RESUMO
Background: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. Aim: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. Materials and Methods: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. Results: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. Conclusions: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Sistemas Automatizados de Assistência Junto ao Leito/normas , Coeficiente Internacional Normatizado/instrumentação , Padrões de Referência , Capilares , Tromboplastina/uso terapêutico , Chile , Reprodutibilidade dos Testes , Monitoramento de Medicamentos/instrumentação , Monitoramento de Medicamentos/normas , Coeficiente Internacional Normatizado/normas , Anticoagulantes/uso terapêuticoRESUMO
BACKGROUND: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. AIM: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. MATERIALS AND METHODS: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. RESULTS: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. CONCLUSIONS: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.
Assuntos
Coeficiente Internacional Normatizado/instrumentação , Sistemas Automatizados de Assistência Junto ao Leito/normas , Idoso , Anticoagulantes/uso terapêutico , Capilares , Chile , Monitoramento de Medicamentos/instrumentação , Monitoramento de Medicamentos/normas , Feminino , Humanos , Coeficiente Internacional Normatizado/normas , Masculino , Pessoa de Meia-Idade , Padrões de Referência , Reprodutibilidade dos Testes , Tromboplastina/uso terapêuticoRESUMO
INTRODUCTION: Point-of-care (POC) devices have been widely adopted for monitoring prothrombin time (PT) (INR) following the demonstration of their accuracy compared to standard INR determination. However, guidelines suggest confirmation of POC results when INRs increase above therapeutic range, due to concerns regarding possible inferior performance of POC devices in high INR levels. Unfortunately, patients with supra-therapeutic INRs are underrepresented in studies that validated these devices. METHODS: We performed a prospective evaluation of the performance of a POC device in monitoring oral anticoagulation in patients with INR values above 3.5 in a University outpatient anticoagulation clinic. During a 6-month period, 2322 INR determinations were performed with a POC device, and results above 3.5 were immediately repeated on an automated coagulometer. RESULTS: Dual INR determinations by two methods were obtained in 160 visits, with a mean INR from the POC device of 4.52 ± 0.96. Both classical statistics and clinical concordance analysis yielded satisfactory results when the two methods were compared. CONCLUSION: Our results demonstrate that POC devices present good correlation with standard laboratory methods for PT determination in supra-therapeutic INRs and that differences in clinical management do not support the need for systematic confirmation of these results in nonbleeding patients.
Assuntos
Coeficiente Internacional Normatizado , Sistemas Automatizados de Assistência Junto ao Leito/normas , Tempo de Protrombina/instrumentação , Tempo de Protrombina/normas , Humanos , Coeficiente Internacional Normatizado/instrumentação , Coeficiente Internacional Normatizado/normasRESUMO
New portable devices for the measurement of the prothrombin time and the international normalized ratio (INR) from capillary blood samples have demonstrated to have good correlation with classic laboratory methods in multiple clinical settings. In this study, we evaluated the performance of the point-of-care device CoaguChek XS (CoaguChek XS; Roche Diagnostics, Basel, Switzerland), comparing the INR results with the standard laboratory method (automatic coagulometer) in an outpatient anticoagulation clinic. Results were compared by linear regression and Bland-Altman plot. Two hundred paired results were collected from 170 patients in a period of 90 days. The main indications for anticoagulation were prophylaxis of venous thromboembolic events, atrial fibrillation and prosthetic heart valves. Mean INR results obtained with the portable device and with the standard laboratory method were 2.22â±â0.70 and 2.30â±â0.77, respectively. The proportion of patients with supratherapeutic INRs was 13.5%. The CoaguChek XS monitor tended to underestimate the INR on average by 0.08âU. The correlation coefficient (R) between the two methods was 0.91 (Pâ<â0.0001). The CoaguChek XS device is suitable for INR monitoring in patients in outpatient oral anticoagulation clinics.