Analyzing the Costs and Impact of the TakeMeHome Program, a Public-Private Partnership to Deliver HIV Self-Test Kits in the United States.

BACKGROUND: HIV testing is an entry point to access HIV care and prevention services. Building Healthy Online Communities developed a website ( TakeMeHome.org ) where participants can order HIV home test kits. The purpose of this study was to analyze the costs and impact of the TakeMeHome program. METHODS: We estimated the costs of TakeMeHome across all participating jurisdictions for the first year of the program. We estimated program costs using purchase orders and invoices, contracts, and allocation of staff time, and the costs included website design, participant recruitment, administration and overhead, HIV self-test kits, and shipping and handling. Primary outcomes of the analysis were total program cost, cost per HIV test, and cost per new HIV diagnosis. RESULTS: The TakeMeHome program distributed 5323 HIV self-tests to 4859 participants over a 12-month period. The total program cost over this period was $314,870. The cost per HIV test delivered was estimated at $59, and the cost per person tested was $65. The program identified 18 confirmed new HIV diagnoses (0.6% positivity) verified with surveillance data in 7 health jurisdictions at $169,890. The cost per confirmed new HIV diagnosis was estimated at $9440. CONCLUSIONS: The TakeMeHome program delivered HIV self-testing at a reasonable cost, and the program may be a cost-effective use of HIV prevention resources. The public-private partnership can be an effective mechanism to validate HIV diagnoses identified with self-testing and provide HIV prevention and linkage to care services.

Associations Between Clinic-Based HIV Testing Guidelines and Population-Level HIV Testing Rates in the United States.

ABSTRACT: Between 2005 and 2006, the United States Preventive Services Task Force and the Centers for Disease Control and Prevention revised their risk-based HIV testing guidelines to include universal HIV testing in routine health care. We examined trends in HIV testing and associations with changing policy recommendations using the 2000-2017 National Health Interview Surveys. Multivariable logistic regression and difference-in-difference approach were used to assess rates and correlates of HIV testing before and after the policy changes. Changes in recommendations had minimal effects on overall HIV testing rates but had significant effects on selected subpopulations. The odds of HIV testing increased disproportionately among African Americans, Hispanics, individuals with some college education, low perceived HIV risks, and those who were never married but decreased among those with no regular source of care. A strategy combining risk-based and routine opt-out testing holds promise to rapidly link recently infected individuals to care while reaching individuals who have never been tested.

Repercussões físicas, emocionais e sociais produzidas pelo HIV/AIDS na vida dos idosos / Physical, emotional and social repercussions caused by HIV/AIDS in the lives of the elderly: thematic oral history perspectives

Introdução: os dados epidemiológicos mostram um aumento da população idosa vivendo com HIV/AIDS no Brasil. Esta doença impacta de diferentes formas a vida da pessoa constituindo um desafio para os serviços de saúde. Objetivo: verificar as alterações físicas, emocionais e sociais produzidas pelo HIV/AIDS na vida de idosos. Metodologia: estudo qualitativo com método história oral temática. Realizado no Serviço de Atendimento Especializado (SAE) em HIV/AIDS de uma cidade do Oeste Catarinense com a inclusão de três idosos, duas mulheres e um homem, com média de idade de 66 anos e diagnóstico do HIV/AIDS há mais de cinco anos. Foram realizados cinco encontros, dois de observação no domicílio e três para realização da entrevista em profundidade com validação de todas as etapas. A análise dos dados foi realizada por meio da análise de conteúdo temática. A pesquisa foi aprovada no comitê de ética. Resultados e discussão: os idosos apresentaram sintomas físicos decorrentes da imunossupressão sendo o principal deles o emagrecimento, que se constituiu como um sinal de alerta para o diagnóstico do HIV/AIDS. As repercussões emocionais foram o medo e a angústia, mais presentes no momento do diagnóstico e início dos tratamentos. As repercussões sociais estiveram atreladas ao isolamento social, saída de grupos e perda do papel no trabalho. Considerações finais: o HIV/AIDS repercute na vida dos idosos e produz diferentes alterações, quer sejam físicas, emocionais e/ou sociais. Nessa direção, incluir essas demandas no planejamento de ações para esse grupo populacional tornará a assistência à saúde mais resolutiva.(AU)

