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1. Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study

Author

Vubil, Adolfo, Nhachigule, Carina, Loquiha, Osvaldo, Meggi, Bindiya, Mabunda, Nedio, Bollinger, Timothy, Sacks, Jilian A., Jani, Ilesh, and Vojnov, Lara

Subjects
Highly active antiretroviral therapy -- Research, HIV -- Research -- Diagnosis, Antiretroviral agents -- Research, Health, World Health Organization
Abstract

Introduction: Viral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis (EID) is performed using nucleic-acid testing in children under 18 months. Resource-limited health systems face severe chalenges to scale-up both viral load and EID to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an EID assay in children younger than 18 months. Methods: This study was an observational, prospective study, including children between one and 18 months of age who were born to HIV-positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and viral load testing using the Roche CAP/CTM HIV-1 Qualitative v2 and Roche CAP/CTM HIV-1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard. Results: A total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994. Conclusions: The comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional EID testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management. Keywords: diagnostics; paediatrics; testing; virology; LMIC; Africa; viral load monitoring Additional information may be found under the Supporting Information tab for this article., 1 | INTRODUCTION Although significant increases in early infant diagnosis (EID) testing coverage has occurred globally in the past ten years, only approximately 50% of HIV-exposed infants received an EID [...]

Published
2020
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4. Exploring the relationships between genetic, linguistic and geographic distances in Bantu‐speaking populations

Author

González‐Santos, Miguel, primary, Montinaro, Francesco, additional, Grollemund, Rebecca, additional, Marnetto, Davide, additional, Atadzhanov, Masharip, additional, May, Celia A., additional, Mabunda, Nedio, additional, Maret, Pierre de, additional, Oosthuizen, Ockie, additional, Oosthuizen, Erica, additional, and Capelli, Cristian, additional

Published
2022
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5. A year of genomic surveillance reveals how the SARS-CoV-2 pandemic unfolded in Africa

