medigraphic.com
ISSN 1561-3054 (Electronic)

2021, Number 3

<< Back Next >>

Rev Cubana Med Trop 2021; 73 (3)

Evaluation of the clinical performance of the SUMASIGNAL HCV assay for detection of hepatitis C virus RNA

Montalvo VMC, Rodríguez-Lay LÁ, López HD, Bello CM, Martínez MY, Marrero SB, González GYJ, Armas CA

Language: Spanish
References: 11
Page: 1-11
PDF size: 328.06 Kb.


ABSTRACT

Introduction: Detection and quantification of the hepatitis C virus genome (HCV RNA) by real time reverse transcription PCR (RT-qPCR) are vital for the diagnosis and antiviral treatment follow-up of hepatitis C patients.
Objective: Evaluate the clinical performance of the SUMASIGNAL HCV assay for quantification of HCV viral load.
Methods: A panel was formed with 70 serum samples: 46 HCV RNA positive, 12 HCV RNA negative and 12 positive for molecular markers of other viruses. Pearson's correlation coefficient (r) and the Bland-Altman plot were used to compare the HCV viral loads obtained by SUMASIGNAL HCV techniques with reference values, which were expressed as base 10 logarithm (log10) UI/ml. Values of p <0.05 were considered statistically significant.
Results: The clinical sensitivity and specificity of SUMASIGNAL HVC were 100%, and no cross-reactivity was detected with the other viruses evaluated. The study assay exhibited a good correlation (r= 0.89) and strong concordance (mean= -0.01 Log10 UI/ml) with the reference test (p< 0.0001). Reproducibility of the HCV RNA quantification with the SUMASIGNAL HCV test at two different moments displayed an excellent correlation (r= 0.97; p< 0.0001).
Conclusions: The SUMASIGNAL HVC assay provides valid, reproducible and technically reliable data for specific HCV diagnosis. It is also a useful tool to monitor the viral load of this agent in the Cuban National Health System.


REFERENCES

  1. Organización Mundial de la Salud. Hepatitis C. 27 de julio de 2020. [acceso: 17/02/2020]. Disponible en: Disponible en: http://www.who.int/es/news-room/fact-sheets/detail/hepatitis-c

  2. Smith DB, Bukh J, Kuiken C, Muerhoff AS, Rice CM, Stapleton JT, et al. Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment web resource. Hepatol. 2014;59(1):318-27. Doi: https://doi.org/10.1002/hep.26744

  3. Lee MH, Yang HI, Yuan Y, L'Italien G, Chen CJ. Epidemiology and natural history of hepatitis C virus infection. World J Gastroenterol. 2014:20:9270-80. Doi: https://doi.org/10.3748/wjg.v20.i28.9270

  4. Maurine CO, Hasan I, Sulaiman AS, Gani RA. Evaluation of GeneXpert for Quantification Viral Load Hepatitis C Virus. Ind J Gastroenterol Hepatol Dig Endos. 2020;21(3):182-87. Doi: https://doi.org/10.24871/2132020182-187

  5. Lin SF, Tung SY, Wei KL, Chen CH, Hu TH, Shen CH, et al. Clinical utility of hepatitis C virus core antigen assay in the monitoring of direct-acting antivirals for chronic hepatitis C. PLoS One. 2020;15(3). Doi: https://doi.org/10.1371/journal.pone.0229994

  6. Schalasta G, Speicher A, Börner A, Enders M. Performance of the New Aptima HCV Quant Dx Assay in Comparison to the Cobas TaqMan HCV2 Test for Use with the High Pure System in Detection and Quantification of Hepatitis C Virus RNA in Plasma or Serum. J Clin Microbiol. 2016;54(4):1101-7. Doi: https://doi.org/10.1128/JCM.03236-15

  7. Rodríguez L, Montalvo MC, Bello M, Sariego S, Marante J, Dueñas S, et al. HCV genotype determination in monoinfected and HIV co-infected patients in Cuba. Trans R Soc Trop Med Hyg. 2012;106(12):711-7. Doi: https://doi.org/10.1016/j.trstmh.2012.08.001

  8. Huang X, Deng Z, Long L, Chen J, Tan D, Zhu L, et al. Traceability, reproducibility and clinical evaluation of Sansure Realtime HCV RNA assay. BMC Infect Dis. 2016;16:47. Doi: https://doi.org/10.1186/s12879-016-1390-9

  9. Perea Y, Armas A, Gonzalez Y, Figueredo JE, Laza CM, Acevedo BE. Mejoras al ensayo UMELOSA HCV cualitativo para la detección el ARN del virus de la hepatitis C. Biotecnol Apl. 2016;33(3):3301-7. [acceso: 17/12/2020]. Disponible en: Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1027-28522016000300005

  10. European Association for the Study of the Liver. Electronic address eee. EASL recommendations on treatment of Hepatitis C 2016. J Hepatol. 2017;66:153-94. Doi: https://doi.org/10.1016/j.jhep.2016.09.001

  11. Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Overestimation and underestimation of hepatitis C virus RNA levels in a widely used real-time polymerase chain reaction based method. Hepatol. 2007;46:22-31. Doi: https://doi.org/10.1128/JCM.02219-16




2020     |     www.medigraphic.com