Pylori Detect IgG and IgA EIAs
Assay Precision
The intra- and inter-assay precision were calculated by running three patient sera (negative, low positive, and high positive) in 24replicates using two independent operators. The following results were obtained:
Pylori Detect IgG
| | Serum 1 | Serum 2 | Serum 3 |
| Operator 1 CV Intra-Assay | 3.85% | 4.79% | 1.39% |
| Operator 2 CV Intra-Assay | 3.22% | 5.91% | 1.56% |
| Inter-Assay CV | 4.35% | 6.86% | 5.53% |
Pylori Detect IgA
| | Serum 1 | Serum 2 | Serum 3 |
| Operator 1 CV Intra-Assay | 7.94% | 2.81% | 4.94% |
| Operator 2 CV Intra-Assay | 4.43% | 2.97% | 4.42% |
| Inter-Assay CV | 7.61% | 4.19% | 4.86% |
Interpretation of Results Using ELISA Values
| ELISA | Interpretation |
| ≥1.0 | Positive |
| 0.89–0.99 | Equivocal (retest the specimen) |
| <0.89 | Negative |