Author

Wilkinson, Eduan, primary, Giovanetti, Marta, additional, Tegally, Houriiyah, additional, San, James E., additional, Lessells, Richard, additional, Cuadros, Diego, additional, Martin, Darren P., additional, Rasmussen, David A., additional, Zekri, Abdel-Rahman N., additional, Sangare, Abdoul K., additional, Ouedraogo, Abdoul-Salam, additional, Sesay, Abdul K., additional, Priscilla, Abechi, additional, Kemi, Adedotun-Sulaiman, additional, Olubusuyi, Adewunmi M., additional, Oluwapelumi, Adeyemi O. O., additional, Hammami, Adnène, additional, Amuri, Adrienne A., additional, Sayed, Ahmad, additional, Ouma, Ahmed E. O., additional, Elargoubi, Aida, additional, Ajayi, Nnennaya A., additional, Victoria, Ajogbasile F., additional, Kazeem, Akano, additional, George, Akpede, additional, Trotter, Alexander J., additional, Yahaya, Ali A., additional, Keita, Alpha K., additional, Diallo, Amadou, additional, Kone, Amadou, additional, Souissi, Amal, additional, Chtourou, Amel, additional, Gutierrez, Ana V., additional, Page, Andrew J., additional, Vinze, Anika, additional, Iranzadeh, Arash, additional, Lambisia, Arnold, additional, Ismail, Arshad, additional, Rosemary, Audu, additional, Sylverken, Augustina, additional, Femi, Ayoade, additional, Ibrahimi, Azeddine, additional, Marycelin, Baba, additional, Oderinde, Bamidele S., additional, Bolajoko, Bankole, additional, Dhaala, Beatrice, additional, Herring, Belinda L., additional, Njanpop-Lafourcade, Berthe-Marie, additional, Kleinhans, Bronwyn, additional, McInnis, Bronwyn, additional, Tegomoh, Bryan, additional, Brook, Cara, additional, Pratt, Catherine B., additional, Scheepers, Cathrine, additional, Akoua-Koffi, Chantal G., additional, Agoti, Charles N., additional, Peyrefitte, Christophe, additional, Daubenberger, Claudia, additional, Morang’a, Collins M., additional, Nokes, D. James, additional, Amoako, Daniel G., additional, Bugembe, Daniel L., additional, Park, Danny, additional, Baker, David, additional, Doolabh, Deelan, additional, Ssemwanga, Deogratius, additional, Tshiabuila, Derek, additional, Bassirou, Diarra, additional, Amuzu, Dominic S. Y., additional, Goedhals, Dominique, additional, Omuoyo, Donwilliams O., additional, Maruapula, Dorcas, additional, Foster-Nyarko, Ebenezer, additional, Lusamaki, Eddy K., additional, Simulundu, Edgar, additional, Ong’era, Edidah M., additional, Ngabana, Edith N., additional, Shumba, Edwin, additional, El Fahime, Elmostafa, additional, Lokilo, Emmanuel, additional, Mukantwari, Enatha, additional, Philomena, Eromon, additional, Belarbi, Essia, additional, Simon-Loriere, Etienne, additional, Anoh, Etilé A., additional, Leendertz, Fabian, additional, Ajili, Faida, additional, Enoch, Fakayode O., additional, Wasfi, Fares, additional, Abdelmoula, Fatma, additional, Mosha, Fausta S., additional, Takawira, Faustinos T., additional, Derrar, Fawzi, additional, Bouzid, Feriel, additional, Onikepe, Folarin, additional, Adeola, Fowotade, additional, Muyembe, Francisca M., additional, Tanser, Frank, additional, Dratibi, Fred A., additional, Mbunsu, Gabriel K., additional, Thilliez, Gaetan, additional, Kay, Gemma L., additional, Githinji, George, additional, van Zyl, Gert, additional, Awandare, Gordon A., additional, Schubert, Grit, additional, Maphalala, Gugu P., additional, Ranaivoson, Hafaliana C., additional, Lemriss, Hajar, additional, Anise, Happi, additional, Abe, Haruka, additional, Karray, Hela H., additional, Nansumba, Hellen, additional, Elgahzaly, Hesham A., additional, Gumbo, Hlanai, additional, Smeti, Ibtihel, additional, Ayed, Ikhlas B., additional, Odia, Ikponmwosa, additional, Ben Boubaker, Ilhem Boutiba, additional, Gaaloul, Imed, additional, Gazy, Inbal, additional, Mudau, Innocent, additional, Ssewanyana, Isaac, additional, Konstantinus, Iyaloo, additional, Lekana-Douk, Jean B., additional, Makangara, Jean-Claude C., additional, Tamfum, Jean-Jacques M., additional, Heraud, Jean-Michel, additional, Shaffer, Jeffrey G., additional, Giandhari, Jennifer, additional, Li, Jingjing, additional, Yasuda, Jiro, additional, Mends, Joana Q., additional, Kiconco, Jocelyn, additional, Morobe, John M., additional, Gyapong, John O., additional, Okolie, Johnson C., additional, Kayiwa, John T., additional, Edwards, Johnathan A., additional, Gyamfi, Jones, additional, Farah, Jouali, additional, Nakaseegu, Joweria, additional, Ngoi, Joyce M., additional, Namulondo, Joyce, additional, Andeko, Julia C., additional, Lutwama, Julius J., additional, O’Grady, Justin, additional, Siddle, Katherine, additional, Adeyemi, Kayode T., additional, Tumedi, Kefentse