(108 days)
For the qualitative detection of human IgM antibodies to Rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection. A positive result is presumptive for the detection of rubella antibodies and presumptive for the diagnosis of active or recent rubella infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.
- For the qualitative detection of IgM antibodies to Rubella in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection.
- A positive result is presumptive for the detection of anti-rubella antibodies and presumptive for the diagnosis of acute or recent rubella infection.
- Useful for the above indications, with specimens obtained from women of childbearing age.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
The SeraQuest Rubella IgM test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgM antibodies which are directed against Rubella virus, in human serum.
The Calibrators in the SeraQuest Rubella IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Here's a breakdown of the acceptance criteria and study information for the SeraQuest Rubella IgM Device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall agreement with predicate device (excluding equivocal results) | 97.7% agreement with Diamedix Rubella IgM Microassay. |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 91 archival serum specimens.
- Data Provenance:
- 49 specimens from patients presenting with symptoms consistent with rubella infection.
- 42 specimens reported to be positive for IgM antibodies to rubella, obtained from serum brokers.
- All specimens were tested at Quest International, Inc., Miami, FL. (Retrospective data, as samples were "archival").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Note: The ground truth appears to be based on the results of a legally marketed predicate device (Diamedix Rubella IgM Microassay) and a second legally marketed device for discordant results, rather than expert interpretation of a gold standard independent of these assays.
4. Adjudication Method for the Test Set:
- Adjudication Method: Specimens giving discordant results between the SeraQuest Rubella IgM test and the Diamedix Rubella IgM Microassay were tested with a second legally marketed device. A representative number of positive and negative samples with concordant results were also tested with this second device. This implies a form of tie-breaking or verification using an additional assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, this was not an MRMC study. This study compares the performance of a new device against a predicate device, not human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the device's performance was evaluated in a standalone manner, directly comparing its results (Index values indicating IgM antibodies) against a predicate device. The "algorithm" here refers to the immunoassay itself and its interpretation criteria, not a digital algorithm in the typical AI sense.
7. The Type of Ground Truth Used:
- Ground Truth: The "ground truth" for evaluating the SeraQuest Rubella IgM device was the results obtained from a legally marketed predicate device (Diamedix Rubella IgM Microassay), and for discordant results, a second legally marketed device. This is a form of comparative ground truth against an established commercial assay.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not specified. The document primarily describes the clinical testing for validation, not the development or training of the assay. The Calibrators used had Index values based on an "in-house standard," which suggests an internal process for setting assay parameters, but not a separate "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not explicitly detailed. The document mentions "Calibrators in the SeraQuest Rubella IgM test set have been assigned Index values based on an in-house standard." This implies an internal process for calibration and standardization during the device's development, rather than a separate "ground truth" derived from patient samples with independently confirmed disease status for a training set.
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.