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Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio
...
ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
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National Essential Diagnostic List
recommended
Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic
...
tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
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PLoS ONE 13(8): e0202499. https://doi.org/10.1371/journal.pone.0202499
This was a school-based cross-sectional study conducted in 2015 among 305 school children aged 7–16 years from two primary schools located in Ilemela and Magu Districts, north-western Tanzania. Single stool and urine samples w
...
ere collected from each participant and examined for the presence of Schistosoma mansoni eggs, parasite antigen, and parasite DNA using KK thick smears, POC-CCA tests, and real-time PCR, respectively.
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Interferon-γ Assays - Description and Assessment of a New Tool in the Diagnosis of Tuberculosis.
Haür B et al. Interferon-γ-Tests in der ...Pneumologie 2006; 60: 29-44
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulc
...
er in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19
recommended
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing f
...
or Diagnosis of COVID-19. This framework aims to provide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of
...
rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of po
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int-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response
...
to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing
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This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic
...
tools usable in the field as well as disability prevention methods”.
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
more
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.
more
FIND and Standard Diagnostics (SD) have developed a lateral flow rapid diagnostic test (RDT) to screen for
T.b. gambiense HAT that is cheap and easy to use. The
...
tests are packed individually and are stable at 40°C for
up to 25 months; they are performed on fresh blood obtained from a finger prick, and no instrument or electricity is required. The RDT detects host antibodies to infection in populations that are at risk, or in suspect individuals. Positive cases are subjected to further confirmatory methods to identify HAT patients.
more
Meningitis Outbreak Response in Sub-Saharan Africa
Christina Brandes-Barbier, Véronique Millot, Tomas Allen et al
World Health Organization WHO
(2014)
C_WHO
WHO Guideline. Since 2010, countries in the meningitis belt have started to introduce a new serogroup A meningococcal conjugate vaccine conferring individual protection and herd immunity. Following the successful roll-out of this vaccine, epidemics due to Neisseria meningitidis serogroup A (NmA) are
...
disappearing, but other serogroups (e.g. NmW, NmX and NmC) still cause epidemics, albeit at a lower frequency and of a smaller size. Due to these changes, WHO organized the review of the evidence to provide recommendations for epidemic control, related to operational thresholds for investigation and response to outbreaks, the use of rapid diagnostic tests, antibiotic regimens in epidemics, and prophylaxis for household contacts of cases
more
18 Janaury 2021
EU/EEA Member States and the UK have increased their laboratory capacity tremendously over the past 11 months as the majority of the Member States reported sufficient testing capacity until March 2021.
Many countries are adding ra
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pid antigen detection tests (RADT) to their testing strategies in order to reduce pressure on RT-PCR testing.
Some Member States have already included RADT in their case definition.
The main bottlenecks, such as shortages of laboratory consumables and human resources, as well as sample storing facilities, continue to exist and may affect the overall laboratory response to COVID-19.
more
23 March 2021
The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans.
Dr Montresor’s presentation highlighted that whil
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e there is currently no “gold standard” for the diagnosis of S. stercoralis, there is a felt urgency to optimize diagnostic regimens that are currently available, and in the context of population-based testing (as opposed to individual focused diagnostics in clinical settings).
In other words, the diagnostic test(s) should have good accuracy, but we should remember that in public health we do not aim at individual diagnosis: rather, we need a tool that should help to estimate the prevalence in a population.
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Market and technology landscape x HIV rapid diagnostic tests for self-testing - 4th edition (Supplement)
Unitaid (Innovation in Global Health), World Health Organization (WHO)
Unitaid (Innovation in Global Health), World Health Organization (WHO)
(2018)
C2
July 2018
All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform testing, ensure quality testin
...
g and interpret results. This course is developed to provide theoretical knowledge on SARS-CoV-2 Ag-RDT testing. The learning package consists of 10 modules, which include recorded presentations and videos.
Availble in different languages
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