A., additional, Said, Khadija M., additional, Hae-Young, Kim, additional, Duedu, Kwabena O., additional, Belyamani, Lahcen, additional, Fki-Berrajah, Lamia, additional, Singh, Lavanya, additional, Martins, Leonardo de O., additional, Tyers, Lynn, additional, Ramuth, Magalutcheemee, additional, Mastouri, Maha, additional, Aouni, Mahjoub, additional, el Hefnawi, Mahmoud, additional, Matsheka, Maitshwarelo I., additional, Kebabonye, Malebogo, additional, Diop, Mamadou, additional, Turki, Manel, additional, Paye, Marietou, additional, Nyaga, Martin M., additional, Mareka, Mathabo, additional, Damaris, Matoke-Muhia, additional, Mburu, Maureen W., additional, Mpina, Maximillian, additional, Nwando, Mba, additional, Owusu, Michael, additional, Wiley, Michael R., additional, Youtchou, Mirabeau T., additional, Ayekaba, Mitoha O., additional, Abouelhoda, Mohamed, additional, Seadawy, Mohamed G., additional, Khalifa, Mohamed K., additional, Sekhele, Mooko, additional, Ouadghiri, Mouna, additional, Diagne, Moussa M., additional, Mwenda, Mulenga, additional, Allam, Mushal, additional, Phan, My V. T., additional, Abid, Nabil, additional, Touil, Nadia, additional, Rujeni, Nadine, additional, Kharrat, Najla, additional, Ismael, Nalia, additional, Dia, Ndongo, additional, Mabunda, Nedio, additional, Hsiao, Nei-yuan, additional, Silochi, Nelson B., additional, Nsenga, Ngoy, additional, Gumede, Nicksy, additional, Mulder, Nicola, additional, Ndodo, Nnaemeka, additional, Razanajatovo, Norosoa H, additional, Iguosadolo, Nosamiefan, additional, Judith, Oguzie, additional, Kingsley, Ojide C., additional, Sylvanus, Okogbenin, additional, Peter, Okokhere, additional, Femi, Oladiji, additional, Idowu, Olawoye, additional, Testimony, Olumade, additional, Chukwuma, Omoruyi E., additional, Ogah, Onwe E., additional, Onwuamah, Chika K., additional, Cyril, Oshomah, additional, Faye, Ousmane, additional, Tomori, Oyewale, additional, Ondoa, Pascale, additional, Combe, Patrice, additional, Semanda, Patrick, additional, Oluniyi, Paul E., additional, Arnaldo, Paulo, additional, Quashie, Peter K., additional, Dussart, Philippe, additional, Bester, Phillip A., additional, Mbala, Placide K., additional, Ayivor-Djanie, Reuben, additional, Njouom, Richard, additional, Phillips, Richard O., additional, Gorman, Richmond, additional, Kingsley, Robert A., additional, Carr, Rosina A. A., additional, El Kabbaj, Saâd, additional, Gargouri, Saba, additional, Masmoudi, Saber, additional, Sankhe, Safietou, additional, Lawal, Salako B., additional, Kassim, Samar, additional, Trabelsi, Sameh, additional, Metha, Samar, additional, Kammoun, Sami, additional, Lemriss, Sanaâ, additional, Agwa, Sara H. A., additional, Calvignac-Spencer, Sébastien, additional, Schaffner, Stephen F., additional, Doumbia, Seydou, additional, Mandanda, Sheila M., additional, Aryeetey, Sherihane, additional, Ahmed, Shymaa S., additional, Elhamoumi, Siham, additional, Andriamandimby, Soafy, additional, Tope, Sobajo, additional, Lekana-Douki, Sonia, additional, Prosolek, Sophie, additional, Ouangraoua, Soumeya, additional, Mundeke, Steve A., additional, Rudder, Steven, additional, Panji, Sumir, additional, Pillay, Sureshnee, additional, Engelbrecht, Susan, additional, Nabadda, Susan, additional, Behillil, Sylvie, additional, Budiaki, Sylvie L., additional, van der Werf, Sylvie, additional, Mashe, Tapfumanei, additional, Aanniz, Tarik, additional, Mohale, Thabo, additional, Le-Viet, Thanh, additional, Schindler, Tobias, additional, Anyaneji, Ugochukwu J., additional, Chinedu, Ugwu, additional, Ramphal, Upasana, additional, Jessica, Uwanibe, additional, George, Uwem, additional, Fonseca, Vagner, additional, Enouf, Vincent, additional, Gorova, Vivianne, additional, Roshdy, Wael H., additional, Ampofo, William K., additional, Preiser, Wolfgang, additional, Choga, Wonderful T., additional, Bediako, Yaw, additional, Naidoo, Yeshnee, additional, Butera, Yvan, additional, de Laurent, Zaydah R., additional, Sall, Amadou A., additional, Rebai, Ahmed, additional, von Gottberg, Anne, additional, Kouriba, Bourema, additional, Williamson, Carolyn, additional, Bridges, Daniel J., additional, Chikwe, Ihekweazu, additional, Bhiman, Jinal N., additional, Mine, Madisa, additional, Cotten, Matthew, additional, Moyo, Sikhulile, additional, Gaseitsiwe, Simani, additional, Saasa, Ngonda, additional, Sabeti, Pardis C., additional, Kaleebu, Pontiano, additional, Tebeje, Yenew K., additional, Tessema, Sofonias K., additional, Happi, Christian, additional, Nkengasong, John, additional, and de Oliveira, Tulio, additional

