Introducción • Co-infección TB-VIH primera causa de muerte de pacientes VIH positivo • Diagnóstico y tratamiento temprano mejora el pronóstico y reduce la transmisión de TB • Diagnóstico de TB complejo en pacientes VIH positivo
Introducción Xpert®MTB/Rif: prueba molecular, detección simultánea de TB y susceptibilidad a rifampicina -
PCR automatizado Resultados en 2 horas Tiempo de manipulación 15 minutos Entrenamiento personal: 2 días Requisitos de bioseguridad mínimos OMS – 2010 para tamizaje de pacientes con TB-MDR y co-infección TB-VIH
Justificación, objetivo y diseño • Estudios de desempeño de Xpert®MTB/Rif (MTB/Rif) en países donde epidemia de VIH es generalizada • Evaluar desempeño de MTB/Rif en pacientes HIV positivos con alta sospecha clínica de TB pulmonar en dos centros de referencia de Lima
• Estudio de evaluación diagnóstica
Criterios inclusión y exclusión Criterios inclusión 1. Adultos con diagnóstico VIH confirmado 2. Alta sospecha clínica de TB – tos ≥ 10 d – RX tórax anormal – por lo menos un síntoma sistémico
3. Aceptar participar en el estudio 4. Dos muestras de esputo (4 ml) Criterios exclusión: 1. Haber recibido > 2 dosis de tratamiento anti-TB
Procedimientos • Abril 2010 - mayo 2012 • HNCH y HNHU Muestras de esputo – 1era muestra: BK, LJ, MGIT, método de proporciones LJ – 2da muestra: BK, LJ, MGIT, método de proporciones LJ, MTB/Rif
• MTB/Rif: dos versiones de software 2.1 y 4.0 (valores de corte de rifampicina)
Estándar de referencia • Compuesto (LJ-MGIT) – Positivo: crecimiento en al menos un tubo de LJ o MGIT – Negativo: cultivo negativo en las dos muestras – Contaminado: cultivo contaminado en las dos muestras
Resultados: algoritmo del estudio
45/131 (34.4%) pacientes con TB
Desempeño MTB/RIF para diagnóstico de TB Parámetro
n
% (IC 95%)
Sensibilidad
44/45
97.8 (88.4-99.6)
Especificidad
84/86
97.7 (88.4-99.6)
Valor predictivo positivo
44/46
95.7 (85.5-98.8)
Valor predictivo negativo
84/85
98.8 (93.6-99.8)
MTB/RIF y BK • MTB/RIF detectó 97.8% (44/45) vs 68.9% (31/45) detectados por BK • De los 14/45 pacientes BK negativoscultivo positivo, MTB/RIF detectó a 13/14
Desempeño MTB/RIF en diagnóstico de resistencia a rifampicina • Estándar de referencia: 6/39 (15.4%) resistentes a rifampicina • MTB/RIF detectó los 6 casos y detectó resistencia a RIF en 3 pacientes adicionales
Resultados discordantes MTB/RIF y estándar de referencia • 3/134 (2.3%) resultados discordantes detección MTb – 1 BK neg, MTB/Rif neg, estándar pos, curado – 1 BK pos, MTB/Rif pos, estándar neg, curado – 1 BK neg, MTB/Rif pos, estándar neg, falleció
Limitaciones - No se pudo realizar genotipificación para resultados discordantes - Tamaño muestral pequeño para una adecuada evaluación de resistencia a rifampicina
Conclusiones • Excelente desempeño de MTB/RIF para detectar o descartar Mtb • MTB/RIF superó al BK en casi 1/3 de los pacientes • Es necesario realizar más estudios en Latino América • Realizar estudios operacionales, evaluar costoefectividad en distintos contextos y evaluar el impacto en el resultado de tratamiento
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