(81 days)
(1) Immunoassay for the in vitro qualitative detection of IgM antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the diagnosis of recent or current CMV infection in individuals for which a CMV IgM test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This assay is not intended for use in screening blood and plasma donors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys immunoassay analyzers.
(2) PreciControl CMV IgM is used for quality control of the Elecsys CMV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) Elecsys CMV IgM is a u-capture immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined using a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent bar code. The test system contains the human serum-based calibrators intended for use with the system.
The CMV IgM assay begins with an automatic 1:20 predilution of sample with Elecsys Diluent Universal and the addition of biotinylated monoclonal anti-h-IgM-specific antibodies.
During the second incubation, CMV-specific recombinant antigen labeled with a ruthenium complex and streptavidin-coated microparticles are added. Anti-CMV IgM antibodies present in the sample react with the ruthenium-labeled CMV-specific recombinant antigen. The complex becomes bound to the solid phase via interaction of biotin and streptavidin.
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode induces chemiluminescent emission which is measured by a photomultiplier.
The analyzer automatically calculates the cutoff based on the measurement of Cal 1 and Cal2. The result of the samples is given either as reactive or non-reactive as well as in the form of a cutoff index (signal samples/cutoff). Samples with a cutoff index (COI)
Here's a breakdown of the acceptance criteria and the study details for the Elecsys CMV IgM Immunoassay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating that the device met its predefined acceptance criteria rather than explicitly listing the criteria in a single table with performance. However, I can construct a table summarizing the performance metrics and their implicit acceptance criteria from the "Analytical Performance Data" and "Clinical Performance Data" sections.
| Study/Test Area | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Repeatability) | CV (%) UCL95% values to be within acceptable limits (specific limits not explicitly stated, but implied by passing results). | All repeatability CVs ranged from 0.9% to 2.0% for controls and 1.0% to 1.8% for human serum samples. All met pre-defined acceptance criteria. |
| Precision (Intermediate) | CV (%) UCL95% values to be within acceptable limits. | All intermediate precision CVs ranged from 2.9% to 5.3% for controls and 2.0% to 4.4% for human serum samples. All met pre-defined acceptance criteria. |
| Reagent Stability (Unopened) | Stable for 15 months at 2-8°C. | Stable for up to 18 months at 2-8°C, supporting the 15-month claim. |
| Reagent Stability (Opened) | Stable for 12 weeks at 2-8°C. | Stable for up to 13 weeks at 2-8°C, supporting the 12-week claim. |
| On-Board Reagent Stability | Stable for 2 weeks at 20°C ± 3°C. | Stable for 34 days at 20°C ± 3°C, supporting the 2-week claim. |
| On-Board/Refrigerated R. Stability | Stable for 6 weeks when stored alternately in refrigerator and on analyzer. | Met acceptance criteria for 6 weeks. |
| Sample Stability (2-8°C) | Stable for 4 weeks at 2-8°C. | Stable for up to 35 days (5 weeks) at 2-8°C, supporting the 4-week claim. |
| Sample Stability (20-25°C) | Stable for 7 days at 20-25°C. | Stable for up to 10 days at 20-25°C, supporting the 7-day claim. |
| Sample Stability (-20°C) | Stable for 3 months at -20°C. | Stable for approximately 4 months (119 days) at -20°C, supporting the 3-month claim. |
| Sample Stability (Freeze/Thaw) | Stable through 5 freeze/thaw cycles. | Stable through 5 freeze/thaw cycles, with samples aliquoted for 6 cycles. |
| Calibration Stability (Lot) | Stable for 28 days. | Met acceptance criteria for 28 days. |
| Calibration Stability (On-Board) | Stable for 8 days (on the Elecsys 2010 analyzer). | Met acceptance criteria for 8 days. |
| Calibrator Stability (2-8°C) | Stable for 8 weeks at 2-8°C. | Met acceptance criteria for 8 weeks (tested for 10 weeks). |
| Open Vial Calibrator Stability | Stable for 5 hours. | Met acceptance criteria for 5 hours. |
| Control Stability (2-8°C) | Stable for 8 weeks at 2-8°C. | Met acceptance criteria for 8 weeks. |
| Control Open Vial Stability | Stable for 5 hours. | Met acceptance criteria for 5 hours. |
| Control Shelf-Life Stability | Stable for 15 months. | Met acceptance criteria for 15 months (tested during and beyond 18 months). |
| High Dose Hook Effect | No hook effect up to a specified high concentration. | No high dose hook effect observed up to 32.9 COI. |
| Endogenous & Drug Interferences | For COI 90% against comparator. No interference from 20 pharmaceutical compounds. | Hemoglobin: |
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).