Table 1.
HSV-2 Antibody Detection in Kenyan Adolescent Orphans.
| Number of samples with result indicated / Total number tested (%) Kalon ELISA Testing | ||||
|---|---|---|---|---|
|
|
||||
| Index Value Range | Initial | Product Insert Finala | Study Algorithm Finalb | Positive by Western blot |
| ≥ 2.5 | 12/837 (1.4) | 12/12 (100) Positive | 12/12 (100) Positive | 9/9 (100) |
|
| ||||
| ≥ 1.5, < 2.5 | 16/837 (2.0) | 16/16 (100) Positive | 14/16 (87.5) Positive 2/16 (12.5) Indeterminate | 13/14 (92.9) 1/2 (50.0) |
|
| ||||
| ≥ 1.1, < 1.5 | 5/837 (0.6) | 4/5 (80.0) Positive | 2/5 (40.0) Positive 2/5 (40.0) Indeterminate | 1/2 (50.0) 2/2 (100) |
|
| ||||
| 1/5 (20.0) Negative | 1/5 (20.0) Negative | ND | ||
|
| ||||
| ≥ 0.9, < 1.1 | 2/837 (0.2) | 1/2 (50.0) Positive 1/2 (50.0) Indeterminate | 2/2 (100) Indeterminate | 2/2 (100) |
|
| ||||
| < 0.9 | 802/837 (95.8) | 802/802 (100) Negative | 802/802 (100) Negative | ND |
a
Final Kalon results determined according to the product insert, including repeat testing when applicable; no repeat ELISA testing was performed for initial index values ≥ 2.5 or < 0.9.
b
Final Kalon results determined according to the algorithm described in Methods.
ND, not done.