Mass Spectrometry-based Diagnostics: The Upcoming Revolution in Disease Detection Has Already Arrived
Interference by hemoglobin is clearly labeled in the VITROS ® Troponin I assay’s “Instructions For Use” and Package Insert. The hemoglobin con-centrations used and the differences measured are stated under“Limita-tions of the Procedure”(1 ). Our upper reference limit (URL) study used a total...
Guardado en:
| Autores principales: | , , , , |
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| Formato: | Artículo |
| Lenguaje: | Inglés |
| Publicado: |
Universidad de Belgrano - Documentos CEEGMD - Centro para el estudio de enfermedades genéticas, metabólicas y discapacidades. Facultad de Ciencias Exactas
2014
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| Materias: | |
| Acceso en línea: | http://repositorio.ub.edu.ar/handle/123456789/2858 |
| Aporte de: |
| Sumario: | Interference by hemoglobin is clearly
labeled in the VITROS
®
Troponin I
assay’s “Instructions For Use” and
Package Insert. The hemoglobin con-centrations used and the differences
measured are stated under“Limita-tions of the Procedure”(1 ).
Our upper reference limit (URL)
study used a total of 768 fresh hepa-rin-plasma samples from healthy
individuals, which were collected
at four different centers and tested
with the VITROS Troponin I assay
to establish a reference interval for
healthyindividuals and to validate
the product claims in the Package
Insert and Instructions For Use. No
samples were excluded because of
hemolysis, and only two samples
(0.25%) were above the URL of 0.08
g/L (ng/mL).
The incidence of hemolyzed sam-ples in Dr. Hawkins’ study appears
to be higher than our experience
based on our customer service
records. A hemoglobin concentration
of 1000 mg/L (100 mg/dL) causes
substantial discoloration of the sam-ple, which can be easily observed by
most laboratory technicians and
therefore flagged for potential inter-ferences.
We recommend that customers
continue to use the cutoffs stated in
our labeling for the VITROS Tropo-nin I, i.e., 0.08 g/L as the URL and
0.4 g/L as the cutoff for acute
myocardial infarction. Use of the
cutoff of 0.22 g/L suggested by
the author may lead to false nega-tives, which are clearly less desir-able from a medical point of view
than the false positives that may
result from a small number of
greatly hemolyzed samples that
have not been excluded by good
laboratory practice |
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