Introduction: epidemiological data show an increase in the elderly population living with HIV/AIDS in Brazil. This disease affects people's lives in different ways and constitutes a challenge for health services. Objective: To verify the physical, emotional, and social repercussions caused by HIV/AIDS in the lives of the elderly. Methodology: a qualitative study which used thematic oral history as a method. The research was carried out at the Specialized Care Service (SAE) on HIV/AIDS in a city in western Santa Catarina, which included three elderly diagnosed with HIV/AIDS for more than five years. Two meet-ings were held for approximation and three moments of in-depth interviews with validation in all stages. Data analysis had performed through thematic content analysis, according to Minayo (2014). Results and discussion: The elderly presented physical symptoms resulting from immunosuppression, the main one being weight loss, which constitutes a warning sign for the diagnosis of HIV/AIDS. The emotional repercussions were the fear and anguish most present at the time of diagnosis and the beginning of treatments. The social repercussions were linked to social isolation, leaving groups, and losing the social role of work, being partially reintroduced. Final considerations: HIV/AIDS affects the lives of the elderly, producing different changes, whether physical, emotional, and social, and health services and an interprofessional team need to ensure a broader view of this whole context to qualify assistance.(AU)

Estigmatização do HIV nas relações de trabalho em Imperatriz, Maranhão, Brasil: barreiras, perdas e silêncio / HIV stigmatization in work relations in Imperatriz, Maranhão, Brazil: barriers, losses, and silence

Objetivos: compreender as problemáticas decorrentes da estigmatização do HIV sobre a vida profissional de trabalhadores soropositivos. Métodos: estudo de abordagem qualitativa com realização de entrevistas semiestruturadas, cujos dados foram categorizados utilizando a técnica de análise de conteúdo na modalidade temática. Os sujeitos da pesquisa foram 15 participantes do grupo de adesão do Centro de Testagem e Aconselhamento de Imperatriz, Maranhão, Brasil. Os discursos foram tratados à luz da teoria do estigma proposta por Erving Goffman. Resultados: a partir da análise, emergiram três categorias: barreiras ­ "[…] porque nunca vão me querer"; perdas ­ "[…] umas me deram amizade, outros me deram preconceito"; e silêncio ­ "[…] ficar… em silêncio todo o tempo". Discussão: as barreiras interpostas aos interlocutores contribuem para uma percepção negativa da possibilidade de reinserção no mercado de trabalho. A prática de demissões discriminatórias leva os trabalhadores a manterem silêncio constante sobre a situação soropositiva, para que o estigma do HIV não os torne alvo de discriminação no ambiente de trabalho

Objectives: to understand the issues from HIV stigmatization over the professional life of seropositive workers. Methods: qualitative study with semistructured interviews, whose data were categorized by using the technique of content analysis in the thematic modality. The subjects of the research are 15 participants of the Group of Adhesion of the Testing and Counseling Center of Imperatriz, Maranhão, Brazil. The discourses were treated in the light of the Theory of Stigma proposed by Erving Goffman. Results: from the analysis, three categories emerged: barriers ­ "[…] because they will never want me;" losses ­ "[…] some showed me friendship, some showed me prejudice;" and silence ­ "[…] keep… silent all the time." Discussion: the barriers imposed to the interlocutors contribute to a negative perception of the possibility of reinsertion in the job market. The practice of discriminatory lay-offs leads workers to keep constant silence about the seropositive situation so that the HIV stigma does not turn them into targets of discrimination at the work environment

Increasing HIV early diagnosis by implementing an automated screening strategy in emergency departments.

