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  • Congo’s Ebola epidemic—a failed response and the need for a reset

    Huster, K; Healy, J (BMJ Publishing Group, 2019-05-24)
  • Molecular epidemiology of hepatitis C virus in Cambodia during 2016-2017.

    Nouhin, J; Iwamoto, M; Prak, S; Dousset, JP; Phon, K; Heng, S; Kerleguer, A; Le Paih, M; Dussart, P; Maman, D; Rouet, F (Nature Publishing Group, 2019-05-13)
    In Cambodia, little epidemiological data of hepatitis C virus (HCV) is available. All previous studies were limited to only small or specific populations. In the present study, we performed a characterization of HCV genetic diversity based on demography, clinical data, and phylogenetic analysis of HCV non-structural 5B (NS5B) sequences belonging to a large cohort of patients (n = 3,133) coming from majority part of Cambodia between September 2016 and December 2017. The phylogenetic analysis revealed that HCV genotype 1 and 6 were the most predominant and sharing equal proportions (46%). The remaining genotypes were genotype 2 (4.3%) and unclassified variants (3.6%). Among genotype 1, subtype 1b was the most prevalent subtype accounting for 94%. Within genotype 6, we observed a high degree of diversity and the most common viral subtypes were 6e (44%) and 6r (23%). This characteristic points to the longstanding history of HCV in Cambodia. Geographic specificity of viral genotype was not observed. Risks of HCV infection were mainly associated with experience of an invasive medical procedure (64.7%), having partner with HCV (19.5%), and blood transfusion (9.9%). In addition, all of these factors were comparable among different HCV genotypes. All these features define the specificity of HCV epidemiology in Cambodia.
  • Antibiotic resistance in conflict settings: lessons learned in the Middle East

    Kanapathipillai, R; Malou, N; Hopman, J; Bowman, C; Yousef, N; Michel, J; Hussein, N; Herard, P; Ousley, J; Mills, C; Seguin, C; Saim, M (Oxford University Press, 2019-04-10)
    Me´decins Sans Frontie`res (MSF) has designed context-adapted antibiotic resistance (ABR) responses in countries across the Middle East. There, some health systems have been severely damaged by conflict resulting in delayed access to care, crowded facilities and supply shortages. Microbiological surveillance data are rarely available, but when MSF laboratories are installed we often find MDR bacteria at alarming levels.1 In MSF’s regional hospital in Jordan, where surgical patients have often had multiple surgeries in field hospitals before reaching definitive care (often four or more), MSF microbiological data analysis reveals that, among Enterobacteriaceae isolates, third-generation cephalosporin and carbapenem resistance is 86.2% and 4.3%, respectively; MRSA prevalence among Staphylococcus aureus is 60.5%; and resistance types and rates are similar in patients originating from Yemen, Syria and Iraq.1–3 These trends compel MSF to aggressively prevent and diagnose ABR in Jordan, providing ABR lessons that inform the antibiotic choices, microbiological diagnostics and anti-ABR strategies in other Middle Eastern MSF trauma projects (such as Yemen and Gaza). As a result, MSF has created a multifaceted, context-adapted, field experience-based, approach to ABR in hospitals in Middle Eastern conflict settings. We focus on three pillars: (1) infection prevention and control (IPC); (2) microbiology and surveillance; and (3) antibiotic stewardship.
  • An Epidemic of Suspicion - Ebola and Violence in the DRC

    Nguyen, VK (Massachusetts Medical Society, 2019-04-04)
    Until the 2014 Ebola epidemic in West Africa, Ebola outbreaks had been sporadic, small, and largely confined to isolated rural villages in Central Africa. But the 2014 epidemic broke all the rules and killed more than 15,000 people; since then, more outbreaks have been reaching larger urban centers, sometimes resulting in uncontrolled spread. The current epidemic in the Democratic Republic of Congo (DRC) has triggered a massive international response, which has been met by violence, culminating in attacks at the end of February that partially destroyed Ebola treatment units in the regional hub of Butembo and its township, Katwa. This area is the epicenter of the epidemic, which is likely to be fueled by any breakdown of isolation and treatment efforts.
  • 2017 Outbreak of Ebola Virus Disease in Northern Democratic Republic of Congo

