Accepted for/Published in: JMIR Biomedical Engineering
Date Submitted: Aug 14, 2020
Date Accepted: Feb 1, 2021
Point-of-care Quantification of Serum Alpha-Fetoprotein for Screening Birth Defects in Resource-Limited Settings: Proof of Concept
ABSTRACT
Background:
Maternal serum alpha-fetoprotein (MSAFP) concentration typically rises during pregnancy and is routinely measured during the second trimester as part of the screening for fetal neural tube defects (NTDs) and Down syndrome. However, most pregnancy screening tests are not available in the settings they are needed the most. A mobile device-enabled for birth defects based on MSAFP could enable rapid screening and triage of high-risk pregnancies at the point of care. Shifting the approach from clinic- and lab- dependent care to a mobile platform-based on our point-of-care approach will enable translation to resource-poor settings and the global healthcare market.
Objective:
To develop and validate a lateral flow immunoassay on a mobile platform for rapid quantification of serum alpha-fetoprotein (AFP) at the point-of-care from a drop of serum within a few minutes.
Methods:
Development of the immunoassay involved selection of commercially available antibodies and optimization of their concentrations by iterative method to achieve the required detection limits. We compared the performance of our method with commercially obtained human serum samples, with known AFP concentrations quantified by Abbott ARCHITECT chemiluminescent magnetic microparticle immunoassay (CMIA).
Results:
We tested commercially obtained serum samples (n=20) with concentrations ranging from 2.2 to 446 ng/ml to compare the results of our point-of-care assay with Abbott ARCHITECT results.
Results:
On preliminary testing and comparison with Abbott ARCHITECT, a correlation of 0.98 (P < .001) was observed. The detection range of our point-of-care assay covers the range of maternal serum AFP levels observed in pregnancy.
Conclusions:
The analytical performance of the AFP test on the mobile platform in the study has the potential to enable screening of high-risk pregnancies in various settings for appropriate diagnostic and clinical follow-up. AFP test on the mobile platform can be applied to enable: (1) screening for high-risk pregnancies within a few minutes at the point-of-care even in remote areas; (2) identify patients needing continued healthcare advice and counseling; (3) planning for enrolling newborns in state-specific early intervention programs as soon as possible to improve short- and long-term outcomes (4) surveillance tool for birth defects.
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