(332 days)
The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative measurement of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency. HoloTC RIA is calibrated with HoloTC Calibrators. HoloTC controls are assayed for the verification of the accuracy and precision of the HoloTC RIA.
The Axis-Shield HoloTC RIA is a competitive binding immunoassay in which a specific monoclonal antibody is used to capture transcobalamin from the patient sample. Thereafter the procedure is as commonly used in vitamin B12 assays. The cobalamin (vitamin B12) is released from the transcobalamin using dithiothreitol and sodium hydroxide. The released cobalamin (vitamin B12) then competes for a limited amount of intrinsic factor with added 'Co labelled vitamin B12. The Axis-Shield HoloTC RIA differs from the predicate device in two main aspects:
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- The use of a transcobalamin specific antibody, this allows the quantitation of only the cobalamin bound to the protein transcobalamin as opposed to measurement of cobalamin bound to all proteins in the predicate device and
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- The detection signal is radioactivity (37Co) as opposed to chemiluminescence in the predicate device.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for all performance metrics. However, where implicitly stated or inferable, they are included.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Close linear correlation, ideally slope ≈ 1, intercept ≈ 0, high r² | HoloTC pmol/L = 0.55 * VB12-2 pmol/L; r² = 0.52 (compared to predicate Bayer Advia Centaur VB12 assay) |
| Reference Interval | n/a (established for diagnosis) | 37-171 pmol/L (95% central interval for Finnish population, n=303) |
| External Evaluation (CV) |
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.