Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-30 (of 51 Records) |
Query Trace: Nkengasong JN [original query] |
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Leveraging gains from African Center for Integrated Laboratory Training to combat HIV epidemic in sub-Saharan Africa.
Shrivastava R , Poxon R , Rottinghaus E , Essop L , Sanon V , Chipeta Z , van-Schalkwyk E , Sekwadi P , Murangandi P , Nguyen S , Devos J , Nesby-Odell S , Stevens T , Umaru F , Cox A , Kim A , Yang C , Parsons LM , Malope-Kgokong B , Nkengasong JN . BMC Health Serv Res 2021 21 (1) 22 BACKGROUND: In sub-Saharan Africa, there is dearth of trained laboratorians and strengthened laboratory systems to provide adequate and quality laboratory services for enhanced HIV control. In response to this challenge, in 2007, the African Centre for Integrated Laboratory Training (ACILT) was established in South Africa with a mission to train staffs from countries with high burdens of diseases in skills needed to strengthen sustainable laboratory systems. This study was undertaken to assess the transference of newly gained knowledge and skills to other laboratory staff, and to identify enabling and obstructive factors to their implementation. METHODS: We used Kirkpatrick model to determine training effectiveness by assessing the transference of newly gained knowledge and skills to participant's work environment, along with measuring enabling and obstructive factors. In addition to regular course evaluations at ACILT (pre and post training), in 2015 we sent e-questionnaires to 867 participants in 43 countries for course participation between 2008 and 2014. Diagnostics courses included Viral Load, and systems strengthening included strategic planning and Biosafety and Biosecurity. SAS v9.44 and Excel were used to analyze retrospective de-identified data collected at six months pre and post-training. RESULTS: Of the 867 participants, 203 (23.4%) responded and reported average improvements in accuracy and timeliness in Viral Load programs and to systems strengthening. For Viral Load testing, frequency of corrective action for unsatisfactory proficiency scores improved from 57 to 91%, testing error rates reduced from 12.9% to 4.9%; 88% responders contributed to the first national strategic plan development and 91% developed strategies to mitigate biosafety risks in their institutions. Key enabling factors were team and management support, and key obstructive factors included insufficient resources and staff's resistance to change. CONCLUSIONS: Training at ACILT had a documented positive impact on strengthening the laboratory capacity and laboratory workforce and substantial cost savings. ACILT's investment produced a multiplier effect whereby national laboratory systems, personnel and leadership reaped training benefits. This laboratory training centre with a global clientele contributed to improve existing laboratory services, systems and networks for the HIV epidemic and is now being leveraged for COVID-19 testing that has infected 41,332,899 people globally. |
Long-term immunological responses to treatment among HIV-2 patients in Cote d'Ivoire
Minchella PA , Adje-Toure C , Zhang G , Tehe A , Hedje J , Rottinghaus ER , Kohemun N , Aka M , Diallo K , Ouedraogo GL , De Cock KM , Nkengasong JN . BMC Infect Dis 2020 20 (1) 213 BACKGROUND: Studies indicate that responses to HIV-2 treatment regimens are worse than responses to HIV-1 regimens during the first 12 months of treatment, but longer-term treatment responses are poorly described. We utilized data from Cote d'Ivoire's RETRO-CI laboratory to examine long-term responses to HIV-2 treatment. METHODS: Adult (>/=15 years) patients with baseline CD4 counts < 500 cells/mul that initiated treatment at one of two HIV treatment centers in Abidjan, Cote d'Ivoire between 1998 and 2004 were included in this retrospective cohort study. Patients were stratified by baseline CD4 counts and survival analyses were employed to examine the relationship between HIV type and time to achieving CD4 >/= 500 cells/mul during follow up. RESULTS: Among 3487 patients, median follow-up time was 4 years and 57% had documented ART regimens for > 75% of their recorded visits. Kaplan-Meier estimates for achievement of CD4 >/= 500 cells/mul after 6 years of follow-up for patients in the lower CD4 strata (< 200 cells/mul) were 40% (HIV-1), 31% (HIV-dual), and 17% (HIV-2) (log-rank p < 0.001). Cox Regression indicated that HIV-1 was significantly associated with achievement of CD4 >/= 500 cells/mul during follow-up, compared to HIV-2. CONCLUSIONS: Sub-optimal responses to long-term HIV-2 treatment underscore the need for more research into improved and/or new treatment options for patients with HIV-2. In many West African countries, effective treatment of both HIV-1 and HIV-2 will be essential in the effort to reach epidemic control. |
Use of pre-ART laboratory screening to identify renal, hepatic and haematological abnormalities in Cote d'Ivoire
Minchella PA , Adje-Toure C , Zhang G , Tehe A , Hedje J , Rottinghaus ER , Natacha K , Diallo K , Ouedraogo GL , Nkengasong JN . Trop Med Int Health 2020 25 (4) 408-413 BACKGROUND: High demand for HIV-services and extensive clinical guidelines force health systems in low-resource settings to dedicate resources to service delivery at the expense of other priorities. Simplifying services may reduce the burden on health systems and pre-antiretroviral therapy (ART) laboratory screening is among the services under consideration for simplification. METHODS: We assessed the frequencies of conditions linked to ART toxicities among 34,994 adult, ART-naive patients with specimens referred to the RETRO-CI laboratory in Abidjan, Cote d'Ivoire between 1998 and 2017. Screening included tests for serum creatinine, alanine aminotransferase (ALT) and haemoglobin (Hb) to identify renal dysfunction (estimated glomerular filtration rate < 50 mL/min), hepatic abnormalities (ALT > 5x upper limit of normal) and severe anaemia (Hb < 6.5 g/dL), respectively. We considered screening results across four eras and identified factors associated with the conditions in question. RESULTS: The prevalence of renal dysfunction, hepatic abnormalities and severe anaemia were largely unchanged over time and just 8.4% of patients had any of the three conditions. Key factors associated with renal dysfunction and severe anaemia were age > 50 years (adjusted odds ratio (aOR): 2.53; 95% confidence interval (CI): 2.19-2.92; P < 0.001) and CD4 < 100 cells/microl (aOR: 2.57; 95% CI: 2.30-2.88; P < 0.001). CONCLUSION: The relative infrequency of conditions linked to toxicity in Cote d'Ivoire supports the notion that simplification of pre-ART laboratory screening may be undertaken with limited negative impact on identification of adverse events. Targeted screening may be a feasible strategy to balance detection of conditions associated with ART toxicities with simplification of services. |
