Table. 1.

Test parameters and results of anti-HCV ICA performed between 2016–2018

Assay type Category Technician Lot no. Total test no. Positive Retest CMIA (S/CO)

Initial ICA After reflecting CMIA
Humasis HCV card Group 1 T1 CBM6001 2,524 45 (1.78) 38 (1.51) 13.96 (4.69–15.05)
Group 2 T2 CBM6002 3,079 40 (1.30) 32 (1.04) 12.79 (4.7–14.34)
Group 3 T2 CBM6004 4,906 50 (1.02) 50 (1.02) 14.27 (12.89–15.14)
Group 4 T2 CBM6011 3,604 27 (0.75) 23 (0.64) 12.27 (10.22–14.75)
Group 5 T3 CBM6011 1,964 21 (1.07) 16 (0.81) 8.79 (1.72–14.4)
Group 6 T3 CBM6014 5,027 94 (1.87) 59 (1.17) 11.11 (0.17–14.71)
Group 7 T4 CBM6014 2,986 50 (1.67) 36 (1.21) 12.09 (0.68–14.3)
ASAN Easy Test HCV Group 1 T5 DAS001B 1,299 23 (1.77) 16 (1.23) 12.71 (0.2–14.66)
Group 2 T5 DAS002A 4,625 56 (1.21) 49 (1.06) 13.38 (4.8–14.1)
Group 3 T6 DAS002A 1,346 18 (1.34) 16 (1.19) 12.73 (8.51–14.88)
Group 4 T6 DAS003A 4,397 60 (1.36) 57 (1.30) 12.87 (9.77–13.65)
Group 5 T6 DAS004A 2,892 17 (0.59) 17 (0.59) 12.86 (11.63–14.12)
Group 6 T7 DAS005A 4,786 46 (0.96) 45 (0.94) 13.73 (12.92–14.76)
Group 7 T8 DAS005A 2,807 15 (0.53) 15 (0.53) 13.61 (12.86–14.41)
Group 8 T8 DAS006A 4,485 36 (0.74) 36 (0.74) 12.33 (8.01–14.08)

Values are presented as number, number (%), or median (interquartile range). The instruments used were from the following companies: Humasis HCV card (Humasis Co. Ltd., Anyang, Korea) and Asan Easy Test HCV (Asan Pharmaceutical, Seoul, Korea).

Abbreviations: HCV, hepatitis C virus; ICA, immunochromatographic assay; CMIA, chemiluminescent microparticle immunoassay; S/CO, signal to cutoff.

Lab Med Qual Assur 2021;43:37~42 https://doi.org/10.15263/jlmqa.2021.43.1.37
© Lab Med Qual Assur