Evaluation of sporadic bovine alkaline phosphatase interference in the Beckman Access unconjugated estriol (uE3) assay affecting maternal serum screening results.
Clin Biochem
; 87: 93-99, 2021 Jan.
Article
em En
| MEDLINE
| ID: mdl-33188774
ABSTRACT
OBJECTIVES:
Bovine alkaline phosphatase (BALP) mediated interference is a potential issue in the Beckman Access unconjugated estriol (uE3) assay. As the uE3 assay is a component of second trimester maternal serum screening characterizing this interference is essential for delivering accurate trisomy 18 and trisomy 21 risks. DESIGN ANDMETHODS:
Residual serum samples (n = 517) were measured by two different lots of uE3 assay. Scavenger BALP (sBALP) was added to all samples to remove potential BALP dependent interference and assessed using both lots of uE3 reagent.RESULTS:
BALP mediated interference was observed in similar frequency in both lots of reagent (~3%), although the patterns of positive and negative interference differed between the lots. Pretreatment with sBALP improved lot-to-lot comparison. The presence of BALP related interference was not related to the concentration of endogenous human alkaline phosphatase. The use of polyethylene glycol and sBALP treatment appeared to mitigate BALP mediated interference equally well, and resulted in concordance in measured uE3 concentrations between reagent lots. Additionally, heterophile antibody interference was observed in two samples affected with BALP interference, and the heterophile antibody interference was resolved by both PEG and heterophile antibody blocking reagent treatment, but not sBALP treatment. While the maternal screen numeric risk for affected samples changed, the risk classification changed from a negative to positive screen in two samples.CONCLUSIONS:
Interference in the uE3 assay has the potential to affect maternal serum risk calculations in different reagent lots, and pretreatment of samples with scavenger BALP or PEG should be considered in cases of unexplained uE3 concentrations.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Diagnóstico Pré-Natal
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Biomarcadores
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Síndrome de Down
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Testes Diagnósticos de Rotina
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Fosfatase Alcalina
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Estriol
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Testes para Triagem do Soro Materno
Tipo de estudo:
Diagnostic_studies
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Evaluation_studies
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Screening_studies
Limite:
Animals
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Female
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Humans
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Pregnancy
Idioma:
En
Revista:
Clin Biochem
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos