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Session Title: Category 08b: Viral Hepatitis C: Clinical (except therapy)
Presentation Date: 02 APR, 2011

A NOVEL RAPID NON-INVASIVE SCREENING DEVICE (C-FAST) FOR HEPATITIS C VIRUS WITH HIGH SENSITIVITY AND SPECIFICITY

G. Shiha¹*, A. Amien², W. Samir³, H. Bader^4
1Internal Medicine, Mansoura University- Faculty of Medicine, Mansoura, ²Engineering Authority, Ministry of Defence, Cairo, ³Biochemistry Laboratory, Specialized Medical Hospital-Mansoura University, Mansoura, ⁴Engineering Authority, Ministry of defenceD, Cairo, Egypt. *g_shiha@hotmail.com

Introduction: Chronic hepatitis C virus (HCV) infection is a major health problem with around 200 million individuals affected worldwide. The screening test for detection of HCV was the determination of the anti-HCV antibodies by ELISA method. However, RT-PCR was still the accurate and standard technique for detection of HCV. All substances consist of molecules, each molecule has a specific frequency (Molecular Signature).We developed a novel, rapid, non-invasive screening device C-FAST (trade mark), which is patented Bio-sensor slash spectroscopy based technology for the detection of hepatitis C virus. When the signal is picked up a pivoting antenna of the C- FAST is drawn like a compass needle, to indicate alignment between the patient and the frequency card in the C-FAST .
Aim: Evaluation of the sensitivity and specificity of HCV detection using C-FAST device as compared to RT-PCR.
Methods: The study included 879 cases seen at out-patients hepatology clinic at Mansoura, Egypt. HCV RNA was detected for all cases using RT-PCR. C-FAST device was applied for all cases to detect the infected patients with HCV. Sensitivity, specificity, positive and negative predictive values were determined for comparison between the two methods.
Results: 879 cases (868 male & 11 female) with age ranged from 18-46 years were included in the study. 159 cases were positive for HCV-RNA and 720 cases were negative for HCV-RNA using RT-PCR. The results of C-FAST showed that 178 cases were infected with HCV while 701 cases were not infected with HCV. The efficacy of C-FAST was 97.8 %, sensitivity 100 %, specificity 97.3 %, PPV 89.3 % and NPV 100 %.
Conclusion: C-FAST is rapid, non-invasive, accurate, simple ,highly sensitive and specific tool for screening of hepatitis C virus and have the potential for early detection of viral load which will enhance the therapeutic outcome.