Accuracy and technical characteristics of CYP2C19 point of care tests: a systematic review

Pharmacogenomics. 2024;25(8-9):407-423. doi: 10.1080/14622416.2024.2392479. Epub 2024 Sep 4.

Abstract

Aim: To assess the accuracy and technical characteristics of CYP2C19 point of care tests (POCTs).Patients & methods: Systematic review of primary studies, in any population or setting, that evaluated POCTs for detecting CYP2C19 loss of function (LOF) alleles.Results: Eleven studies provided accuracy data (eight Spartan; one Genomadix Cube; one GMEX; one Genedrive). The POCTs had very high sensitivity and specificity for the alleles they tested for. Twenty-two studies reported technical characteristics: POCTs were easy to operate and provided results quickly. Limited data were reported for test failure rate and cost.Conclusion: CYP2C19 POCTs may be a useful alternative to laboratory-based testing to guide antiplatelet therapy. Further data are required on accuracy (GMEX; Genedrive), test failure and cost (all POCT).

Keywords: CYP2C19 testing; antiplatelet therapy; clopidogrel; diagnostic test accuracy; meta-analysis; systematic review.

Plain language summary

[Box: see text].

Publication types

  • Systematic Review

MeSH terms

  • Alleles
  • Cytochrome P-450 CYP2C19* / genetics
  • Humans
  • Platelet Aggregation Inhibitors / therapeutic use
  • Point-of-Care Systems / standards
  • Point-of-Care Testing / standards

Substances

  • CYP2C19 protein, human
  • Cytochrome P-450 CYP2C19
  • Platelet Aggregation Inhibitors