(258 days)
The Diamedix Is-Rubella IgG Test Kit is an Enzyme Immunoassay (EIA) for the qualitative and quantitative determination of IgG antibodies in human serum to aid in the assessment of the patient's immunological response to infection with rubellaand in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of recent or current infection with rubella. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is-Rubella IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative and quantitative detection of IgG to rubella in human serum. Partially purified rubella antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If antibodies which recognize the rubella antigen are present in the patient sample they will bind to the antigen on the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from the prior step, the reaction is stopped and the color intensity is measured photometrically producing an indirect measure of the specific antibody present in the patient sample.
Here's a breakdown of the acceptance criteria and the study details for the Diamedix Is-Rubella IgG Test System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific quantitative thresholds that the device must meet to be considered effective. Instead, it presents performance characteristics in comparison to existing marketed tests (predicate devices) and a CDC reference panel. The overall goal appears to be demonstrating substantial equivalence to these predicate devices.
However, we can infer performance targets from the reported results, particularly overall agreement, sensitivity, and specificity. The data is presented as a comparison, implying that similar performance to established methods is the 'acceptance criteria.'
| Metric | Acceptance Criteria (Implied from predicate performance/benchmark) | Reported Device Performance (Range Across Sites/Methods) | Study Section Where Found |
|---|---|---|---|
| Relative Sensitivity (Qualitative) | High agreement with predicate (e.g., >95%) | 93.3-100.0% (Site #1: 97.1%; Site #2: 100.0%; Site #3 Manual: 98.1%; Site #3 MAGO Plus: 99.5%) | A. Comparison Testing |
| Relative Specificity (Qualitative) | High agreement with predicate (e.g., >95%) | 82.4-100.0% (Site #1: 100.0%; Site #2: 83.8%; Site #3 Manual: 100.0%; Site #3 MAGO Plus: 100.0%) | A. Comparison Testing |
| Overall Agreement (Qualitative) | High agreement with predicate (e.g., >95%) | 92.2-99.6% (Site #1: 97.4%; Site #2: 96.3%; Site #3 Manual: 98.4%; Site #3 MAGO Plus: 99.6%) | A. Comparison Testing |
| Agreement with CDC Panel (Negative) | 100% | 100% (Manual & Automated) | C. CDC Serum Panel Data |
| Agreement with CDC Panel (Positive) | High (e.g., >95%) | 97.6% (Manual & Automated) | C. CDC Serum Panel Data |
| Correlation (Manual vs. Automated) | Strong positive linear correlation (r approaching 1) | r = 0.9550 | B. Correlation of Manual and MAGO Plus Results |
| Linearity (R-squared) | High (e.g., >0.99) | R-squared: 0.9933 (Manual), 0.9969 (MAGO Plus) | C. Linearity |
| Correlation to WHO Standard (R-squared) | High (e.9, >0.98) | R-squared: 0.9846 | D. Correlation to WHO Standard |
| Lack of Cross-Reactivity | No cross-reactivity with common viral antibodies | 0 positive results for rubella IgG in samples positive for other viruses | F. Cross-Reactivity Data |
| Precision (CV%) | Lower CV% preferred, especially for quantitative assays. Typically |
§ 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.