    Nsio, J; Kapetshi, J; Makiala, S; Raymond, F; Tshapenda, G; Boucher, N; Corbeil, J; Okitandjate, A; Mbuyi, G; Kiyele, M; Mondonge, V; Kikoo, MJ; Van Herp, M; Barboza, P; Petrucci, R; Benedetti, G; Formenty, P; Muzinga, BM; Kalenga, OI; Ahuka, S; Fausther-Bovendo, H; Ilunga, BK; Kobinger, GP; Muyembe, JJT (Oxford University Press, 2019-04-03)
    Background In 2017, the Democratic Republic of the Congo (DRC) recorded its eighth Ebola virus disease (EVD) outbreak, approximately 3 years after the previous outbreak. Methods Suspect cases of EVD were identified on the basis of clinical and epidemiological information. Reverse transcription–polymerase chain reaction (RT-PCR) analysis or serological testing was used to confirm Ebola virus infection in suspected cases. The causative virus was later sequenced from a RT-PCR–positive individual and assessed using phylogenetic analysis. Results Three probable and 5 laboratory-confirmed cases of EVD were recorded between 27 March and 1 July 2017 in the DRC. Fifty percent of cases died from the infection. EVD cases were detected in 4 separate areas, resulting in > 270 contacts monitored. The complete genome of the causative agent, a variant from the Zaireebolavirus species, denoted Ebola virus Muyembe, was obtained using next-generation sequencing. This variant is genetically closest, with 98.73% homology, to the Ebola virus Mayinga variant isolated from the first DRC outbreaks in 1976–1977. Conclusion A single spillover event into the human population is responsible for this DRC outbreak. Human-to-human transmission resulted in limited dissemination of the causative agent, a novel Ebola virus variant closely related to the initial Mayinga variant isolated in 1976–1977 in the DRC.
  • Antibiotic Resistance in Pacific Island Countries and Territories: A Systematic Scoping Review

    Foxlee, ND; Townell, N; McIver, L; Lau, CL (Multidisciplinary Digital Publishing Institute, 2019-03-19)
    Several studies have investigated antimicrobial resistance in low- and middle-income countries, but to date little attention has been paid to the Pacific Islands Countries and Territories (PICTs). This study aims to review the literature on antibiotic resistance (ABR) in healthcare settings in PICTs to inform further research and future policy development for the region. Following the PRISMA-ScR checklist health databases and grey literature sources were searched. Three reviewers independently screened the literature for inclusion, data was extracted using a charting tool and the results were described and synthesised. Sixty-five studies about ABR in PICTs were identified and these are primarily about New Caledonia, Fiji and Papua New Guinea. Ten PICTs contributed the remaining 21 studies and nine PICTs were not represented. The predominant gram-positive pathogen reported was community-acquired methicillin resistant S. aureus and the rates of resistance ranged widely (>50% to <20%). Resistance reported in gram-negative pathogens was mainly associated with healthcare-associated infections (HCAIs). Extended spectrum beta-lactamase (ESBL) producing K. pneumoniae isolates were reported in New Caledonia (3.4%) and Fiji (22%) and carbapenem resistant A. baumannii (CR-ab) isolates in the French Territories (24.8%). ABR is a problem in the PICTs, but the epidemiology requires further characterisation. Action on strengthening surveillance in PICTs needs to be prioritised so strategies to contain ABR can be fully realised.
  • Clinical Practice Guidelines for Chagas Disease: Recent Developments and Future Needs

    Forsyth, C; Marchiol, A; Herazo, R; Chatelain, E; Batista, C; Strub-Wourgraft, N; Bilbe, G; Sosa-Estani, S (Brazilian Society of Tropical Medicine, 2019-03-08)
  • Control of Ebola virus disease outbreaks: Comparison of health care worker-targeted and community vaccination strategies.

