Biomedica Immunoassays

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osteomiR - microRNA Biomarkers

Determination of fracture risk independent of BMD. Simple and standardized miRNA analysis in serum and plasma.

PRODUCT DETAILS

Assay characteristics:

Cat.No.: TW-KT-011-OT
Method:RT-qPCR, relative quantification without standard curve
Kit content:miRCURY™ RNA extraction,
osteomiR panel, SYBR Green
Kit size:for 48 samples*
Sample type:Serum, plasma (EDTA)
Control:optional: reference serum available on request
Sample size:200 µl serum or plasma required
Incubation time: sample to data in 8 hours with 2 hours hands-on time
Result read-out:The osteomiR™ software uses a proprietary algorithm to convert the individual miRNA data into a single fracture-risk score for the diagnosis of osteoporosis

*): The standardized kit results in a specific osteomiR™ signature. 11 miRNAs will be analysed for each sample resulting in 528 data points in total.

Sensitivity:
LOD: 10 copies/µl (6 replicates, 95% positive detection); LLOQ: 35 copies/µl

Precision:
Intra-assay (n=6) ≤ 20%, Inter-assay (n=3) ≤ 20%

Dilution linearity:
synthetic osteomiRs:
The mean dilution linearity of synthetic controls in human serum samples yields an R² of 0.99 over 6 logs (Cq-range from 20 to 35).

Species cross reactivity:
The sequence homology of osteomiRs in rats and mice is high, however, detection can only be guaranteed for 100% conserved sequences. The assay detects the following microRNAs in:
Rats: rno-miR-203a-3p, rno-miR-127-3p, rno-let-7b-5p, rno-miR-29b-3p, rno-miR-335, rno-miR23a-3p, rnomiR-451-5p
Mouse: mmu-miR-203-3p, mmu-miR-188-3p, mmu-miR-127-3p, mmu-let-7p-5p, mmu-miR-214-3p, mmu-miR-29b-3p, mmu-miR-335, mmu-miR-23a-3p, mmu-miR-451-5p

Upon request, customized-assays for complete coverage of rodent or primate osteomiRs can be designed.

Service analysis: we can measure for you. Click link to get your personal customized service quotation.

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INSTRUCTIONS FOR USE

Click link for:

osteomiR™ IFU, cat# TW-KT-011-OT

miRNA Analytical Service Quotation Form

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ADDITIONAL INFORMATION

All osteomiRs have been carefully selected for this test kit based on a series of studies conducted in human patients with:

- postmenopausal (primary) osteoporosis
- idiopathic male and female osteoporosis
- type-2 diabetic osteopathy

Bone densitometry (DEXA) provides the criterion for diagnosis of osteoporosis, but is not sufficiently sensitive to identify patients at immediate fracture risk. In addition, patients of type-2 diabetic osteopathy exhibit elevated fracture risk in spite of elevated bone marrow density. 

The osteomiR microRNA signature is intended to assess the risk of a first fracture in female patients of postmenopausal osteoporosis and type-2 diabetes. This information enables timely interventions and can help to avoid fractures.

Studies identified a consistent regulation of osteomiRs due to osteoporosis.
Correct classification rates of > 90 % have been repeatedly observed (see data and publications).

Click links for:

osteomiR™ - microRNA biomarkers

TAmiRNA osteomiR™ - Product Folder

TAmiRNA Sample Testing - Service Folder

TAmiRNA osteomiR™ FAQs

TAmiRNA microRNA Services FAQs

 

 

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REFERENCES, APPLICATIONS


Click link for: osteomiR™ key publications

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