Flow diagram of the validation process for the combined Nanobody ELISA.

Flow diagram of the validation process for the combined Nanobody ELISA.

<p>Human serum samples were collected at Orán Hospital, Salta (2016–2019) and classified by a reference diagnostic test (positive, n=94; negative, n=74). Samples were analyzed using the cNb-ELISA, and results were subjected to statistical validation. Diagnostic validation included ROC curve an...

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Main Author: María Florencia Pavan (22538063) (author)
Other Authors: Cristian Miguel Malnero (22538066) (author), María Emilia Mora Alvarado (22538069) (author), María Camila Carzoglio (22538072) (author), Yesica Paredes Rojas (22538075) (author), Agostina Bruno (9708143) (author), Laura Perez Vidakovics (14372943) (author), Leo Hanke (14245409) (author), Alejandro Castello (11822201) (author), Gerald McInerney (167172) (author), Cybele Carina García (22538078) (author), Viviana Parreño (409570) (author), Lorena Itatí Ibañez (22538081) (author)
Published: 2025
Subjects:
Medicine
Genetics
Biotechnology
Cancer
Infectious Diseases
Virology
Computational Biology
system exhibits limitations
successfully identified cases
sera pool dilutions
public health system
cases increasing sharply
borne flavivirus responsible
target ns1 across
reported ns1 concentrations
precision diagnostic tools
3 &# 8211
four denv serotypes
denv genome encodes
structural protein 1
6 &# 8211
early infection detection
ns1 ),
diagnostic sensitivity
detecting ns1
3 %).
denv ),
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urgent need
symptom onset
sporadic disease
results underscore
regions facing
recurrent epidemic
recent decades
limited access
key biomarker
human samples
exposing gaps
engineered nanobodies
detection antibodies
detection aligning
detected signals
affecting 18
accurate diagnosis
9 ),
6 %)
23 provinces
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Summary:<p>Human serum samples were collected at Orán Hospital, Salta (2016–2019) and classified by a reference diagnostic test (positive, n=94; negative, n=74). Samples were analyzed using the cNb-ELISA, and results were subjected to statistical validation. Diagnostic validation included ROC curve analysis (sensitivity, specificity, AUC, and cut-off determination), followed by assessment of diagnostic performance (sensitivity, specificity, Cohen’s kappa agreement, and DIA-PRO analysis for discordant samples). Analytical validation included determination of sensitivity and limit of detection (LOD).</p> <p>(TIF)</p>

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