INTRODUCTION: Late HIV diagnosis is associated with increased morbidity, mortality and risk of onward transmission. Increasing HIV early diagnosis is still a priority. In this observational study with historical control, we determined the impact of an opportunistic HIV screening strategy in the reduction of late diagnosis and missed opportunities for earlier diagnosis. METHODS: The screening programme was implemented in the emergency department (ED) of the Hospital de Cascais between September 2018 and September 2021. Eligible patients were aged 18-64 years, with no known HIV diagnosis or antibody testing performed in the previous year, and who required blood work for any reason. Out of the 252 153 emergency visits to the ED, we identified 43 153 (17.1%) patients eligible for HIV testing. Among the total population eligible for the screening, 38 357 (88.9%) patients were ultimately tested for HIV. Impact of the ED screening was determined by analysing late diagnosis in the ED and missed opportunities at different healthcare settings 3 years before and 3 years after the start of the ED screening. RESULTS: After 3 years of automated HIV ED testing, we found 69 newly diagnosed HIV cases (54% male, 39% Portuguese nationals, mean age 40.5 years). When comparing the characteristics of HIV diagnoses made in the ED, we observed a significant reduction in the number of people with late HIV diagnosis before and after implementation of the screening programme (78.4% vs. 39.1%, respectively; p = 0.0291). The mean number of missed opportunities for diagnosis also fell (2.6 vs. 1.5 annual encounters with the healthcare system per patient, p = 0.0997). CONCLUSIONS: People living with HIV in Cascais and their providers miss several opportunities for earlier diagnosis. Opportunistic screening strategies in settings previously deemed to be unconventional, such as EDs, are feasible and effective in mitigating missed opportunities for timely HIV diagnosis.

HIV testing in a high prevalence urban area in the US: Identifying missed opportunities two ways.

BACKGROUND: Routine opt-out HIV testing in healthcare settings is often not implemented to its fullest extent. We assessed factors contributing to missed HIV testing opportunities at an academic medical center in Chicago, Illinois, with a routine HIV screening program. METHODS: Retrospective analysis of HIV testing in clinical encounters was performed using multivariate regession models. Missed opportunities were defined as 1) an encounter during which an HIV test was not conducted on a patient later diagnosed with HIV, or 2) an encounter in which a bacterial STI test was performed without HIV testing. RESULTS: Of 122 people newly diagnosed with HIV from 2011-2018, 98 patients had 1215 prior encounters, of which 82.8% were missed opportunities. Female gender, persons not known to be men who have sex with men, and encounter location other than inpatient had higher odds of a missed opportunity. Nearly half (48.4%) of 104,678 bacterial STI testing encounters were missed opportunities. Female gender, older age, lack of syphilis testing, and location outside the emergency department had higher odds of a missed opportunity. CONCLUSIONS: We found a high number of missed HIV testing opportunities, which could be reduced by strengthening routine screening and increasing targeted testing concurrent with STI screening.

Electronic medical record alert increases HIV screening rates: the Foch hospital pilot POP-up project.

BACKGROUND: Despite significant national human immunodeficiency virus (HIV) screening activity, there are persistent delays in screening, and many missed diagnostic opportunities. To facilitate targeted screening, an electronic medical record (EMR) alert reminder was applied in the Foch hospital. Screening rates after implementation were reported. METHODS: A prospective cohort analysis was performed in Foch Hospital between 24 April 2018 and 4 October 2019 among hospitalized patients born in high HIV prevalence countries and/or having social vulnerability criteria (universal health coverage). From the admissions software, when specific low health coverage was provided and/or high-prevalence country of birth was registered, an electronic alert (EMR alert) appeared on the ward where the patient was hospitalized. The EMR alert database was examined for HIV screening and activity responses from each service of the Hospital. RESULTS: Eight thousand one hundred eighty-one alerts were recovered during the period for 1448 patients. 27 services used the EMR alert. Most of the alerts were directly closed (74.4%), 14.5% of the alerts were closed due to doctors declaring that they did not have time to respond. 297 (3.6%) of the 8181 alerts resulted in a prescription of HIV serology corresponding for 20.5% of the patients. CONCLUSION: EMR alert can help to increase the rate of HIV screening in hospital care practice. Through this EMR alert system, HIV screening can be implemented as a common practice like any other medical alternative. Future research should examine the factors influencing physicians' attitudes to this alert system to improve the HIV screening rate.

