β2-MG test Rapid Test poct Kits
Methodology
Fluorescence Immunoassay
β2-MG is important indicator to reflect glomerular filtration rate, renal transplantation, renal function, with higher analytical sensitivity, wider of lower detection line, lower concentration values for better precision, and more efficient operation.
Product Name
General Name:β2-MG Test Kit(Immunofluorescence)
Package
Test card: Aluminum foil pouch 1pc/bag, desiccant
Package size: 25pcs/box
Interpretation of test results
1.The analysis of test results are accomplished by immune-fluorescence quantitative
analyzer of our company's NORMAN series.
2.The concentration of β2-MG in the unknown samples can be read directly in the
corresponding batch of ID card standard curve by fluorescence signal value we
measured. The default results use mg/L as a unit.
Performance Indicators
1.Detection limit: ≤0.1 mg/L.
2.Linear range:0.1-20mg/L, the linear correlation coefficient r should not be less than
0.9900 in this range.
3.Accuracy: Recovery rate is within the range (80% ~ 120%).
4.Repeatability: CV≤15%.
5.Difference between batches: CV≤15%.
Expected values/Reference range
The reference range study was conducted based on β2-MG content of 95% of the
distribution range of statistical analysis in 120 healthy people, the result was as follows:
Sample | Reference range(mg/L) |
Blood serum | 1.01-2.97 |
Urine | 0.10-0.30 |
It is recommended that each laboratory established its own reference range, which may
be unique to the population it serves depending upon geographical, patient, dietary, or
environmental factors.
Notice Of Detection Result
1.The test results should take clinical symptoms,health history,other laboratory tests,
etc. into account, just for clinical reference, nor as a sole factor of clinical diagnostic.
2.All operation must be strictly in accordance with operating procedures to get the correct
result. The accuracy of test results may be affected by any changes to operational
procedures.
Clinical Significance
Sample reference range (mg/L)
Serum 1.01-2.97
Urine 0.10-0.30
Product Advantage
Strong anti-interference ability
Different sample types: serum, urine
Wide test range:0.1-20mg/L
High sensitivity,
Good repeatability
Single sample test or batch test.
Package & Delivery
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About Us
Nanjing Norman Biological Technology Co., Ltd is dedicated to R&D and manufacturing of automated chemiluminescence system. Founded in 2008, Norman biological has been upholding the idea that R&D shapes future ,and concentration determines success. Ever since the beginning, Norman has been focusing on developing and manufacturing chemiluminescence instruments and reagents.
Norman's manufacture center is located in the Yuhua District and owns an over 2,000m2 GMP-approved clean workshop. The R&D base, which is over 2,000m2 , is located in state-level new Jiangbei district. Now there are over 100 R&D engineers, 40% of which hold a PhD or master's degree.
R&D shapes future, and concentration determines success. Driven by the commitment to "provide complete solution to improve human health", Norman will consistently do its utmost to drive the IVD industry forward and contribute more to human health.
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