| Kits | ImmunoassayMethod | Reference Commercial Kit R +PPA | Reference Commercial Kit R −NPA |
|---|---|---|---|
| Commercial Kit Y | CLIA | 108 / 108 (100.0%) | 56 / 60 (93.3%) |
| Commercial Kit A | CLIA | 85 / 92 (92.4%) | 60 / 65 (92.3%) |
Key result: Two independent customer CLIA kits powered by ABCCP-001 both reach commercial-grade agreement with leading Kit R.
| Performance Indicator | Reference Antigen | ABCCP-001 | Improvement |
|---|---|---|---|
| Detection on Clinical RA (n = 152) | 129 / 152 | 148 / 152 | +12.5 pp |
| False Positives on Healthy Donors (n = 30) | 1 / 30 | 0 / 30 | −1 FP |
Key result: Head-to-head on the same CLIA platform, ABCCP-001 lifts RA detection by +12.5 pp (97.4% vs 84.9%) and eliminates the lone healthy-donor false positive vs the reference antigen.
| Kits | ImmunoassayMethod | SensitivityRA-confirmed CCP+ | SpecificityCCP− cohort¹ |
|---|---|---|---|
| In-house Kit (ABCCP-710) | LETIA | 49 / 55 (89.1%) | 34 / 34 (100.0%) |
| Commercial Reference Kit R | CLIA | 51 / 54 (94.4%) | 34 / 34 (100.0%) |
| Commercial Reference Kit W | CLIA | 52 / 55 (94.5%) | 34 / 34 (100.0%) |
¹ CCP− cohort = 14 sero-negative RA patients + 20 healthy donors.
Key result: ABCCP-710 shows high potential to perform anti-CCP testing on clinical chemistry analyzers.
Building an anti-CCP assay — on CLIA or a biochemistry analyzer?
We'd love to share supporting data, discuss co-development, or explore custom engineering — raw material, or a bulk reagent for OEM.