficient of variation (CVI) and reference change values (RCVs) for delta check limits were investigated by comparing the population distributionbased delta check limits. @*Methods@#For six tests, including aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transferase, glucose, creatinine, and hemoglobin, the RCV95%, RCV99%, and RCV99.9% delta limits were obtained. The nonparametric 95% and 99% delta limits were obtained from the population distribution of the delta percentage difference of the health examination group (January 2014 to December 2018) and the outpatient and inpatient groups (January to December 2018). Delta check alerts (%) in total and all three subgroups were examined according to the five different delta check limits. Additionally, we analyzed the correlation of the median CVIF estimates with population-delta check limits for the six tests. @*Results@#The delta percentage difference of the six tests showed a nonnormal distribution, and median value significantly differed among the health examination, outpatient, and inpatient groups (all, P <0.001). The overall delta check alerts of six tests decreased in the order of RCV95%, RCV99%, and RCV99.9%, population distribution -95%, and -99% delta limits; the proportion of the health examination group gradually decreased and that of inpatients increased. A good correlation was observed between median CVI (range, 2.7% to 10.1%) and population distribution delta limits (r =0.96 to 0.99). @*Conclusions@#The RCV delta check limits should be applied differently depending on the health and disease group. CVI can be useful for estimating the delta check limits of the population.
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Methods@#The precision, linearity, limit of detection (LOD), correlation with the Abbott m2000 assay, and interference were evaluated. @*Results@#The within-laboratory standard deviation ranged from 0.106 to 0.137 log IU/mL for HBV and from 0.073 to 0.097 log IU/mL for HCV, which was lower than the manufacturer’s specification of 0.25 log IU/mL, indicating good precision. Linearity was observed from 1.14 to 8.14 log IU/mL for the HBV assay and from 1.09 to 7.09 log IU/mL for the HCV assay. The LODs of HBV and HCV were 10 and 6.39 IU/mL, respectively, which were equivalent to or better than those claimed by the manufacturer. For comparative evaluation between Alinity m and m2000 assays, 142 HBV and 70 HCV samples were tested. The correlation test revealed a strong correlation for both markers, and the Passing–Bablok regression analysis did not reveal any significant deviation. @*Conclusions@#The Alinity m assay demonstrated excellent performance for HBV and HCV quantifications with reduced hands-on time and a randomaccess format.
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BACKGROUND: The aim of this study was to investigate the current status of fungal cultures and the identification tests used by diagnostic laboratories in Korea. METHODS: From 22 October to 30 November 2013, we surveyed 76 laboratories, participating in the regular proficiency survey program of The Korean Association of Quality Assurance for Clinical Laboratory, with a questionnaire on fungal cultures and their identification tests. In March 2014, five mold were distributed to ninety-one participating laboratories, as an educational challenge. RESULTS: Fifty-six (73.7%) out of seventy-six laboratories replied to the survey questionnaire. Yeast was identified using commercial kits in all laboratories and to species level in 82.1% of the laboratories, whereas moulds were mainly identified by morphological examinations, to species level in 41.1% of the laboratories. The response rate to the five proficiency specimens was 67.0%–71.1%. The percentage of correctly identified dermatophytes was lower than that of Aspergillus species. CONCLUSIONS: An improvement is required in the mould culturing and identification techniques used in diagnostic laboratories in Korea.