Application analysis of two nucleic acid detection systems in blood detection of hepatitis B virus, hepatitis C virus and human immunodeficiency virus
Year: 2025
Type: article
Abstract: Objective This study aimed to compare the diagnostic efficacy between the Kehua and Roche nucleic acid testing (NAT) systems for detecting hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in blood donation screening. Methods We analyzed retrospective data from 670,775 transient blood donation samples collected between 2016 and 2024. Key performance indicators (KPIs) included the types of reactive samples, effective split rate, effective reaction rate, single pool invalid number, batch invalid number, and pooling missing samples. Annual trends in cycle threshold (CT) value distributions and overall system performance were also evaluated. Results Among 419 reactive samples (Kehua: 202; Roche: 217), no significant differences were observed in the effective split rates ( P > 0.05) or overall specimen reaction rates ( P > 0.05) between the two systems. The HCV detection rate was significantly lower for the Kehua system ( P < 0.05), while the detection rates for HBV and HIV showed no significant inter-system differences ( P > 0.05). The separation efficiency of reactive pools varied significantly across different CT value ranges ( P < 0.05). The Kehua system demonstrated stable annual effective split and reaction rates ( P > 0.05), whereas the Roche system exhibited significant annual fluctuations in these metrics ( P < 0.05). The Kehua system had significantly fewer single pool invalid numbers and pooling omissions than the Roche system ( P < 0.05). Conclusion The Kehua and Roche NAT systems demonstrated comparable overall performance in blood screening, with Kehua proving non-inferior to Roche. Kehua’s advantages included fewer invalid tests and fewer pooling errors, which could reduce economic and time costs. The Roche system exhibited higher automation, supporting continuous batch processing. The observed CT value-dependent separation efficiency suggests potential for protocol optimization in detecting low viral load samples.
Source: PeerJ
DOI: 10.7717/peerj.20365
Authors: Tao Wang, Jianwei Zhang
Language: English
Subfield: Management of Technology and Innovation
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $1,395
OpenAlex ID: W4416733177