Multicountry Validation of SAMBA - A Novel Molecular Point-of-Care Test for HIV-1 Detection in Resource-Limited Setting.

INTRODUCTION: Early diagnosis of HIV-1 infection and the prompt initiation of antiretroviral therapy are critical to achieving a reduction in the morbidity and mortality of infected infants. The Simple AMplification-Based Assay (SAMBA) HIV-1 Qual Whole Blood Test was developed specifically for early infant diagnosis and prevention of mother-to-child transmission programs implemented at the point-of-care in resource-limited settings. METHODS: We have evaluated the performance of this test run on the SAMBA I semiautomated platform with fresh whole blood specimens collected from 202 adults and 745 infants in Kenya, Uganda, and Zimbabwe. Results were compared with those obtained with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 assay as performed with fresh whole blood or dried blood spots of the same subjects, and discrepancies were resolved with alternative assays. RESULTS: The performance of the SAMBA and CAP/CTM assays evaluated at 5 laboratories in the 3 countries was similar for both adult and infant samples. The clinical sensitivity, specificity, positive predictive value, and negative predictive value for the SAMBA test were 100%, 99.2%, 98.7%, and 100%, respectively, with adult samples, and 98.5%, 99.8%, 99.7%, and 98.8%, respectively, with infant samples. DISCUSSION: Our data suggest that the SAMBA HIV-1 Qual Whole Blood Test would be effective for early diagnosis of HIV-1 infection in infants at point-of-care settings in sub-Saharan Africa.

Evaluation of syndromic management of sexually transmitted infections within the Kisumu Incidence Cohort Study.

While laboratory aetiological diagnosis is considered the gold standard for diagnosis and management of sexually transmitted infections (STIs), syndromic management has been presented as a simplified and affordable approach for STI management in limited resource settings. STI signs and symptoms were collected using staff-administered computer-assisted personal interview and audio computer-assisted self-interview. Participants underwent a medical examination and laboratory testing for common STIs. The performance of syndromic management was assessed on the agreement between interviewing methods as well as accurate diagnosis. We screened 846 participants, of whom 88 (10.4%) received syndromic STI diagnosis while 272 (32.2%) received an aetiological diagnosis. Agreement between syndromic and aetiological diagnoses was very poor (overall kappa = 0.09). The most prevalent STI was herpes simplex virus type 2 and the percentage of persons with any STI was higher among women (48.6%) than men (15.6%, p < 0.0001). Agreement between audio computer-assisted self-interview and computer-assisted personal interview interviewing methods for syndromic diagnosis of STIs ranged from poor to good. Our findings suggest that syndromic management of STIs is not a sufficient tool for STI diagnosis in this setting; development and improvement of STI diagnostic capabilities through laboratory confirmation is needed in resource-limited settings.