Field validation of limiting-antigen avidity enzyme immunoassay to estimate HIV-1 incidence in cross-sectional survey in Swaziland
Duong Pottinger Y , Dobbs T , Mavengere Y , Manjengwa J , Rottinghaus EK , Saito S , Bock N , Philip N , Justman J , Bicego G , Nkengasong JN , Parekh B . AIDS Res Hum Retroviruses 2019 35 (10) 896-905 Reliable and accurate laboratory assays to detect recent HIV-1 infection have potential as simple and practical methods of estimating HIV-1 incidence in cross-sectional surveys. This study describes validation of the limiting-antigen (LAg) Avidity enzyme immunoassay (EIA) in a cross-sectional national survey, conducted in Swaziland, comparing it to prospective follow up incidence. As part of the Swaziland HIV-1 Incidence Measurement Survey (SHIMS), 18,172 individuals underwent counselling and HIV rapid testing in a household-based, population survey conducted from December 2010 to June 2011. Plasma samples from HIV-positive persons were classified as recent infections using an incidence testing algorithm with LAg-Avidity EIA (ODn 1.5) followed by viral load (VL >/=1,000 copies/mL). All HIV-seronegative samples were tested for acute HIV-1 infection by nucleic acid amplification test (NAAT) pooling. HIV-seronegative individuals who consented to follow-up, were retested approximately 6 months later to detect observed HIV-1 seroconversion. HIV-1 incidence estimates based on LAg+VL and NAAT were calculated using assay-specific parameters and were compared with prospective incidence estimate. A total of 5,803 (31.9%) of 18,172 survey participants tested HIV-seropositive; of these 5683 (97.9%) were further tested with LAg+VL algorithm. The weighted annualized incidence from the longitudinal cohort study was 2.4% [95% CI 2.0, 2.7]. Based on cross-sectional testing of HIV-positives with LAg+VL algorithm, overall weighted annualized HIV-1 incidence was 2.5% [2.0, 3.0], while NAAT-based incidence was of 2.6%. In addition, LAg-based incidence in men (1.8%; 1.2-2.5) and women (3.2%; 2.4-3.9) were similar to estimates based on observed incidence (men=1.7%, women=3.1%). Changes in HIV-1 incidence with age in men and women further validate plausibility of the algorithm. These results demonstrate that the LAg EIA, in a serial algorithm with VL, is a cost-effective tool to estimate HIV-1 incidence in cross-sectional surveys. |
Role of public-private partnerships in achieving UNAIDS HIV treatment targets
Shrivastava R , Fonjungo PN , Kebede Y , Bhimaraj R , Zavahir S , Mwangi C , Gadde R , Alexander H , Riley PL , Kim A , Nkengasong JN . BMC Health Serv Res 2019 19 (1) 46 BACKGROUND: Despite progress towards achieving UNAIDS 90-90-90 goals, barriers persist in laboratory systems in sub-Saharan Africa (SSA) restricting scale up of early infant diagnosis (EID) and viral load (VL) test monitoring of patients on antiretroviral therapy. If these facilities and system challenges persist, they may undermine recorded gains and appropriate management of patients. The aim of this review is to identify Public Private Partnerships (PPP) in SSA that have resolved systemic barriers within the VL and EID treatment cascade and demonstrated impact in the scale up of VL and EID. METHODS: We queried five HIV and TB laboratory databases from 2007 to 2017 for studies related to laboratory system strengthening and PPP. We identified, screened and included PPPs that demonstrated evidence in alleviating known system level barriers to scale up national VL and EID testing programs. PPPs that improved associated systems from the point of viral load test request to the use of the test result for patient management were deemed eligible. RESULTS: We identified six PPPs collaborations with multiple activities in select countries that are contributing to address challenges to scale up national viral load programs. One of the six PPPs reached 14.5 million patients in remote communities and transported up to 400,000 specimens in a year. Another PPP enabled an unprecedented 94% of specimens to reach national laboratory through improved sample referral network and enabled a cost savings of 62%. Also PPPs reduced cost of reagents and enabled 300,000 tested infants to be enrolled in care as well as reduced turnaround time of reporting results by 50%. CONCLUSIONS: Our review identified the benefits, enabling factors, and associated challenges for public and private sectors to engage in PPPs. PPP contributions to laboratory systems strengthening are a model and present opportunities that can be leveraged to strengthen systems to achieve the UNAIDS 90-90-90 treatment targets for HIV/AIDS. Despite growing emphasis on engaging the private sector as a critical partner to address global disease burden, PPPs that specifically strengthen laboratories, the cornerstone of public health programs, remain largely untapped. |
Africa Centres for Disease Control and Prevention's framework for antimicrobial resistance control in Africa
Varma JK , Oppong-Otoo J , Ondoa P , Perovic O , Park BJ , Laxminarayan R , Peeling RW , Schultsz C , Li H , Ihekweazu C , Sall AA , Jaw B , Nkengasong JN . Afr J Lab Med 2018 7 (2) 830 Antimicrobial resistant (AMR) organisms are increasing globally, threatening to render existing treatments ineffective against many infectious diseases.1,2 AMR strains of bacteria, fungi, parasites, and viruses prolong illness, increase case fatality, facilitate transmission, and increase treatment costs.3,4 In Africa where many health systems are weak, the likelihood of AMR increasing and the consequences of AMR infections are particularly high, and drug resistance has already been documented for HIV and the pathogens that cause malaria, tuberculosis, typhoid, cholera, meningitis, gonorrhoea, and dysentery.5 Patients in these countries have limited access to accurate diagnosis and adequate antimicrobial treatment, which can lead to sepsis and other life-threatening complications.6,7 |
