(203 days)
For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.
The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.
This document describes the performance characteristics of the Is-H. pylori IgG ELISA Kit, an in vitro diagnostic (IVD) device used for the qualitative determination of IgG antibodies to Helicobacter pylori antigen in human sera.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported performance metrics, demonstrating the device's accuracy and precision.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity (Biopsy GT) | High sensitivity (e.g., >85-90%) | 94.9% (95% CI: 89.3-98.1%) |
| Specificity (Biopsy GT) | High specificity (e.g., >85-90%) | 90.4% (95% CI: 83.8-94.9%) |
| Overall Agreement (Biopsy GT) | High overall agreement (e.g., >85-90%) | 92.6% (95% CI: 88.5-95.6%) |
| Relative Agreement (vs. Predicate ELISA) | High agreement (e.g., >95%) | 99.6% |
| Precision (Intra-assay CV%) | Low variability (e.g., 0.95) | Pearson Correlation Coefficient: 0.993 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Sensitivity and Specificity Study (Section A): 249 patients.
- 121 sera characterized as positive for H. pylori.
- 128 sera characterized as negative for H. pylori.
- Sample Size for Relative Agreement Study (Section B): 249 patients (same samples as in Section A).
- Data Provenance: The sera were frozen retrospective samples from patients. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for characterizing H. pylori infection in the test set (Section A) was established using "biopsy with culture, stain and CLO results for H.pylori". While these are considered reference standard clinical tests, the document does not specify the number of experts (e.g., pathologists, microbiologists) who interpreted these results or their specific qualifications (e.g., years of experience as a pathologist). The interpretation of such tests inherently involves expert judgment, but the level of detail is not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for resolving discrepancies in the biopsy, culture, stain, or CLO results that formed the ground truth. It states that "Based on the results of this testing, the patient sera were characterized." This implies that a consensus or a defined decision rule based on these multiple tests was used to establish the positive or negative status for each patient, but the specific adjudication process is not detailed. Equivocal results from the device under test were excluded from calculations, but this is a different kind of exclusion from an adjudication of ground truth.
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 MRMC comparative effectiveness study was mentioned. This device is an immunoassay kit, not an AI-based image analysis or interpretation tool that would typically involve human readers and AI assistance for interpretation. Therefore, this section is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For the sensitivity and specificity study (Section A), the device (Is-H. pylori IgG Test Kit) was tested on sera, and its results were compared to the biopsy-based ground truth. This represents standalone performance, as the interpretation of the ELISA results would be direct based on the established cut-off, without a human "reader" making a subjective judgment in the same way a radiologist reads an image.
The section on "Correlation of Manual and MAGO Plus Results" (Section D) and "MAGO Plus Precision" (Section E) studies the performance of the device when used with an automated EIA processor. This also represents standalone performance of the device in either manual or automated modes, where the device directly produces a result.
7. The Type of Ground Truth Used
The primary ground truth used for the sensitivity and specificity study (Section A) was based on biopsy with culture, stain, and CLO results for H. pylori. These are objective laboratory and histopathological methods considered gold standards for H. pylori infection diagnosis.
For the "Relative Agreement Versus Another ELISA" study (Section B), the "ground truth" was the results from "another commercially available kit for H. pylori IgG antibodies." However, the notice explicitly states: "Please be advised that 'relative' refers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease." This clarifies that the predicate ELISA was used for relative performance comparison, not as a true gold standard for disease presence.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay kit (ELISA), which is a biochemical test, not an algorithm that requires a separate training set. The various studies described (Sensitivity/Specificity, Relative Agreement, Precision) are all validation studies for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As this is an immunoassay and not an AI/ML algorithm requiring a training set, this question is not applicable. The device itself produces a result based on a biochemical reaction and predefined interpretation rules.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).