Toolkit
HIV Treatment and Care
Este algoritmo está dirigido a aquellos laboratorios que cuentan con capacidad instalada para la detección (molecular, antigénica y/o serológica) de dengue (DENV), Zika (ZIKV) y chikungunya(CHIKV),y como parte del diagnóstico diferencial para Arbovirus. Para la manipulación de muestras sosp...echosas, se requiere un nivel de contención BSL2
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Aлгоритм лабораторной диагностики и мониторинга лечения туберкулеза легких и туберкулеза с лекарственной устойчивостью на основе применения современных быстрых... молекулярных методов.
Экспертное заключение членов основной группы Европейской лабораторной инициативы, подготовленное для Европейского региона ВОЗ.
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Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
Le défi des pays en voie de développement est la disponibilité de méthodes de diagnostic rapide et précis pour le management de la tuberculose. Des techniques moléculaires offrent cet avantage et nous avons utilisé le test GeneXpert MTB/RIF dans le diagnostic de la tuberculose extra-pulmonair...e pour évaluer sa performance par rapport aux méthodes conventionnelles.
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Molecular methods for antimicrobial resistance (AMR)diagnostics to enhance the Global Antimicrobial Resistance Surveillance System
Timely detection of novel coronavirus (2019-nCoV) infection cases is crucial to interrupt the spread of this virus. We assessed the required expertise and capacity for molecular detection of 2019-nCoV in specialised laboratories in 30 European Union/European Economic Area (EU/EEA) countries. Thirty-...eight laboratories in 24 EU/EEA countries had diagnostic tests available by 29 January 2020. A coverage of all EU/EEA countries was expected by mid-February. Availability of primers/probes, positive controls and personnel were main implementation barriers.
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Many in-house and commercial assays that detect the COVID-19 virus have been developed or are currently under development. Many of these molecular assays are currently being validated in partner laboratories. An overview of assays that have applied to FIND for participation in their assay assessment... work can be found here
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FIND conducted independent evaluations at the University Hospitals of Geneva (HUG), to verify the limit of detection (LOD) and the clinical performance (as reported by the manufacturers) of the following molecular test kits. The LOD analysis was performed using cultured viral stocks from a clinical ...isolate from Switzerland, and quantified using an E gene standard. The clinical performance analysis was conducted on extracted samples from individuals suspected to have COVID-19 that were tested using an in-house PCR protocol that was optimized based on the Tib Molbiol assay.
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Intensificar o reforço das abordagens de monitorização do tratamento através dos testes da carga viral, assim como o diagnóstico pediátrico precoce, será fundamental para garantir cuidados e tratamentos de boa qualidade e o êxito dos programas. Considerar uma boa rede de diagnósticos, tipos... de amostras, intervenções e estratégias em cada um dos países e em todas as partes interessadas nacionais, regionais e parceiros contribuirá para apoiar este esforço, melhorar a colaboração e maximizar o investimento nos diagnósticos para um impacto clínico visível.
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L’expansion de la mise en œuvre des approches de suivi du traitement par la réalisation de tests de mesure de la charge virale et de tests de diagnostic chez le nourrisson sera indispensable pour garantir la qualité des soins et des traitements ainsi que le succès des programmes. Le fait de ch...oisir le réseau de diagnostic, les types d’échantillons ainsi que les interventions et les stratégies les plus appropriés dans chaque pays et pour chaque partenaire au niveau national et régional permettra de soutenir cet effort, de renforcer la collaboration et d’optimiser les investissements réalisés dans la mise en œuvre des tests en vue d’obtenir des effets manifestes.
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This Rapid Communication aims to inform national TB programmes and other stakeholders about the key implications of the latest evidence on the use of specific molecular assays as initial diagnostic tests of pulmonary and extrapulmonary TB and RR-TB, in adults and children.
La presente publicación describe la evidencia científica disponible sobre la utilidad del uso complementario de pruebas moleculares y de detección de anticuerpos para mejorar el diagnóstico de sospechosos de COVID-19. La utilización complementaria de ambas pruebas podría mejorar la identificac...ión correcta de pacientes con COVID-19, incluyendo a los pacientes asintomáticos o con enfermedad leve, contribuyendo a disminuir su propagación.