Diagnosis of human immunodeficiency virus infection
Parekh BS , Ou CY , Fonjungo PN , Kalou MB , Rottinghaus E , Puren A , Alexander H , Hurlston Cox M , Nkengasong JN . Clin Microbiol Rev 2019 32 (1) HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission "hot spots," thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control. |
Laboratory medicine in Africa since 2008: then, now, and the future
Nkengasong JN , Mbopi-Keou FX , Peeling RW , Yao K , Zeh CE , Schneidman M , Gadde R , Abimiku A , Onyebujoh P , Birx D , Hader S . Lancet Infect Dis 2018 18 (11) e362-e367 The Maputo Declaration of 2008 advocated for commitment from global stakeholders and national governments to prioritise support and harmonisation of laboratory systems through development of comprehensive national laboratory strategies and policies in sub-Saharan Africa. As a result, HIV laboratory medicine in Africa has undergone a transformation, and substantial improvements have been made in diagnostic services, networks, and institutions, including the development of a competent workforce, introduction of point-of-care diagnostics, and innovative quality improvement programmes that saw more than 1100 laboratories enrolled and 44 accredited to international standards. These improved HIV laboratories can now be used to combat emerging continental and global health threats in the decades to come. For instance, the unprecedented Ebola virus disease outbreak in west Africa exposed the severe weaknesses in the overall national health systems in affected countries. It is now possible to build robust health-care systems in Africa and to combat emerging continental and global health threats in the future. In this Personal View, we aim to describe the remarkable transformation that has occurred in laboratory medicine to combat HIV/AIDS and improve global health in sub-Saharan Africa since 2008. |
Laboratory medicine in low-income and middle-income countries: progress and challenges
Nkengasong JN , Yao K , Onyebujoh P . Lancet 2018 391 (10133) 1873-1875 Laboratory medicine is essential for disease detection, surveillance, control, and management.1 However, access to quality-assured laboratory diagnosis has been a challenge in low-income and middle-income countries (LMICs) resulting in delayed or inaccurate diagnosis and ineffective treatment with consequences for patient safety.1 In the new Lancet Series2–4 on pathology and laboratory medicine (PALM) in LMICs, Michael Wilson and colleagues2 provide a comprehensive analysis of the challenges and gaps that limit access to PALM services. Some of the challenges include the absence of essential infrastructure, laboratory supplies, basic equipment, skilled personnel, supply chain management, and equipment maintenance; reliance on empirical treatment; inadequate quality management systems; and no government standards for laboratory testing. In their Series paper, Shahin Sayed and colleagues3 provide a roadmap to solutions for improving laboratory medicine, and Susan Horton and colleagues4 call for all stakeholders to ensure the effective provision of PALM services in resource-limited settings. |
Improving laboratory efficiency in the Caribbean to attain the World Health Organization HIV Treat All recommendations
Alemnji GA , Chase M , Branch S , Guevara G , Nkengasong JN , Albalak R . AIDS Res Hum Retroviruses 2017 34 (2) 132-139 Scientific evidence showing the benefits of early initiation of antiretroviral therapy (ART) prompted World Health organization (WHO) to recommend that all persons diagnosed HIV-positive should commence ART irrespective of CD4 count and disease progression. Based on this recommendation, countries should adopt and implement the HIV "Treat All" policy to achieve the UNAIDS 90-90-90 targets and ultimately reach epidemic control. Attaining this goal along the HIV treatment cascade depends on the laboratory to monitor progress and measure impact. The laboratory plays an important role in HIV diagnosis to attain the first 90 and in viral load (VL) and HIV drug resistance testing to reinforce adherence, improve viral suppression, and measure the third 90. Countries in the Caribbean region have endorsed the WHO HIV "Treat all" recommendation; however, they are faced with diminishing financial resources to support laboratory testing, seen as a rate-limiting factor to achieving this goal. To improve laboratory coverage with fewer resources in the Caribbean there is the need to optimise laboratory operations to ensure the implementation of high quality, less expensive, evidence-based approaches that will result in more efficient and effective service delivery. Suggested practical and innovative approaches to achieve this include: 1) targeted testing within HIV hotspots; 2) strengthening sample referral systems for VL; 3) better laboratory data collection systems; and 4) use of treatment cascade data for programmatic decision making. Furthermore, strengthening quality improvement and procurement systems will minimize diagnostic errors and guarantee a continuum of uninterrupted testing which is critical for routine monitoring of patients to meet the stated goal. |
A proposed framework for the implementation of early infant diagnosis point-of-care
Diallo K , Modi S , Hurlston M , Beard RS , Nkengasong JN . AIDS Res Hum Retroviruses 2017 33 (3) 203-210 Early diagnosis of HIV infection in infants and children remains a challenge in resource-limited settings, with approximately half of all HIV-exposed infants receiving virological testing for HIV by the recommended age of 2 months in 2015. To reduce morbidity and mortality among HIV-infected children and close the treatment gap for HIV-infected children, there is an urgent need to evaluate existing programmatic and laboratory practices for early infant diagnosis and introduce strategies to improve identification of HIV-exposed infants and ensure access to systematic, early HIV testing, with early linkage to treatment for HIV-infected infants. This article describes progress made in follow-up of HIV-exposed infants since 2006, including remaining unmet laboratory and programmatic needs, and recommends strategies for improvement, especially those related to the implementation of point-of-care technology for early infant diagnosis. |
