Table 3.
The performance of serology kits for HIV screening§.
| Blood screening laboratories | HIV serology kits | Sensitivity n = 136 (%), 95% CI | Specificity n = 893 (%), 95% CI | Concordance rate||n = 1029 (%), 95% CI | PPV, 95% CI | NPV, 95% CI | Kappa (κ) |
|---|---|---|---|---|---|---|---|
| BJ | Wantai | 134 (98.5%), 96.5%–100.5% | 859 (96.2%)∗∗††, 95.0%–97.4% | 993 (96.5%)∗∗††, 95.4%–97.6% | 79.8%∗∗††, 73.7%–85.8% | 99.8%, 99.4%–100.1% | 0.861 |
| HN | Wantai | 131 (96.3%)∗†, 93.1%–99.5% | 839 (94.0%)∗∗††, 92.5%–95.5% | 970 (94.3%)∗∗††, 92.9%–95.7% | 70.8%∗∗††, 64.3%–77.3% | 99.4%∗†, 98.9%–99.9% | 0.783 |
| Wantai§ | 134 (98.5%), 96.5%–100.5% | 861(96.4%)∗∗††, 95.2%–97.6% | 995 (96.7%)∗∗††, 95.6%–97.8% | 80.7%∗∗††, 74.8%–86.7% | 99.8%, 99.4%–100.1% | 0.868 | |
| YN | KHB | 134 (98.5%), 96.5%–100.5% | 872 (97.6%)∗†, 96.6%–98.6% | 1006 (97.8%)∗††, 96.9%–98.7% | 86.5%∗†, 81.1%–91.8% | 99.8%, 99.5%–100.1% | 0.908 |
| JN | KHB | 131 (96.3%)∗†, 93.1%–99.5% | 868 (97.2%)∗∗††, 96.1%–98.3% | 999 (97.1%)∗∗††, 96.1%–98.1% | 84.0%∗∗††, 78.2%–89.7% | 99.4%∗†, 98.9%–99.9% | 0.880 |
| LN | KHB | 129 (94.9%)∗∗††, 91.2%–98.6% | 843 (94.4%)∗∗††, 92.9%–95.9% | 972 (94.5%)∗∗††, 95.4%–97.6% | 72.1%∗∗††, 65.5%–78.6% | 99.2%∗∗††, 98.6%–99.8% | 0.787 |
| KHB§ | 134 (98.5%), 96.5%–100.5% | 873 (97.8%)∗†, 96.8%–98.8% | 1007 (97.9%)∗†, 97.0%–98.8% | 87.0%∗†, 81.7%–92.3% | 99.8%, 99.5%–100.1% | 0.912 | |
| SD | InTec | 133 (97.8%), 95.3%–100.3% | 879 (98.4%), 97.6%–99.2% | 1012 (98.3%), 97.5%–99.1% | 90.5%, 85.8%–95.2% | 99.7%, 99.3%–100.0% | 0.930 |
| JS | InTec | 133 (97.8%), 95.3%–100.3% | 880 (98.5%), 97.7%–99.3% | 1013 (98.4%), 97.6%–99.2% | 91.1%, 86.5%–95.7% | 99.7%, 99.3%–100.0% | 0.934 |
| HLJ | InTec | 133 (97.8%), 95.3%–100.3% | 875 (98.0%)†, 97.1%–98.9% | 1008 (98.0%)∗†, 97.1%–98.9% | 88.1%, 82.9%–93.2% | 99.7%, 99.3%–100.0% | 0.915 |
| LN | InTec | 132 (97.1%)∗†, 94.3%–99.9% | 872 (97.6%)∗†, 96.6%–98.6% | 1004 (97.6%)∗∗††, 96.7%–98.5% | 86.3%∗†, 80.8%–91.7% | 99.5%, 99.1%–100.0% | 0.899 |
| CQ | InTec | 133 (97.8%), 95.3%–100.3% | 876 (98.1%), 97.2%–99.0% | 1009 (98.1%)∗†, 97.3%–98.9% | 88.7%, 83.6%–93.7% | 99.7%, 99.3%–100.0% | 0.919 |
| InTec§ | 133 (97.8%), 95.3%–100.3% | 881 (98.7%), 98.0%–99.4% | 1014 (98.5%), 97.8%–99.2% | 91.7%, 87.3%–96.2% | 99.7%, 99.3%–100.0% | 0.938 | |
| HZ | Livzon | 133 (97.8%), 95.3%–100.3% | 875 (98.0%)†, 97.1%–98.9% | 1008 (98.0%)∗†, 97.1%–98.9% | 88.1%, 82.9%–93.2% | 99.7%, 99.3%–100.0% | 0.915 |
| ZH | Livzon | 133 (97.8%), 95.3%–100.3% | 873 (97.8%)∗†, 96.8%–98.8% | 1006 (97.8%)∗††, 96.9%–98.7% | 86.9%∗†, 81.6%–92.2% | 99.7%, 99.3%–100.0% | 0.907 |
| Livzon§ | 133 (97.8%), 95.3%–100.3% | 876 (98.1%), 97.2%–99.0% | 1009 (98.1%)∗†, 97.3%–98.9% | 88.7%, 83.6%–93.7% | 99.7%, 99.3%–100.0% | 0.919 | |
| SD | Bio-Rad (4th) | 136 (100%), 100.0%–100.0% | 795 (89.0%)∗∗††, 87.0%–91.0% | 931 (90.5%)∗∗††, 88.7%–92.3% | 58.1%∗∗††, 51.8%–64.4% | 100%, 100.0%–100.0% | 0.682 |
| SZ | Bio-Rad (4th) | 136 (100%), 100.0%–100.0% | 795 (89.0%)∗∗††, 87.0%–91.0% | 931 (90.5%)∗∗††, 88.7%–92.3% | 58.1%∗∗††, 51.8%–64.4% | 100%, 100.0%–100.0% | 0.682 |
