Original Title: Dosage sanguin de la cystatine C par immunoturbidimétrie

Authors' objectives: The MSSS has mandated the Institut national d'excellence en santé et en services sociaux (INESSS) to assess whether immunoturbidimetry cystatin C blood testing should be introduced into the Répertoire. For the INESSS, this is the 2nd assessment of this test. Although the first, conducted in 2018, resulted in a refusal to introduce the test, cystatin C blood test access in recent years has nevertheless been possible through sample shipments outside Quebec.

Authors' results and conclusions: RESULTS (#1 POPULATION DIMENSION): The target population for the cystatin C blood test would include adult and pediatric patients with non-GFR determinants of SCr, and whose eGFR is likely to be imprecise or biased. Cystatin C blood test would then be used to calculate eGFR or eGFR, for clinical decision-making. (#2 CLINICAL DIMENSION): In patients with elevated SCr during oncology treatment with targeted therapy, eGFR would help to distinguish cases of drug-induced AKI from pseudo-AKI caused by the anticancer agent more rapidly than with current practice. In these patients, eGFR could enable treatment to be continued unchanged, without relying on nuclear medicine resources, and without compromising treatment outcomes. The clinically acceptable turnaround time for this test should be comparable to that of creatinine blood testing. (#3 ORGANIZATIONAL DIMENSION): In following the pathway for serum creatinine samples, the implementation of the cystatin C blood test would not require any new sampling or handling. Organizational impacts associated with the implementation of this test are therefore perceived as minor. Should the cystatin C blood test be introduced into the Répertoire, it would be essential to oversee its use to ensure that the test is reserved for the target populations and limited to clinical situations where it is justified. (#4 SOCIOCULTURAL DIMENSION): KDIGO recommends using the cystatin C blood test to calculate the eGFR or eGFR in certain specific clinical situations. This recommendation is supported by several organizations in laboratory medicine, nephrology, onco-nephrology and pharmacy. (#5 ECONOMIC DIMENSION): Although the cost-effectiveness of the cystatin C blood test cannot be estimated due to the absence of data quantifying the health benefits derived from its use, the cost associated with the test recommended by the applicant is lower than the cost of conducting the test outside Quebec (-$136), but more costly than not conducting the test at all ($8.56). This additional cost remains relatively low compared to the costs of other tests and consultations that could be avoided from implementing the test.

Authors' recommendations: In light of the above findings, the INESSS recommends that the Minister introduce the cystatin C blood test into the Répertoire. However, considering the risks of use beyond the specific context of oncology treatment with targeted therapies known to decrease tubular secretion of creatinine, the INESSS recommends the implementation of the following measures to properly supervise use of the test: -Restrict prescription of the test to patients undergoing oncological treatment with targeted therapy known to reduce tubular secretion of creatinine, in the context of suspected therapyinduced AKI. -Provide guidance for the prescription of the test through various strategies or interventions to ensure its optimal use. -Monitor the number of requests and costs associated with the test, and adjust the strategies or interventions used. -Ensure that the test meets ISO 15189 requirements.

Authors' methods: The assessment approach included a review of the scientific literature, a grey literature search, consultations with clinicians and other stakeholders, and a budget impact analysis.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-de-la-cystatine-c-par-immunoturbidimetrie.html

Year Published: 2025

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-de-la-cystatine-c-par-immunoturbidimetrie.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)