Specimen origin, type and testing laboratory are linked to longer turnaround times for HIV viral load testing in Malawi
Minchella PA , Chipungu G , Kim AA , Sarr A , Ali H , Mwenda R , Nkengasong JN , Singer D . PLoS One 2017 12 (2) e0173009 BACKGROUND: Efforts to reach UNAIDS' treatment and viral suppression targets have increased demand for viral load (VL) testing and strained existing laboratory networks, affecting turnaround time. Longer VL turnaround times delay both initiation of formal adherence counseling and switches to second-line therapy for persons failing treatment and contribute to poorer health outcomes. METHODS: We utilized descriptive statistics and logistic regression to analyze VL testing data collected in Malawi between January 2013 and March 2016. The primary outcomes assessed were greater-than-median pretest phase turnaround time (days elapsed from specimen collection to receipt at the laboratory) and greater-than-median test phase turnaround time (days from receipt to testing). RESULTS: The median number of days between specimen collection and testing increased 3-fold between 2013 (8 days, interquartile range (IQR) = 6-16) and 2015 (24, IQR = 13-39) (p<0.001). Multivariable analysis indicated that the odds of longer pretest phase turnaround time were significantly higher for specimen collection districts without laboratories capable of conducting viral load tests (adjusted odds ratio (aOR) = 5.16; 95% confidence interval (CI) = 5.04-5.27) as well as for Malawi's Northern and Southern regions. Longer test phase turnaround time was significantly associated with use of dried blood spots instead of plasma (aOR = 2.30; 95% CI = 2.23-2.37) and for certain testing months and testing laboratories. CONCLUSION: Increased turnaround time for VL testing appeared to be driven in part by categorical factors specific to the phase of turnaround time assessed. Given the implications of longer turnaround time and the global effort to scale up VL testing, addressing these factors via increasing efficiencies, improving quality management systems and generally strengthening the VL spectrum should be considered essential components of controlling the HIV epidemic. |
Combatting global infectious diseases: A network effect of specimen referral systems
Fonjungo PN , Alemnji GA , Kebede Y , Opio A , Mwangi C , Spira TJ , Beard RS , Nkengasong JN . Clin Infect Dis 2017 64 (6) 796-803 The recent Ebola virus outbreak in West Africa clearly demonstrated the critical role of laboratory systems and networks in responding to epidemics. Because of the huge challenges in establishing functional laboratories at all tiers of health systems in developing countries, strengthening specimen referral networks is critical. In this review article, we propose a platform strategy for developing specimen referral networks based on 2 models: centralized and decentralized laboratory specimen referral networks. These models have been shown to be effective in patient management in programs in resource-limited settings. Both models lead to reduced turnaround time and retain flexibility for integrating different specimen types. In Haiti, decentralized specimen referral systems resulted in a 182% increase in patients enrolling in human immunodeficiency virus treatment programs within 6 months. In Uganda, cost savings of up to 62% were observed with a centralized model. A platform strategy will create a network effect that will benefit multiple disease programs. |
Implementation science: the laboratory as a command centre
Boeras DI , Nkengasong JN , Peeling RW . Curr Opin HIV AIDS 2017 12 (2) 171-174 PURPOSE OF REVIEW: Recent advances in point-of-care technologies to ensure universal access to affordable quality-assured diagnostics have the potential to transform patient management, surveillance programmes, and control of infectious diseases. Decentralization of testing can put tremendous stresses on fragile health systems if the laboratory is not involved in the planning, introduction, and scale-up strategies. RECENT FINDINGS: The impact of investments in novel technologies can only be realized if these tests are evaluated, adopted, and scaled up within the healthcare system with appropriate planning and understanding of the local contexts in which these technologies will be used. SUMMARY: In this digital age, the laboratory needs to take on the role of the Command Centre for technology introduction and implementation. Implementation science is needed to understand the political, cultural, economic, and behavioural context for technology introduction. The new paradigm should include: building a comprehensive system of laboratories and point-of-care testing sites to provide quality-assured diagnostic services with good laboratory-clinic interface to build trust in test results and linkage to care; building and coordinating a comprehensive national surveillance and communication system for disease control and global health emergencies; conducting research to monitor the impact of new tools and interventions on improving patient care. |
Improving laboratory efficiencies to scale-up HIV viral load testing
Alemnji G , Onyebujoh P , Nkengasong JN . Curr Opin HIV AIDS 2017 12 (2) 165-170 PURPOSE OF REVIEW: Viral load measurement is a key indicator that determines patients' response to treatment and risk for disease progression. Efforts are ongoing in different countries to scale-up access to viral load testing to meet the Joint United Nations Programme on HIV and AIDS target of achieving 90% viral suppression among HIV-infected patients receiving antiretroviral therapy. However, the impact of these initiatives may be challenged by increased inefficiencies along the viral load testing spectrum. This will translate to increased costs and ineffectiveness of scale-up approaches. This review describes different parameters that could be addressed across the viral load testing spectrum aimed at improving efficiencies and utilizing test results for patient management. RECENT FINDINGS: Though progress is being made in some countries to scale-up viral load, many others still face numerous challenges that may affect scale-up efficiencies: weak demand creation, ineffective supply chain management systems; poor specimen referral systems; inadequate data and quality management systems; and weak laboratory-clinical interface leading to diminished uptake of test results. SUMMARY: In scaling up access to viral load testing, there should be a renewed focus to address efficiencies across the entire spectrum, including factors related to access, uptake, and impact of test results. |
Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay
Kalou MB , Castro A , Watson A , Jost H , Clay S , Tun Y , Chen C , Karem K , Nkengasong JN , Ballard R , Parekh B . Afr J Lab Med 2016 5 (1) 433 BACKGROUND: Use of rapid diagnostic tests for HIV and syphilis has increased remarkably in the last decade. As new rapid diagnostic tests become available, there is a continuous need to assess their performance and operational characteristics prior to use in clinical settings. OBJECTIVES: In this study, we evaluated the performance of the Chembio Dual Path Platform (DPP(®)) HIV-Syphilis Assay to accurately diagnose HIV, syphilis, and HIV/syphilis co-infection. METHOD: In 2013, 990 serum samples from the Georgia Public Health Laboratory in Atlanta, Georgia, United States were characterised for HIV and syphilis and used to evaluate the platform. HIV reference testing combined third-generation Enzyme Immunoassay and Western Blot, whereas reference testing for syphilis was conducted by the Treponema pallidum passive particle agglutination method and the TrepSure assay. We assessed the sensitivity and specificity of the DPP assay on this panel by comparing results with the HIV and syphilis reference testing algorithms. RESULTS: For HIV, sensitivity was 99.8% and specificity was 98.4%; for syphilis, sensitivity was 98.8% and specificity was 99.4%. Of the 348 co-infected sera, 344 (98.9%) were detected accurately by the DPP assay, but 11 specimens had false-positive results (9 HIV and 2 syphilis) due to weak reactivity. CONCLUSION: In this evaluation, the Chembio DPP HIV-Syphilis Assay had high sensitivity and specificity for detecting both HIV and treponemal antibodies. Our results indicate that this assay could have a significant impact on the simultaneous screening of HIV and syphilis using a single test device for high-risk populations or pregnant women needing timely care and treatment. |
Early antiretroviral therapy initiation: Access and equity of viral load testing for HIV treatment monitoring
Peter T , Ellenberger D , Kim AA , Boeras D , Messele T , Roberts T , Stevens W , Jani I , Abimiku A , Ford N , Katz Z , Nkengasong JN . Lancet Infect Dis 2016 17 (1) e26-e29 Scaling up access to HIV viral load testing for individuals undergoing antiretroviral therapy in low-resource settings is a global health priority, as emphasised by research showing the benefits of suppressed viral load for the individual and the whole population. Historically, large-scale diagnostic test implementation has been slow and incomplete because of service delivery and other challenges. Building on lessons from the past, in this Personal View we propose a new framework to accelerate viral load scale-up and ensure equitable access to this essential test. The framework includes the following steps: (1) ensuring adequate financial investment in scaling up this test; (2) achieving pricing agreements and consolidating procurement to lower prices of the test; (3) strengthening functional tiered laboratory networks and systems to expand access to reliable, high-quality testing across countries; (4) strengthening national leadership, with prioritisation of laboratory services; and (5) demand creation and uptake of test results by clinicians, nurses, and patients, which will be vital in ensuring viral load tests are appropriately used to improve the quality of care. The use of dried blood spots to stabilise and ship samples from clinics to laboratories, and the use of point-of-care diagnostic tests, will also be important for ensuring access, especially in settings with reduced laboratory capacity. For countries that have just started to scale up viral load testing, lessons can be learnt from countries such as Botswana, Brazil, South Africa, and Thailand, which have already established viral load programmes. This framework might be useful for guiding the implementation of viral load with the aim of achieving the new global HIV 90-90-90 goals by 2020. |
HIV testing and human rights: the right to the right test
Nkengasong JN , Parekh BS , Hader SL . Lancet HIV 2016 3 (10) e457-8 In September, 2015, Stefano Vella published an important commentary in The Lancet HIV on addressing barriers to end the HIV epidemic by 2030.1 An additional barrier that needs to be addressed is to ensure the quality of HIV diagnostic testing as programmes are scaled up. About 150 million children and adults in 129 low-income and middle-income countries reportedly received HIV testing services in 2014.2 Optimistically assuming a 1% error rate (ie, 99% accuracy), a large number of individuals could be wrongly initiated on antiretroviral therapy (ART) as we enter the test-and-treat era while others who need therapy would not receive it. In fact, although diagnostic tests have high sensitivity and specificity, some studies have reported misdiagnosis rates of 2·6–4·8% that occur in HIV testing programme settings.3, 4 | Almost 20 years ago, in 1998, the Office of the High Commissioner for Human Rights (OHCHR) and the Joint UN Programme on HIV/AIDS (UNAIDS) issued the International Guidelines on HIV/AIDS and Human Rights.5 The guidelines emphasised the need for countries to take steps to protect human rights in the context of HIV/AIDS. The epidemic is ever evolving at a rapid pace, and much has happened since the guidelines were adopted: at the time, fewer than 50 000 people with HIV were receiving life-saving ART in developing countries, now more than 17 million are estimated to be on treatment.6 As the global community responds to the prospects of ending the HIV/AIDS epidemic by 2030, UNAIDS has set an ambitious target of 90% of infected individuals being diagnosed, 90% of those being on ART, and 90% of those achieving viral load suppression by 2020.7 |
Improving the quality of and access to HIV rapid testing in the Caribbean region: Program implementation, outcomes, and recommendations
