(143 days)
For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children
The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mumps IgG ELISA Kit:
Acceptance Criteria and Device Performance for Is-Mumps IgG Test Kit
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy (vs. Predicate) | High relative sensitivity (close to 100%) and acceptable relative specificity and overall agreement when compared to a commercially available predicate Mumps IgG ELISA kit. This implies the device should perform comparably to a legally marketed equivalent device in identifying positive and negative samples for Mumps IgG antibodies. (No explicit numerical targets are given, but the comparison aims to show "substantial equivalence"). | Relative Sensitivity: 100% (160/160) (95% Cl: 97.7% - 100%) |
| Relative Specificity: 76.9% (10/13) (95% Cl: 46.2% - 95.0%) | ||
| Overall Agreement: 98.3% (170/173) (95% Cl: 95.0% - 99.5%) | ||
| Reproducibility (Manual) | Acceptable intra-assay and interassay coefficients of variation (CV%) for both positive and negative sera across multiple runs and sites. (No explicit numerical targets are given for CV%, but the tables demonstrate the observed variability). | Intra-Assay/Interassay CV% (Site #1): |
- Positive Sera (A, B, C, D): CV% generally in the range of 4-9% (Interassay CV% 6.36%-8.70%).
- Negative Sera (E, F): CV% generally in the range of 21-40% (Interassay CV% 32.18%-39.03%).
Intra-Assay/Interassay CV% (Site #2): - Positive Sera (A, B, C, D): CV% generally in the range of 4-10% (Interassay CV% 8.92%-9.63%).
- Negative Sera (E, F): CV% generally in the range of 4-18% (Interassay CV% 13.02%-18.06%).
Intra-Assay/Interassay CV% (Site #3): - Positive Sera (A, B, C, D): CV% generally in the range of 2-10% (Interassay CV% 4.06%-8.04%).
- Negative Sera (E, F): CV% generally in the range of 8-35% (Interassay CV% 17.49%-35.19%). |
| Correlation (Manual vs. MAGO Plus) | Strong correlation between manual assay results and results obtained using the MAGO® Plus Automated EIA Processor. (Implicitly, a high Pearson Correlation Coefficient is expected). | Pearson Correlation Coefficient: 0.954 (indicating good correlation, as stated). |
| Reproducibility (MAGO Plus) | Acceptable intra-assay and interassay coefficients of variation (CV%) for both positive and negative sera when performed on the MAGO® Plus. (No explicit numerical targets are given for CV%). | Intra-Assay/Interassay CV% (MAGO Plus - Site #2): - Positive Sera (A, B, C, D): CV% generally in the range of 6-13% (Interassay CV% 8.84%-11.50%).
- Negative Sera (E, F): CV% generally in the range of 0-28% (Interassay CV% 21.19%-23.79%). |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Accuracy (Comparison Study): 173 fresh sera samples.
- Provenance: "a clinical commercial laboratory, located in the Mid-Atlantic area" (United States, retrospective).
- Reproducibility (Manual & MAGO Plus): 6 sera (4 positive, 2 negative) for each site, assayed 10 times in 3 runs. This means for each Reproducibility section (Manual, MAGO Plus), a total of (6 sera * 10 replicates * 3 runs) + (interassay variability) were evaluated at each site. This refers to the number of measurements/replicates rather than unique patient samples like in the accuracy study.
- Provenance: Not explicitly stated for the source of these 6 sera, but the testing was done at "the manufacturer, a research and development laboratory, and a clinical laboratory."
- Accuracy (Comparison Study): 173 fresh sera samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the comparison study was established by a "commercially available kit for Mumps IgG antibodies" (the predicate device), not by human experts. The study clarifies: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease."
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Adjudication method for the test set:
- Not applicable as the ground truth was established by another ELISA test, not by human interpretation requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) assay, not a medical imaging or interpretation device that would typically involve multiple human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (accuracy against a predicate, reproducibility) are reported for the device as a standalone test system, both in manual operation and when automated with the MAGO® Plus. Human "readers" are not part of the performance evaluation beyond performing the lab procedures.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Comparative Device Results: The primary "ground truth" for the accuracy study was the results from a predicate, commercially available Mumps IgG ELISA kit.
- IFA Reference: The footnotes in Table 1 mentioned "313 sera were positive by IFA" and "373 sera were positive by II/A", suggesting that some samples may have also been referenced against Immunofluorescence Assay (IFA), but the main comparison was with the predicate ELISA. The report explicitly states it was not correlated with disease presence/absence.
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The sample size for the training set:
- The document does not explicitly mention a separate "training set" for the device itself. For IVDs, the development process typically involves internal validation and optimization, but the performance data presented here are usually from a "test set" demonstrating the final product's characteristics.
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How the ground truth for the training set was established:
- Not applicable, as a distinct training set with established ground truth is not detailed in the provided information. If there were a training phase, it would likely involve similar methods as the test set (e.g., comparison to a reference method, known positive/negative samples).
§ 866.3380 Mumps virus serological reagents.
(a)
Identification. Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.