    Robert, A; Camacho, A; Edmunds, WJ; Rosello A; Baguelin, M; Muyembe, JJT; Eggo, RM; Keita, S (Elsevier, 2019-03-02)
    Health care workers (HCW) are at risk of infection during Ebola virus disease outbreaks and therefore may be targeted for vaccination before or during outbreaks. The effect of these strategies depends on the role of HCW in transmission which is understudied. To evaluate the effect of HCW-targeted or community vaccination strategies, we used a transmission model to explore the relative contribution of HCW and the community to transmission. We calibrated the model to data from multiple Ebola outbreaks. We quantified the impact of ahead-of-time HCW-targeted strategies, and reactive HCW and community vaccination. We found that for some outbreaks (we call "type 1″) HCW amplified transmission both to other HCW and the community, and in these outbreaks prophylactic vaccination of HCW decreased outbreak size. Reactive vaccination strategies had little effect because type 1 outbreaks ended quickly. However, in outbreaks with longer time courses ("type 2 outbreaks"), reactive community vaccination decreased the number of cases, with or without prophylactic HCW-targeted vaccination. For both outbreak types, we found that ahead-of-time HCW-targeted strategies had an impact at coverage of 30%. The vaccine strategies tested had a different impact depending on the transmission dynamics and previous control measures. Although we will not know the characteristics of a new outbreak, ahead-of-time HCW-targeted vaccination can decrease the total outbreak size, even at low vaccine coverage.
  • Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape

    Emperador DM; Mazzola LT; Trainor BW; Chua A; Kelly-Cirino C (BMJ Publishing Group, 2019-02-07)
    Ebolaviruses and Marburg virus (MARV) both belong to the family Filoviridae and cause severe haemorrhagic fever in humans. Due to high mortality rates and potential for spread from rural to urban regions, they are listed on the WHO R&D blueprint of high-priority pathogens. Recent ebolavirus outbreaks in Western and Central Africa have highlighted the importance of diagnostic testing in epidemic preparedness for these pathogens and led to the rapid development of a number of commercially available benchtop and point-of-care nucleic acid amplification tests as well as serological assays and rapid diagnostic tests. Despite these advancements, challenges still remain. While products approved under emergency use licenses during outbreak periods may continue to be used post-outbreak, a lack of clarity and incentive surrounding the regulatory approval pathway during non-outbreak periods has deterred many manufacturers from seeking full approvals. Waning of funding and poor access to samples after the 2014–2016 outbreak also contributed to cessation of development once the outbreak was declared over. There is a need for tests with improved sensitivity and specificity, and assays that can use alternative sample types could reduce the need for invasive procedures and expensive equipment, making testing in field conditions more feasible. For MARV, availability of diagnostic tests is still limited, restricted to a single ELISA test and assay panels designed to differentiate between multiple pathogens. It may be helpful to extend the target product profile for ebolavirus diagnostics to include MARV, as the viruses have many overlapping characteristics.
  • Accelerating the Elimination of Viral Hepatitis: a Lancet Gastroenterology & Hepatology Commission.

    Cooke, GS; Andrieux-Meyer, I; Applegate, TL; Atun, R; Burry, JR; Cheinquer, H; Dusheiko, G; Feld, JJ; Gore, C; Griswold, MG; Hamid, S; Hellard, ME; Hou, J; Howell, J; Jia, J; Kravchenko, N; Lazarus, JV; Lemoine, M; Lesi, OA; Maistat, L; McMahon, BJ; Razavi, H; Roberts, TR; Simmons, B; Sonderup, MW; Spearman, WC; Taylor, BE; Thomas, DL; Waked, I; Ward, JW; Wiktor, SZ (Elsevier, 2019-02-01)
    Viral hepatitis is a major public health threat and a leading cause of death worldwide. Annual mortality from viral hepatitis is similar to that of other major infectious diseases such as HIV and tuberculosis. Highly effective prevention measures and treatments have made the global elimination of viral hepatitis a realistic goal, endorsed by all WHO member states. Ambitious targets call for a global reduction in hepatitis-related mortality of 65% and a 90% reduction in new infections by 2030. This Commission draws together a wide range of expertise to appraise the current global situation and to identify priorities globally, regionally, and nationally needed to accelerate progress. We identify 20 heavily burdened countries that account for over 75% of the global burden of viral hepatitis. Key recommendations include a greater focus on national progress towards elimination with support given, if necessary, through innovative financing measures to ensure elimination programmes are fully funded by 2020. In addition to further measures to improve access to vaccination and treatment, greater attention needs to be paid to access to affordable, high-quality diagnostics if testing is to reach the levels needed to achieve elimination goals. Simplified, decentralised models of care removing requirements for specialised prescribing will be required to reach those in need, together with sustained efforts to tackle stigma and discrimination. We identify key examples of the progress that has already been made in many countries throughout the world, demonstrating that sustained and coordinated efforts can be successful in achieving the WHO elimination goals.
  • Demonstration of the Diagnostic Agreement of Capillary and Venous Blood Samples, Using Hepatitis-C Virus SD Bioline© Rapid Test: A Clinic-based Study

