RESUMEN
BACKGROUND: Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDR-TB). TB-SPRINT 59-Plex Beamedex® is a microbead-based assay developed for the simultaneous spoligotyping and detection of MDR-TB. The accuracy and cost evaluation of new assays and technologies are of great importance for their routine use in clinics and in research laboratories. The aim of this study was to evaluate the performance of TB-SPRINT at three laboratory research centers in Brazil and calculate its mean cost (MC) and activity-based costing (ABC). METHODS: TB-SPRINT data were compared with the phenotypic and genotypic profiles obtained using Bactec™ MGIT™ 960 system and Genotype® MTBDRplus, respectively. RESULTS: Compared with MGIT, the accuracies of TB-SPRINT for the detection of rifampicin and isoniazid resistance ranged from 81 to 92% and 91.3 to 93.9%, respectively. Compared with MTBDRplus, the accuracies of TB-SPRINT for rifampicin and isoniazid were 99 and 94.2%, respectively. Moreover, the MC and ABC of TB-SPRINT were USD 127.78 and USD 109.94, respectively. CONCLUSION: TB-SPRINT showed good results for isoniazid and rifampicin resistance detection, but still needs improvement to achieve In Vitro Diagnostics standards.
Asunto(s)
Farmacorresistencia Bacteriana , Citometría de Flujo/métodos , Mycobacterium tuberculosis/genética , Tuberculosis/diagnóstico , Antituberculosos/farmacología , Proteínas Bacterianas/genética , Catalasa/genética , Costos y Análisis de Costo , ARN Polimerasas Dirigidas por ADN/genética , Farmacorresistencia Bacteriana/efectos de los fármacos , Citometría de Flujo/economía , Genotipo , Humanos , Isoniazida/farmacología , Pruebas de Sensibilidad Microbiana , Mutación , Mycobacterium tuberculosis/efectos de los fármacos , Mycobacterium tuberculosis/aislamiento & purificación , Regiones Promotoras Genéticas , Juego de Reactivos para Diagnóstico , Rifampin , Sensibilidad y Especificidad , Tuberculosis/economíaRESUMEN
INTRODUCTION: The present study sought to assess the mean and activity based cost (ABC) of the laboratory diagnosis for tuberculosis through the application of conventional and molecular techniques-Xpert®MTB/RIF and Genotype®MTBDRplus-in a tertiary referral hospital in Brazil. METHODS: The mean cost and ABC formed the basis for the cost analysis of the TB laboratory diagnosis. RESULTS: The mean cost and ABC were US$ 4.00 and US$ 3.24, respectively, for a bacilloscopy; US$ 6.73 and US$ 5.27 for a Lowenstein-Jensen (LJ) culture; US$ 105.42 and US$ 76.56 for a drug sensitivity test (DST)-proportions method (PM) in LJ; US$ 148.45 and US$ 136.80 for a DST-BACTECTM MGITTM 960 system; US$ 11.53 and US$ 9.89 for an Xpert®MTB/RIF; and US$ 84.21 and US$ 48.38 for a Genotype®MTBDRplus. CONCLUSIONS: The mean cost and ABC proved to be good decision-making parameters in the diagnosis of TB and MDR-TB. The effective implementation of algorithms will depend on the conditions at each location.
Asunto(s)
Costos y Análisis de Costo/estadística & datos numéricos , Mycobacterium tuberculosis/genética , Tuberculosis Resistente a Múltiples Medicamentos/diagnóstico , Tuberculosis Resistente a Múltiples Medicamentos/economía , Tuberculosis Pulmonar/diagnóstico , Tuberculosis Pulmonar/economía , Brasil , Genotipo , Humanos , Mycobacterium tuberculosis/aislamiento & purificación , Sensibilidad y Especificidad , Centros de Atención TerciariaRESUMEN
INTRODUCTION: Rapid and accurate tuberculosis detection is critical for improving patient diagnosis and decreasing tuberculosis transmission. Molecular assays can significantly increase laboratory costs; therefore, the average time and economic impact should be evaluated before implementing a new technology. The aim of this study was to evaluate the cost and average turnaround time of smear microscopy and Xpert assay at a university hospital. METHODS: The turnaround time and cost of the laboratory diagnosis of tuberculosis were calculated based on the mean cost and activity based costing (ABC). RESULTS: The average turnaround time for smear microscopy was 16.6 hours while that for Xpert was 24.1 hours. The Xpert had a mean cost of USD 17.37 with an ABC of USD 10.86, while smear microscopy had a mean cost of USD 13.31 with an ABC of USD 6.01. The sensitivity of smear microscopy was 42.9% and its specificity was 99.1%, while the Xpert assay had a sensitivity of 100% and a specificity of 96.7%. CONCLUSIONS: The Xpert assay has high accuracy; however, the turnaround time and cost of smear microscopy were lower than those of Xpert.
