Table 2.
Comparison of automated serology (“Serology”) and rapid antibody test (“Rapid”) between ART-Def versus ART-96W at CHER trial week 84.
| ART-Def n (%) | ART-96W n (%) | ||||
|---|---|---|---|---|---|
| Serology | Rapid | Serology | Rapid | p-value | |
| Total processed | 75 | 74 | 107 | 101 | <0.0001* |
| Reactive | 62 (83) | 64 (85) | 38 (35) | 41 (41) | |
| Weakly reactive | 5 (7) | 2 (3) | 20 (19) | 6 (6) | |
| Non-reactive | 8 (10) | 8 (11) | 49 (46) | 54 (53) | |
| Insufficient | 0 | 1 | 2 | 8 | |
| Sensitivity | 89.3% | 89.1% | 54% | 56.5% | |
Chi-square test for difference between CHER arms is p<0.0001 for both routine antibody test methods (serology and rapid antibody tests). Sensitivity of these antibody tests was calculated based on known HIV-infection in all CHER participants, diagnosed by HIV DNA PCR and confirmed with a RNA viral load >1000 copies/ml in all children at enrolment. ART-Def = ART deferred until clinical/immunological progression; ART-96W = ART initiated at median 7 weeks of age for 96 weeks. A weakly reactive test will yield a weak line present in the test area and follow-up testing is recommended to confirm an initial weakly reactive result. Unless stated, the analysis presented in this paper used “weakly reactive” results re-classified as seropositive.