A1 Refereed original research article in a scientific journal
A rapid lateral flow immunoassay for serological diagnosis of pertussis
Authors: Salminen T, Knuutila A, Barkoff AM, Mertsola J, He QS
Publisher: ELSEVIER SCI LTD
Publication year: 2018
Journal: Vaccine
Journal name in source: VACCINE
Journal acronym: VACCINE
Volume: 36
Issue: 11
First page : 1429
Last page: 1434
Number of pages: 6
ISSN: 0264-410X
DOI: https://doi.org/10.1016/j.vaccine.2018.01.064
Abstract
Current serological diagnosis of pertussis is usually done by ELISA. However, the ELISAs are often central laboratory based, require trained staff and have long turnaround times. A rapid point-of-care (POC) assay for pertussis serology would aid in both diagnosis and surveillance of the disease. While lateral flow immunoassays (LFIA) are simple to use and ideal for point-of-care diagnostics, they were limited to qualitative assays until recently. In this study, we developed a quantitative LFIA with fluorescent Eu-nanoparticle reporters for the detection of anti-pertussis toxin (PT) IgG. The assay was evaluated by testing 198 serum samples with varying anti-PT IgG levels and the result was compared to those obtained with standardized anti-PT IgG ELISA. At the diagnostic cutoff of 100 IU/mL in ELISA, the LFIA had a concordance of 92% with the ELISA, with a specificity of 96% [95% confidence interval (CI): 89-99%] and a sensitivity of 88% [0: 77-94%]. The developed LFIA has a turnaround time of one hour and requires only a simple manipulation by the user and an instrument for the quantitative detection of the signal. We conclude that the LFIA is specific and sensitive for serological diagnosis of pertussis and is suitable for a POC test. (C) 2018 Elsevier Ltd. All rights reserved.
Current serological diagnosis of pertussis is usually done by ELISA. However, the ELISAs are often central laboratory based, require trained staff and have long turnaround times. A rapid point-of-care (POC) assay for pertussis serology would aid in both diagnosis and surveillance of the disease. While lateral flow immunoassays (LFIA) are simple to use and ideal for point-of-care diagnostics, they were limited to qualitative assays until recently. In this study, we developed a quantitative LFIA with fluorescent Eu-nanoparticle reporters for the detection of anti-pertussis toxin (PT) IgG. The assay was evaluated by testing 198 serum samples with varying anti-PT IgG levels and the result was compared to those obtained with standardized anti-PT IgG ELISA. At the diagnostic cutoff of 100 IU/mL in ELISA, the LFIA had a concordance of 92% with the ELISA, with a specificity of 96% [95% confidence interval (CI): 89-99%] and a sensitivity of 88% [0: 77-94%]. The developed LFIA has a turnaround time of one hour and requires only a simple manipulation by the user and an instrument for the quantitative detection of the signal. We conclude that the LFIA is specific and sensitive for serological diagnosis of pertussis and is suitable for a POC test. (C) 2018 Elsevier Ltd. All rights reserved.
UTU Research Portal