Published
2021
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6. Evaluating the Impact of Sex-Biased Genetic Admixture in the Americas through the Analysis of Haplotype Data

Author

Ongaro, Linda, primary, Molinaro, Ludovica, additional, Flores, Rodrigo, additional, Marnetto, Davide, additional, Capodiferro, Marco R., additional, Alarcón-Riquelme, Marta E., additional, Moreno-Estrada, Andrés, additional, Mabunda, Nedio, additional, Ventura, Mario, additional, Tambets, Kristiina, additional, Achilli, Alessandro, additional, Capelli, Cristian, additional, Metspalu, Mait, additional, Pagani, Luca, additional, and Montinaro, Francesco, additional

Published
2021
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7. Continental-scale genomic analysis suggests shared post-admixture adaptation in the Americas

Author

Ongaro, Linda, primary, Mondal, Mayukh, additional, Flores, Rodrigo, additional, Marnetto, Davide, additional, Molinaro, Ludovica, additional, Alarcón-Riquelme, Marta E, additional, Moreno-Estrada, Andrés, additional, Mabunda, Nedio, additional, Ventura, Mario, additional, Tambets, Kristiina, additional, Hellenthal, Garrett, additional, Capelli, Cristian, additional, Kivisild, Toomas, additional, Metspalu, Mait, additional, Pagani, Luca, additional, and Montinaro, Francesco, additional

Published
2021
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8. Continental-scale genomic analysis suggests shared post-admixture adaptation in Americas

Author

Ongaro, Linda, primary, Mondal, Mayukh, additional, Flores, Rodrigo, additional, Marnetto, Davide, additional, Molinaro, Ludovica, additional, Alarcón-Riquelme, Marta E., additional, Moreno-Estrada, Andrés, additional, Mabunda, Nedio, additional, Ventura, Mario, additional, Tambets, Kristiina, additional, Hellenthal, Garrett, additional, Capelli, Cristian, additional, Kivisild, Toomas, additional, Metspalu, Mait, additional, Pagani, Luca, additional, and Montinaro, Francesco, additional

Published
2020
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9. High HIV incidence in the postpartum period sustains vertical transmission in settings with generalized epidemics: a cohort study in southern Mozambique

Author

De Schacht, Caroline, Mabunda, Nedio, Ferreira, Jr., Orlando C., Ismael, Nalia, Calu, Nurbai, Santos, Iolanda, Hoffman, Heather J., Alons, Catharina, Guay, Laura, and Jani, Ilesh V.

Subjects
HIV testing -- Research -- Usage, Breast feeding -- Analysis -- Health aspects -- Research, Disease transmission -- Analysis -- Health aspects -- Research, Pregnant women -- Research -- Health aspects, HIV infection -- Analysis -- Health aspects -- Research -- Genetic aspects -- Diagnosis -- Patient outcomes -- Care and treatment, Health
Abstract

