Genotype data comparing the PCR-SSO test with the HLA-B*27 targeted tag-SNP assay. Both tag SNP were 100% concordant. The HLA-B allele designation corresponding to the false-positive and -negative calls were false-positive (HLA-B*39:06/*49:XX) and false-negative samples (HLA-B*27:05/*35:XX; HLA-B*27:05/*18:01; HLA-B*27:05/*52:01, and HLA-B*27:05/*35:XX). Values are n unless otherwise specified.
| Variables | PCR-SSO | HLA-B*27 Tag-SNP, rs4349859 | HLA-B*27 Tag-SNP, rs116488202 |
|---|---|---|---|
| HLA-B*27–positive samples | 172 | 167 | 167 |
| HLA-B*27–negative samples | 828 | 831 | 832 |
| False-positive samples | N/A | 1 | 1 |
| False-negative samples | N/A | 4 | 4 |
| Analytical sensitivity, % | 100 | 97.6 | 97.6 |
| Analytical specificity, % | 100 | 99.9 | 99.9 |
| Analytical accuracy, % | 100 | 99.6 | 99.6 |
| Analytical precision1, % | 100 | N/A | 100 |
| Samples with reportable genotype | 1000 | 998† | 999# |
↵1 Precision analysis was performed using 89 samples run in duplicate only for the rs116488202 assay.
↵† Two samples failed to generate a result for the rs4349859 assay due to insufficient DNA for amplification (1 sample) and a variant under the primer-binding site (1 sample).
↵# A single sample failed to generate a result for the rs116488202 assay due to insufficient DNA for amplification. PCR-SSO: PCR-sequence–specific oligonucleotide; SNP: single-nucleotide polymorphism; N/A: not applicable.