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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 MUL_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.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus
...
they are not confirmatory of infection. With the current low disease prevalence, the positive predictive value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus
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they are not confirmatory of infection. With the current low disease prevalence, the positive predictive value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
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This training toolkit by the European Laboratory Initiative for TB, HIV and Viral Hepatitis provides a unique combination of practical guidance and expert advice on the interpretation of selected WHO-endorsed
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tests for drug-resistant tuberculosis (DR-TB).
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To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral hea
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lthcare facilities by non-specialist staff. Also included are recently developed self-tests.
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This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs)
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for malaria. It provides a comparative measure of their performance in a standardized way to distinguish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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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 expensiv
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e 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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South Africa has recorded its first case of monkeypox today, 23 June 2022. The Minister of
Health Dr. Joe Phaahla explained that he received a report from the National Health
Laboratory Services’ CEO that they have confirmed through
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laboratory tests the first case of
monkeypox in South Africa. South Africa's monkeypox patient zero is a 30-year-old man from
Johannesburg.
The South African Health Products Regulatory Authority (SAHPRA) has prepared an
information sheet to better understand monkeypox, the symptoms to treatment.
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-
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gamma release assays (IGRA) are also valid for Beijing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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It is Zika virus (ZIKV) that most often causes these neurological effects it appears to be the only arbovirus than can cause congenital malformations such as microcephaly. In any case, more scientific tests are needed to establish the causal relatio
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nship between the virus and this malformation (7-10).
This document is a practical tool designed to help health workers improve clinical diagnosis and provide timely care for patients infected
with the dengue, chikungunya, or Zika virus. It is intended mainly for
health workers in primary care facilities where laboratory diagnosis of
arboviruses is not always available. However, this guide may also be
very useful in hospitals that provide second- and third-level care, as it
describes the clinical manifestations of each of the three most important
arboviral diseases currently found in the Region, the elements for
differential diagnosis, and their clinical behavior.
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The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests for early outbreak detection in resource-limited
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settings. The document sets desired and acceptable performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
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This manual is designed to provide comprehensive malaria case management training for health workers at all levels, including clinical, nursing, dispensing, laboratory and records staff. The training covers the use of malaria rapid diagnostic
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tests (RDTs) and the treatment of severe malaria. The five-day training programme includes interactive modules supported by job aids. The ideal group size is 20–30 participants, supported by a team of three trainers. Trainers should thoroughly review the manual, including the 'Adult Learning Techniques' module, and follow the 'Facilitator's Guide', while participants should use the 'Simplified Participant's Guide'. The training includes pre- and post-tests to assess knowledge improvement. Continuing Medical Education (CME) is encouraged after the training, and resources are provided in the appendix.
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Communicable Diseases: Part 4 Other Diseases of Public Health Importance and Surveillance.
HEAT, UNICEF, Open University, AMREF
Ministry of Health, Federal Democratic Republic of Ethiopia
(2015)
C1
Blended Learning Modulef or the Health Extension Programme
In this study session, you will learn about the general features of faeco-oraldiseases: the main types commonly found in Ethiopia, their general symptomsand signs, how to treat mild cases and when to refer patients with severeconditions for
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specialised treatment, or laboratory tests to confirm thediagnosis. You will also learn about the importance of giving effective healtheducation to your community on ways to prevent and control faeco-oraldiseases.
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The waves of yellow fever transmission in the Region of the Americas in 2016–2018 involved the largest number of human and epizootic cases to be reported in several decades. Yellow fever is a serious viral hemorrhagic disease that poses a challenge for health professionals. It requires early recog
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nition of signs and symptoms, which are often nonspecific, and it can mimic other acute febrile syndromes. Early detection of suspected or confirmed cases, monitoring of vital signs, life support measures, and treatment of acute kidney failure continue to be the recommended strategies for case management. This report is the result of discussions among experienced specialists in the Americas on the clinical management of yellow fever patients, especially during outbreaks and epidemics, in the context of current medical and scientific evidence and taking into account the technical guidelines already available in the countries of the Region. It includes flowcharts for initially addressing patients with clinical suspicion of yellow fever and proposes a minimum package of laboratory tests that may be useful in contexts where resources are limited. In addition, it considers aspects of health system organization for dealing with yellow fever outbreaks and epidemics.
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- The goal of diagnostic testing for Ebola and Marburg virus diseases is to identify cases to provide timely and appropriate care and to stop disease transmission.
- All individuals meeting the case definition for Ebola or Marburg virus diseases should be tested.
- The recommended sample type
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for testing for orthoebolaviruses and orthomarburgviruses is whole blood or plasma for living patients, and oral swab for deceased individuals.
- Laboratory confirmation of Orthoebolavirus and Orthomarburgvirus infections and further species identification should be done using nucleic acid amplification testing (NAAT).
- If a suspected case tests negative (living patient) and the blood was drawn less than 72 hours after symptom onset, a second test should be performed with blood drawn more than 72 hours after symptom onset.
- All manipulations in laboratory settings of samples originating from suspected, probable or confirmed cases of Ebola and Marburg virus diseases should be conducted with appropriate biosafety measures according to a risk-based approach.
- Whole or partial genome sequencing can be used to characterize viruses and complement epidemiologic investigations.
- Member States are strongly encouraged to share genetic sequence data (GSD) in publicly accessible databases.
- Member States are required to immediately notify the World Health Organization (WHO) under the International Health Regulations (IHR) 2005 of positive laboratory results.
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Under-diagnosis of asthma in ‘under-fives’ may be alleviated by improved inquiry into disease history. We assessed a questionnaire-based screening tool for asthma among 614 ‘under-fives’ with severe respiratory illness in Uganda. The questionnaire responses were compared to post hoc consensu
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s diagnoses by three pediatricians who were guided by study definitions that were based on medical history, physical examination findings, laboratory and radiological tests, and response to bronchodilators. Children with asthma or bronchiolitis were categorized as “asthma syndrome”. Using this approach, 253 (41.2%) had asthma syndrome. History of and present breathing difficulties and present cough and wheezing was the best performing combination of four questionnaire items [sensitivity 80.8% (95% CI 77.6–84.0); specificity 84.7% (95% CI 81.8–87.6)]. The screening tool for asthma syndrome in ‘under-fives’ may provide a simple, cheap and quick method of identifying children with possible asthma. The validity and reliability of this tool in primary care settings should be tested.
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This manual has been designed to be used in conjunction with two earlier WHO publications, "Basic tests for pharmaceutical substances" (1986) and "Basic tests for pharmaceutical dosage forms" (1991)
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. Most of the pharmaceutical substances and dosage forms covered are included in the WHO Model List of Essential Drugs. The present volume describes procedures for testing a further 23 pharmaceutical substances and 58 pharmaceutical dosage forms and also for testing 4 medicinal plant materials.
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In most malaria-endemic countries, temperatures frequently exceed the recommended storage temperatures for malaria RDTs. Correct storage of the RDTs may be difficult, especially during transport and in locations where air-conditioning is unavailable.
This publication is intended to support health p
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ersonnel who use RDTs. It describes the basic principles for management and storage of RDT stock; outlines practical solutions for protecting RDTs against high temperatures during storage and transport; and describes how to manage waste generated from RDT use in health clinics and central and peripheral storage facilities.
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HIV rapid diagnostic test market landscape
recommended
The analysis includes the three most commonly used HIV rapid diagnostic test
(RDT) categories: HIV-only professional use RDTs, dual HIV/syphilis professional use
RDTs, and HIV self-tests (HIVST).
