Point-of-Care Quantification of Serum Alpha-Fetoprotein for Screening Birth Defects in Resource-Limited Settings: Proof-of-Concept Study

摘要: Background: Maternal serum alpha-fetoprotein (MSAFP) concentration typically increases during pregnancy and is routinely measured the second trimester as a part of screening for fetal neural tube defects Down syndrome. However, most tests are not available in settings they needed most. A mobile device–enabled technology based on MSAFP birth could enable rapid triage high-risk pregnancies, especially where maternal ultrasound scan facilities easily accessible. Shifting approach from clinic- laboratory-dependent care to platform our point-of-care will translation resource-limited global health market. Objective: The objective this study develop perform proof-of-concept testing lateral flow immunoassay rapid, quantification (AFP) levels, drop human serum, within few minutes. Methods: development involved selection commercially antibodies optimization their concentrations by an iterative method achieve required detection limits. We compared performance with that obtained samples, known AFP quantified Abbott ARCHITECT chemiluminescent magnetic microparticle (CMIA). Results: tested samples (N=20) ranging 2.2 446 ng/mL compare results assay CMIA. correlation 0.98 (P<.001) was observed preliminary comparison range covers levels pregnancy. Conclusions: test performed represent proof concept pave way future work focused developing quad-screen potential pregnancies various settings. can be applied minutes, at point even remote areas scans accessible; assessment whether clinical follow-up diagnostic may after positive initial evaluation; surveillance tools defects.