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Recency assays use one or more biomarkers to identify whether HIV infection in a person is recent (usually within a year or less) or longstanding. Recency assays have been used to estimate incidence in representative cross-sectional surveys and in epidemiological studies to better understand the pat... more
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Lipoarabinomannan Antigen Assay (TB-LAM) for Diagnosing Pulmonary Tuberculosis in Children with Severe Acute Malnutrition in Mozambique

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Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children

World Health Organization (2013)
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Rapid Communication: Molecular assays as initial tests for the diagnosis of tuberculosis and rifampicin resistance

World Health Organization WHO (2020) C_WHO
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.
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SARS-CoV-2 molecular assay evaluation: results
recommended

Foundation for Innovative and New Diagnostics (2020) C2
FIND conducted independent evaluations at the University Hospitals of Geneva (HUG), to verify the limit of detection (LOD) and the clinical performance (as reported by the manufacturers) of the following molecular test kits. The LOD analysis was performed using cultured viral stocks from a clinical ... more
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Use of alternative interferon-gamma release assays for the diagnosis of TB infection: WHO policy statement

World Health Organization WHO (2022) C_WHO
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 Beij... more
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Operational guidance on the use of yellow fever assays in the context of surveillance

World Health Organization WHO (2023) C_WHO
This publication aims to provide updated guidance on the specific use of yellow fever laboratory assays in the context of surveillance to be used across the Global Yellow Fever Laboratory Network for disease surveillance. In the recent years, new commercial assays became available and are now recomm... more
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Technical Update on HIV incidence assays for surveillance and monitoring purposes

UNAIDS; World Health Organization (2015) C2
UNAIDS/WHO 2015 | Reference
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The use of lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis and screening of active tuberculosis in people living with HIV

World Health Organization (Europe) (2015) C_WHO
Policy guidance.
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Implementation Guideline for Gene Xpert MTB/RIF Assay in Ethiopia

Ministry of Health Ethiopian Public Heath Institute, Federal Democratic Republic of Ethiopia (2014) C1
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The use of molecular line probe assays for the detection of resistance to second-line anti-tuberculosis drugs

World Health Organization (2016) C_WHO
Policy Guidance.
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Coronavirus (COVID-19)genesig®Real-Time PCR assay

Primerdesign LTD (2020) C1
Instruction for Use
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Selection and use of Ebola in vitro diagnostic (IVD) assays. Emergency guidance

World Health Organization (2015)
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Comparison of the Influence of Different Nucleic Acid Extraction Assays on the Sensitivity of Trypanosoma cruzi-Specific Real-Time PCR

Kann, S.; Zabala-Monterroza, W.; García, C. et al. Multidisciplinary Digital Publishing Institute MDPI (2022) CC
For the molecular diagnosis of Chagas disease by real-time PCR (polymerase chain reaction), optimization of diagnostic accuracy is desirable. The detection limit of real-time PCR assays for the diagnosis of Trypanosoma cruzi in human serum is affected by various influences including the choice of th... more
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Aktuelle Fragestellungen zum Tuberkulose-Screening mit Interferon-Gamma-Release Assays (IGRAs)

R. Diel, A. Nienhaus (2015) C2
Current Issüs Arising from Tuberculosis Screening with Interferon-Gamma- Release Assays (IGRAs) Pneumologie 2015; 69: 271–275
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: GeeniusTM HIV 1/2 Confirmatory Assay with GeeniusTM HIV 1/2 Confirmatory Controls, WHO reference number: PQDx 0181-031-00)

World Health Organization (2017) C_WHO
PQDx 0181-031-00 WHO PQ Public Report March/2017, version 3.0
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: DPP® HIV 1/2 Assay, WHO reference number: PQDx 0053-006-00)

World Health Organization (2016) C_WHO
PQDx 0053-006-00 WHO PQ Public Report June/2016, version 2.0