(83 days)
For in vitro diagnostic use in the quantitative determination of Btype Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure. This assay is not intended for use on any other system.
The ADVIA® Centaur® BNP assay is a fully automated two-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')> fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Lite Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a luminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.
The Bayer Diagnostics ADVIA Centaur BNP Assay is an in vitro immunoassay designed for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma, to be used as an aid in the diagnosis of heart failure.
1. A table of acceptance criteria and the reported device performance
The provided text describes comparative performance against a predicate device and clinical agreement, rather than explicit pre-defined acceptance criteria with pass/fail thresholds. However, based on the comparative effectiveness study, we can infer the desired performance characteristics.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (ADVIA Centaur® BNP Immunoassay) |
|---|---|---|
| Analytical Agreement | High agreement with predicate device (Biosite Triage® BNP Test) at the 100 pg/mL decision threshold. | 94.7% (177/187) with a 95% Confidence Interval of 90.4% to 97.4%. |
| Clinical Agreement | High overall agreement with clinical diagnosis (HF vs. non-HF) at the 100 pg/mL decision threshold. | 87.2% (163/187) with a 95% Confidence Interval of 81.5% to 91.6%. The predicate device showed 86.1% clinical agreement. |
| Sensitivity | High sensitivity for detecting heart failure at the 100 pg/mL decision threshold. | 87.4% (146/167) with a 95% Confidence Interval of 81.4% to 92.0%. This is identical to the predicate device's sensitivity. |
| Specificity | Good specificity for not misidentifying non-heart failure patients as heart failure at the 100 pg/mL decision threshold. | 85.0% (17/20) with a 95% Confidence Interval of 62.1% to 96.8%. This is higher than the predicate device's specificity of 75.0%. |
| Precision | Comparable or better precision than the predicate device. | Within-run: 1.8 - 4.3 %CV from 29.4 - 1736.0 pg/mL. Total: 2.3 - 4.7 %CV from 29.4 - 1736.0 pg/mL. (Predicate: Average within-day 9.4 - 15.2 %CV; Average total 10.1 - 16.2 %CV). The ADVIA Centaur shows significantly better precision. |
| Analytical Sensitivity | Low detection limit. | ** |
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”