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 mee...t 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
more
This document outlines minimum requirements of laboratory testing for COVID-19 and link laboratory testing with surveillance and contact tracing to guide the outbreak response by national health aut...horities using a reduced number of tests performed. The strategies are organized according to stages of transmission: (1) No cases reported or observed (Stage 0); (2) Imported cases (Stage 1); (3) Localized community transmission (Stage 2); (4) Large-scale community transmission (Stage 3). For each stage, the recommended approaches indicate which testing strategy to prioritize when there are severe limitations on laboratory testing. The document is based on the current epidemiology of COVID-19 and available molecular testing methods.
more
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 ...light medbox">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
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 ...ox">tests for drug-resistant tuberculosis (DR-TB).
more
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...lthcare facilities by non-specialist staff. Also included are recently developed self-tests.
more
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)... 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.
more
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...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.
more
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 ..."attribute-to-highlight medbox">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.
more
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-...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.
more
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...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.
more
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... 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.
more
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...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.
more
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...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.
more
This document provides detailed guidance on laboratory testing for suspected diphtheria cases during significant outbreaks or in low-resource settings. It aims to supplement and build on other existing WHO guidance documents on surveillance standard...s, diagnostics and research on Corynebacterium by providing key considerations for laboratories that allow the rationalization and optimization of testing during outbreaks. The recommendations given here have been prepared by WHO in consultation with, and reviewed by, global experts with experience in laboratory analysis of Corynebacterium species and in outbreak settings, or with expertise in developing new technologies for diphtheria research and diagnosis. Unless otherwise stated, the considerations provided apply to diphtheria outbreaks caused by toxin-producing C. diphtheriae with a classical respiratory diphtheria presentation.
more
Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nac...h §§ 25 und 30 Medizinproduktegesetz (MPG) anzeigepflichtig. Das DIMDI betreibt dafür die Datenbank "In-vitro-Diagnostika-Anzeigen (MPIVDA)", in welcher demnach auch Daten von "Corona-Tests" von den anzeigepflichtigen deutschen Herstellern und Bevollmächtigten bzw. Einführern erfasst werden.
more
WHO has launched an online course on tobacco product regulation in response to the need for clear, practical advice on building laboratory testing capacity. This course is based on the Tobacco Product Regulation: Building ...ighlight medbox">Laboratory Testing Capacity handbook, launched during the 2018 World Conference on Tobacco or Health in Cape Town.
more
Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi...ng real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
more
Available in Arabic, Chinese, English, French, Portuguese, Russian and Spanish
https://apps.who.int/iris/handle/10665/334254