The Role of Genedrive in Point of Care Method For Hepatitis C Elimination in Hemodialysis Center.

BACKGROUND: Point of care is laboratory testing conducted close to the site of the patient. Point of care assessment is essential to detect and treat the hepatitis C virus in a single visit. The potential use of Genedrive extends to remote areas and key populations Therefore, there is a need for a simple, and cost-effective examination of methods, such as Genedrive. Genedrive is a rapid and low-cost diagnostic tool for the identification and treatment selection of infectious diseases. The World Health Organization targets to eliminate hepatitis by 2030, which decreases infections by 90%, and decreases deaths by 65%. Point of care could play a significant role in contributing to the elimination of hepatitis C. Chronic kidney disease (CKD) patients on hemodialysis are among the population at risk of hepatitis C due to nosocomial transmission. This study aimed to assess the role of Genedrive in measuring hepatitis C in chronic hepatitis C patients with chronic kidney disease on hemodialysis. METHODS: This study used a cross-sectional design. There were 64 CKD on Hd patients in Cipto Mangunkusumo Hospital tested by Genedrive. ROC analysis was conducted to assess significant hepatitis C among chronic kidney disease on hemodialysis. RESULTS: The calculated detection limit of Genedrive was 3.1x103 IU/mL. Genedrive HCV assay showed 90.6% sensitivity, 96.8% specificity, 92% negative predictive value, and 97% positive predictive value to detect HCV, 10.36 positive likelihood ratio, and 0.09 negative likelihood ratio. CONCLUSION: Genedrive could be a simple and reliable point of care method to detect hepatitis C with chronic kidney disease on hemodialysis.

Diagnostic Performance of Mac-2-Binding Protein Glycosylation Isomer (M2BPGi), compared to Transient Elastography to Assess Liver Stiffness in Treatment Naïve Chronic Hepatitis C Patients.

BACKGROUND: Liver fibrosis is an essential factor in the management of Hepatitis C virus infection. Its assessment is crucial in decision-making regarding the therapeutic decisions, and the patients' follow up. However, the established liver measurement methods have several limitations. Therefore, this study aims to assess the role of Mac-2-Binding Protein Glycosylation Isomer (M2BPGi) as a novel biomarker to measure liver stiffness in treatment naïve Chronic Hepatitis C Indonesian patients. METHODS: This study used a cross-sectional design to determine the correlation between serum M2BPGi and the degree of liver stiffness, Transient Elastrography, and differences in serum M2BPGi levels in chronic hepatitis C patients. Serum M2BPGi level and Transient Elastography results were evaluated in 56 Chronic Hepatitis C patients and 48 healthy controls. Pearson correlation analysis was conducted to find the correlation between the level of M2BPGi and Transient Elastography result. ROC analysis was conducted to find the optimum cut-off to assess fibrosis's degree among Chronic Hepatitis C Patients. RESULTS: The level of serum M2BPGi and Transient Elastography result was strongly correlated with the median level of serum M2BPGi. It was also significantly higher among Chronic Hepatitis C Patients than among healthy controls (r: 0.708, p<0.001; 0.590 COI vs. 4.130 COI, p<0.001). Among the Chronic Hepatitis C patients, the median serum of M2BPGi increased according to the degree of liver fibrosis: 1.500 COI (F0-F1), 2.985 COI (F2-F3) and 8.785 COI (≥F4). The optimum cut-off value for diagnosing significant fibrosis (F2-F3) was 1.820 COI (AUC: 90.8%) and for diagnosing cirrhosis (≥F4) was 3.770 COI (AUC: 89.3%). CONCLUSION: Serum M2BPGi was a reliable diagnostic tool for identifying liver fibrosis in Indonesian patients with Chronic Hepatitis C.