Background
Methods
Statistical analyses
Results
HTLV screening test
S/CO of CLIA | Hebei blood center | Changsha blood center | Shenzhen blood center | Sum | ||||
---|---|---|---|---|---|---|---|---|
Initial test | Retest | Initial test | Retest | Initial test | Retest | Initial test | Retest | |
0.1 | 2529 | / | 2675 | / | 2930 | / | 8134 | / |
0.2 | 6996 | / | 6433 | / | 12,707 | / | 26,136 | / |
0.3 | 4341 | / | 4335 | / | 8712 | / | 17,388 | / |
0.4 | 1582 | / | 1276 | / | 2997 | / | 5855 | / |
0.5 | 490 | / | 318 | / | 861 | / | 1669 | / |
0.6 | 142 | / | 88 | / | 214 | / | 444 | / |
0.7 | 46 | / | 27 | / | 65 | / | 138 | / |
0.8 | 10 | / | 5 | / | 22 | / | 37 | / |
0.9 | 3 | / | 3 | / | 8 | / | 14 | / |
≥1.0 | 5 | 4 | 4 | 2 | 105 | 26 | 114 | 32 |
Number of donations | 16,144 | 15,164 | 28,621 | 59,929 | ||||
L2400 non-reactive | 16,140 (99.9752%) | 15,162 (99.9868%) | 28,595 (99.9092%) | 59,897 (99.9466%) | ||||
L2400 reactive | 4 (0.0248%) | 2 (0.0132%) | 26 (0.0908%) | 32 (0.0534%) | ||||
ELISA non-reactive | 16,144 (100.0000%) | 15,162 (99.9868%) | 28,617 (99.9860%) | 59,923 (99.9900%) | ||||
ELISA reactive | 0 (0.0000%) | 2 (0.0132%) | 4 (0.0140%) | 6 (0.0100%) | ||||
INNO-LIA negative | 2 | 3 | 24 | 28 | ||||
INNO-LIA positive | 0 | 0 | 1 | 1 | ||||
INNO-LIA indeterminate | 2 | 0 | 1 | 3 | ||||
Indeterminate rate | 0.0124% | 0.0000% | 0.0035% | 0.0050% | ||||
Negative rate | 99.9876% | 100.0000% | 99.9930% | 99.9933% | ||||
Positive rate | 0.0000% | 0.0000% | 0.0035% | 0.0017% |
HTLV confirmatory test
Code | ELISA | L2400 | INNO-LIA HTLV I/II Score | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
S/CO mean (Retest) | S/CO (Initial test) | S/CO (Retest) | Result | Confirmation | Discrimination | Result | |||||||
n = 1 | n = 2 | p19 I/II | p24 I/II | gp46 I/II | gp21 I/II | p19I | gp46I | gp46II | |||||
Hebei-1 | – | 7.5 | 7.3 | 7.4 | reactive | – | – | 2+ | – | – | – | 2+ | negative |
Hebei-2 | – | 1.8 | 1.6 | 1.6 | reactive | – | – | – | 1+ | – | – | – | indeterminate |
Hebei-3 | – | 6.1 | 6.0 | 6.2 | reactive | – | – | – | – | – | – | – | negative |
Hebei-4 | – | 2.4 | 2.5 | 2.6 | reactive | – | – | – | 2+ | – | – | – | indeterminate |
Changsha-1 | 1.8 | – | – | – | reactive | – | – | – | – | – | – | – | negative |
Changsha-2 | 2.3 | 1.1 | 1.2 | 1.2 | reactive | – | – | – | – | – | – | – | negative |
Changsha-3 | – | 2.3 | 1.2 | 1.2 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-1 | – | 1.5 | 1.3 | 1.3 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-2 | – | 3.8 | 3.4 | 3.4 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-3 | – | 3.1 | 3.1 | 3.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-4 | – | 1.3 | 1.4 | 1.4 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-5 | – | 50.0 | 50.0 | 50.0 | reactive | – | – | 1+ | – | – | 1+ | – | negative |
Shenzhen-6 | – | 50.0 | 50.0 | 50.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-7 | – | 1.3 | 1.3 | 1.3 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-8 | – | 1.6 | 1.6 | 1.6 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-9 | – | 1.1 | 1.0 | 1.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-10 | – | 1.2 | 1.2 | 1.2 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-11 | – | 1.9 | 1.9 | 2.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-12 | 11.63 | 50.0 | 50.0 | 50.0 | reactive | 2+ | 2+ | 3+ | 2+ | 2+ | 2+ | – | positive |
Shenzhen-13 | – | 1.0 | 0.9 | 1.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-14 | – | 2.6 | 2.6 | 2.5 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-15 | – | 1.7 | 1.8 | 1.8 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-16 | – | 2.3 | 2.3 | 2.4 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-17 | – | 1.2 | 1.0 | 1.1 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-18 | – | 2.1 | 2.0 | 2.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-19 | 6.89 | 3.5 | 3.6 | 3.7 | reactive | – | – | – | 1 + − | – | – | – | indeterminate |
Shenzhen-20 | – | 1.4 | 1.3 | 1.3 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-21 | – | 1.1 | 1.0 | 1.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-22 | 2.27 | 1.0 | 1.1 | 1.0 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-23 | – | 1.4 | 1.3 | 1.3 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-24 | – | 1.3 | 1.1 | 1.1 | reactive | – | – | 1+ | – | – | 1+ | – | negative |
Shenzhen-25 | – | 1.7 | 1.6 | 1.6 | reactive | – | – | – | – | – | – | – | negative |
Shenzhen-26 | 3.7 | 3.0 | 2.9 | 3.1 | reactive | – | – | – | – | – | – | – | negative |
Code | Result of INNO-LIA | Blood center | Native place | Gender | Marital status | Age range | Previous donation history | Ethnicity | Education | Occupation | Follow-up test of INNO-LIA | |
---|---|---|---|---|---|---|---|---|---|---|---|---|
First time (3 months) | Second time (3 months) | |||||||||||
Shenzhen-12 | Positive | Shenzhen | Fujian Ningde | Female | Unmarried | 26–35 | First-time | SHE | High school degree | Worker | Positive | Positive |
Shenzhen-19 | Indeterminate | Shenzhen | Guangdong Meizhou | Male | Unmarried | 18–25 | First-time | HAN | Associate degree | Worker | Indeterminate | Indeterminate |
Hebei-2 | Indeterminate | Hebei | Hebei Handan | Female | Unmarried | 18–25 | First-time | HAN | Associate degree | Student | Indeterminate | Negative |
Hebei-4 | Indeterminate | Hebei | Hebei Shijiazhuang | Male | Married | 46–55 | Repeated | HAN | High school degree | Worker | Indeterminate | Indeterminate |