| BJ | Bio-Rad (4th) | 136 (100%), 100.0%–100.0% | 798 (89.4%)∗∗††, 87.4%–91.4% | 934 (90.8%)∗∗††, 89.0%–92.6% | 58.9%∗∗††, 52.6%–65.2% | 100%, 100.0%–100.0% | 0.689 |
| HLJ | Bio-Rad (4th) | 136 (100%), 100.0%–100.0% | 797 (89.2%)∗∗††, 87.2%–91.2% | 933 (90.7%)∗∗††, 88.9%–92.5% | 58.6%∗∗††, 52.3%–64.9% | 100%, 100.0%–100.0% | 0.687 |
| Bio-Rad (4th)§ | 136 (100%), 100.0%–100.0% | 812 (90.9%)∗∗††, 89.0%–92.8% | 948 (92.1%)∗∗††, 90.5%–93.7% | 62.7%∗∗††, 56.3%–69.1% | 100%, 100.0%–100.0% | 0.726 | |
| JL | Wantai (4th) | 135 (99.3%), 97.9.0%–100.7% | 843 (94.4%)∗∗††, 92.9%–95.9% | 978 (95.0%)∗∗††, 93.7%–96.3% | 73.0%∗∗††, 66.6%–79.3% | 99.9%, 99.7%–100.1% | 0.813 |
| JS | Wantai (4th) | 135 (99.3%), 97.9.0%–100.7% | 863 (96.6%)∗∗††, 95.4%–97.8% | 998 (97.0%)∗∗††, 96.0%–98.0% | 81.8%∗∗††, 76.0%–87.7% | 99.9%, 99.7%–100.1% | 0.88 |
| TJ | Wantai (4th) | 133 (97.8%), 95.3%–100.3% | 853 (95.5%)∗∗††, 94.1%–96.9% | 986 (95.8%)∗∗††, 94.6%–97.0% | 76.9%∗∗††, 70.6%–83.1% | 99.6%, 99.3%–100.0% | 0.837 |
| HB | Wantai (4th) | 134 (98.5%), 96.5%–100.5% | 854 (95.6%)∗∗††, 94.3%–96.9% | 988 (96.0%)∗∗††, 94.8%–97.2% | 77.5%∗∗††, 71.3%–83.7% | 99.8%, 99.4%–100.1% | 0.844 |
| Wantai (4th)§ | 135 (99.3%), 97.9.0%–100.7% | 863 (96.6%)∗∗††, 95.4%–97.8% | 998 (97.0%)∗∗††, 96.0%–98.0% | 81.8%∗∗††, 76.0%–87.7% | 99.9%, 99.7%–100.1% | 0.880 | |
| TZ | Murex (4th) | 135 (99.3%), 97.9.0%–100.7% | 833 (93.3%)∗∗††, 91.7%–94.9% | 968 (94.1%)∗∗††, 92.7%–95.5% | 69.2%∗∗††, 62.8%–75.7% | 99.9%, 99.6%–100.1% | 0.782 |
| CZ | Murex (4th) | 135 (99.3%), 97.9.0%–100.7% | 834 (93.4%)∗∗††, 91.8%–95.0% | 969 (94.2%)∗∗††, 92.8%–95.6% | 69.6%∗∗††, 63.1%–76.0% | 99.9%, 99.6%–100.1% | 0.785 |
| HB | Murex (4th) | 135 (99.3%), 97.9.0%–100.7% | 849 (95.1%)∗∗††, 93.7%–96.5% | 984 (95.6%)∗∗††, 94.4%–96.8% | 75.4%∗∗††, 69.1%–81.7% | 99.9%, 99.7%–100.1% | 0.832 |
| Murex (4th)§ | 135 (99.3%), 97.9.0%–100.7% | 842 (94.3%)∗∗††, 92.8%–95.8% | 977 (94.9%)∗∗††, 93.6%–96.2% | 72.6%∗∗††, 66.2%–79.0% | 99.9%, 99.7%–100.1% | 0.809 | |
| ZH | Livzon (4th) | 135 (99.3%), 97.9.0%–100.7% | 869 (97.3%)∗∗††, 96.2%–98.4% | 1004 (97.6%)∗∗††, 96.7%–98.5% | 84.90%∗††, 79.4%–90.4% | 99.90%, 99.7%–100.1% | 0.901 |
| NCCL | ECLIA | 136 (100%), 100.0%–100.0% | 884 (99.0%), 98.4%–99.6% | 1020 (99.1%), 98.5%–99.7% | 93.8%, 89.9%–97.7% | 100%, 100.0%–100.0% | 0.963 |
| NCCL | CLIA | 136 (100%), 100.0%–100.0% | 885 (99.1%), 98.5%–99.7% | 1021 (99.2%), 98.7%–99.7% | 94.4%, 90.7%–98.2% | 100%, 100.0%–100.0% | 0.967 |
§The final result of each ELISA among 1029 blood donations was determined by more than half results of different blood centers using the same ELISA and S/CO if the number of reactive and nonreactive results was equal. ||The proportion of true results among samples screened by HIV serology kits. ∗P < 0.05, ∗∗P < 0.01, †P < 0.05, ††P < 0.01, ELISA, and ECLIA: the values (∗) were compared with ECLIA (Roche Elecsys HIV combi PT); ELISA and CLIA: the values (†) were compared with CLIA (Abbott ARCHITECT HIV Ag/Ab Combo).