    Sun, C; Iwamoto, M; Calzia, A; Sreng, B; Yann, S; Pin, S; Lastrucci, C; Kimchamroeun, S; Dimanche, C; Dousset, JP; Le Paih, M; Balkan, S; Marquardt, T; Carnimeo, V; Lissouba, P; Maman, D; Loarec, A (Elsevier, 2019-02)
    Simplifying hepatitis C virus (HCV) screening is a key step in achieving the elimination of HCV as a global public health threat by 2030.
  • Post-traumatic osteomyelitis in Middle East war-wounded civilians: resistance to first-line antibiotics in selected bacteria over the decade 2006-2016.

    Fily, F; Ronat, JB; Malou, N; Kanapathipillai, R; Seguin, C; Hussein, N; Fakhri, RM; Langendorf, C (BioMed Central, 2019-01-31)
    War-wounded civilians in Middle East countries are at risk of post-traumatic osteomyelitis (PTO). We aimed to describe and compare the bacterial etiology and proportion of first-line antibiotics resistant bacteria (FLAR) among PTO cases in civilians from Syria, Iraq and Yemen admitted to the reconstructive surgical program of Médecins Sans Frontières (MSF) in Amman, Jordan, and to identify risk factors for developing PTO with FLAR bacteria.
  • Genomic Insights into the 2016-2017 Cholera Epidemic in Yemen

    Weill, FX; Domman, D; Njamkepo, E; Almesbahi, AA; Naji, M; Nasher, SS; Rakesh, A; Assiri, AM; Sharma, NC; Kariuki, S; Pourshafie, MR; Rauzier, J; Abubakar, A; Carter, JY; Wamala, JF; Seguin, C; Bouchier, C; Malliavin, T; Bakhshi, B; Abulmaali, HHN; Kumar, D; Njoroge, SM; Malik, MR; Kiiru, J; Luquero, FJ; Azman, AS; Ramamurthy, T; Thomson, NR; Quilici, ML (Nature Publishing Group, 2019-01-02)
    Yemen is currently experiencing, to our knowledge, the largest cholera epidemic in recent history. The first cases were declared in September 2016, and over 1.1 million cases and 2,300 deaths have since been reported1. Here we investigate the phylogenetic relationships, pathogenesis and determinants of antimicrobial resistance by sequencing the genomes of Vibrio cholerae isolates from the epidemic in Yemen and recent isolates from neighbouring regions. These 116 genomic sequences were placed within the phylogenetic context of a global collection of 1,087 isolates of the seventh pandemic V. cholerae serogroups O1 and O139 biotype El Tor2-4. We show that the isolates from Yemen that were collected during the two epidemiological waves of the epidemic1-the first between 28 September 2016 and 23 April 2017 (25,839 suspected cases) and the second beginning on 24 April 2017 (more than 1 million suspected cases)-are V. cholerae serotype Ogawa isolates from a single sublineage of the seventh pandemic V. cholerae O1 El Tor (7PET) lineage. Using genomic approaches, we link the epidemic in Yemen to global radiations of pandemic V. cholerae and show that this sublineage originated from South Asia and that it caused outbreaks in East Africa before appearing in Yemen. Furthermore, we show that the isolates from Yemen are susceptible to several antibiotics that are commonly used to treat cholera and to polymyxin B, resistance to which is used as a marker of the El Tor biotype.
  • Strategies for access to affordable hepatitis C testing and treatment in Asia

    Khwairakpam, G; Burry, J (2019-01)
    With increasing availability of generic direct-acting antivirals (DAAs) and associated price reductions, various governments, multilateral institutions, and donors have started providing testing and treatment for hepatitis C virus (HCV) infection. More data on the quality of these generic medicines and on cost-effectiveness of their use are becoming widely available. This review seeks to describe some of the treatment programs for HCV that are evolving in Cambodia, India, Indonesia, Malaysia, Myanmar, and Thailand.
  • From Risk to Care: The Hepatitis C Screening and Diagnostic Cascade in a Primary Health Care Clinic in Karachi, Pakistan—a Cohort Study