Alemnji GA , Guevara G , Parris K , Kalou M , Behel SK , Parekh B , Nkengasong JN , Albalak R . AIDS Res Hum Retroviruses 2016 32 (9) 879-84 In 2008 HIV rapid testing (HIV RT) was only minimally used in the Caribbean region. Collaboration with countries and international partners since then has resulted in greater availability and use of HIV RT services. Surveys were conducted in 2012 and 2014 among 11 selected Caribbean countries to inform stakeholders of progress made since 2008 and to identify strategies to further improve access and uptake of high-quality HIV RT in community- and facility-based settings in support of the UNAIDS 90-90-90 targets. Key accomplishments during this period include: 1) presence of in-country national HIV RT algorithms; 2) use of the dried tube specimen (DTS) as an external quality assessment (EQA) program; 3) use of standardized logbooks for data collection and monitoring; and, 4) use of oral fluid for HIV RT, particularly for key population surveys. Although progress has been made since 2008 to increase access and improve the quality of HIV RT among countries in the Caribbean some work remains to be done. This includes the development of new policies and implementation of existing ones, task shifting, quality and access to testing, testing strategies, and integration of HIV RT into HIV Testing Services (HTS). |
Importance of public-private partnerships: strengthening laboratory medicine systems and clinical practice in Africa
Shrivastava R , Gadde R , Nkengasong JN . J Infect Dis 2016 213 Suppl 2 S35-40 After the launch of the US President's Emergency Plan for AIDS Relief in 2003, it became evident that inadequate laboratory systems and services would severely limit the scale-up of human immunodeficiency virus infection prevention, care, and treatment programs. Thus, the Office of the US Global AIDS Coordinator, Centers for Disease Control and Prevention, and Becton, Dickinson and Company developed a public-private partnership (PPP). Between October 2007 and July 2012, the PPP combined the competencies of the public and private sectors to boost sustainable laboratory systems and develop workforce skills in 4 African countries. Key accomplishments of the initiative include measurable and scalable outcomes to strengthen national capacities to build technical skills, develop sample referral networks, map disease prevalence, support evidence-based health programming, and drive continuous quality improvement in laboratories. This report details lessons learned from our experience and a series of recommendations on how to achieve successful PPPs. |
Improved specimen-referral system and increased access to quality laboratory services in Ethiopia: The role of the public-private partnership
Kebede Y , Fonjungo PN , Tibesso G , Shrivastava R , Nkengasong JN , Kenyon T , Kebede A , Gadde R , Ayana G . J Infect Dis 2016 213 Suppl 2 S59-64 BACKGROUND: Nonstandardized specimen-transport logistics, lack of laboratory personnel to transport specimens, lack of standard specimen containers, and long turnaround time (TAT) hindered access to quality laboratory services. The objective of the Becton, Dickinson, and Company (BD)-US President's Emergency Plan for AIDS Relief (PEPFAR) Public-Private Partnership (PPP) was to support country-specific programs to develop integrated laboratory systems, services, and quality improvement strategies, with an emphasis on strengthening the specimen-referral system (SRS). METHODS: In 2007, through the Centers for Disease Control and Prevention (CDC), the Ethiopian Public Health Institute (EPHI) joined with the BD-PEPFAR PPP to strengthen laboratory systems. A joint planning and assessment committee identified gaps in the SRS for prioritization and intervention and piloted the system in Addis Ababa and Amhara Region. RESULTS: The PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network in which 554 facilities referred specimens to 160 laboratories. The PPP supported procuring 400 standard specimen containers and the training of 586 laboratory personnel and 81 postal workers. The average TAT was reduced from 7 days (range, 2-14 days) to 2 days (range, 1-3 days) in Addis Ababa and from 10 days (range, 6-21 days) to 5 days (range, 2-6 days) in Amhara Region. CONCLUSIONS: This study highlights the feasibility and untapped potential of PPPs to strengthen laboratory systems. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services. |
Strengthening the tuberculosis specimen referral network in Uganda: The role of public-private partnerships
Joloba M , Mwangi C , Alexander H , Nadunga D , Bwanga F , Modi N , Downing R , Nabasirye A , Adatu FE , Shrivastava R , Gadde R , Nkengasong JN . J Infect Dis 2016 213 Suppl 2 S41-6 BACKGROUND: Diagnosis of multidrug-resistant tuberculosis and prompt initiation of effective treatment rely on access to rapid and reliable drug-susceptibility testing. Efficient specimen transport systems and appropriate training on specimen referral contribute to optimal and timely access to tuberculosis diagnostic services. METHODS: With support and technical assistance from a public-private partnership (PPP) between Becton Dickinson and the US President's Emergency Plan for AIDS Relief, the Uganda National TB Reference Laboratory (NTRL) and National TB and Leprosy Program redesigned the tuberculosis specimen transport network and trained healthcare workers with the goal of improving multidrug-resistant tuberculosis detection. RESULTS: Between 2008 and 2011, the PPP mapped 93% of health facilities and trained 724 healthcare and postal staff members covering 72% of districts. Strengthening the tuberculosis specimen referral system increased referrals from presumptive multidrug-resistant tuberculosis cases by >10-fold, with 94% of specimens reaching the NTRL within the established target transport time. CONCLUSIONS: This study demonstrates the potential of PPP collaborations with ministries of health to positively influence patient care by strengthening laboratory systems through increased access to drug-susceptibility testing in Uganda. Ongoing efforts to integrate specimen transport networks will maximize resources and improve patient management. |
Molecular Epidemiology and Transmission Dynamics of Recent and Long-Term HIV-1 Infections in Rural Western Kenya.
