Brief Report: High Sensitivity and Specificity of the Cepheid Xpert HIV-1 Qualitative Point-of-Care Test Among Newborns in Botswana
Maryanne Ibrahim, Sikhulile Moyo, Terence Mohammed, Lucy Mupfumi, Simani Gaseitsiwe, Kenneth Maswabi, Gbolahan Ajibola, Rebecca Gelman, Oganne Batlang, Maureen Sakoi, Chloe Auletta-Young, Joseph Makhema, Shahin Lockman, Roger L Shapiro, Maryanne Ibrahim, Sikhulile Moyo, Terence Mohammed, Lucy Mupfumi, Simani Gaseitsiwe, Kenneth Maswabi, Gbolahan Ajibola, Rebecca Gelman, Oganne Batlang, Maureen Sakoi, Chloe Auletta-Young, Joseph Makhema, Shahin Lockman, Roger L Shapiro
Abstract
Background: HIV point-of-care (POC) testing allows for early infant HIV diagnosis and treatment, but POC accuracy at birth and in the setting of antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission is unknown.
Methods: We evaluated the Cepheid Xpert HIV-1 Qual POC test against the Roche Taqman HIV-1 DNA polymerase chain reaction (PCR) platform using dried blood spots from 15 HIV-infected and 75 HIV-exposed uninfected newborns. These infants were screened for HIV at <96 hours of life at 5 hospital maternity wards in Botswana; all infants received postexposure antiretroviral prophylaxis with single-dose nevirapine and zidovudine, and most mothers received 3-drug antiretroviral therapy in pregnancy and at delivery.
Results: Fourteen of the 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95% confidence interval: 68.1 to 99.8). Baseline viral load among positive infants ranged from <40 to >10,000,000 copies/mL, with a median of 2403 copies/mL. The HIV RNA for the infant with false-negative POC testing was 1661 copies/mL. Of note, 2 infants with low HIV RNA (<40 and 272 copies/mL) were correctly identified as HIV positive by Cepheid POC. All the 75 PCR-negative samples tested negative by Cepheid POC, yielding a specificity of 100% (95% confidence interval: 96.1 to 100).
Discussion: Our study demonstrates high sensitivity and specificity for the Cepheid POC assay in the first week of life despite early infection and antiretroviral prophylaxis. This platform may be a useful approach for adding early infant HIV diagnosis to current testing programs.
Conflict of interest statement
Conflicts of Interest and Sources of Funding: This study was supported by funding from the National Institute of Allergy and Infectious Disease (Award #: 1UO1AI114235) This work was also supported in part by the Doris Duke Charitable Foundation through a grant supporting the Doris Duke International Clinical Research Fellows Program at Harvard Medical School. Maryanne Ibrahim was a Doris Duke International Clinical Research Fellow.
Source: PubMed