Catalog No.
KDJ48702
Description
PRINCIPLE OF THE ASSAY
This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human SOST has been pre-coated onto a microplate. Standards or samples are premixed with
biotin-labeled antibody and then pipetted into the wells. Romosozumab in the sample competitively binds to the pre-coated protein with biotin-labeled Romosozumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Romosozumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Applications
Used for the quantitative determination of Romosozumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
125 - 8,000 ng/mL
Sensitivity
42.86 ng/mL
Precision
Intra-Assay Precision (Precision within an assay): <20%
Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays): <20%
Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.
|
|
Intra-Assay Precision
|
Inter-Assay Precision
|
|
Sample
|
1
|
2
|
3
|
1
|
2
|
3
|
|
n
|
16
|
16
|
16
|
24
|
24
|
24
|
|
Mean (ng/mL)
|
3744.0
|
1019.7
|
242.5
|
3473.3
|
830.7
|
169.8
|
|
Standard deviation
|
265.8
|
111.3
|
26.3
|
388.9
|
99.2
|
30.7
|
|
CV (%)
|
7.1
|
10.9
|
10.8
|
11.2
|
11.9
|
18.1
|
Recovery
80-120%
Shipping
2-8 ℃
Stability and Storage
When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%. For unopened kits, if you want to prolong the storage time, please store the Standard, Detection A, Detection B and Microplate at - 20℃, the rest reagents should be store at 4℃.
Alternative Names
785A070802, AMG 785, CDP-7851, romosozumab-aqqg, sclerostin Ab, CAS: 909395-70-6
Background
Romosozumab, a specific inhibitor of sclerostin, is a unique approach to therapy for postmenopausal osteoporosis and related disorders. The elucidation of sclerostin deficiency as the molecular defect of syndromes of high bone mass with normal quality, and the pivotal role of sclerostin as a mediator of osteoblastic activity and bone formation, provided the platform for the evaluation of inhibitors of sclerostin to activate bone formation.
Romosozumab increases bone mineral density in Japanese older adults with osteoporosis., PMID:40488406
Fragility of Evidence for the Efficacy of Anti-fracture Medications., PMID:40488289
Development of a novel macroscopic regulation and microscopic intervention mode nanosystem for osteoporosis treatment., PMID:40475860
Diagnosis of skeletal fragility due to Loeys-Dietz syndrome and treatment with romosozumab followed by denosumab., PMID:40469084
Novel Aptamers Targeting Sclerostin Loop3 Improve Skeletal and Muscle Properties Without Adverse Cardiovascular Effects in Orchiectomized Mice., PMID:40464222
Association of anti-citrullinated protein antibodies with changes in bone density in patients with rheumatoid arthritis treated with romosozumab for one year: a cohort study., PMID:40459239
Treatment of Osteoporosis in Patients with Chronic Kidney Disease., PMID:40457078
Methodological concerns, implausibly early fracture reduction, and potential outcome misclassification: Comment on "Comparative effectiveness of romosozumab versus teriparatide for fracture prevention: A new-user, active comparator design"., PMID:40456504
Characteristics and treatment options of 272,152 geriatric patients with very high and high fracture risk., PMID:40445411
Role of Sclerostin in Cardiovascular System., PMID:40429697
Five-Year Sales Trends of Osteoporosis Medications in Korea: A Market Analysis Based on IMS Health Sales Audit Data (2018-2023)., PMID:40428763
Comprehensive Evaluation of Treatment Patterns in Postmenopausal Patients with Osteoporosis without Fractures: Insights from Tertiary Care Institutions and Nationwide OMOP-CDM Data., PMID:40426310
Examining Romosozumab Adherence and Side Effects in Osteoporotic Patients After Surgical Fracture Fixation: A Comparative, Descriptive, and Hypothesis-Generating Study with Non-Fractured Controls., PMID:40422580
Expression of Concern: Comparative cardiovascular safety of romosozumab versus bisphosphonates in Japanese patients with osteoporosis: a new-user, active comparator design with instrumental variable analyses., PMID:40413791