    Khalid, GG; Kyaw, KWY; Bousquet, C; Auat, R; Donchuk, D; Trickey, A; Hamid, S; Qureshi, H; Mazzeo, V; Aslam, K; Khowaja, S; Van den Bergh, R; Operational Center Brussels, Médecins Sans Frontières, Islamabad, Pakistan; Department of Operational Research, International Union Against Tuberculosis and Lung Disease, Mandalay, Myanmar; Operational Center Brussels, Médecins Sans Frontières, Islamabad, Pakistan; Operational Center Brussels, Brussels, Belgium; Operational Center Brussels, Brussels, Belgium; School of Social and Population Sciences, University of Bristol, Bristol, UK; Department of Medicine, Agha Khan Medical University, Karachi, Pakistan; Pakistan Health Research Council, Islamabad, Pakistan; Operational Center Brussels, Médecins Sans Frontières, Islamabad, Pakistan; Operational Center Brussels, Médecins Sans Frontières, Islamabad, Pakistan; Operational Center Brussels, Médecins Sans Frontières, Islamabad, Pakistan; Operational Center Brussels, Brussels, Belgium (Oxford University Press, 2018-12-28)
    Background In the high-prevalence setting of Pakistan, screening, diagnosis and treatment services for chronic hepatitis C (CHC) patients are commonly offered in specialized facilities. We aimed to describe the cascade of care in a Médecins Sans Frontières primary health care clinic offering CHC care in an informal settlement in Karachi, Pakistan. Methods This was a retrospective cohort analysis using routinely collected data. Three different screening algorithms were assessed among patients with one or more CHC risk factors. Results Among the 87 348 patients attending the outpatient clinic, 5003 (6%) presented with one or more risk factors. Rapid diagnostic test (RDT) positivity was 38% overall. Approximately 60% of the CHC patients across all risk categories were in the early stage of the disease, with an aspartate aminotransferase:platelet ratio index score <1. The sequential delays in the cascade differed between the three groups, with the interval between screening and treatment initiation being the shortest in the cohort tested with GeneXpert onsite. Conclusions Delays between screening and treatment can be reduced by putting in place more patient-centric testing algorithms. New strategies, to better identify and treat the hidden at-risk populations, should be developed and implemented.
  • Increased Hepatitis C Virus Co-infection and Injection Drug Use in HIV-infected Fishermen in Myanmar

    Ousley, J; Nesbitt, R; Kyaw, NTT; Bermudez, E; Soe, KP; Anicete, R; Mon, PE; Le Shwe Sin Ei, W; Christofani, S; Fernandez, M; Ciglenecki, I (BioMed Central, 2018-12-14)
    In Southeast Asia, though fishermen are known to be a key population at high risk of HIV, little is known about their co-infection rates with Hepatitis C virus (HCV), or how illness and risk behaviors vary by occupation or type of fishermen. In Myanmar, this lack of knowledge is particularly acute, despite the fact that much of the country's border is coastline.
  • Urban yellow fever outbreak—Democratic Republic of the Congo, 2016: Towards more rapid case detection

    Ingelbeen, B; Weregemere, NA; Noel, H; Tshapenda, GP; Mossoko, M; Nsio, J; Ronsse, A; Ahuka-Mundeke, S; Cohuet, S; Kebela, BI (Public Library of Sciences, 2018-12-07)
    Background Between December 2015 and July 2016, a yellow fever (YF) outbreak affected urban areas of Angola and the Democratic Republic of the Congo (DRC). We described the outbreak in DRC and assessed the accuracy of the YF case definition, to facilitate early diagnosis of cases in future urban outbreaks. Methodology/Principal findings In DRC, suspected YF infection was defined as jaundice within 2 weeks after acute fever onset and was confirmed by either IgM serology or PCR for YF viral RNA. We used case investigation and hospital admission forms. Comparing clinical signs between confirmed and discarded suspected YF cases, we calculated the predictive values of each sign for confirmed YF and the diagnostic accuracy of several suspected YF case definitions. Fifty seven of 78 (73%) confirmed cases had travelled from Angola: 88% (50/57) men; median age 31 years (IQR 25–37). 15 (19%) confirmed cases were infected locally in urban settings in DRC. Median time from symptom onset to healthcare consultation was 7 days (IQR 6–9), to appearance of jaundice 8 days (IQR 7–11), to sample collection 9 days (IQR 7–14), and to hospitalization 17 days (IQR 11–26). A case definition including fever or jaundice, combined with myalgia or a negative malaria test, yielded an improved sensitivity (100%) and specificity (57%). Conclusions/Significance As jaundice appeared late, the majority of cases were diagnosed too late for supportive care and prompt vector control. In areas with known local YF transmission, a suspected case definition without jaundice as essential criterion could facilitate earlier YF diagnosis, care and control.
  • Real-Time PCR for the Evaluation of Treatment Response in Clinical Trials of Adult Chronic Chagas Disease: Usefulness of Serial Blood Sampling and qPCR Replicates

