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.