Evaluation of the Vitros NT-proBNP II Assay
Author Information
Author(s): Xiao Yi, Sun Chao, Tsan Justin, Leung Edward Ki Yun, Capobianco Enrico, Plebani Mario
Primary Institution: Children’s Hospital Los Angeles
Hypothesis
This study aims to evaluate the analytical performance of the Vitros NT-proBNP II assay.
Conclusion
The evaluation demonstrated acceptable analytical performances of the Vitros NT-proBNP II assay except for a positive proportional bias compared with the Vitros NT-proBNP assay.
Supporting Evidence
- Repeatability and reproducibility were ≤10% CV.
- The analytical measurement range was verified as 20–30,000 pg/mL.
- Positive proportional bias was observed with a slope of 1.37.
- NT-proBNP is stable for up to five days at various temperatures.
- Instrument-to-instrument comparisons showed no significant biases.
Takeaway
The Vitros NT-proBNP II test is generally good for measuring heart failure, but it sometimes gives higher results than expected compared to the older test.
Methodology
The study assessed repeatability, reproducibility, carryover, analytical measurement range, and clinical reportable range using patient specimens and commercial materials.
Potential Biases
There is a significant positive proportional bias when comparing results from the Vitros NT-proBNP II assay with the Vitros NT-proBNP assay.
Limitations
The study did not verify serum as an alternative specimen type and the positive bias was not resolved by dilution or other methods.
Participant Demographics
The study used leftover patient specimens from the core laboratory at Children's Hospital Los Angeles.
Statistical Information
P-Value
0.53
Confidence Interval
95%CI: 1.21–1.52
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website