Estudio comparativo de equipos INR capilar "point of care" versus INR venoso, en pacientes en tratamiento con antagonistas de vitamina K / Comparison of point of care capillary international normalized ratio (INR) with INR measured in venous samples

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.

Is point-of-care accurate for indicating thrombolysis in anticoagulated patients on oral anticoagulation treatments? / Teste rápido de RNI tem acurácia para indicar trombólise em pacientes em uso de anticoagulante oral?

The use of oral anticoagulation treatment (OAT) in patients with an international normalized ratio (INR) higher than 1.7 is a contraindication to thrombolysis in acute ischemic stroke. The aim of the present study is to compare the use of point-of-care (POC) coagulometers to the standard coagulation analysis (SCA) procedure of the INR as a decision-making test for use with patients taking OAT. Method: Eighty patients on chronic OAT underwent a POC and an SCA during a regular outpatient evaluation. Results: When comparing the abilities of the POC test and the SCA test to identify adequate levels for thrombolysis (≤1.7), the POC had a sensitivity of 96.6% (95%CI 88.4-99.1) and a specificity of 60.0% (95%CI 38.6-78). POC overestimated INR levels by 0.51 points compared to the SCA test. Conclusion: POC has a high sensitivity compared to the SCA test for the identification of patients within the cut-off point for thrombolysis. .

Valores acima de 1.7 no RNI de pacientes em uso de terapia anticoagulante (ACO) é uma contraindicação para a trombólise no AVC isquêmico. O Objetivo do presente estudo é comparar o teste capilar rápido (TCR) com o exame tradicional de RNI como método de decisão para indicação de terapia trombolítica em pacientes em uso de ACO. Método: Oitenta pacientes em uso crônico de ACO foram submetidos ao TCR e ao exame tradicional durante consulta ambulatorial. Resultados: Ao serem comparados os resultados do TCR com o exame tradicional com o ponto de corte de 1,7 de RNI, o teste rápido teve sensibilidade de 96,6% (IC95% 88,4-99,1) e especificidade de 60,0% (IC95% 38,6-78). O TCR superestimou os níveis de RNI em 0,51 pontos comparado ao exame tradicional. Conclusão: O TCR apresentou elevada sensibilidade, comparado ao exame tradicional para a identificação de pacientes em uso de ACO com indicação de trombólise. .

RNI Point-of-care test (POCT): esperança ou ilusão? / Point-of-care test (POCT) INR: hope or illusion?

Na última década, foram desenvolvidos os testes point-of-care visando à geração rápida de resultados de exames. Na área da hemostasia, a razão normatizada internacional, o RNI point-of-care test (RNI-POCT), constitui o principal exame dessa nova proposta. Esse teste tem grande potencial de benefício em situações em que o resultado rápido da RNI influencia a tomada de decisão clínica, como no acidente vascular cerebral isquêmico agudo, antes de procedimentos cirúrgicos e durante cirurgias cardíacas, além de permitir que o próprio paciente faça a monitoração da anticoagulação oral. Entretanto, a precisão e a acurácia da RNI-POCT ainda precisam ser aprimoradas para aumentar a eficácia e a eficiência do teste. A RDC/ANVISA Nº 302 deixa claro que os testes POCT devem ser supervisionados pelo responsável técnico do Laboratório Clínico nas fases pré-analítica, analítica e pós-analítica. Na prática, o laboratório não participa da execução desses testes e liberação dos resultados, não sendo, portanto, o mais indicado para garantir a qualidade dos mesmos. Os clínicos, especialmente aqueles envolvidos com a anticoagulação oral de pacientes, têm grande expectativa na incorporação da RNI-POCT na prática diária, apesar das limitações desse método. Esses profissionais mostram-se dispostos a treinar o paciente para realizar o teste, mas legalmente não são os responsáveis pela qualidade do mesmo e não estão preparados para a manutenção dos equipamentos. A definição do responsável pelo RNI-POCT precisa ser reavaliada pelos órgãos competentes, de forma a garantir que seja cumprida, e constitui etapa essencial para assegurar a qualidade do teste e, consequentemente, sua maior utilização.

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

HIV testing in developing countries: What is required.

HIV diagnostic and follow up testing are usually done in laboratory settings. However, in developing countries there is a need to decentralize testing as the majority of the population lives in rural settings. In developing countries stringent quality assurance (QA) practices, which include appropriate training, development of standard operating procedures, maintenance of operator proficiency, routine use of quality control (QC) specimens, standardized data management, equipment calibration and maintenance, and biohazard safety with proper disinfection/disposal procedures are not routinely followed to ensure reliability of results and a safe work environment. The introduction of point-of-care testing technologies involving the use of non-laboratorians in routine testing has further increased the complexity of QA. Therefore, a careful approach towards improvement of laboratories that encourages best practices, coupled with incentives, and review of government policies in point-of-care testing is needed to improve quality of testing as decentralization takes place. Development of a functional laboratory tiered network that facilitates communication, referral, training and problem solving could further enhance confidence in laboratory testing. There is also a need for special considerations in implementing a stepwise approach towards quality improvement, strengthening of the supply chain management, human capacity development, infrastructure upgrade, and strong public private partnerships to ensure long term sustainability of these efforts.

¿Podemos confiar en una glicemia realizada en un glucómetro al lado de la cama del enfermo? / Are blood glucose measurements made with portable glucometers reliable?

