The practical evaluation of these RDT devices in HIV-positive patients in an African peripheral setting is key in order to study the utility of including them in diagnostic routines. In this study, we product information prospectively assessed the diagnostic accuracy and feasibility of a scalable product locally in a large HIV outpatient clinic in rural Tanzania. Materials and Methods Patient Recruitment, Data Acquisition and Ethics Statement Between November 2011 and June 2012, female and male, adult (��18 years), antiretroviral-na?ve, HIV-1 infected patients consecutively attending the Chronic Disease Clinic of the St. Francis Referral Hospital in Ifakara, Kilombero district, Tanzania, were prospectively offered enrollment into this study. Care at the facility was provided according to the guidelines of the national AIDS control program (NACP) [13].

Childhood vaccination for hepatitis B in this region has been introduced after the year 2002. Patient data was retrieved from the electronic patient database of the Kilombero and Ulanga antiretroviral cohort (KIULARCO) [14]. All subjects included were given oral and written information and signed an informed consent form. Ethical approval was granted by the ethical committee of the Ifakara Health Institute (IHI-IRB Clearence #21/2011) and the Medical Research coordination Committee of the National Institute of Medical Research of Tanzania (NIMR/HQ/R.8a/Vol.IX/620-Amendment 01). Plasma Sample Preparation Following inclusion into the study, 8 mL of blood were withdrawn into vacutainers containing ethylenediaminetetraacetic acid (EDTA).

After completion of CD4+ cell counts and the index test (Determine HBsAg) on whole blood, samples were centrifuged for 10 min at 2000��g. Alanine aminotransferase (ALT) and creatinine levels were determined, the plasma transferred into freezer vials and stored at ?80��C for later serological analysis. Serological Assays All samples were tested both with the index lateral flow assay Determine HBsAg (Alere Inc., Massachusetts, USA) and the reference enzyme immunoassay Murex HBsAg 3.0 (Abbott Diagnostics, Wiesbaden, Germany). Initial reactivity in the reference assay was confirmed using the Murex HBsAg confirmatory 3.0 neutralization assay. HCV antibodies were screened using Murex anti-HCV 4.0 and HBeAg/anti-HBeAg using DiaSorin ETI-EBK plus and ETI-AB-EBK plus, respectively.

All analyses have been performed on samples obtained from one blood draw per subject. For the evaluation of Determine HBsAg, one index assay was conducted using 50 ��L of whole, fresh EDTA blood, Dacomitinib followed by a repeat index test using 50 ��L of stored plasma of the identical aliquot utilized for the reference assay. Both Determine assays were performed by technicians blinded to the results of the reference test and read by two independent observers (the first being FF or RN, the second being a laboratory technician).