(72 days)
ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.
ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
ImmunoCard STAT! CAMPY is an immunochromatographic, rapid test for the detection of specific Campylobacter antigens 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 ImmunoCard STAT! Test Devices (containing specific capture antibodies and colloidal gold-antibody conjugate detector antibodies), ImmunoCard STAT! CAMPY Sample Diluent/Negative Control and ImmunoCard STAT! CAMPY Positive Control.
No calibrators are used with this device.
The ImmunoCard STAT! CAMPY device is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens (specifically C. jejuni and C. coli) in human stool samples. Test results are intended to be used in conjunction with a patient's clinical evaluation and other diagnostic procedures within hospital, reference, regional, private, or state laboratory settings, not for point-of-care use.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list predefined "acceptance criteria" for sensitivity and specificity. However, based on the clinical study results, the collective performance demonstrates acceptable diagnostic accuracy for the intended use. The table below presents the overall combined site performance:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Combined Sites) |
|---|---|---|
| Sensitivity | High sensitivity for detecting Campylobacter infection | 98.1% (95% CI: 90.1-99.7%) |
| Specificity | High specificity to minimize false positives | 95.9% (95% CI: 93.4-97.5%) |
| Analytical Sensitivity (C. jejuni) | Detect C. jejuni at low concentrations | 1.2 x 10^5 cells/mL |
| Analytical Sensitivity (C. coli) | Detect C. coli at low concentrations | 3.0 x 10^5 cells/mL |
| Reproducibility | Consistent results across sites, operators, and days | 99.7% correlation for expected results |
| Cross-reactivity | No significant cross-reactivity with common enteric pathogens or normal flora | None of the tested organisms reacted with the device |
| Interference | No significant interference from common stool substances or medications | None of the tested substances met criteria for an interferent |
2. Sample size used for the test set and the data provenance:
- Sample Size: A total of 421 qualified patient samples were used in the clinical trials.
- Data Provenance: The data was collected from three independent test sites located in the Midwestern and Southeastern regions of the United States. 189 of these samples were retrospective frozen samples, while the remaining were likely prospective as they were tested in an unpreserved state. Forty-nine percent of samples were collected in Cary-Blair-based transport and preservative media, and the rest were unpreserved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth for the clinical test set was established using bacterial culture as the reference comparator method. The document does not specify the number of experts or their qualifications for performing and interpreting these bacterial cultures. However, bacterial culture is a standard microbiological reference method.
4. Adjudication method for the test set:
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical test set results. The comparison was primarily made between the ImmunoCard STAT! CAMPY result and the bacterial culture result.
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:
This device is an in vitro diagnostic test (a lateral flow immunoassay) and not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader performance improvement with or without AI assistance is not applicable to this device. The reading method is visual, indicating a positive result by a visible pink-red line and a negative result by no line.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The ImmunoCard STAT! CAMPY is a standalone in vitro diagnostic test that provides a visual reading (presence or absence of a line). Its performance is inherently "standalone" in the sense that the test device itself produces the result, which is then interpreted visually by a human operator. There is no algorithm involved in the interpretation process described.
7. The type of ground truth used:
The ground truth used for the clinical performance evaluation was bacterial culture.
8. The sample size for the training set:
The document does not explicitly specify a "training set" in the context of machine learning or algorithm development. For this type of in vitro diagnostic device, the development typically involves analytical studies (like analytical sensitivity, specificity, interference, cross-reactivity) and then clinical validation. The samples used for design and development (which could be considered analogous to a training set in some contexts) are not quantified here.
9. How the ground truth for the training set was established:
As there is no explicitly defined "training set" in the context of an algorithm, the method for establishing its ground truth is not detailed. However, for the analytical studies (e.g., analytical sensitivity), known quantities of C. jejuni or C. coli were used to spike samples, establishing a controlled and known "ground truth" for those specific tests. For cross-reactivity and interference studies, known organisms and substances were introduced to assess their impact on the device's accuracy.
§ 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).