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ISSN 1027-2852 (Electronic)
ISSN 0864-4551 (Print)

2018, Number 3

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Biotecnol Apl 2018; 35 (3)

Effect of temperature on the analytical performance of the UMELISA® TIR NEONATAL assay for newborn screening of cystic fibrosis

Castells-Martínez EM, Frómeta A, Pérez PL, Martín O, del Río L, Espinosa M, Almira C, Núñez Z, González-Reyes EC

Language: English
References: 28
Page: 3301-3304
PDF size: 497.20 Kb.


ABSTRACT

UMELISA® TIR NEONATAL is a kit developed to quantify immunoreactive trypsin in newborns’ dry blood spots on filter paper. Reagents were stored at –20, 23 and 37 °C for 2, 4, 6, 8, 14 and 20 days. The mean of the fluorescence values of the calibrators, the recovery percentage (%R) and the concentration of the assay control were calculated. The kit showed different behaviors at each tem-perature studied, obtaining % Rhigher than 80 %, when it was stored at –20 ºC. For 37 °C it was not possible to exceed 6 days of the test due to a decrease in %R. For 23 °C, at 14 days a decrease in %R was observed, but still permissible as described in the specifications of the assay. Temperature directly influences the analytical performance of the UMELISA® TIR Neonatal. The kit can be exposed to a temperature of –20 ± 2ºC for 20 days and at a temperature of 23 ± 2 ºC, for 14 days without affecting its functional characteristics but it cannot be stored at a temperature of 37 ± 2 ºC for more than 4 days, since its optimum quality parameters are affected. It was demonstrated that the quality parameters of the UMELISA® TIR NEONATAL are affected according to their storage conditions.


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