(314 days)
The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Table 5) |
|---|---|---|
| EBV Infectious Mononucleosis Sensitivity | High sensitivity required for diagnostic aid | 98.8% (238/241) with Range 96-99.7% |
| EBV Infectious Mononucleosis Specificity | High specificity required for diagnostic aid | 93% (42/45) with Range 93-99% |
| Mononucleosis Syndrome Sensitivity | High sensitivity required for diagnostic aid | 98.7% (236/239) with Range 96-99.7% |
| Mononucleosis Syndrome Specificity | High specificity required for diagnostic aid | 89% (42/47) with Range 77-96% |
| Precision (Qualitative Discrimination) | 100% agreement for moderate and low antibody levels | 100% for Heterophil (L1, L2), VCA IgM, CMV IgM (Table 6) and VCA IgG, EBNA IgG, CMV IgG (Table 7) for Moderate and Low levels, except for Toxoplasma IgG (85% at low) |
Note: Explicit acceptance criteria are not stated in the provided text. The "Implicit" criteria are inferred from the context of a diagnostic aid device, which typically requires high sensitivity and specificity. The precision results, indicating 100% agreement in most cases, demonstrate excellent qualitative discrimination, which would be an implicit acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- EBV Performance (Combined Data - Table 3):
- Negative: 42
- Current: 33
- Past/Recent: 204
- Indeterminate: 16 (2+6+8)
- Total (excluding Indeterminate for calculations in Table 5): 42 + 33 + 204 = 279 samples
- Overall Performance (Combined Data - Table 4):
- Negative: 42
- Current: 36
- Past/Recent: 199
- Indeterminate: 16 (2+6+8)
- Total (excluding Indeterminate for calculations in Table 5): 42 + 36 + 199 = 277 samples
- Precision Test (Table 6 & 7): Varies by antibody level and analyte, ranging from 36 replicates to 144 replicates for different conditions.
- EBV Performance (Combined Data - Table 3):
- Data Provenance: Prospective study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was conducted to support a U.S. market application. The study involved two sites (Site A and Site B).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications used to establish the "Reference Results" for the test set.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. The device is an ELISA test for laboratory use, not an AI-assisted diagnostic imaging or interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The ImmunoDOT Mono-M Test is an in vitro diagnostic (IVD) device (ELISA test) that generates results directly, which are then interpreted by laboratory personnel. The performance characteristics (sensitivity, specificity, precision) presented are for the device's standalone operation.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance study is referred to as "Reference Results" (Tables 1, 2, 3, 4). While the exact method for obtaining these reference results is not explicitly detailed, in the context of serodiagnosis for infectious diseases, these typically involve a combination of:
- Confirmatory tests (e.g., Western blot, PCR)
- Clinical diagnosis (symptoms, patient history)
- Expert interpretation of other serological markers or a gold standard method for mononucleosis diagnosis.
Given the nature of the device, it is highly probable that the "Reference Results" represent a well-established serological or clinical gold standard for diagnosing mononucleosis.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of the study. This is typical for traditional in vitro diagnostic devices like ELISA assays, which do not typically involve machine learning or AI models with distinct training and test sets in the same way. The performance studies presented here are primarily for validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct training set (in the machine learning sense) and its ground truth establishment are not described for this device type.
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).