In the current regulatory climate of 2026, the European Union's In Vitro Diagnostic Regulation (IVDR) has made "State of the Art" (SOTA) a mandatory benchmark for performance. For manufacturers of HLA typing kits, this means that clinical performance is no longer compared just against their own previous versions, but against the highest tier of technology available in the industry. As high-resolution data becomes the clinical norm, the shift from traditional PCR methods to Next-Generation Sequencing (NGS) has defined the new SOTA for most transplant applications.

According to latest HLA Typing Market Data, molecular assay technologies now dominate over 92% of the market. While PCR-based methods like SSP (Sequence-Specific Primers) and SSO (Sequence-Specific Oligonucleotides) remain useful for rapid turnaround in deceased donor cases, they are increasingly seen as "legacy" for hematopoietic stem cell transplants (HSCT) and complex solid organ matches. The following table illustrates the SOTA comparison required for IVDR Class C technical documentation, contrasting traditional molecular methods with the current 2026 gold standard: NGS and Long-Read Sequencing.

SOTA Performance Comparison: PCR vs. NGS (2026)

Frequently Asked Questions (FAQ)

Q: Why is NGS now considered "State of the Art" for IVDR?A: IVDR requires that a device provide a clinical benefit. NGS offers "unambiguous" results by sequencing the entire gene, which has been clinically proven to reduce the risk of Graft-versus-Host Disease (GvHD) and improve long-term graft survival compared to the lower resolution of PCR.

Q: Can PCR-SSP still be CE-marked under IVDR?A: Yes, but its "Intended Purpose" must be specifically defined. For example, it is still the SOTA for "Emergency/STAT" typing of deceased donors where the 24-hour turnaround of NGS is not viable. However, it may no longer be considered SOTA for routine bone marrow matching.

Q: What is "Allelic Ambiguity" and why does it matter for regulation?A: Ambiguity occurs when a test cannot distinguish between several possible alleles. Under IVDR, manufacturers must document how their technology handles this. NGS is preferred because its ability to "phase" DNA (separate maternal and paternal strands) eliminates these uncertainties.

Q: Is the cost of NGS now comparable to PCR?A: While the initial instrument cost is higher, the "cost per sample" for high-volume NGS runs is now equal to or lower than multiple PCR-SSO runs, especially when the cost of "reflex" testing (repeating tests to clear ambiguities) is included.

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