Zeh C , Inzaule SC , Ondoa P , Nafisa LG , Kasembeli A , Otieno F , Vandenhoudt H , Amornkul PN , Mills LA , Nkengasong JN . PLoS One 2016 11 (2) e0147436 OBJECTIVE: To identify unique characteristics of recent versus established HIV infections and describe sexual transmission networks, we characterized circulating HIV-1 strains from two randomly selected populations of ART-naive participants in rural western Kenya. METHODS: Recent HIV infections were identified by the HIV-1 subtype B, E and D, immunoglobulin G capture immunoassay (IgG BED-CEIA) and BioRad avidity assays. Genotypic and phylogenetic analyses were performed on the pol gene to identify transmitted drug resistance (TDR) mutations, characterize HIV subtypes and potential transmission clusters. Factors associated with recent infection and clustering were assessed by logistic regression. RESULTS: Of the 320 specimens, 40 (12.5%) were concordantly identified by the two assays as recent infections. Factors independently associated with being recently infected were age ≤19 years (P = 0.001) and history of sexually transmitted infections (STIs) in the past six months (P = 0.004). HIV subtype distribution differed in recently versus chronically infected participants, with subtype A observed among 53% recent vs. 68% chronic infections (p = 0.04) and subtype D among 26% recent vs. 12% chronic infections (p = 0.012). Overall, the prevalence of primary drug resistance was 1.16%. Of the 258 sequences, 11.2% were in monophyletic clusters of between 2-4 individuals. In multivariate analysis factors associated with clustering included having recent HIV infection P = 0.043 and being from Gem region P = 0.002. CONCLUSIONS: Recent HIV-1 infection was more frequent among 13-19 year olds compared with older age groups, underscoring the ongoing risk and susceptibility of younger persons for acquiring HIV infection. Our findings also provide evidence of sexual networks. The association of recent infections with clustering suggests that early infections may be contributing significant proportions of onward transmission highlighting the need for early diagnosis and treatment as prevention for ongoing prevention. Larger studies are needed to better understand the structure of these networks and subsequently implement and evaluate targeted interventions. |
Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs
Fonjungo PN , Osmanov S , Kuritsky J , Ndihokubwayo JB , Bachanas P , Peeling RW , Timperi R , Fine G , Stevens W , Habiyambere V , Nkengasong JN . AIDS 2016 30 (8) 1317-23 OBJECTIVE: The objective of the World Health Organization (WHO)/U.S. President's Emergency Plan for AIDS Relief (PEPFAR) consultation was to discuss innovative strategies, offer guidance and develop a comprehensive policy framework for implementing quality-assured HIV-related point-of-care testing (POCT). METHODS: The consultation was attended by representatives from international agencies (WHO, UNICEF, UNITAID, Clinton Health Access Initiative [CHAI]), USAID, Centers for Disease Control and Prevention [CDC]/PEPFAR Cooperative Agreement Partners, and experts from more than 25 countries including policy makers, clinicians, laboratory experts and program implementers. MAIN OUTCOMES: There was strong consensus among all participants that ensuring access to quality of POCT represents one of the key challenges for the success of HIV prevention, treatment and care programs. The following four strategies were recommended: 1) implement a newly proposed concept of a sustainable quality assurance cycle that includes (a) careful planning; (b) definition of goals and targets; (c) timely implementation; (d) continuous monitoring; (e) improvements and adjustments, where necessary; and (f) a detailed evaluation; 2) the importance of supporting a cadre of workers (e.g. volunteer quality corps [Q-Corps]) with the role to ensure that the quality assurance cycle is followed and sustained; 3) implementation of the new strategy should be seen as a step-wise process, supported by development of appropriate policies and tools; and 4) joint partnership under the leadership of the Ministries of Health to ensure sustainability of implementing novel approaches. CONCLUSIONS: The outcomes of this consultation have been well received by program implementers in the field. The recommendations also laid the groundwork for developing key policy and quality documents for the implementation of HIV-related POCT. |
Are post-Ebola reconstruction efforts neglecting public health laboratory systems?
Nkengasong JN , Skaggs BA . Lancet Glob Health 2015 3 (11) e678 David Evans and colleagues (August, 2015)1 modelled how the loss of health-care workers to Ebola virus disease (EVD) might have affected infant, under 5, and maternal mortality in Guinea, Liberia, and Sierra Leone. Unfortunately, laboratory workers were not included in the health-care worker definition used in their model. Laboratory workers are a central part of an effective health system. In the same issue, Ranu Dhillon and Robert Yates2 propose five priorities for Ebola-affected countries. These also did not include the need for an effective public health laboratory system. | The Ebola epidemic repeatedly showed that delays in laboratory confirmation impeded control and prevention efforts. Without effective public health laboratory systems, public health responses will be delayed and global health security will be threatened. Strengthening public health laboratory systems should be a priority in the reconstruction and recovery efforts. |
Access and quality of HIV-related point of care diagnostic testing in global health programs
Fonjungo PN , Boeras DI , Zeh C , Alexander H , Parekh BS , Nkengasong JN . Clin Infect Dis 2015 62 (3) 369-374 Access to point-of-care testing (POCT) improves patient care, especially in resource-limited settings where laboratory infrastructure is poor and the bulk of the population lives in rural settings. However, because of challenges in rolling out the technology and weak quality assurance measures, the promise of HIV-related POCT in resource-limited settings has not been fully exploited to improve patient care and impact public health. Because of these challenges, the Joint United Nations Programme on HIV/AIDS in partnership with other organizations recently launched the Diagnostics Access Initiative. Expanding HIV programs, including the "test and treat" strategies and the newly established UNAIDS 90-90-90 targets will require increased access to reliable and accurate POC test results. In this review, we examine various components that could improve access and uptake of quality-assured POC tests to ensure coverage and public health impact. These components include evaluation, policy, regulation, and innovative approaches to strengthen the quality of POCT. |
Monitoring the quality of HIV-1 viral load testing through proficiency testing program using dried tube specimens in resource-limited settings
