The evaluation of low cut-off index values of Elecsys® HIV combi PT assay in predicting false-positive results.
J Clin Lab Anal
; 34(11): e23503, 2020 Nov.
Article
em En
| MEDLINE
| ID: mdl-32841422
ABSTRACT
OBJECTIVE:
To analyze the results of different cut-off index (COI) values of Elecsys® HIV combi PT assay and to assess the role of COI in reducing the frequency of false-positive results.METHODS:
We conducted a retrospective study of samples analyzed by Elecsys® HIV combi PT assay, a 4th-generation ECLIA, between 2016 and 2017. A total amount of 379 122 samples were collected for HIV (Human Immunodeficiency Virus) screening.RESULTS:
A total of 379 122 samples were analyzed. 2528 (0.67%) were positive by Elecsys® HIV combi PT. Of these, 468 were false-positive results, and most of them (94.87%) were in samples with 1 < COI <â¯15. The false-positive rate was 0.12%. Patients with false-positive samples were more distributed in elder (P < .001) and female (P < .001) than true-positive specimens. The median COI in true-positive specimens was (385.20), which is significantly higher than false-positive specimens (2.08). The consistency between Elecsys® HIV combi PT assay and 3rd-generation and positive predictive value (PPV) increased with higher COI values. Cancer, infection, and neurological diseases were considered the potential confounding factors of HIV false-positive results (19.44%, 11.11%, and 6.62%, respectively).CONCLUSION:
Samples with low COI values, especially those contain confounding factors, need to be further scrutinized to determine whether the confounding factors may cause false-positive problem. In addition, the hypothesis that low COI values may predict false-positive results is valid.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Infecções por HIV
Tipo de estudo:
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article