(189 days)
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.
The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.
Here's a breakdown of the acceptance criteria and study information for the ACON® Mononucleosis Rapid Test Strip and Test Device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (ACON® Mononucleosis Rapid Test Strip) | Reported Device Performance (ACON® Mononucleosis Rapid Test Device) |
|---|---|---|
| Similar performance to Genzyme OSOM® Mono Test | ||
| Whole Blood: | ||
| Positive Agreement (Accuracy) | 96% (87%-99% CI) | 99% (90%-99% CI) |
| Negative Agreement (Accuracy) | > 99% (95%-100% CI) | > 99% (95%-100% CI) |
| Overall Agreement (Accuracy) | 98% (95%-99% CI) | > 99% (96%-99% CI) |
| Plasma: | ||
| Positive Agreement (Accuracy) | 98% (91%-99% CI) | 98% (91%-99% CI) |
| Negative Agreement (Accuracy) | > 99% (98%-100% CI) | > 99% (98%-100% CI) |
| Overall Agreement (Accuracy) | > 99% (98%-99% CI) | > 99% (98%-99% CI) |
| Serum: | ||
| Positive Agreement (Accuracy) | > 99% (95%-100% CI) | 99% (93%-99% CI) |
| Negative Agreement (Accuracy) | > 99% (98%-100% CI) | > 99% (98%-100% CI) |
| Overall Agreement (Accuracy) | > 99% (98%-100% CI) | > 99% (98%-99% CI) |
| All Specimens Combined: | ||
| Positive Agreement (Accuracy) | 98% (95%-99% CI) | 98% (95%-99% CI) |
| Negative Agreement (Accuracy) | > 99% (99%-100% CI) | > 99% (99%-100% CI) |
| Overall Agreement (Accuracy) | > 99% (99%-99.9% CI) | > 99% (99%-99.9% CI) |
| Point-of-Care (POL) Performance | ||
| Plasma (overall agreement with expected results) | 98.9% (178/180) | Not explicitly separated, but included in overall POL results |
| Whole Blood (overall agreement with expected results) | 100% (180/180) | Not explicitly separated, but included in overall POL results |
| Comparability to trained lab technician | 100% (120/120) | 100% (120/120) |
Note: The acceptance criteria are implicitly based on the device demonstrating substantial equivalence to the predicate device (Genzyme OSOM® Mono Test). The performance metrics provided (positive agreement, negative agreement, overall agreement) are directly compared against the predicate device. The confidence intervals are provided for each agreement calculation.
Study Information
-
Sample sizes used for the test set and the data provenance:
- Total Test Set Sample Size (Clinical Evaluation): 611 clinical specimens (whole blood, serum, and plasma combined).
- Breakdown by specimen type:
- Whole Blood: 131 specimens (51 positive, 80 negative)
- Plasma: 240 specimens (60 positive, 180 negative)
- Serum: 240 specimens (73 positive, 167 negative)
- POL Study Sample Size:
- Plasma: 180 coded, blinded, and randomized specimens
- Whole Blood: 180 coded, blinded, and randomized specimens
- Comparison to trained lab technician: 120 specimens (presumably a subset read by both)
- Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It only mentions "clinical specimens."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" (or reference standard) for the clinical specimens against which the ACON test and predicate test were compared.
- For the POL study, the comparison was made against "expected results" and "those obtained by a trained lab technician," implying an expert or reference method defined the true positive/negative status, but details are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for reconciling discrepancies in results. The study compared the ACON device directly against the Genzyme OSOM® Mono Test. Discrepancies between the two tests would contribute to the calculated agreement percentages, but no specific adjudication process for these discrepancies is mentioned.
-
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 was not a multi-reader, multi-case (MRMC) comparative effectiveness study with AI assistance. This study evaluates the performance of a rapid diagnostic test (ACON Mononucleosis Rapid Test) against a predicate rapid diagnostic test (Genzyme OSOM® Mono Test). There is no mention of AI or human readers improving with AI assistance.
- However, a "POL Study Summary" describes evaluating the device's performance when used by personnel at "three distinct sites" (doctors' offices) and compares their results to "expected results" and "those obtained by a trained lab technician." This segment might be considered a form of multi-reader study, but it's not in the context of AI assistance. The "effect size" of improvement is not quantified, but the study showed 98.9% agreement for plasma and 100% agreement for whole blood by POL users compared to expected results, and 100% agreement compared to a trained lab technician (120/120), indicating high accuracy by non-specialized personnel.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic test (a lateral flow immunoassay) intended for human interpretation of colored lines. There is no algorithm involved in the test's result generation or interpretation in the way AI would be. The test itself is the "standalone" diagnostic.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the main accuracy study was effectively the results from the Predicate Device, Genzyme OSOM® Mono Test. This is a common approach for demonstrating substantial equivalence for rapid diagnostic tests.
- For the POL study, the ground truth was referred to as "expected results" and comparisons were made to "those obtained by a trained lab technician." This implies a reference method or expert-derived result was used to determine the true positive/negative status.
-
The sample size for the training set:
- The document does not mention a training set. This is a traditional immunoassay device, not a machine learning or AI-based device, so the concept of a "training set" for model development does not apply. The clinical evaluation and POL studies are performance validation studies.
-
How the ground truth for the training set was established:
- As there is no training set for this type of device, this question is not applicable.
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).