Comparative effectiveness of romosozumab versus teriparatide for fracture prevention: A new-user, active comparator design., PMID:40381877
Agents to treat osteoporosis in chronic kidney disease., PMID:40377654
Impact of Frailty and Other Factors as Estimated by HU to Predict Response to Anabolic Bone Medications., PMID:40364278
Real-World Evaluation of 12-Month Romosozumab Treatment in Korean Women with Severe Osteoporosis: Potential Synergy with Hormone Therapy., PMID:40363988
Cost-effectiveness of opportunistic osteoporosis screening using chest radiographs with deep learning in Germany., PMID:40355760
Romosozumab for managing severe osteoporosis in patients undergoing kidney transplantation: a retrospective case series., PMID:40353207
Pregnancy and lactation-related osteoporosis associating multiple vertebral fragility fractures treated with romosozumab: a case report., PMID:40330931
Assessing the Efficacy of Romosozumab in Postmenopausal Osteoporosis: An Updated Systematic Review and Meta-analysis., PMID:40323656
National guidelines for diagnosis and treatment of osteoporosis in Slovakia., PMID:40319419
Male Osteoporosis: A Comprehensive Review of Treatment Approaches in Modern Pharmacotherapy and Traditional Chinese Medicine Interventions., PMID:40304326
Managing delayed union of fragility fractures of the pelvis successfully using romosozumab: A case report., PMID:40291407
Anti-osteoporosis medication in patients with posterior spine fusion: a systematic review and meta-analysis., PMID:40280495
Use of raloxifene as a sequential therapy after romosozumab : an observational study., PMID:40268433
[Sequential drug treatments for osteoporosis]., PMID:40241552
[Clinical efficacy of osteoporosis treatments]., PMID:40241551
Bone disease and osteoporosis associated with Pompe disease., PMID:40224915
A Commentary on "Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes"., PMID:40211518
Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes., PMID:40211517
Role of Anabolic Anti-Osteoporosis Therapy in Diabetes Subjects., PMID:40181849
An update on the pharmacotherapy of osteoporosis., PMID:40178951
Mechanical Analysis of Romosozumab's Effects on Bone Strength in a Rat Posterolateral Lumbar Fusion Model., PMID:40161136
Use of Teriparatide, Denosumab, and Romosozumab in a Postpartum Monogenic Osteoporosis With a WNT1 Pathogenic Variation., PMID:40144478
Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results., PMID:40134082
Twenty-Year Trends in Osteoporosis Treatment and Post-Fracture Care in South Korea: A Nationwide Study., PMID:40098430
L5 osteotomy combined with adjuvant romosozumab therapy for L5 osteoporotic vertebral fracture-induced spinal deformity: illustrative case., PMID:40096736
[Osteoporosis therapy - Update 2025, Part 1: Antiresorptive and osteoanabolic therapy options]., PMID:40091709
[Osteoporosis therapy - Update 2025, Part 2: Sequential osteoporosis therapy]., PMID:40091708
[Risk of jaw osteonecrosis and atypical femoral fracture: how to inform patients with osteoporosis?]., PMID:40091707
Romosozumab and cardiovascular safety in Japan., PMID:40057912
Response to Letter to the Editor of JBMR: sequential osteoanabolic therapy for osteoporosis., PMID:40044117
Sequential and combination therapy with romosozumab., PMID:40024934
Misaligned cardiovascular safety warnings for romosozumab in Japan., PMID:39994044
Assessment of evidence for the off-label application of osteoanabolic drugs in fracture healing and spinal fusion., PMID:39964554
Basic and Clinical Scientists Working Together-Do We Make the Best of Both Worlds?, PMID:39953279
Optimisation of romosozumab plus denosumab sequential treatments against postmenopausal osteoporosis. Insights from in silico simulations., PMID:39951226
Monoclonal Antibodies and Small-Molecule Inhibitors Associated Osteonecrosis of Jaw: A Retrospective Pharmacovigilance Study., PMID:39922223
For research use only. Not for human or drug use.
