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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
Get the latest recommendations on COVID-19 diagnostics and testing, and how to improve testing capacity in low-income settings.
Parasites & Vectors volume 11, Article number: 264 (2018)
Dengue creates a staggering epidemiological and economic burden for endemic countries. Without a specific therapy and with a commercial vaccine that presents some problems relative to its full effectiveness, initiatives to improve vector
...
control strategies, early disease diagnostics and the development of vaccines and antiviral drugs are priorities. In this study, we present the probable origins of dengue in America and the trajectories of its spread. Overall, dengue diagnostics are costly, making the monitoring of dengue epidemiology more difficult and affecting physicians’ therapeutic decisions regarding dengue patients, especially in developing countries. This review also highlights some recent and important findings regarding dengue in Brazil and the Americas. We also summarize the existing DENV polymerase chain reaction (PCR) diagnostic tests to provide an improved reference since these tests are useful and accurate at discriminating DENV from other flaviviruses that co-circulate in the Americas. Additionally, these DENV PCR assays ensure virus serotyping, enabling epidemiologic monitoring.
more
Molecular methods for antimicrobial resistance (AMR)diagnostics to enhance the Global Antimicrobial Resistance Surveillance System
Stop TB`s GDF provides a wide range of diagnostic equipment and laboratory supplies in its Diagnostics Catalog
Mem Inst Oswaldo Cruz . 2021 Jan 29;115:e200287. doi: 10.1590/0074-02760200287. eCollection 2021. Sensitivity and negative predictive value were directly affected by sample storage conditions. RT-PCR and virus isolation showed greater dependence on well-conserved samples for an accurate diagnosis
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AlereTM HIV/Syphilis Duo, Number: PQDx 0179-012-00)
World Health Organization
(2017)
C_WHO
PQDx 0179-012-00 WHO
PQDx Public Report
June/2017, version 4.0
These guidelines provide updated evidence-based recommendations on the priority HCV-related topics from the 2018 WHO Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C infection and the 2017 WHO Guidelines on hepatitis B and C testing. These priority areas are:
...
direct-acting antiviral (DAA) treatment of adolescents and children ages ≥3 years of age
simplified HCV service delivery (decentralization, integration and task sharing)
HCV diagnostics – use of point-of-care (POC) HCV ribonucleic acid (RNA) assays and reflex HCV RNA testing.
These guidelines also update existing chapters without new recommendations, such as the inclusion of new manufacturers’ protocols on the use of dried blood spot (DBS) for HCV RNA testing and new data to inform the limit of detection for HCV RNA assays as a test of cure, in addition to their use for diagnosis.
more
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: First Response® HIV 1-2-0 Card Test, Number: PQDx 0018-010-00)
World Health Organization
(2016)
C_WHO
PQDx 0018-010-00 WHO
PQDx PR
July/2016, version 3.0
Updated recommendations on simplified service delivery and diagnostics for hepatitis C infection
recommended
Policy Brief. 24 June 2022. This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public health approach to HCV testing, care and treatment. These recommendations include decentralization, integration and ta
...
sk-sharing, in addition to the use of point-of-care (POC) HCV viral load assays and reflex viral load testing.
more
Specifications and quantities for efficient procurement of essential equipment and laboratory commodities for HIV
Francis Aboagye-Nyame, Heather Alexander, Zelalem Gizachew Belachew et al.
World Health Organization
(2015)
C_WHO
Second Edition
AIDS Medicines and diagnostics services
July 2015
WHO Prequalification of Diagnostics Programme - Public Report (Product: ABONtm HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device, Number: PQDx 0141-051-00)
World Health Organization
(2017)
C_WHO
PQDx 0141-051-00 WHO
PQDx Public Report
April/2017, version 5.0
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Murex HIV Ag/Ab Combination, Number: PQDx 0144-043-00)
World Health Organization
(2016)
C_WHO
PQDx 0144-043-00 WHO
PQDx Public Report
November/2016, version 4.0
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: SD BIOLINE HIV-1/2 3.0, Number: PQDx 0027-012-00)
World Health Organization
(2017)
C_WHO
PQDx 0027-012-00 WHO
PQDx Public Report
May/2017, version 4.0
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Enzygnost HIV Integral 4, WHO reference number: PQDx 0214-064-00
World Health Organization
(2016)
C_WHO
PQDx 0214-064-00
WHO PQDx PR
April/2016, version 3.0
The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will
...
were abundant. This rapidity was also due to the fact that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
more
WHO Prequalification of Diagnostics Programme - Public report (Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts) )
World Health Organization
(2016)
C_WHO
Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts)
Number: PQDx 0133-045-00
0133-045-00 WHO
PQDx PR
June/2016, version 2.0
