(87 days)
The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).
The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
The BioPlex 2200 ToRC IgM Calibrator Set is intended for the BioPlex 2200 ToRC IgM Reagent Pack.
The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.
BioPlex ToRC IgM Reagent Pack includes the following components:
- One (1) 10 mL vial, containing dyed beads coated with lysates of T. gondii, Rubella and CMV ● plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine and caprine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device's performance, as requested.
The provided text describes the performance characteristics of the BioPlex 2200 ToRC IgM kit, which is a multiplex flow immunoassay for detecting IgM antibodies to Toxoplasma gondii, Rubella, and Cytomegalovirus (CMV).
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as a section titled "Acceptance Criteria" with pass/fail metrics. Instead, the document presents various analytical and clinical performance studies, and the results of these studies implicitly represent the device's acceptable performance. For the purpose of this response, I will infer the acceptance criteria from the reported performance, particularly where quantitative results are presented.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Specific Metric (Inferred Acceptance Criteria) | Reported Device Performance | Comments |
|---|---|---|---|
| Analytical Performance | Precision/Reproducibility | ||
| Within-run Precision | See tables below | Measured as SD for AI 0.8. Generally low %CVs (e.g., 3.7% to 14.2% for Negative samples, 3.8% to 7.2% for Positives). | |
| Between-run Precision | See tables below | Generally low %CVs across analytes and sample types. | |
| Between-day Precision | See tables below | Generally low %CVs across analytes and sample types. | |
| Total Reproducibility (Across Sites) | See tables below | Generally low %CVs (e.g., Toxo IgM Total %CV for high positive is 10.7%). | |
| Analytical Specificity | Cross-Reactivity (Percent Negative Agreement) | Assessed by testing against various potential cross-reactants. Primarily 100% negative agreement, with few exceptions (e.g., Rubella IgM with Hypergamma-globulinemia IgM: 20/21 negative; Rubella IgM with Parvovirus B19 IgM: 13/14 negative; VZV IgM with T. gondii IgM and CMV IgM: 12/13 negative for both). | |
| Interfering Substances | No significant interference observed. | Tested substances include Hemoglobin, Bilirubin, Cholesterol, Red Blood Cells, Gamma Globulin, Triglycerides, Beta Carotene, Protein, Ascorbic Acid, Sodium Heparin, Lithium Heparin, EDTA. | |
| Clinical Performance | Method Comparison (Prospective Samples) | Comparison against commercially available predicate devices. | |
| T. gondii IgM (Pregnant Women) | Positive Agreement: N/A, Negative Agreement: 98.0% (196/200) CI 95.0-99.2% | High negative agreement. | |
| T. gondii IgM (Test Ordered) | Positive Agreement: N/A, Negative Agreement: 97.4% (481/494) CI 95.6-98.5% | High negative agreement. | |
| Rubella IgM (Pregnant Women) | Positive Agreement: N/A, Negative Agreement: 100.0% (198/198) CI 98.1-100.0% | Excellent negative agreement. | |
| Rubella IgM (Test Ordered) | Positive Agreement: 40.0% (4/10) CI 16.8-68.7%, Negative Agreement: 99.6% (498/500) CI 98.6-99.9% | Lower positive agreement for test-ordered samples, but very high negative agreement. Note: 10 samples considered positive by predicate, 5 negative and 1 equivocal by BioPlex. | |
| CMV IgM (Pregnant Women) | Positive Agreement: 50.0% (8/16) CI 28.0-72.0%, Negative Agreement: 100.0% (183/183) CI 97.9-100.0% | Lower positive agreement for pregnant women, but excellent negative agreement. Discrepant samples were confirmed negative by another FDA-cleared device. | |
| CMV IgM (Test Ordered) | Positive Agreement: 55.6% (20/36) CI 39.6-70.5%, Negative Agreement: 98.6% (480/487) CI 97.1-99.3% | Lower positive agreement for test-ordered samples, but high negative agreement. Discrepant samples were confirmed negative by another FDA-cleared device. | |
| Method Comparison (Retrospective Samples - Presumptive Positive) | Comparison against commercially available predicate devices. | ||
| T. gondii IgM | Positive Agreement: 97.1% (203/209) CI 93.9-98.7% | High positive agreement. | |
| Rubella IgM | Positive Agreement: 98.0% (96/98) CI 92.9-99.4% | High positive agreement. | |
| CMV IgM | Positive Agreement: 98.5% (198/201) CI 95.7-99.5% | High positive agreement. | |
| Clinical Supportive Data | Correlation with CDC Evaluation Panels (T. gondii IgM) | Positive Agreement: 100.0%, Negative Agreement: 100.0% | Excellent agreement with CDC reference sera. |
| Seroconversion Testing | Qualitative agreement with predicate devices for seroconversion panels. | Demonstrates expected seroconversion patterns. | |
| IgM Specificity (DTT Treatment) | High reduction in IgM activity (very low % recovery - typically 1.1 AI for positive, |
§ 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.