(251 days)
The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
The ARCHITECT i Vancomycin assay is a device for the quantitative measurement of vancomycin in human serum or plasma. The device is a chemiluminescent microparticle immunoassay (CMIA) for in vitro diagnostic use, intended to aid in the diagnosis and treatment of vancomycin overdose and in monitoring its levels to ensure appropriate therapy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Total run %CV ≤ 10% | Total run %CV was ≤ 10% |
| Recovery | Not explicitly stated, but implied to be near 100% and within a reasonable range. | Overall percent recovery was 100.2%. Ranged from 98.0% to 105.4% for 5-45 ug/mL, and 86.4% for 3.2 µg/mL. |
| Interferences | Not explicitly stated, but implied that substances should not significantly impact recovery. | The mean recovery ranged from 93.0% to 104.5% for supplemented samples within specific interfering concentrations. |
| Linearity | Not explicitly stated, but implied to demonstrate a linear range across the assay's intended use. | Established linear range of 3.0 ug/mL to 50.0 ug/mL. |
| Sensitivity | Not explicitly stated, but values for LoB, LoD, and LoQ are provided. | Limit of Blank (LoB) was 0.27 ug/mL. Limit of Detection (LoD) was 0.42 ug/mL. Limit of Quantitation (LoQ) was 2.50 ug/mL. |
| Matrix Comparison | Not explicitly stated, but verified for various human serum and plasma types. | Verified for human serum and human plasma collected in Lithium heparin, Dipotassium EDTA, Sodium Citrate, Sodium Heparin, and Sodium Fluoride/Potassium Oxalate. |
| Specificity (Cross-reactivity) | Different criteria for CDP-1 (less than 0.42 µg/mL in absence of vancomycin, but interferes > 5 µg/mL in measurement range) and other compounds (less than 0.42 µg/mL for cross-reactivity, 100±10% recovery for interference). | CDP-1 at 10 ug/mL showed cross-reactivity 5 µg/mL interferes with samples containing vancomycin in the measurement range. Isoniazid at > 300 ug/mL interferes with samples containing vancomycin in the measurement range. Other tested compounds showed cross-reactivity |
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.