Diagnostic Performance of GeneXpert HCV VL Finger Stick and GeneXpert HCV Viral Load Compared to RT-PCR in POCT settings : Establishing the Diagnosis of Chronic Hepatitis C in Hemodialysis Patients
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Background
The most widely utilized method for detecting HCV RNA is Nucleic Acid Testing (NAT) via RT PCR. In response to the need for more accessible and faster testing, particularly in high risk populations, an accessible method : Point of Care Molecular Testing (PoCT). International studies have demonstrated the use of fingerstick samples with this PoCT molecular method among injecting drug users in prisons, where HCV RNA PoCT exhibited a sensitivity of 98.4% for detecting viral loads (>4 IU/mL), and 100% sensitivity for quantifiable viral loads (≥10, 1000, and 3000 IU/mL), with a specificity of 100%. This PoCT testing is also a key element in the WHO’s strategy for achieving the Hepatitis elimination target by 2030. However, its application in Indonesia remains limited, and as such, the efficacy of this simple testing approach has yet to be fully evaluated in comparison to real-time PCR.
Method
This study is a diagnostic test with a cross-sectional design. There were 57 CKD on Hd patients in Cipto Mangunkusumo and Pelni Hospital tested by GeneXpert Fingerstick, Plasma and confimerd by PCR Cobas Taqman
Result
The probability test comparing the Fingerstick, GeneXpert, and Cobas Taqman 96 platforms yielded a p-value of <0.001, indicating a highly significant correlation. Both the Fingerstick and GeneXpert HCV viral load assays demonstrated exceptional diagnostic performance, achieving 100% sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV)
Conclusion
The GeneXpert fingerstick POCT may serve as a simple and reliable point-of-care method for detecting hepatitis C in patients with chronic kidney disease undergoing hemodialysis