Examinations performed beside the bed of patients ("Point-ofcare testing, POCT") provide immediate results and are simple to perform. The most common of these tests is the self control of blood glucose levels in diabetic patients. The use of these devices at the hospital level, introduces a new set of requirements to health institutions, which should monitor all aspects of the process, including training of final users, proper quality control, development of written procedures for use and even participation in surveys of external quality control, avoiding the generation of errors and guaranting patient safety (Rev Méd Chile 2009; 137:1261-4).

Los exámenes realizados al lado de la cama del enfermo ("Point of care testing, POCT") tienen como mayor ventaja la rapidez en la entrega de resultados y la simplicidad de uso, siendo su principal aplicación el autocontrol de la glicemia en pacientes diabéticos. El uso de estos equipos a nivel hospitalario introduce exigencias a las instituciones de salud, las cuales deben monitorizar todos ¡os aspectos del proceso, incluyendo la capacitación de los usuarios, el adecuado control de calidad, el desarrollo de procedimientos escritos para su uso e inclusive la participación en encuestas de control de calidad externo, evitando la generación de errores y colaborando así con la seguridad del paciente.

Comparison between cardiac output values measured by thermodilution and partial carbon dioxide rebreathing in patients with acute lung injury

CONTEXTO: A termodiluição, considerada técnica padrão para medida do débito cardíaco em pacientes graves, não é isenta de riscos relevantes. Faz-se necessário encontrar métodos alternativos não invasivos, automáticos, simples e acurados para monitorar o débito cardíaco à beira do leito. OBJETIVO: Comparar as medidas do débito cardíaco obtido com os métodos termodiluição e reinalação parcial de gás carbônico em pacientes com lesão pulmonar aguda em dois níveis de gravidade (índice de lesão pulmonar - LIS abaixo de 2,5 grupo A; e acima de 2,5, grupo B). TIPO DO ESTUDO: Comparativo, prospectivo, controlado. LOCAL: Unidades de Terapia Intensiva de dois hospitais-escola. MÉTODOS: Vinte pacientes acometidos de insuficiência respiratória aguda (PaO2/FiO2 < 300), sob ventilação pulmonar artificial, nos quais foram realizadas 294 medidas, 164 medidas no grupo A (n = 11) e 130 no grupo B (n = 9),variando de 14 a 15 medidas por paciente, foram estudados. Débito cardíaco foi medido com termodiluição e reinalação parcial de gás carbônico. RESULTADOS: A correlação entre os métodos estudados foi fraca no grupos A (r = 0,52, p < 0,001*) e no B: r = 0,47, p < 0,001*). A aplicação do teste de Bland-Altman permitiu evidenciar a discordância entre os métodos (grupo A: -0,9 ± 2,71 l/min; IC 95% = - 1,14 a -0,48; e grupo B: -1,75 ± 2,05 l/min (IC 95% = -2,11 a -1,4). A comparação dos resultados (testes t para grupos emparelhados e Mann-Whitney) obtidos nos grupos e entre os grupos de estudo revelou diferenças ( p = 0,00*, p < 0,05). DISCUSSAO: Erros em estimar o CaCO2 (conteúdo arterial de CO2) através da ETCO2 (CO2 de final de corrente) e situações de circulação hiperdinâmica associados a espaço morto e/ou shunt possivelmente expliquem nossos resultados. CONCLUSAO: Em pacientes com lesão pulmonar aguda, o débito cardíaco determinado pela reinalação parcial de gás carbônico difere dos valores medidos com termodiluição. Esta diferença se acentua com a maior gravidade da lesão pulmonar.

Comparison of outpatient point of care glucose testing vs venous glucose in the clinical laboratory

The purpose of this study was to evaluate the accuracy of glucometers in assessing glucose levels in outpatients. The investigation consisted in the analysis of retrospective validation data (obtained at the Clinical Laboratory of the Puerto Rico Medical Services Administration) and the analysis of data obtained from forty outpatients. Glucose concentration was obtained from these outpatient samples using the patients' glucometers and a clinical laboratory analyzer (hexokinase method). Statistical analysis included descriptive and correlation measures and t-test. Results revealed that accurate glucose values were obtained by the glucometers utilized in both the validation process and the outpatients (POCT) procedure. The investigation also demonstrated the need by outpatients to receive proper training in handling their glucometers.

Evaluation of the bedside glucose monitoring system in neonatal units.

OBJECTIVE: To evaluate the performance of a commercial reader compared with a laboratory method in neonates with a variety of diseases and conditions. PATIENTS AND METHOD: A total of 175 patients were included in the present study. Venous whole blood samples were analyzed with a commercial reader by trained nurse. Through the same sampling site, specimens were collected, spun and plasma were sent to the laboratory for measurement of plasma glucose. RESULTS: The regression analysis between the results of a commercial reader and laboratory glucose were significantly correlated (r = 0.97; p < 0.001) with the result as follows: A commercial reader = Laboratory glucose - 0.17 (n = 175). A positive slope of 0.04 was found between hematocrit and difference between a commercial reader and laboratory plasma glucose. However, this correlation was of little clinical significance. CONCLUSIONS: A commercial reader showed a good correlation with the standard laboratory method for the measurement of plasma glucose in neonates with a variety of diseases and conditions.