Search Results

This in vitro diagnostic method is intended to quantitatively measure Rubella IgG in human serum on the Technicon Immuno 1® System. Measurements of Rubella IgG are designed to aid in the determination of immune status by detecting IgG class antibodies to rubella virus in human sera. The method is not intended for use on any other system.

Not Found

The provided document describes the Immuno 1® Rubella IgG method and its performance.

1. Table of Acceptance Criteria and Reported Device Performance

• vs. Sanofi Platelia: 83.6% (Exp1), 83.0% (Exp2)
• vs. Abbott IMx (Site 1): 85.7% (RCG), 86.5% (RDG)
• vs. Abbott IMx (Site 2): 88.2% (RCG), 89.0% (RDG)
  Relative Specificity:
• vs. Sanofi Platelia: 98.0% (Exp1), 98.6% (Exp2)
• vs. Abbott IMx (Site 1): 100% (RCG & RDG)
• vs. Abbott IMx (Site 2): 100% (RCG & RDG) |
  | Accuracy (Relative to Comparator Assays) - HAI Resolved | Not explicitly stated as acceptance criteria, but evaluated against comparator assays with HAI resolution. | Relative Sensitivity:
• vs. Sanofi Platelia: 96.6% (Exp1), 96.2% (Exp2)
• vs. Abbott IMx (Site 1): 94.3% (RCG), 94.8% (RDG)
• vs. Abbott IMx (Site 2): 98.2% (RCG & RDG)
  Relative Specificity:
• vs. Sanofi Platelia: 99.5% (Exp1), 99.6% (Exp2)
• vs. Abbott IMx (Site 1): 100% (RCG & RDG)
• vs. Abbott IMx (Site 2): 100% (RCG & RDG) |
  | Overall Agreement (OA) - Initial | Not explicitly stated as acceptance criteria. | OA:
• vs. Sanofi Platelia: 86.5% (Exp1), 86.4% (Exp2)
• vs. Abbott IMx (Site 1): 87.9% (RCG), 88.6% (RDG)
• vs. Abbott IMx (Site 2): 90.0% (RCG), 90.7% (RDG) |
  | Overall Agreement (OA) - HAI Resolved | Not explicitly stated as acceptance criteria. | OA:
• vs. Sanofi Platelia: 97.5% (Exp1), 97.2% (Exp2)
• vs. Abbott IMx (Site 1): 95.6% (RCG), 96.0% (RDG)
• vs. Abbott IMx (Site 2): 98.6% (RCG & RDG) |
  | ROC Area Under Curve (AUC) - Initial | Not explicitly stated as acceptance criteria, but reported. | AUC:
• vs. Platelia (In-House): 0.976
• vs. IMx (Site 1): 0.988
• vs. IMx (Site 2): 0.989 |
  | ROC Area Under Curve (AUC) - HAI Resolved | Not explicitly stated as acceptance criteria, but reported. | AUC:
• vs. Platelia (In-House): 0.998
• vs. IMx (Site 1): 0.997
• vs. IMx (Site 2): 0.996 |
  | Imprecision (CV) | Not explicitly stated as acceptance criterion, but results are summarized in Table 1. | Total CV:
• 10 IU/mL: 7.1%
• 20 IU/mL: 7.5%
• 200 IU/mL: 6.7% |
  | Reproducibility (Overall Agreement %) | Not explicitly stated as acceptance criterion, but results are presented. | Overall Agreement:
• Miles In House: 99.5% (Exp1), 99.5% (Exp2)
• NC Baptist Hospital: 99.0% (RCG), 98.7% (RDG)
• Huntsville Hospital: 99.0% (RCG), 98.2% (RDG) |
  | Interference | "No clinically significant effect on method performance" for specified substances. | - Hemolyzed: Up to 1000 mg/dL hemoglobin, no clinically significant effect.
• Lipemic: Up to 900 mg/dL triglycerides, no clinically significant effect.
• Icteric: Up to 25 mg/dL total bilirubin, no clinically significant effect.
• Cross-reactivity: No false positives with rheumatoid factor, EBV, CMV, VZV, HSV-1, HSV-2, or rubeola relative to Sanofi Platelia. |
  | CDC Proficiency Panel | Correct classification of CDC panel samples. | All CDC Rubella proficiency panel samples correctly classified. |

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sanofi Platelia comparison (In-House at Miles Inc.):
  • Sample Size: 719 clinical samples.
  • Data Provenance: 520 samples from "Michigan Department of Public Health" and the remaining purchased from "an outside vendor, Boston Biomedica," to increase negative samples. This suggests a retrospective collection, likely from a US population (Michigan).
• Abbott IMx comparison (Outside Clinical Sites):
  • Site 1 (NC Baptist Hospital, Winston-Salem, NC):
    • Sample Size: 296 samples.
    • Data Provenance: From NC Baptist Hospital, Winston-Salem, NC (USA). Likely retrospective clinical samples.
  • Site 2 (Huntsville Hospital, Huntsville, AL):
    • Sample Size: 287 samples.
    • Data Provenance: From Huntsville Hospital, Huntsville, AL (USA). Likely retrospective clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document refers to "All HAI testing was done by a state health agency reference laboratory" and "A report provided by Dr. John Stewart. VEH Branch of the CDC in Atlanta." This indicates that Haemagglutination Inhibition (HAI) testing, a recognized standard for Rubella immunity, was used for resolution. The expertise is implied by the "state health agency reference laboratory" and "CDC," both highly reputable organizations in infectious disease diagnostics, but the specific number or qualifications of individual experts are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The adjudication method described is discrepant analysis by HAI (Haemagglutination Inhibition).
For samples where the Immuno 1 method and the comparator assays (Sanofi Platelia or Abbott IMx) disagreed, HAI testing was used to resolve the discrepancy ("Discrepant samples were analyzed by HAI and the results used for resolution").

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study evaluates an automated in vitro diagnostic device (Immuno 1 Rubella IgG method), not an AI system assisting human readers. Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the study primarily demonstrates standalone performance. The Immuno 1 Rubella IgG method is an automated quantitative assay for measuring Rubella IgG in human serum. Its performance is compared directly against other established assays (Sanofi Platelia, Abbott IMx) and against a ground truth resolved by HAI, without explicit human interpretation contributing to the Immuno 1 result itself. The device itself is the "algorithm only" (automated assay) in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for resolving discrepancies and establishing clinical performance was Haemagglutination Inhibition (HAI) testing. This is a well-established serological method for determining Rubella immune status, effectively serving as an "expert reference method" or a "gold standard assay" in this context.

Additionally, the "CDC Rubella proficiency panel" was used, for which the CDC establishes the ground truth classification.

8. The sample size for the training set

The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The data presented are for method validation and comparison studies. If the term "training set" is interpreted broadly as data used for developing and optimizing the assay itself prior to its final validation, that information is not provided in this summary. The "calibrators" (0, 10, 20, 50, 200, 500 IU/mL) are used for internal calibration, not typically considered a training set in the context of AI.

9. How the ground truth for the training set was established

As there is no explicit "training set" described in the context of an AI/algorithm, the method for establishing its ground truth is not applicable and not described in this document. The assay's analytical characteristics (e.g., calibrator values) are traceable to the WHO 2nd International Standard for Anti-Rubella Serum.

Ask a specific question about this device