VII Simposio Internacional de Ciencias Farmacéuticas 2019 "VII SICF" -VII Simposio "Diseño, Obtención y Desarrollo de Fármacos"

VII Simposio Internacional de Ciencias Farmacéuticas 2019

VII SICF

Performance characteristics of a fast real-time PCR assay for HBV DNA quantification

Resumen [ES]

Detection of hepatitis B virus (HBV) DNA is particularly important for detection of early acute and of occult HBV infection. On the other hand, HBV DNA detection and quantification are essential to diagnose and treat chronic HBV infection. In this study, we evaluated the performance of the real-time PCR SUMASIGNAL VHB (un paso) (Immunoassay Center, Cuba). The clinical and analytical specificity of the assay was 100%. Intra-assay and interassay coefficients of variation ranged from 0.50 to 2.53% and from 1.23 to 3.03%, respectively. A strong correlation (r=0.926; P<0.001) with the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 (Roche Molecular Systems, Inc.) was obtained. The limit of detection using the third WHO international standard for HBV DNA was 377.47 IU/mL. The test was able to detect the most prevalent HBV genotypes (A-G) equally well. In conclusion, the SUMASIGNAL VHB (un paso) is a sensitive, specific, precise and accurate assay for the quantification of serum and plasma HBV DNA. Thus, this simple and fast real-time PCR test can be used as an aid in diagnosing an HBV infection and monitoring drug efficacy.

Resumen [EN]

Detection of hepatitis B virus (HBV) DNA is particularly important for detection of early acute and of occult HBV infection. On the other hand, HBV DNA detection and quantification are essential to diagnose and treat chronic HBV infection. In this study, we evaluated the performance of the real-time PCR SUMASIGNAL VHB (un paso) (Immunoassay Center, Cuba). The clinical and analytical specificity of the assay was 100%. Intra-assay and interassay coefficients of variation ranged from 0.50 to 2.53% and from 1.23 to 3.03%, respectively. A strong correlation (r=0.926; P<0.001) with the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 (Roche Molecular Systems, Inc.) was obtained. The limit of detection using the third WHO international standard for HBV DNA was 377.47 IU/mL. The test was able to detect the most prevalent HBV genotypes (A-G) equally well. In conclusion, the SUMASIGNAL VHB (un paso) is a sensitive, specific, precise and accurate assay for the quantification of serum and plasma HBV DNA. Thus, this simple and fast real-time PCR test can be used as an aid in diagnosing an HBV infection and monitoring drug efficacy.

Sobre el ponente

Anny Armas Cayarga

MsC. Anny Armas Cayarga

Centro de Inmunoensayo Flag of Cuba
Información Práctica
English (US)
No definido
30 minutos
No definido
Autores
Yenitse Perea Hernández
Niurka Santos Hernández
Deyanira La Rosa
Yaimé J. González González
MsC. Anny Armas Cayarga
Irinia Y. Valdivia Álvarez
Ivonne Gómez Cordero
Juan E. Figueredo Lago
Ernesto L. Martínez
Héctor Vega Sánchez
Palabras clave
dna
hepatitis b virus
quantification
real-time pcr