(67 days)
Premier™ CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Premier CAMPY is an in vitro diagnostic, microwell-based enzyme-linked immunoassay for the detection of common antigens found on Campylobacter jejuni and C. coli in stool samples from patients with signs and symptoms of Campylobacteriosis. The assay is intended to be used by hospital and reference laboratories to test for bacterial colonization. It is used in conjunction with information obtained from the patient's clinical symptoms and with other tests to diagnose Campylobacter infection. The assay consists of Premier CAMPY microwells coated with specific antibodies (capture antibodies). Premier CAMPY Enzyme Conjugate, Premier CAMPY Sample Diluent/Negative Control, Premier 20X Wash Buffer III, Premier Substrate Solution I, Premier Stop Solution I and Premier CAMPY Positive Control.
No calibrators are used with this device.
Acceptance Criteria and Device Performance for Premier CAMPY
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Overall) |
|---|---|---|
| Clinical Sensitivity | High (exact numeric not specified, but typically >90% desired for diagnostic tests) | 96.7% (95% CI: 88.8 – 99.1%) |
| Clinical Specificity | High (exact numeric not specified, but typically >90% desired for diagnostic tests) | 95.6% (95% CI: 94.6 – 96.4%) |
| Analytical Sensitivity (C. jejuni) | Achievable at a certain cell/mL concentration | 1.2 x 10^5 cells/mL (with 95% probability of positive response) |
| Analytical Sensitivity (C. coli) | Achievable at a certain cell/mL concentration | 8.0 x 10^5 cells/mL (with 95% probability of positive response) |
| Reproducibility | Expected results obtained consistently (100% agreement shown) | 100% correlation with expected results across sites, days, and technologists. Total CVs for controls and samples generally below 25%, indicating good precision. |
| Interference | No significant interference from common substances in stool | None of the tested substances (Barium sulfate, fecal fat, hemoglobin, Imodium AD®, Kaopectate®, mucin, Mylanta®, Pepto-Bismol®, Prilosec®, Tagamet®, TUMS®, whole blood) met criteria for an interferent. |
| Cross-reactivity | No cross-reactivity with common intestinal flora or other gastroenteritis-associated microorganisms | None of the 30+ tested microorganisms (including other Campylobacter species, common bacteria, fungi, and viruses) reacted with Premier CAMPY. |
Study Proving Device Meets Acceptance Criteria:
The device's performance was established through a series of non-clinical (analytical) tests and clinical trials.
2. Sample Size Used for the Test Set and Data Provenance:
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Clinical Test Set:
- Total Sample Size: 2073 qualified patient samples.
- Data Provenance: Four independent test sites located in the Western, Midwestern, and Southeastern regions of the United States.
- Retrospective/Prospective: Majority (1862/2073) were collected in a Cary Blair-based transport and preservative medium and tested prospectively (implied by "collected in a Cary Blair-based transport and preservative medium" and "The remaining 211 samples were tested in the unpreserved state"). 166 samples were explicitly stated as retrospective frozen samples.
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Non-clinical (Interference and Cross-reactivity) Test Set:
- Interference Testing: Not specified as a patient sample size, but involved "three positive and three negative samples" inoculated with C. jejuni, tested in triplicate.
- Cross-reactivity Study: Not specified as a patient sample size, but involved "Microorganisms that were present as normal intestinal flora or associated with gastroenteritis" tested at specific concentrations in human stool. The number of unique organisms tested was over 30.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical test set. The ground truth method, bacterial culture, is typically performed by trained laboratory personnel, but no specifics on expert involvement in interpreting these cultures for ground truth are provided.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the clinical test set. It states that "bacterial culture" was used as the "reference comparator method." This implies that the bacterial culture results were directly used as the ground truth without further expert adjudication or consensus with the Premier CAMPY results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed for laboratory use, not an interpretation aid for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The clinical performance data presented (Sensitivity and Specificity against bacterial culture) reflects the performance of the Premier CAMPY assay as an algorithm-only device, without human intervention in the result interpretation beyond what is inherent in standard laboratory EIA testing procedures (e.g., reading spectrophotometric values).
7. Type of Ground Truth Used:
For the clinical performance evaluation, the ground truth used was bacterial culture.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. As an in vitro diagnostic (EIA) intended for detection of specific antigens, it's unlikely to involve machine learning models that require a distinct "training set" in the conventional sense. The "training" of such assays is defined by their manufacturing process, reagent formulation, and quality control, rather than algorithmic training on patient data.
9. How the Ground Truth for the Training Set was Established:
Since there is no explicit "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for a training set does not directly apply here. The device's performance relies on its biochemical properties and how well its antibodies bind to the target antigens. The development process would involve extensive analytical validation against known positive and negative samples, but these are part of the assay's development and analytical characterization, not typically labeled as a "training set" with ground truth for algorithm learning.
§ 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).