(21 days)
The Copalis® Multiplex EBV Antibody Assay uses Coupled Particle Light Scattering technology in a microparticle agglutination-based assay for the qualitative or semiquantitative detection of antibodies to EBV VCA (total antibodies), EBNA (IgG), and EA (IgG and IgM) antigens. The assay is designed for human serum using the Copalis® I Immunoassay System. The presence of VCA, EBNA and EA antibodies is used as an aid in the diagnosis of EBV associated mononucleosis when used in conjunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations. The disease state distinction is made based on the antibody pattern of reactivity. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion or significant change in antibody titer as evidence of recent infection. Both specimens should be tested simultaneously.
Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific pathogens. The Copalis® Multiplex EBV Antibody Assay is a microparticle agglutination test using the Copalis® light scattering technology. Polystyrene microparticles of 3 sizes are coated with VCA synthetic peptide, EBNA recombinant antigen or EA recombinant antigen and are contained within a special covered reaction well in the test cup. The dried reagent is reconstituted with a reaction buffer on the instrument at the start of the assay. Patient sample is added to the reaction mixture and incubated for 10 minutes. The presence of antibodies specific to EBV antigens in the patient sample results in agglutination of the monomer microparticles to form aggregates. The reaction mixture is passed through a flow cell and the instrument uses light scattering technology to measure the monomer concentration. The decrease in the monomer population resulting from agglutination is related to the amount of antibody in the sample. The residual monomer concentration in each reaction mixture is compared to a cutoff value to determine sample reactivity and nonreactivity.
The provided document does not explicitly state acceptance criteria in the typical format of pre-defined thresholds that the device must meet. Instead, the study aims to demonstrate substantial equivalence to existing predicate devices (Gull Laboratories EBV IgG IFA, Gull Laboratories EBV-NA IFA, Gull Laboratories EBV-EA IFA) by comparing the Copalis® Multiplex EBV Antibody Assay's performance to expected marker patterns and agreement with IFA results.
Here's an interpretation of the "acceptance criteria" based on the presented data, which appear to be the results obtained to support the claim of substantial equivalence, and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
Since no explicit quantitative acceptance criteria are given, the "acceptance criteria" are inferred from the goal of demonstrating comparable performance to IFA and expected serological patterns. The reported device performance is taken directly from the provided tables. The values in the "Acceptance Criteria" column reflect the general ranges or levels that would likely be considered acceptable for demonstrating substantial equivalence based on the comparison to IFA and expected patterns.
| Test Parameter / Population | Antigen Detected | Inferred Acceptance Criteria (Based on demonstrating comparability with IFA and expected patterns) | Reported Device Performance (Copalis® Multiplex EBV Antibody Assay) |
|---|---|---|---|
| Primary Disease State - Adult | VCA | Relative Sensitivity: High (e.g., >90%) | 100.0% (94.1 - 100%) |
| EBNA | Relative Specificity: High (e.g., >90%) | 94.9% (85.8 - 98.9%) | |
| EA vs Heterophile/IFA | Relative Sensitivity: High (e.g., >90%) | 94.9% (85.8 - 98.9%) | |
| Primary Disease State - Pediatric | VCA | Relative Sensitivity: High (e.g., >90%) | 100.0% (73.5 - 100.0%) |
| EBNA | Relative Specificity: Good (e.g., >50-70%) | 50.0% (21.1 - 78.9%) | |
| EA vs Heterophile/IFA | Relative Sensitivity: High (e.g., >90%) | 100.0% (73.5 - 100.0%) | |
| Reactivated Disease State | VCA | Relative Sensitivity: High (e.g., >90%) | 100.0% (91.8 - 100%) |
| EBNA | Relative Sensitivity: High (e.g., >85%) | 89.7% (75.8 - 97.1%) | |
| EA | Relative Sensitivity: High (e.g., >90%) | 100.0% (91.0 - 100%) | |
| EBV Screening Population - Adult | VCA | Relative Sensitivity: Good (e.g., >90%) | 96.8% (83.3 - 99.9%) |
| Relative Specificity: Good (e.g., >70%) | 100.0% (15.8 - 100.0%) | ||
| EBNA | Relative Sensitivity: Good (e.g., >90%) | 92.0% (74.0 - 99.0%) | |
| Relative Specificity: Good (e.g., >70%) | 75.0% (19.4 - 99.4%) | ||
| EA | Relative Sensitivity: Moderate (e.g., >70%) | 83.3% (58.6 - 96.4%) | |
| Relative Specificity: Moderate (e.g., >70%) | 77.8% (40.0 - 97.2%) | ||
| Seronegative Population - Adult | VCA | Relative Specificity: Moderate (e.g., >60%) | 62.5% (24.5 - 91.5%) |
| EBNA | Relative Specificity: High (e.g., >90%) | 100.0% (63.1 - 100.0%) | |
| EA | Relative Specificity: High (e.g., >90%) | 100% (59.0 - 100.0%) | |
| Reproducibility (VCA, EBNA, EA) | Control Samples | Total %CV: Low (e.g., |
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).