Introduction: Acute infection with HIV in the postpartum period results in a high risk of vertical transmission through breastfeeding. A study was done to determine the HIV incidence rate and associated risk factors among postpartum women in Southern Mozambique, where HIV prevalence among pregnant women is 21%. Methods: A prospective cohort study was conducted in six rural health facilities in Gaza and Maputo provinces from March 2008 to July 2011. A total of 1221 women who were HIV-negative on testing at delivery or within two months postpartum were recruited and followed until 18 months postpartum. HIV testing, collection of dried blood spot samples and administration of a structured questionnaire to women were performed every three months. Infant testing by DNA-PCR was done as soon as possible after identification of a new infection in women. HIV incidence was estimated, and potential risk factors at baseline were compared using Poisson regression. Results: Data from 957 women were analyzed with follow-up after the enrolment visit, with a median follow-up of 18.2 months. The HIV incidence in postpartum women is estimated at 3.20/100 women-years (95% CI: 2.30-4.46), with the highest rate among 18- to 19-year-olds (4.92 per 100 women-years; 95% CI: 2.65-9.15). Of the new infections, 14 (34%) were identified during the first six months postpartum, 11 (27%) between 6 and 12 months and 16 (39%) between 12 and 18 months postpartum. Risk factors for incident HIV infection include young age, low number of children, higher education level of the woman's partner and having had sex with someone other than one's partner. The vertical transmission was 21% (95% CI: 5- 36) among newly infected women. Conclusions: Incidence of HIV is high among breastfeeding women in Southern Mozambique, contributing to increasing numbers of HIV-infected infants. Comprehensive primary prevention strategies targeting women of reproductive age, particularly pregnant and postpartum women and their partners, will be crucial for the elimination of paediatric AIDS in Africa. Keywords: PMTCT; breastfeeding; incidence; HIV; elimination paediatric HIV; Mozambique., Introduction In 2012, 2.3 million new HIV infections occurred worldwide with 1.6 million of these in sub-Saharan Africa. Every day, about 6300 adults are infected globally, of which 34% are [...]

Published
2014
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10. Performance of point-of-care birth HIV testing in primary health care clinics: An observational cohort study

Author

Meggi, Bindiya, primary, Vojnov, Lara, additional, Mabunda, Nedio, additional, Vubil, Adolfo, additional, Zitha, Alcina, additional, Tobaiwa, Ocean, additional, Mudenyanga, Chishamiso, additional, Mutsaka, Dadirayi, additional, Bollinger, Timothy, additional, Loquiha, Osvaldo, additional, Peter, Trevor F., additional, and Jani, Ilesh V., additional

Published
2018
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15. Performance of a True Point-of-Care Assay for HIV-1/2 Viral Load Measurement at Antenatal and Postpartum Services.

Author

Meggi B, Bollinger T, Zitha A, Mudenyanga C, Vubil A, Mutsaka D, Nhachigule C, Mabunda N, Loquiha O, Kroidl A, and Jani IV

Subjects
Adult, Anti-Retroviral Agents therapeutic use, Chicago, Cross-Sectional Studies, Female, HIV-1, Humans, Infectious Disease Transmission, Vertical, Linear Models, Middle Aged, Mozambique, Pregnancy, Primary Health Care, Regression Analysis, Sensitivity and Specificity, Serologic Tests, Specimen Handling, HIV Infections diagnosis, Point-of-Care Testing, Postpartum Period, Prenatal Care, Viral Load methods
Abstract

Background: Timely viral load (VL) results during pregnancy and the postpartum period are crucial for HIV disease management and for preventing mother-to-child transmission. Point-of-care (POC) VL testing could reduce turnaround times and streamline patient management. We evaluated the diagnostic performance of the novel m-PIMA HIV-1/2 VL assay (Abbott, Chicago, IL) in Mozambique., Setting: The study was conducted in prenatal and postpartum consultation rooms in 2 primary health care clinics. Sample collection and testing on m-PIMA were performed by trained nurses., Methods: HIV-infected pregnant and postpartum women on antiretroviral treatment (ART) or ART naive were tested using both on-site m-PIMA POC and referral laboratory-based real-time VL assays. Linear regression analysis and Bland-Altman plots were used to calculate the agreement between both., Findings: Correlation between venous blood plasma POC and plasma laboratory-based VL was strong (r2 = 0.850, P < 0.01), with good agreement between the methods [overall bias 0.202 log copies/mL (95% CI: 0.366 to 0.772 log copies/mL)]. Using the threshold of 1000 copies/mL, which is used to determine ART failure, the sensitivity and specificity of the POC VL assay were 95.0% (95% CI: 91.6% to 97.3%) and 96.5% (95% CI: 94.2% to 98.0%), respectively. The correlation coefficient between the venous and capillary sample types was 0.983 (r2 = 0.966)., Conclusions: On-site, nurse-performed POC VL testing is feasible and accurate in resource-limited primary health care settings. The operational challenge of plasma separation within clinics for POC testing was successfully overcome using minicentrifuges. The use of capillary blood could simplify the execution of the assay in a clinical environment., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2021
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