Esta publicación pertenece al compendio Publicaciones Minsa sobre COVID-19
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El Ministerio de Salud de manera articulada con el Instituto Nacional de Salud (INS) presenta la lista de laboratorios a nivel nacional que realizan la prueba molecular SARS-CoV-2 para la detección o descarte de la COVID-19. Los laboratorios son: Laboratorios Instituto Nacional de Salud (INS), Lab...oratorios Referenciales DIRESAS/GERESAS/DIRIS, Laboratorios Institutos / Hospitales Minsa, Laboratorios Hospitales Fuerzas Armadas, Laboratorios Hospitales ESSALUD, Laboratorios Universidad, Laboratorios Privados
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Pulmonary tuberculosis predictors and rapid molecular diagnosis
Preditores de tuberculose pulmonar e experiência com o diagnóstico molecular rápido
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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For the molecular diagnosis of Chagas disease by real-time PCR (polymerase chain reaction), optimization of diagnostic accuracy is desirable. The detection limit of real-time PCR assays for the diagnosis of Trypanosoma cruzi in human serum is affected by various influences including the choice of th...e nucleic acid extraction assay. In this study, three nucleic acid extraction assays were compared regarding their influence on the sensitivity of a T. cruzi-specific real-time PCR with 62 reference sera containing T. cruzi target DNA (deoxyribonucleotide acid). More than 95% of the positive sera were correctly identified after all three nucleic acid extraction strategies with a detection rate ranging from 96.8% (60/62) for the worst assay to 100% (62/62) for the best one. A matched pairs analysis for the comparison of the cycle threshold (Ct) values obtained with the 59 reference samples with positive real-time PCR results after all three nucleic acid extraction schemes indicated differences in a range of about 3 Ct steps. Summarized, all three compared nucleic acid extraction schemes were basically suitable for T. cruzi-specific PCR from serum with some minor differences. However, in the case of low quantities of circulating parasite DNA in the serum of a patient with Chagas disease, even minor effects can make a difference in the individual diagnosis.
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Dengue is a significant public health problem. There are four dengue virus serotypes identified; however, its diagnosis is difficult due to the existence of many viruses, bacteria, and parasites producing the same clinical presentation, being present in the same geographical area and even producing ...coinfections. Therefore, determining whether a person has, had, or is infected with dengue virus is of great importance. In order to do so, direct and indirect laboratory tests have been developed to identify the virus or part of its structure that generally detects the antibody response. These techniques are used for diagnosis, epidemiological studies, monitoring, assessment and production of vaccines and antivirals, etc. They range from the use of cell cultures, animal models, inoculation by insects, and serology tests to the use of detection molecular tests and quantification of genetic material that are described in this chapter herein, a brief explanation of this methodology, its strengths and weaknesses, and its application in the dengue research.
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Africa CDC Institute of Pathogen Genomics (IPG) was launched in November 2019 and operates under the Division of Laboratory Systems and Networks.
IPG coordinate the implementation of molecular diagnostics, pathogen genomics and bioinformatics in National Public Health Institutions (NPHIs) and/or Re...fe-
-rence Laboratories (NRLs) across Africa.
Africa CDC and APHF are coordinating a continental initiative to maximize the benefits of molecular approaches and pathogen genomics for more effective
outbreak preparedness, prevention, response, and for the control and elimination of endemic diseases in Africa. One of Africa CDC’s flagship initiative is the Africa
Pathogen Genomics Initiative (Africa PGI), a partnership that aims to strengthen laboratory systems and enhance genomic surveillance by equipping the continent’s
public health institutions with the tools, training, and data infrastructure.
About the Project
In 2023, 166 outbreaks and public health events were reported in Africa. This calls for a resilient laboratory systems for timely detection and reporting of current and future outbreaks. This project aims to scale up molecular diagnostic and genomic sequencing-based detection and characterization of outbreaks.
Africa CDC is working with Member States to develop guidance, diagnostic algorithm, training and capacity building to enable outbreak detection, and reporting to inform public health response.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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