Universal HIV screening in the emergency department: an interrupted time series analysis.

We performed a calendar-matched, 12-month, before (November 27, 2017 to November 26, 2018) and after (November 27, 2018 to November 26, 2019) study, to assess the utility of an emergency department-based HIV screening program. There were 710 and 14 335 patients screened for HIV during the pre and post-best practice alert (BPA) periods, respectively, representing more than a 20-fold increase in HIV screening following BPA implementation. Total HIV positive tests increased 5-fold following BPA implementation.

Prevalence of polypharmacy and associated factors among patients living with HIV infection in Spain: The POINT study / Prevalencia y factores asociados a la polifarmacia en pacientes VIH+ en España. Estudio POINT

PurposeSurvival in people living with HIV (PLWH) has increased and thus people are aging with HIV, increasing the frequency of multimorbidity and polypharmacy. This cross-sectional study was conducted to evaluate the prevalence of polypharmacy among PLWH who were on antiretroviral treatment and were followed in an outpatient setting by the pharmacy department of several hospitals across Spain. In addition, we aimed to evaluate factors associated with polypharmacy and treatment complexity among this population.Material and methodsWe recorded information on demographic data, data on disease control including viral load and CD4 count at the time of inclusion, comorbidities, pharmacologic treatment and drugs interactions. Polypharmacy was defined as the use of 6 or more different drugs, including antiretroviral medication; major polypharmacy was defined as the use of ≥11 different drugs.ResultsOverall, 1225 PLWH were eligible in the study. The median (IQR) age was 49 (40–54). Comorbidities were present in 819 (67%) PLWH and 571 (47%) had two or more comorbidities. Overall, 397 (32.4%, 95% CI 29.8–34.9) PLWH met the criteria for polypharmacy, and 67 (5.5%, 95% CI, 4.2–6.7) had major polypharmacy. Several factors were associated with polypharmacy such as type of antiretroviral treatment, presence of potential interactions, the use of several types of medications and the number of comorbidities. Treatment complexity was also a factor strongly associated with polypharmacy; for each point increase in the medication regimen complexity index (MRCI), the likelihood of polypharmacy increased 2.3-fold.ConclusionsPolypharmacy is frequent among PLWH in Spain and contributes to a relevant extent to treatment complexity.

ObjetivoLa supervivencia de las personas con infección por el VIH ha aumentado notablemente en los últimos años incrementado la edad de estos sujetos. Ello se asocia con una mayor presencia de multimorbilidad y polifarmacia. El objetivo de este estudio es evaluar la prevalencia de la polifarmacia en pacientes VIH+ con tratamiento antirretroviral activo seguidos en las consultas externas de los servicios de farmacia hospitalaria en toda España. Adicionalmente, analizar los factores asociados a polifarmacia y a la complejidad farmacoterapéutica en esta población.Material y métodosEstudio multicéntrico, transversal. Se recogieron variables demográficas, variables relacionadas con el control de la enfermedad como la carga viral y los linfocitos CD4, las comorbilidades, el tratamiento farmacológico completo del paciente y la presencia de interacciones. La polifarmacia se definió como el uso de al menos 6 fármacos incluyendo el TAR. Se definió polifarmacia mayor como la toma de más de 11 fármacos diferentes. Se midió la complejidad farmacoterapéutica por la escala de valoración Medication Regimen Complexity Index (MRCI).ResultadosSe incluyeron 1.225 pacientes. La mediana (RIQ) de edad fue de 49 años (40-54). En total 819 (67,0%) pacientes presentaban al menos una comorbilidad en el momento del estudio, teniendo 2 o más comorbilidades, el 47,0% de los mismos. Un total de 397 (32,4%; IC 95%: 29,8-34,9) pacientes cumplieron los criterios de polifarmacia y 67 (5,5%; IC 95%: 4,2-6,7) los de polifarmacia mayor. Los factores asociados con la polifarmacia fueron: el tratamiento antirretroviral, la presencia de interacciones potenciales, el uso de diferentes tipos de fármacos y el número de comorbilidades. La complejidad farmacoterapéutica se asoció de forma importante con la presencia de polifarmacia, incrementándose su probabilidad de aparición entre 2 y 3 veces por cada incremento en un punto en su escala de valoración.Conclusión

