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Disease/health condition - Tuberculosis (TB)
Discipline - Clinical chemistry
C-reactive protein
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Lateral flow RDT
Information History
First added in 2018
Changed in 2024
Purpose type
Screening, Aid to diagnosis, Monitoring
Purpose
Early marker of inflammation or infection. To monitor response to treatment. To screen for pulmonary TB in people living with HIV.
Specimen types
Venous whole blood, Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

58395

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of C-reactive protein (CRP) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . CRP is a marker associated with bacterial infection and inflammatory conditions. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* lateral flow test
EMDN

W0102160601

C-REACTIVE PROTEIN - RT & POC

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
C-reactive protein concentrations as a marker of inflammation or infection for interpreting biomarkers of micronutrient status. Vitamin and Mineral Nutrition Information System. Geneva: World Health Organization; 2014 (WHO/NMH/NHD/EPG/14.7; http://apps.who.int/iris/bitstream/10665/133708/1/WHO_ NMH_NHD_EPG_14.7_eng.pdf?ua=1 ; World Health Organization. (‎2021)‎. WHO consolidated guidelines on tuberculosis: module 2: screening: systematic screening for tuberculosis disease. World Health Organization. https://iris.who.int/handle/10665/340255
Technical specifications
N/A
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A