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Truenat HCV CChip-based Real Time PCR Test for Hepatitis C Virus 4. INTENDEDUSE Truenat™ HCV (REF 60118000SI601180020/601180050) is a chipbased Real Time Reverse Transarpton Polymerase Chain Reacon (RT-PCR) tes or he quanta detection of Hepat vius (HCV) RNA human las, serum and ‘ale bod spies. Tuanat™ HCV asin the gnosis and confimaton of HCV infact in cerunetion ws HCV antibody ts! andinestination of al lad. is retinlerded as a blood dona seoening test. Truenat™ HCV ruts onthe Truslab® RealTime icroPOR Analyzers 2. INTRODUCTION “Te positve-sense single-stranded ribonucleic acid (RNA) vius, Hepaitis C Virus (HOM, belongs othe genus Hepacivius, a member ofthe family Flvvrdae. The care genetic material (RNA) is surounded by an icosahedral protective shel of protsin and further encasodina iid envelop of calllar origin. The HepattsC Vitus ' dassied ito six major genotypes (16) wth soveral subtypes within each genotype. Its the cause of Hepatils C and some cancer phamas in humans Unlike Hepatitis AandB, there is no vacine a yet that protects against contacting Hepalts€. As per WHO reports, 130-150 millon people globally have cron hepattsC infection. Fora sal percentage of people, Hopatts CIs a shar: tem less butfor an estimated 70-65% af peopl whe become infected with Hpatls :itbecomes along, chronic infecton. Approximately al alin people ach year fom complcaton rlaedto HepalisC and HCV~elted ber diseases. ‘Gobaly genotype + (secicaly subtypes fa and bi the most prevalent, causing ‘almost haf ofall HCV infection, Nucleic acd amplification tests (NAAT) forthe

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