Asunto(s)
Bioensayo/economía , Patología Molecular/economía , Tuberculosis Pulmonar/diagnóstico , Bioensayo/métodos , Costos y Análisis de Costo , Humanos , Microscopía , Mycobacterium tuberculosis , Patología Molecular/métodos , Sensibilidad y Especificidad , Tuberculosis , Tuberculosis Pulmonar/economíaRESUMEN
At a global level, with the increase in healthcare costs, there is a need to assess the economic impact of the incorporation of new technologies in different health disorders in different countries. There is scarce information regarding costs incurred with the use of current or new diagnostic tests for tuberculosis or from the vantage point of their incorporation within the healthcare systems of high-burden countries. The present study aimed to assess the mean cost and the activity based cost of the laboratory diagnosis for tuberculosis by means of conventional techniques and from the Detect TB®LabTest molecular test kit in a general high-complexity hospital of the public health system in Brazil. Cost analysis was performed by means of primary data, collected in the Mycobacteria and Molecular Biology Laboratory in 2013. The mean cost and activity based cost were, respectively, U$10.06/U$5.61 for centrifuged bacilloscopy by Ziehl Neelsen (ZN) and Auramine (AU); U$7.42/U$4.15 for direct bacilloscopy by ZN; U$27.38/U$16.50 for culture in a Loweinstein-Jensen solid medium; and U$115.74/U$73.46 for the Detect TB®LabTest Kit. The calculation of the ABC should be used in making decisions by administrators to be the best method of assessing the costs of conventional techniques and molecular method for providing the real value of the tests. So it is need to calculate the ABC, and not of the mean cost, in various scenarios before incorporating new technologies in health institutions.
RESUMEN
Abstract INTRODUCTION: The present study sought to assess the mean and activity based cost (ABC) of the laboratory diagnosis for tuberculosis through the application of conventional and molecular techniques-Xpert®MTB/RIF and Genotype®MTBDRplus-in a tertiary referral hospital in Brazil. METHODS: The mean cost and ABC formed the basis for the cost analysis of the TB laboratory diagnosis. RESULTS: The mean cost and ABC were US$ 4.00 and US$ 3.24, respectively, for a bacilloscopy; US$ 6.73 and US$ 5.27 for a Lowenstein-Jensen (LJ) culture; US$ 105.42 and US$ 76.56 for a drug sensitivity test (DST)-proportions method (PM) in LJ; US$ 148.45 and US$ 136.80 for a DST-BACTECTM MGITTM 960 system; US$ 11.53 and US$ 9.89 for an Xpert®MTB/RIF; and US$ 84.21 and US$ 48.38 for a Genotype®MTBDRplus. CONCLUSIONS: The mean cost and ABC proved to be good decision-making parameters in the diagnosis of TB and MDR-TB. The effective implementation of algorithms will depend on the conditions at each location.
Asunto(s)
Humanos , Tuberculosis Pulmonar/diagnóstico , Tuberculosis Pulmonar/economía , Tuberculosis Resistente a Múltiples Medicamentos/diagnóstico , Tuberculosis Resistente a Múltiples Medicamentos/economía , Costos y Análisis de Costo/estadística & datos numéricos , Mycobacterium tuberculosis/genética , Brasil , Sensibilidad y Especificidad , Centros de Atención Terciaria , Genotipo , Mycobacterium tuberculosis/aislamiento & purificaciónRESUMEN
Abstract INTRODUCTION: Rapid and accurate tuberculosis detection is critical for improving patient diagnosis and decreasing tuberculosis transmission. Molecular assays can significantly increase laboratory costs; therefore, the average time and economic impact should be evaluated before implementing a new technology. The aim of this study was to evaluate the cost and average turnaround time of smear microscopy and Xpert assay at a university hospital. METHODS: The turnaround time and cost of the laboratory diagnosis of tuberculosis were calculated based on the mean cost and activity based costing (ABC). RESULTS: The average turnaround time for smear microscopy was 16.6 hours while that for Xpert was 24.1 hours. The Xpert had a mean cost of USD 17.37 with an ABC of USD 10.86, while smear microscopy had a mean cost of USD 13.31 with an ABC of USD 6.01. The sensitivity of smear microscopy was 42.9% and its specificity was 99.1%, while the Xpert assay had a sensitivity of 100% and a specificity of 96.7%. CONCLUSIONS: The Xpert assay has high accuracy; however, the turnaround time and cost of smear microscopy were lower than those of Xpert.
