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Disease/health condition -
Cardiovascular health
Total cholesterol
Assay format
Point-of-care test
Information History
First added in 2024
Purpose type
Prediction
Purpose
To assess risk of cardiovascular disease (CVD) by measuring cholesterol levels.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN
66524
Total cholesterol lipid IVD, kit, rapid colorimetric, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. 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 2005-2024EMDN
W0101060102
CHOLESTEROL TEST STRIPS
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/emdnWHO supporting publications
World Health Organization. (2018). Technical package for cardiovascular disease management in primary health care: evidence-based treatment protocols. World Health Organization. https://iris.who.int/handle/10665/260421 ; World Health Organization. (2018). Technical package for cardiovascular disease management in primary health care: access to essential medicines and technology. World Health Organization. https://iris.who.int/handle/10665/260420 ; World Health Organization. (2020). Hearts: technical package for cardiovascular disease management in primary health care: risk-based CVD management. World Health Organization. https://iris.who.int/handle/10665/333221; WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
Technical specifications
N/A
SAGE IVD recommended fully listing total cholesterol, point-of-care test in the EDL 5
• as a disease-specific IVD for use in community settings and health facilities without laboratories (Section I.b. Cardiovascular health);
• using a point-of-care test as assay format;
• using capillary whole blood as specimen type;
• to assess risk of cardiovascular disease (CVD) by measuring cholesterol levels.
• as a disease-specific IVD for use in community settings and health facilities without laboratories (Section I.b. Cardiovascular health);
• using a point-of-care test as assay format;
• using capillary whole blood as specimen type;
• to assess risk of cardiovascular disease (CVD) by measuring cholesterol levels.
The application proposed a point-of-care test for total cholesterol.
SAGE IVD members noted that there was strong clinical support for point-of-care testing due to its rapidity (1.5 to 12 minutes). Cost concerns were discussed but largely dismissed, as test costs were considered reasonable (about US$ 3–5 per test). Overall, the test was considered an effective complement to laboratory-based tests despite its slightly lower sensitivity. Its use in primary for cardiovascular risk assessment aligns with WHO guidelines. Its cost–effectiveness was discussed with a focus on screening children for familial hypercholesterolemia. SAGE IVD members highlighted that it should be made clear that these tests are not for self-testing but for use in health care facilities.
SAGE IVD unanimously supported including the cholesterol point-of-care tests in the EDL 5.
Four diagnostic devices seem to have evidence about their diagnostic test accuracy in a clinical sample. Studies seemed to assess the devices’ performance in different settings: family members of hospitalized CVD patients, community, or secondary care. These devices might have a relatively high sensitivity and negative predictive value as demonstrated by low risk of bias studies (as assessed by the NIHR review authors [ref 3]), however the total sample size per device is very low and the setting and used cut-offs may vary. One of the four devices (1 clinical study, n=61) was contrarily reported to have a low sensitivity but a high specificity in secondary care.
Although testing/screening for abnormal cholestrerol levels in itself seems important, there seems to be no information provided about any given PoC test’s clinical utility showing its impact on patient-relevant or health-related outcomes.
Universal cholesterol screening in children under of 18 was suggested to be cost effective, as stated in [ref 3, WHF]. In the document [ref 3], two primary studies, focussing on familial hypercholesterolaemia screening in children were reffered to substantiate this statement. However, this might seem only a subpopulation in which cholesterol levels could be screened. Cost-effectiveness studies in other populations probably need to be conducted to be more certain about these PoC tests’ cost-effectiveness.
The selection and use of essential in vitro diagnostics: report of the fifth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2024. World Health Organization. (To be published)