Screening and Assessment of Bone Health in Indian Women Using an Indigenous ELISA of Human Osteocalcin a Bone Turnover M
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ORIGINAL RESEARCH ARTICLE
Screening and Assessment of Bone Health in Indian Women Using an Indigenous ELISA of Human Osteocalcin a Bone Turnover Marker Sonam S. Hatkar1 • Seema S. Kadam1 • M. Ikram Khatkhatay1 • Meena P. Desai1
Received: 22 April 2019 / Accepted: 15 June 2019 Ó Association of Clinical Biochemists of India 2019
Abstract Osteoporosis a major public health problem of the elderly, is associated with substantial morbidity and socio economic burden. The aim of the study was to screen women with low bone mass using the indigenously developed Osteocalcin (OC) ELISA kit and compare it with commercial ELISA kit and evaluate. The diagnostic potential of the assay was assessed in 359 samples from neighboring tertiary care hospitals over a period of 2 years. OC levels were estimated by the developed indigenous assay in samples, correlated with the Bone Mineral Density (BMD) measurements and compared by a commercial ELISA kit. On the basis of T-scores the women were stratified into Normal and case groups as Osteopenia and Osteoporosis. The serum biochemical parameters calcium and phosphorus were estimated on an auto-analyzer. To compare two different assays Bland–Altman plot and Deming linear regression analysis was performed. The prevalence of Osteopenia was high (56%) and Osteoporosis (13%) in the healthy Indian women aged 21–65 years with significant differences in OC levels in normal and women with low bone mass. Good correlation (p \ 0.0001) in the OC levels by the two assays was observed. Cut off limits established earlier with indigenous assay (11.9 ng/mL and 14.9 ng/mL) for Osteopenia and Osteoporosis were similar to those with the commercial kit (13.2 ng/mL and 16.8 ng/
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12291-019-00841-0) contains supplementary material, which is available to authorized users. & Meena P. Desai [email protected] 1
Department of Molecular Immunodiagnostics, ICMRNational Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai 400012, India
mL) respectively. The diagnostic sensitivity, specificity and accuracy of the OC prototype was [ 85%. The cost effective OC prototype can be used in screening and management of Indian women with low bone mass. Keywords Osteocalcin ELISA Correlation Method comparison Bland–Altman Agreement analysis
Introduction Currently India has more than 36 million population affected by osteoporosis. Due to an increase in longevity of life, osteoporotic fractures are a major cause of morbidity and mortality. Approximately 10% of the Indian population is older than 50 years and these figures are likely to go up by 34% till 2050 [1–3]. Bone mineral density measurements (BMD) by dual energy X-ray absorptiometry (DXA) is considered as the gold standard for the diagnosis of osteoporosis. Estimates suggest that * 50 million people in India over the age of 50 have low bone mass (T-scores of \ - 3), with 20% women and 10–15% of men as osteoporotic [4, 5]. Access to BMD
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