Asunto(s)
Humanos , Tuberculosis Pulmonar/diagnóstico , Bioensayo/economía , Patología Molecular/economía , Tuberculosis , Tuberculosis Pulmonar/economía , Bioensayo/métodos , Sensibilidad y Especificidad , Costos y Análisis de Costo , Patología Molecular/métodos , Microscopía , Mycobacterium tuberculosisRESUMEN
This study compares smear, growth in Lowenstein-Jensen medium, and in-house polymerase chain reaction (PCR) techniques for the detection of Mycobacterium tuberculosis. A total of 72 specimens from 72 patients with clinical symptoms of tuberculosis, including 70 sputum and two bronchial aspirate samples, were tested in parallel by smear, culture, and in-house PCR techniques. From these, 48 (66.6%) were negative by the 3 methods, 2 (2.8%) were smear positive and negative by culture and in-house PCR, 11 (15.3%) were both smear and culture negative, and in-house PCR positive, 7 (9.7%) were positive by the 3 methods, 2 (2.8%) were positive by smear and culture, and negative by PCR, 2 (2.8%) were positive by culture and PCR, but smear negative. After the resolution of discrepancies in PCR results, the sensitivity and specificity for in-house PCR technique to M. tuberculosis relative to the culture, were 81.8% and 81.9%, respectively. These results confirm that this method, in-house PCR, may be a sensitive and specific technique for M. tuberculosis detection, occurring in both positive and negative smear and negative cultures.
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Mycobacterium tuberculosis/aislamiento & purificación , Reacción en Cadena de la Polimerasa/métodos , Tuberculosis Pulmonar/diagnóstico , Líquido del Lavado Bronquioalveolar/microbiología , Medios de Cultivo , ADN Bacteriano/análisis , Femenino , Humanos , Masculino , Reacción en Cadena de la Polimerasa/normas , Sensibilidad y Especificidad , Esputo/microbiologíaRESUMEN
This study compares smear, growth in Lowenstein-Jensen medium, and in-house polymerase chain reaction (PCR) techniques for the detection of Mycobacterium tuberculosis. A total of 72 specimens from 72 patients with clinical symptoms of tuberculosis, including 70 sputum and two bronchial aspirate samples, were tested in parallel by smear, culture, and in-house PCR techniques. From these, 48 (66.6 percent) were negative by the 3 methods, 2 (2.8 percent) were smear positive and negative by culture and in-house PCR, 11 (15.3 percent) were both smear and culture negative, and in-house PCR positive, 7 (9.7 percent) were positive by the 3 methods, 2 (2.8 percent) were positive by smear and culture, and negative by PCR, 2 (2.8 percent) were positive by culture and PCR, but smear negative. After the resolution of discrepancies in PCR results, the sensitivity and specificity for in-house PCR technique to M. tuberculosis relative to the culture, were 81.8 percent and 81.9 percent, respectively. These results confirm that this method, in-house PCR, may be a sensitive and specific technique for M. tuberculosis detection, occurring in both positive and negative smear and negative cultures.
Asunto(s)
Humanos , Masculino , Femenino , Mycobacterium tuberculosis , Reacción en Cadena de la Polimerasa , Tuberculosis Pulmonar , Líquido del Lavado Bronquioalveolar , Medios de Cultivo , ADN Bacteriano , Sensibilidad y Especificidad , EsputoRESUMEN
Com o intuito de identificar e verificar a sensibilidade de cepas de Mycobacterium tuberculosis isoladas de 206 amostras clínicas obtidas de formas pulmonares e extrapulmonares, provenientes de 144 pacientes externos e internos do Hospital de Doenças Tropicais do Estado de Goiás, foi realizado baciloscopia pela técnica de coloraçäo de Ziehl-Neelsen e a cultura em Lowenstein-Jensen e sistema bifásico. A identificaçäo foi realizada através de provas de crescimento na presença de inibidores, produçäo de pigmentos, tempo de crescimento e provas bioquímicas, conjuntamente com a determinaçäo da susceptibilidade às drogas antimicobacterianas. Foram isoladas micobactérias em 13 (6,3 porcento) amostras, sendo 12 (92,3 porcento) identificadas como M. tuberculosis e uma (7,7 porcento) do complexo M. avium (MAC). Das amostras isoladas, 12 apresentaram sensibilidade a isoniazida, etambutol, rifampicina, estreptomicina, pirazinamida, etionamida e somente uma amostra, apresentou resistência à isoniazida, rifampicina, pirazinamida e etionamida