Anti-HIV serological test algorithms to reduce false-positive and inconclusive results for low HIV prevalence and resource-limited areas.

A false-positive anti-human immunodeficiency virus (HIV) test result can have devastating consequences. Sequential HIV serological testing is a strategy that could be applied in resource-limited settings to reduce false-positive results when a nucleic acid test is not affordable. We aimed to compare the results of sequential anti-HIV testing algorithms recommended by the national guidelines and our hospital algorithm in the setting of low HIV prevalence. We retrospectively reviewed individuals whose anti-HIV tested positive by Architect HIV Ag/Ab Combo with a signal/cut-off ratio of 1.00-20.00 between January 2015 and June 2016 at a university hospital in Bangkok, Thailand. A total of 111,224 samples were requested for anti-HIV tests during the study period. Sixty-six adults and nine children/adolescents met the inclusion criteria of this study. Compared to the national guidelines, our hospital HIV diagnosis algorithm could identify two individuals with false-positive anti-HIV tests and a reduction of inconclusive diagnoses from 45 to one adult cases (p <.001). It also eliminated inconclusive diagnoses in four non-infected children with HIV-negative mothers. Our hospital HIV diagnosis algorithm can reduce the number of HIV misdiagnoses of serological tests in an area with low HIV prevalence. The sequential HIV serological test algorithms should be reviewed and evaluated in each institute.

HIV testing and ART initiation among partners, family members, and high-risk associates of index clients participating in the CommLink linkage case management program, Eswatini, 2016-2018.

To help diagnose and initiate antiretroviral therapy (ART) for ≥95% of all persons living with HIV (PLHIV), the World Health Organization (WHO) recommends offering HIV testing to biological children, and sexual and needle-sharing partners of all PLHIV (index-client testing, ICT). Many index clients, however, do not identify or have contactable partners, and often substantially fewer than 95% of HIV-positive partners initiate ART soon after index testing. To help improve early HIV diagnosis and ART initiation in Eswatini (formerly Swaziland), we implemented a community-based HIV testing and peer-delivered, linkage case management program (CommLink) that provided ICT as part of a comprehensive package of WHO recommended linkage services. CommLink was implemented June 2015 -March 2017 (Phase I), and April 2017 -September 2018 (Phase II). In addition to biological children and partners, HIV testing was offered to adult family members (Phases I and II) and high-risk associates including friends and acquaintances (Phase II) of CommLink index clients. Compared with Phase I, in Phase II proportionally more CommLink clients disclosed their HIV-infection status to a partner or family member [94% (562/598) vs. 75% (486/652)], and had ≥1 partners, family members, or high-risk associates (contacts) tested through CommLink [41% (245/598) vs. 18% (117/652)]. Of 537 contacts tested, 253 (47%) were HIV-positive and not currently in HIV care, including 17% (17/100) of family members aged <15 years, 42% (78/187) of non-partner family members aged ≥15 years, 60% (73/121) of sexual partners, and 66% (85/129) of high-risk associates. Among 210 HIV-positive contacts aged ≥15 years who participated in CommLink, nearly all received recommended linkage services including treatment navigation (95%), weekly telephone follow-up (93%), and ≥3 counseling sessions (94%); peer counselors resolved 76% (306/404) of identified barriers to care (e.g., perceived wellness); and 200 (95%) initiated ART at a healthcare facility, of whom 196 (98%) received at least one antiretroviral refill before case-management services ended. To help countries achieve ≥90% ART coverage among all PLHIV, expanding ICT for adult family members and high-risk associates of index clients, and providing peer-delivered linkage case management for all identified PLHIV, should be considered.

