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.
more
Available in Arabic, Chinese, English, French, Portuguese and Spanish
https://apps.who.int/iris/handle/10665/334254
Qualitative assay for use on the cobas®6800/8800 Systems. For in vitro diagnostic use
Mpox is an emerging zoonotic disease caused by the mpox virus, a member of the Orthopoxvirus genus closely related to the variola virus that causes smallpox. Mpox was first discovered in 1958 when outbreaks of a pox-like disease occurred in monkeys kept for research. The first human case was recorde
...
d in 1970 in the Democratic Republic of the Congo (DRC) during a period of intensified effort to eliminate smallpox and since then the infection has been reported in a number of African countries. Mpox can spread in humans through close contact, usually skin-to-skin contact, including sexual contact, with an infected person or animal, as well as with materials contaminated with the virus such as clothing, beddings and towels, and respiratory droplets in prolonged face to face contact. People remain infectious from the onset of symptoms until all the lesions have scabbed and healed. The virus may spread from infected animals through handling infected meat or through bites or scratches. Diagnosis is confirmed by polymerase chain reaction (PCR) testing of material from a lesion for the virus’s DNA. Two separate clades of the mpox virus are currently circulating in Africa: Clade I, which includes subclades Ia and Ib, and Clade II, comprising subclades IIa and IIb. Clade Ia and Clade Ib have been associated with ongoing human-to-human transmission and are presently responsible for outbreaks in the Democratic Republic of the Congo (DRC), while Clade Ib is also contributing to outbreaks in Burundi and other countries.
In 2022‒2023 mpox caused a global outbreak in over 110 countries, most of which had no previous history of the disease, primarily driven by human-to-human transmission of clade II through sexual contact. In just over a year, over 90,000 cases and 150 deaths were reported to the WHO. For the second time since 2022, mpox has been declared a global health emergency as the virus spreads rapidly across the African continent. On 13 Aug 2024, Africa CDC declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS), marking the first such declaration by the agency since its inception in 2017.7 This declaration empowered the Africa CDC to lead and coordinate responses to the mpox outbreak across affected African countries. On August 14, 2024, the WHO declared the resurgence of mpox a Public Health Emergency of International Concern (PHEIC) emphasizing the need for coordinated international response.
As of August 2024, Mpox has expanded beyond its traditional endemic regions, with new cases reported in countries including Sweden, Thailand, the Philippines, and Pakistan. Sweden has confirmed its first case of Clade 1 variant, which has been rapidly spreading in Africa, particularly in DRC. The emergence of this new variant raises concerns about its potential for higher lethality and transmission rates outside Africa.
more
Revised National Tuberculosis Control Programme
The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification test
...
ing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitigation strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
more
The purpose of this document is to provide guidance on the use of pooled sample testing strategy in coronavirus disease (COVID-19)
testing laboratories of the African Union Member States for scaling up SARS-CoV-2 nucleic
...
acid testing capacity with the available resources. The current document describes the effect of factors such as the prevalence of COVID-19 in the population to be tested, the homogeneity of pools, and the sensitivity of the molecular test in optimal pool size determination. It also highlights the importance of monitoring the prevalence of COVID-19 in a population to be tested and proper validation of the test, to limit the potential for false-negative results. Validation studies to determine the optimal pool size by testing laboratories are recommended as the optimum approach. A safe, simple ‘two-stage pooling’ option has been indicated in this guidance to be used by laboratories until such validation can be achieved.
more
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2,
...
including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
more
MSF International AIDS Working Group
This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Journal of Infectious Diseases and Therapeutics, 2013, 1, 17-24
Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, e
...
specially when further testing of sputum smear-negative specimens is necessary.
more