(58 days)
The Trinity Biotech Captia™ Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
The Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgendorferi and can be used to support a clinical diagnosis of Lyme disease.
The Borrelia burgdorferi IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Pretreated test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
The provided document describes the Trinity Biotech Borrelia burgdorferi IgM ELISA Test Kit, an immunoassay for the qualitative detection of IgM antibodies to Borrelia burgdorferi (the causative agent of Lyme disease) in human serum.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X sensitivity and Y specificity"). Instead, it presents performance characteristics from comparative studies against clinical diagnosis and a predicate device (BioWhittaker's Lyme M STAT test) combined with Western Blot confirmation.
Implicit Acceptance Criteria (inferred from context and comparison to predicate):
| Performance Characteristic | Acceptance Criteria (Implicit/Benchmark) | Reported Device Performance (Trinity Biotech) |
|---|---|---|
| Agreement with Clinical Diagnosis (CDC Panel) | Expected to show reasonable agreement, particularly for early disease. No explicit threshold is given. | 47.6% (20/42) agreement with clinical diagnosis of Lyme disease (considering equivocal as 1-step positive). |
| Agreement with Predicate (ELISA 1-step Pos. or Eq.) | Comparable percentage of positive/equivocal results to predicate device. | 10.8% (19/176) (95% CI: 6.1-15.5%) |
| Agreement with Predicate (2-step Pos.) | Comparable percentage of 2-step positive results to predicate device. | 3.41% (6/176) (95% CI: 0.7-6.1%) |
| 2-step Pos. among 1-step Pos. or Eq. | Comparable percentage of Western Blot confirmed positives among ELISA positive/equivocal results to predicate device. | 31.6% (6/19) (95% CI: 10.3-52.9%) |
| Inter-Assay Precision (CV) | Positive samples, Calibrators, and Positive Controls should have 1 year post-onset). |
* **Data Provenance:** From the CDC (Centers for Disease Control and Prevention). This suggests the data is likely retrospective, as it's a "panel obtained from the CDC." The country of origin is the USA.
- Study 2 (Comparative Effectiveness with Predicate):
- Sample Size: 176 sera.
- Data Provenance: From patients submitted to a large clinical lab for B. burgdorferi antibody testing. This suggests the data is retrospective, collected from existing patient samples. The country of origin is not explicitly stated but implied to be the USA given the context of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Study 1 (CDC Lyme Disease Serum Panel): The ground truth is described as "clinical diagnosis" and the panel samples were "masked, characterized serum panel." While the document doesn't specify the exact number or qualifications of experts involved in establishing the clinical diagnosis for this CDC panel, CDC panels are typically established by expert consensus of clinicians and specialists in infectious diseases, based on a comprehensive review of clinical, epidemiological, and laboratory data.
- Study 2 (Comparative Effectiveness with Predicate): The ground truth for this study was established by Mardx Diagnostics Western Blot for both IgG and IgM for any serum found positive or equivocal by either ELISA. This is a laboratory-based gold standard, not directly established by medical experts in this context.
4. Adjudication Method for the Test Set:
- Study 1 (CDC Lyme Disease Serum Panel): "Because the equivocals would have been tested by immunoblotting in a 2-step test system, they were considered 1-step positive for purposes of calculating % agreement." This indicates a specific rule for handling equivocal results in the calculation, rather than a multi-reader/multi-expert adjudication.
- Study 2 (Comparative Effectiveness with Predicate): Equivocal or positive ELISA results were further tested by Western Blot. There's no mention of adjudication between multiple readers for the Western Blot results; the Western Blot itself served as the confirmatory method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated or described. The studies focus on device performance (ELISA) against a clinical diagnosis panel or a predicate device and Western Blot, not on the impact of the device on human reader performance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Yes, the studies presented are primarily standalone performance evaluations of the ELISA kit. The ELISA kit generates a quantitative result which is then interpreted qualitatively (positive, equivocal, negative). This process does not involve human interpretation within a diagnostic workflow that the device is assisting, but rather the device itself provides the result.
7. The Type of Ground Truth Used:
- Study 1: Clinical Diagnosis (from the CDC panel).
- Study 2: Western Blot (laboratory-based gold standard).
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its size. This is typical for traditional in vitro diagnostic (IVD) device submissions (like an ELISA kit), where the device development process might involve internal optimization and validation, but not a formally separate "training set" and "test set" in the same way as machine learning or AI algorithm development. The studies presented are "test set" or "validation set" studies for the final device.
9. How the Ground Truth for the Training Set Was Established:
As no training set is described, this question is not applicable to the provided information.
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).