Abscesos de córnea bilaterales en una paciente con SIDA. Presentación de un caso y revisión de la literatura / Corneal Abscess in a patient with aids: case report and literature review

El epitelio corneal es una importante barrera de defensa que impide el ingreso de una gran variedad de microorganismos. Cualquier alteración de la superficie ocular facilita la invasión bacteriana de la córnea. El germen más frecuentemente identificado es Staphylococcus aureus. Se presenta una paciente con enfermedad debida al virus de la inmunodeficiencia humana (VIH) con diagnóstico de sida, absceso corneal bilateral y lesiones cutáneas. S.aureus meticilino resistente se aisló en hemocultivos y en material obtenido por raspado de la córnea. El absceso corneal es una entidad poco frecuente en pacientes con infección por VIH y síndrome de inmunodeficiencia adquirida.

The corneal epithelium is an important defense barrier that prevents the entry of great variety of microorganisms. Any alteration of the ocular surface facilitates bacterial invasion of the cornea. The most frequently reported germ is Staphylococcus aureus. Here, we present a patient with a diagnosis of HIV/ AIDS disease, who developed bilateral corneal abscess and skin lesions. Methicillin-resistant Staphylococcus aureus was isolated from blood cultures and corneal scrapings. Corneal abscess is a rare entity in patients with HIV and acquired immunodeficiency syndrome

Tensor-structured decomposition improves systems serology analysis.

Systems serology provides a broad view of humoral immunity by profiling both the antigen-binding and Fc properties of antibodies. These studies contain structured biophysical profiling across disease-relevant antigen targets, alongside additional measurements made for single antigens or in an antigen-generic manner. Identifying patterns in these measurements helps guide vaccine and therapeutic antibody development, improve our understanding of diseases, and discover conserved regulatory mechanisms. Here, we report that coupled matrix-tensor factorization (CMTF) can reduce these data into consistent patterns by recognizing the intrinsic structure of these data. We use measurements from two previous studies of HIV- and SARS-CoV-2-infected subjects as examples. CMTF outperforms standard methods like principal components analysis in the extent of data reduction while maintaining equivalent prediction of immune functional responses and disease status. Under CMTF, model interpretation improves through effective data reduction, separation of the Fc and antigen-binding effects, and recognition of consistent patterns across individual measurements. Data reduction also helps make prediction models more replicable. Therefore, we propose that CMTF is an effective general strategy for data exploration in systems serology.

Correlação entre os métodos sorológico e molecular para detecção do HIV na triagem de doadores de sangue na Fundação HEMOPA / Correlation between sorological and molecular methods for HIV detection in blood donor screening in HEMOPA Foundation

Objetivo: Buscar a correlação entre os métodos sorológico e molecular para detecção do HIV na triagem de doadores de sangue na Fundação HEMOPA. Métodos: Realizou-se a busca das amostras reagentes para HIV, referente aos anos de 2015 a 2019 no Sistema de Banco de Sangue da Fundação HEMOPA. Para análise estatística, utilizou-se o programa SPSS para a comparação das medianas dos valores de S/CO com NAT detectável e indetectável. O teste de X² foi utilizado para apontar a correlação dos valores de S/CO com a presença do RNA viral. Resultados: Obtiveram-se para o estudo 910 amostras reagentes, na qual 75,60% (688/910) positivas (S/CO >1,2) e 24,40% (222/910) inconclusivas (S/CO 0,8-1,2). A mediana de S/CO das amostras detectáveis foi de 503,93 e das indetectáveis foi de 1,22 no NAT. Conclusão: Estabelecemos que na triagem sorológica-molecular há uma correlação estatisticamente significante, na qual a presença de anticorpos e/ou antígenos no teste ARCHITECH HIV Ag/Ab Combo orienta a predição de viremia no NAT.

