Comparative Assessment of Risk and Turn-Around Time between Sequence-Based Typing and Next-Generation Sequencing for...

Area of Science:

• Clinical Laboratory Science
• Molecular Diagnostics
• Immunogenetics

Background:

• Sequence-based typing (SBT) and next-generation sequencing (NGS) are methods for human leukocyte antigen (HLA) typing.
• Assessing laboratory risk and turnaround time (TAT) is critical for clinical laboratory efficiency.

Purpose of the Study:

• To compare laboratory risk and TAT between SBT and NGS for HLA typing.
• To evaluate the implications of transitioning from SBT to NGS in HLA typing workflows.

Main Methods:

• Laboratory risk was assessed using failure mode and effect analysis (FMEA) and risk priority number (RPN) scores.
• Risk acceptability matrix (RAM) and Clinical Laboratory Standards Institute (CLSI) guidelines (EP23-A) were applied.
• Total TAT and hands-on time were meticulously documented for both methods.

Main Results:

• NGS exhibited a significantly higher total RPN score (1169) than SBT (465), indicating increased risk.
• NGS demonstrated higher mean RPN, severity, and detectability scores compared to SBT (p < 0.001).
• NGS required more steps (44 vs. 25), longer total TAT (26:47:20 vs. 12:32:06), and greater hands-on time (03:59:35 vs. 00:47:39).

Conclusions:

• The transition from SBT to NGS for HLA typing is associated with increased laboratory risk and extended TAT.
• Implementing NGS for HLA typing necessitates a thorough evaluation of risk and time factors to ensure laboratory efficiency.
• Optimizing laboratory processes is essential when adopting new HLA typing technologies like NGS.