Pre-NAT II | High-Sensitivity HCV RNA Quantitative Nucleic Acid Testing

Hepatitis C Virus (HCV) is an infectious disease characterized primarily by liver damage. It is classified into acute and chronic hepatitis C based on the disease course, with chronic patients being highly susceptible to progressing toward liver cirrhosis or primary hepatocellular carcinoma (HCC). HCV is predominantly transmitted through blood or mother-to-child transmission, as well as through sexual contact with an infected partner, other body fluids, unsafe injections, or exposure to sharp instruments.

China Still Faces Severe Challenges in HCV Diagnosis and Treatment Rates

The World Health Organization (WHO) estimates that in 2019, approximately 58 million people globally were infected with HCV, with nearly 1.5 million new infections occurring annually. Approximately 290,000 people died from HCV-related cirrhosis and primary liver cancer. In 2020, the number of HCV infections in China reached 9.487 million, with 51,000 related deaths. Significant challenges remain regarding diagnosis and treatment rates. HCV genotypes in China span types 1 through 6; among patients under 60, Genotype 1b is the most prevalent (approx. 56.8%), followed by genotypes 2 and 3.

High-Sensitivity HCV RNA Quantification for Effective Full-Course Patient Monitoring

Currently, there is no effective vaccine for preventing HCV infection. However, the treatment of chronic hepatitis C has entered the "pan-genotypic era" of Direct-Acting Antiviral agents (DAAs). Most infected individuals can achieve a Sustained Virological Response (SVR) of over 90%. Early diagnosis and subsequent treatment are critical for the prevention and control of chronic hepatitis C.

HCV RNA is the most direct and specific indicator of HCV infection, serving as the definitive diagnostic tool and a vital basis for pre-treatment evaluation. High-sensitivity HCV RNA testing, characterized by a low detection limit, is utilized to determine the treatment endpoint for HCV patients, thereby mitigating the risk of progression to cirrhosis and liver cancer in patients with low-level viremia (LLV).

Guidelines Recommend High-Sensitivity HCV RNA Quantitative Reagents to Guide Treatment

In 2022, the Hepatology and Infectious Diseases branches of the Chinese Medical Association released the Guidelines for the Prevention and Treatment of Hepatitis C (2022 Edition). The guidelines emphasize expanding screening and simplifying treatment workflows, advocating for universal screening and diagnosis of all infected individuals while improving treatment adherence. The guidelines recommend that for Anti-HCV positive patients, further HCV RNA testing should be performed using assays with a lower limit of quantification (LLoQ) ≤15 IU/mL.

The EASL Recommendations on Treatment of Hepatitis C (2020) from the European Association for the Study of the Liver defines the treatment endpoint as: HCV RNA being undetectable in serum or plasma 12 weeks (SVR12) or 24 weeks (SVR24) post-treatment, using a high-sensitivity assay with a detection limit of ≤15 IU/mL.

Pre-NAT II: Fully Automated Nucleic Acid Extraction and PCR System Setup Platform

The Pre-NAT II High-Sensitivity HCV RNA Quantitative Assay is built upon three core pillars: High Sensitivity, Full Automation, and Wide Linear Range. It focuses on early screening and disease monitoring, providing timely and reliable diagnostics for clinical laboratories and central labs.