TY - JOUR
T1 - Comparison of methods study between a photonic crystal biosensor and certified ELISA to measure biomarkers of iron deficiency in chronic kidney disease patients
AU - Peterson, Ross D.
AU - Wilund, Kenneth R.
AU - Cunningham, Brian T.
AU - Andrade, Juan E.
N1 - Funding Information:
Funded in part by ILLU-971-342 grant to JEA and BTC and ILLU-698-904 grant to JEA. Additionally, Dept. FSHN Block Fellowship and American Society for Nutrition Pfizer Award to RDP.
PY - 2017/10
Y1 - 2017/10
N2 - The total analytical error of a photonic crystal (PC) biosensor in the determination of ferritin and soluble transferrin receptor (sTfR) as biomarkers of iron deficiency anemia in chronic kidney disease (CKD) patients was evaluated against certified ELISAs. Antigens were extracted from sera of CKD patients using functionalized iron-oxide nanoparticles (fAb-IONs) followed by magnetic separation. Immuno-complexes were recognized by complementary detection Ab affixed to the PC biosensor surface, and their signals were followed using the BIND instrument. Quantification was conducted against actual protein standards. Total calculated error (TEcalc) was estimated based on systematic (SE) and random error (RE) and compared against total allowed error (TEa) based on established quality specifications. Both detection platforms showed adequate linearity, specificity, and sensitivity for biomarkers. Means, SD, and CV were similar between biomarkers for both detection platforms. Compared to ELISA, inherent imprecision was higher on the PC biosensor for ferritin, but not for sTfR. High SE or RE in the PC biosensor when measuring either biomarker resulted in TEcalc higher than the TEa. This did not influence the diagnostic ability of the PC biosensor to discriminate CKD patients with low iron stores. The performance of the PC biosensor is similar to certified ELISAs; however, optimization is required to reduce TEcalc.
AB - The total analytical error of a photonic crystal (PC) biosensor in the determination of ferritin and soluble transferrin receptor (sTfR) as biomarkers of iron deficiency anemia in chronic kidney disease (CKD) patients was evaluated against certified ELISAs. Antigens were extracted from sera of CKD patients using functionalized iron-oxide nanoparticles (fAb-IONs) followed by magnetic separation. Immuno-complexes were recognized by complementary detection Ab affixed to the PC biosensor surface, and their signals were followed using the BIND instrument. Quantification was conducted against actual protein standards. Total calculated error (TEcalc) was estimated based on systematic (SE) and random error (RE) and compared against total allowed error (TEa) based on established quality specifications. Both detection platforms showed adequate linearity, specificity, and sensitivity for biomarkers. Means, SD, and CV were similar between biomarkers for both detection platforms. Compared to ELISA, inherent imprecision was higher on the PC biosensor for ferritin, but not for sTfR. High SE or RE in the PC biosensor when measuring either biomarker resulted in TEcalc higher than the TEa. This did not influence the diagnostic ability of the PC biosensor to discriminate CKD patients with low iron stores. The performance of the PC biosensor is similar to certified ELISAs; however, optimization is required to reduce TEcalc.
KW - Analytical quality specification
KW - Iron deficiency biomarkers
KW - Method validation
KW - Photonic crystal biosensor
KW - Total allowable error
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U2 - 10.3390/s17102203
DO - 10.3390/s17102203
M3 - Article
C2 - 28946680
AN - SCOPUS:85030157404
VL - 17
JO - Sensors (Basel, Switzerland)
JF - Sensors (Basel, Switzerland)
SN - 1424-8220
IS - 10
M1 - 2203
ER -