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