Nguyen S , Ramos A , Chang J , Li B , Shanmugam V , Boeras D , Nkengasong JN , Yang C , Ellenberger D . J Clin Microbiol 2015 53 (4) 1129-36 BACKGROUND: HIV-1 RNA viral load (VL) levels are used for monitoring disease progression and antiretroviral therapy outcomes in HIV-infected patients. To assess the performance of laboratories conducting HIV-1 VL testing in resource-limited settings, the US Centers for Disease Control and Prevention implemented a voluntary, free-of-charge, external quality assurance program using dried tube specimens (DTSs). METHODS: DTS proficiency test (PT) panels consisting of 5 specimens were distributed between 2010 and 2012 at ambient temperature to participants. The results from participants (N ≥ 6) using the same assay were grouped, analyzed, and graded as acceptable within a group mean +/- 3SDs. Mean proficiency scores were calculated by dividing the combined PT scores with the number of testing cycles using a linear regression model. RESULTS: Between 2010 and 2012, the number of participants enrolled increased from 32 in 16 countries to 114 in 44 countries. 78.2% of participants reported results using 10 different VL assays. The rates of participants reporting acceptable results were 96.6% (Abbott), 96.3% (Roche COBAS), 94.5% (Roche Amplicor), 93.0% (Biocentric), and 89.3% (NucliSENS). The overall mean proficiency scores improved over time (p = 0.024). CONCLUSION: DTSs are a good alternative specimen type to plasma specimens for VL PT programs as they do not require cold chain transportation and can be used on polymerase chain reaction (PCR)-based assays. Our data suggest that the CDC HIV-1 VL PT program using DTSs positively impacts the testing performance of the participants which might translate into better and accurate VL testing services to patients. |
The SLMTA programme: transforming the laboratory landscape in developing countries
Yao K , Maruta T , Luman ET , Nkengasong JN . Afr J Lab Med 2014 3 (2) 194 BACKGROUND: Efficient and reliable laboratory services are essential to effective and well-functioning health systems. Laboratory managers play a critical role in ensuring the quality and timeliness of these services. However, few laboratory management programmes focus on the competencies required for the daily operations of a laboratory in resource-limited settings. This report provides a detailed description of an innovative laboratory management training tool called Strengthening Laboratory Management Toward Accreditation (SLMTA) and highlights some challenges, achievements and lessons learned during the first five years of implementation (2009-2013) in developing countries. PROGRAMME: SLMTA is a competency-based programme that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training programme spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization's Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training programme. CONCLUSION: Within five years, SLMTA had been implemented in 617 laboratories in 47 countries, transforming the laboratory landscape in developing countries. To our knowledge, SLMTA is the first programme that makes an explicit connection between the performance of specific management behaviours and routines and ISO 15189 requirements. Because of this close relationship, SLMTA is uniquely positioned to help laboratories seek accreditation to ISO 15189. |
Poor performance of the determine HIV-1/2 Ag/Ab combo fourth-generation rapid test for detection of acute infections in a National Household Survey in Swaziland
Duong YT , Mavengere Y , Patel H , Moore C , Manjengwa J , Sibandze D , Rasberry C , Mlambo C , Li Z , Emel L , Bock N , Moore J , Nkambule R , Justman J , Reed J , Bicego G , Ellenberger DL , Nkengasong JN , Parekh BS . J Clin Microbiol 2014 52 (10) 3743-8 Fourth-generation HIV rapid tests (RTs) claim to detect both p24 antigen (Ag) and HIV antibodies (Ab) for early identification of acute infections, important for targeted prevention and reducing HIV transmission. In a nationally representative household survey in Swaziland, 18,172 adults, age 18-49 years, received home-based HIV rapid testing in 2010-2011. Of the 18,172 individuals, 5,822 (32.0%) were Ab+ by Determine HIV-1/2 Ab/Ab Combo and of those, 5,789 (99.4%) were confirmed reactive by Uni-Gold. Determine Combo identified 12 individuals as acute infections (Ag+/Ab-); however, none had detectable HIV-1 RNA and 8 of 12 remained HIV negative at 6-week follow-up visits (4 lost to follow up). All RT non-reactive samples were pooled and tested by nucleic acid amplification testing (NAAT) to identify acute infections. NAAT identified 13 (0.1%) of the 12,338 HIV antibody-negative specimens as HIV RNA positive with RNA levels ranging from 300 to >10,000,000 copies/mL. However, none of them were Ag+ on Determine Combo. Follow-up testing of 12 of the 13 NAAT-positive individuals at 6 months demonstrated 12 seroconversions (1 lost to follow-up). Therefore, the Combo test had a sensitivity of 0% (95% CI 0%-28%) and positive predictive value of 0% for the detection of acute infections. The ability of Determine 4th Generation Combo to detect antigen was very poor in Swaziland. Thus, Determine Combo does not add any value to the current testing algorithm; rather it adds additional costs and complexity to HIV diagnosis. The detection of acute HIV infections may need to rely on other testing strategies. |
Molecular characterization of ambiguous mutations in HIV-1 polymerase gene: implications for monitoring HIV infection status and drug resistance.
Zheng DP , Rodrigues M , Bile E , Nguyen DB , Diallo K , Devos JR , Nkengasong JN , Yang C . PLoS One 2013 8 (10) e77649 Detection of recent HIV infections is a prerequisite for reliable estimations of transmitted HIV drug resistance (t-HIVDR) and incidence. However, accurately identifying recent HIV infection is challenging due partially to the limitations of current serological tests. Ambiguous nucleotides are newly emerged mutations in quasispecies, and accumulate by time of viral infection. We utilized ambiguous mutations to establish a measurement for detecting recent HIV infection and monitoring early HIVDR development. Ambiguous nucleotides were extracted from HIV-1 pol-gene sequences in the datasets of recent (HIVDR threshold surveys [HIVDR-TS] in 7 countries; n=416) and established infections (1 HIVDR monitoring survey at baseline; n=271). An ambiguous mutation index of 2.04x10(-3) nts/site was detected in HIV-1 recent infections which is equivalent to the HIV-1 substitution rate (2x10(-3) nts/site/year) reported before. However, significantly higher index (14.41x10(-3) nts/site) was revealed with established infections. Using this substitution rate, 75.2% subjects in HIVDR-TS with the exception of the Vietnam dataset and 3.3% those in HIVDR-baseline were classified as recent infection within one year. We also calculated mutation scores at amino acid level at HIVDR sites based on ambiguous or fitted mutations. The overall mutation scores caused by ambiguous mutations increased (0.54x10(-2)3.48x10(-2)/DR-site) whereas those caused by fitted mutations remained stable (7.50-7.89x10(-2)/DR-site) in both recent and established infections, indicating that t-HIVDR exists in drug-naive populations regardless of infection status in which new HIVDR continues to emerge. Our findings suggest that characterization of ambiguous mutations in HIV may serve as an additional tool to differentiate recent from established infections and to monitor HIVDR emergence. |
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