Abstract
Measuring bone turnover markers could detect early stages of osteoporosis and early responses to anti-osteoporotic treatments. Currently, commonly used bone turnover markers, N-telopeptides (NTx) and C-telopeptides (CTx), are measured using ELISA tests, which demands time and increases cost. Bone turnover markers need to be measured more easily for general use. Lateral flow-based immunoassay would be an appropriate method for this context. This study was performed to investigate the precision of a newly developed lateral flow-based immunoassay for measuring the urinary NTx and serum CTx, and their correlations with ELISA measurements. Urine NTx and serum CTx concentrations were determined by photoscan of newly developed strips, using a lateral flow-based immunoassay for 36 subjects (mean age 66.2 years, SD 7.5 years; four males and 32 females). Repeated measurement of urinary NTx and serum CTx were performed three times, using this technology for a precision test. The correlation of the lateral flow-based immunoassay with the ELISA measurements was analyzed. Precision of the newly developed lateral flow based immunoassay was 0.974 (ICC, 95% confidence interval, 0.955 to 0.986) and 0.995 (ICC, 95% confidence interval, 0.991 to 0.997) for urinary NTx and serum CTx, respectively. The correlation of lateral flow based immunoassay with ELISA was 0.913 for urinary NTx and 0.872 for serum CTx. These results suggest that measuring the urinary NTx and serum CTx, using a lateral flow-based immunoassay, is a relevant method for point-of-care testing and screening of bone resorption markers.
Highlights
Osteoporosis is one of the most serious diseases of an aging population, causing osteoporotic fractures and raising mortality and morbidity [1,2,3,4]
Standard diagnosis usually depends on measuring the bone mineral density using a dual energy X-ray absorptiometry (DEXA) [5]
The components used for this lateral flow immunoassay are the assembly membrane, conjugate pad, sample pad, wick, and backing materials, which were purchased from Millipore (Bedford, MA, USA)
Summary
Osteoporosis is one of the most serious diseases of an aging population, causing osteoporotic fractures and raising mortality and morbidity [1,2,3,4]. Urinary N-telopeptide (NTx) and serum C-telopeptide (CTx) appears to be the most promising bone resorption markers [10,11] They are currently measured by ELISA methods, which are somewhat costly and slow. Lateral flow-based immunoassay represents a simple and well established technology to detect the presence of a target material by an immune reaction without the need for specialized and costly equipment. It is used in medical diagnostics for field use, point of care testing, or laboratory use [12]. Recognition of the analyte was done by binding to NTx- and CTx receptor conjugated to gold colloids, enabling the visualization
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