    Parrado, R; Ramirez, JC; de la Barra, A; Alonso-Vega, C; Juiz, N; Ortiz, L; Illanes, D; Torrico, F; Gascon, J; Alves, F; Flevaud, L; Garcia, L; Schijman, AG; Ribeiro, I (American Society for Microbiology, 2018-12-03)
    This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real-time PCR (qPCR) for baseline detection and quantification of parasitic loads and post-treatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely DNDi-CH-E1224-001 (NCT01489228) and MSF-DNDi PCR sampling optimization study (NCT01678599). Patients from Cochabamba (N= 294), Tarija (N= 257), and Aiquile (N= 220) were enrolled. Three serial blood samples were collected at each time-point and qPCR triplicates were tested per sample. The first two samples were collected during the same day and the third one seven days later.A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pre-treatment sample positivity from 54.8 to 76.2%, 59.5 to 77.8%, and 73.5 to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively. This strategy increased the detection of treatment failure from 72.9 to 91.7%, 77.8 to 88.9%, and 42.9 to 69.1% for E1224 low, short, and high dosage regimens, respectively; and from 4.6 to 15.9% and 9.5 to 32.1% for the benznidazole arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The addition of the third blood sample and third qPCR replicate in patients with non-detectable PCR results in the first two samples, gave a small, non-statistically significant improvement in qPCR positivity. No change in clinical sensitivity was seen with a blood volume increase from 5 to 10 ml. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasional non-detectable results. In conclusion, serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials, which require an initial positive qPCR result for patient admission.
  • Field evaluation of GeneXpert® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia.

    Iwamoto, M; Calzia, A; Dublineau, A; Rouet, F; Nouhin, J; Yann, S; Pin, S; Sun, C; Sann, K; Dimanche, C; Lastrucci, C; Coulborn, R; Maman, D; Dousset, JP; Loarec, A (Wiley-Blackwell, 2018-12-03)
    GeneXpert® (Cepheid) is the only WHO prequalified platform for hepatitis C virus (HCV) nucleic acid amplification testing that is suitable for point-of-care use in resource-limited contexts. However, its application is constrained by the lack of evidence on genotype 6 (GT6) HCV. We evaluated its field performance among a patient population in Cambodia predominantly infected with GT6. Between August and September 2017, we tested plasma samples obtained from consenting patients at Médecins Sans Frontières' HCV clinic at Preah Kossamak Hospital for HCV viral load (VL) using GeneXpert® and compared its results to those obtained using COBAS® AmpliPrep/Cobas® TaqMan® HCV Quantitative Test, v2.0 (Roche) at the Institut Pasteur du Cambodge. Among 769 patients, 77% of the seropositive patients (n = 454/590) had detectable and quantifiable VL using Roche and 43% (n = 195/454) were GT6. The sensitivity and specificity of GeneXpert® against Roche were 100% (95% CI 99.2, 100.0) and 98.5% (95% CI 94.8, 99.8). The mean VL difference was -0.01 (95% CI -0.05, 0.02) log10  IU/mL for 454 samples quantifiable on Roche and -0.07 (95% CI -0.12, -0.02) log10  IU/mL for GT6 (n = 195). The limit of agreement (LOA) was -0.76 to 0.73 log10  IU/mL for all GTs and -0.76 to 0.62 log10 IU/mL for GT6. Twenty-nine GeneXpert® results were outside the LOA. Frequency of error and the median turnaround time (TAT) for GeneXpert® were 1% and 0 days (4 days using Roche). We demonstrated that the GeneXpert® HCV assay has good sensitivity, specificity, quantitative agreement, and TAT in a real-world, resource-limited clinical setting among GT6 HCV patients.
  • Defining priority medical devices for cancer management: a WHO initiative

    Velazquez Berumen, A; Jimenez Moyao, G; Rodriguez, NM; Ilbawi, AM; Migliore, A; Shulman, LN (The Lancet, 2018-12)

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