A positive HBeAg status is associated with increased HBV DNA levels [7], thus being a surrogate marker of high level HBV replication. such information During HBV infection, HBeAg follows the appearance of HBsAg. In turn, during recovery, HBeAg clearance and seroconversion to anti-HBe precede the loss of HBsAg and detection of anti-HBsAg. Therefore it is likely that almost three quarters of our patients with detectable HBsAg were transitioning from a high replicative state to a low replicative state, with lower risk of progressive liver disease and further transmission. This is one of the first studies prospectively evaluating a rapid test for HBsAg in HIV-infected patients entirely at the point of care in an African peripheral health institution.
We chose Determine HBsAg for its low waste production, undemanding storage requirements and most importantly for its preexisting supply chains, as Determine HIV rapid tests are already part of the routine HIV testing algorithm in Tanzania [22] and many other countries. Also, the assay��s procedures and interpretation are identical with the model used for the diagnosis of HIV; this has the benefit of cutting down efforts and expenses in training staff for appropriate handling of the test in case of a large-scale deployment. Studies performed in Ghana [23] and Madagascar [24] further indicated that it can be focused on such practical factors, as differences in diagnostic accuracies between different products for the detection of HBsAg are marginal. Additionally, a recent meta-analysis [25] on Determine HBsAg test characteristics in HIV-negative subjects showed excellent sensitivity and specificity of 98.
2% and 99.9%, respectively. The few previous studies evaluating this assay in HIV-infected patients did not report encouraging findings but had limitations, notably limited sample sizes: In a study in HIV-positive patients in Kumasi, Ghana, the sensitivity was found to be only 69.3% with a specificity of 100%. The majority of samples giving a false negative result using Determine HBsAg had a concentration of HBsAg below the determined rapid test��s detection limit and a substantially lower HBV DNA viral load than samples giving a true positive result. Unfortunately, that study was retrospective in nature and results could not be linked to individual characteristics of the patients of whom the samples were originally obtained.
Importantly, no information on treatment status or cART regimen was available. It Carfilzomib can be hypothesized that present treatment with the dually-active drug lamivudine partly suppressed replication of HBV in a relevant proportion of patients to the extent that the concentration of HBsAg was below Determine HBsAg��s detection limit. In order to limit the effect of this possible interaction in our study, we only included patients with no prior cART experience.