Objective: Search for the correlation between serological and molecular methods of HIV detection in screening blood donors at the HEMOPA Foundation. Methods: The HIV reagent samples were searched for the years 2015 to 2019 in the Blood Bank System of the HEMOPA Foundation. For statistical analysis, the SPSS program was used to compare the medians of the S / CO values with detectable and undetectable NAT. The X² test was used to point out the correlation between S / CO values and the presence of viral RNA. Results: 910 reagent samples were obtained for the study, in which 75.60% (688/910) positive (S / CO> 1.2) and 24.40% (222/910) inconclusive (S / CO 0.8) -1.2). The median S / CO of the detectable samples was 503.93 and the undetectable was 1.22 in NAT. Conclusion: We established that in serological-molecular screening there is a statistically significant correlation, in which the presence of antibodies and / or antigens in the ARCHITECH HIV Ag / Ab Combo test guides the prediction of viremia in NAT.

Deep learning of HIV field-based rapid tests.

Although deep learning algorithms show increasing promise for disease diagnosis, their use with rapid diagnostic tests performed in the field has not been extensively tested. Here we use deep learning to classify images of rapid human immunodeficiency virus (HIV) tests acquired in rural South Africa. Using newly developed image capture protocols with the Samsung SM-P585 tablet, 60 fieldworkers routinely collected images of HIV lateral flow tests. From a library of 11,374 images, deep learning algorithms were trained to classify tests as positive or negative. A pilot field study of the algorithms deployed as a mobile application demonstrated high levels of sensitivity (97.8%) and specificity (100%) compared with traditional visual interpretation by humans-experienced nurses and newly trained community health worker staff-and reduced the number of false positives and false negatives. Our findings lay the foundations for a new paradigm of deep learning-enabled diagnostics in low- and middle-income countries, termed REASSURED diagnostics1, an acronym for real-time connectivity, ease of specimen collection, affordable, sensitive, specific, user-friendly, rapid, equipment-free and deliverable. Such diagnostics have the potential to provide a platform for workforce training, quality assurance, decision support and mobile connectivity to inform disease control strategies, strengthen healthcare system efficiency and improve patient outcomes and outbreak management in emerging infections.

Evaluation of Geenius HIV-1/2 Confirmatory Assay for the confirmatory and differential diagnosis of HIV-1/HIV-2 in Japan and reliability of the Geenius Reader in the diagnosis of HIV-2.

BACKGROUND: NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. We evaluated the performance of Geenius HIV-1/2 Confirmatory Assay (Geenius), both as a confirmatory test and for differentiation between HIV-1 and HIV-2, in comparison with LAV I and LAV II. METHODS: Eighty-nine HIV-1-positive plasma specimens, one anti-HIV-1 low-titer performance panel, 10 seroconversion panels, and two anti-HIV-1/2 combo performance panels were tested. The results were read with the Geenius Reader and by visual reading. RESULTS: All 89 HIV-1-positive plasma specimens were identified as HIV-1-positive using Geenius; this 100% success rate was superior to that with LAV I (95.5% using WHO criteria, 98.9% using CDC criteria). The HIV-1-positive specimens showed low cross-reactivity with HIV-2 lines in Geenius. The sensitivity of Geenius for HIV-1 detection was the same as or greater than that of LAV I, but less than that of Genscreen HIV Ag-Ab ULT, in our analysis of the commercial performance and seroconversion panels. In contrast, five of the 13 HIV-2-positive specimens that had been identified as HIV-positive untypable by visual reading because of their cross-reactivity to HIV-1 lines were successfully identified by the Geenius Reader as HIV-2-positive with cross-reactivity. CONCLUSIONS: Geenius provides strong performance for HIV confirmatory tests and HIV-1 differentiation tests. However, when visual reading is used, its performance in HIV-2 differentiation is less reliable. Because HIV-2 infection has been sporadically reported in Japan, the use of the Geenius Reader is preferable to ensure more reliable HIV-1/HIV-2 differentiation.