Abstract
Cancer antigen 125 (CA125) is a widely used biomarker in monitoring of epithelial ovarian cancer (EOC). Due to insufficient cancer specificity of CA125, its diagnostic use is severely compromised. Abnormal glycosylation of CA125 is a unique feature of ovarian cancer cells and could improve differential diagnosis of the disease. Here we describe the development of a quantitative lateral flow immunoassay (LFIA) of aberrantly glycosylated CA125 which is widely superior to the conventional CA125 immunoassay (CA125IA). With a 30 min read-out time, the LFIA showed 72% sensitivity, at 98% specificity using diagnostically challenging samples with marginally elevated CA125 (35–200 U/mL), in comparison to 16% sensitivity with the CA125IA. We envision the clinical use of the developed LFIA to be based on the substantially enhanced disease specificity against the many benign conditions confounding the diagnostic evaluation and against other cancers.
Highlights
Cancer antigen 125 (CA125) is a widely used biomarker in monitoring of epithelial ovarian cancer (EOC)
An anti-CA125 mAb (4602, Oy Medix Biochemica, Finland), against the protein epitope was coated on the upconverting nanoparticles (UCNPs) to be used as a reporter (Fig. 1)
The assay configuration based on the STn1242 and 4602 mAb-UCNPs showed significantly lower background and superior signal to noise (S/N) ratio in comparison to the remaining antibody combinations (Supplementary Fig. 1)
Summary
Cancer antigen 125 (CA125) is a widely used biomarker in monitoring of epithelial ovarian cancer (EOC). Epithelial ovarian cancer (EOC) is the deadliest form of gynecological malignancies because of late and vague symptoms, frequently seen in many other conditions[2] Another reason is the difficulty of diagnosing the localized malignancy at an early-stage using existing methods[3,4]. The CA125IA, ELISA test, utilize the specificity of different monoclonal antibodies targeting protein-epitopes on CA125, including OC125 and M11, or OV197 like antibodies[7] These assays have been widely implemented for the monitoring of disease progression or regression, rather than for early detection of ovarian cancer. The inadequate specificity of CA125 impedes its use in early-stage EOC diagnosis and disease progression[5,8,9] For this reason, supplementary biomarkers to CA125 such as HE410 or multimodal diagnostic tests (ROMA, ROCA, OVA1, and Overa) with CA125 as the key component have been studied[11]. Premature sialylation of the core carbohydrate Tn structure Gal-NAc1-O- Ser/
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