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Goldsite Diagnostics Inc.
Specialist of Specific Protein Analysis Goldsite Diagnostics Inc. 2015
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Company Introduction Goldsite Diagnostics Inc. is a professional diagnostic company, which is committed to the research, development, manufacture and marketing of protein analyzer and kits of assaying serum specific proteins since our establishment in Up till now, we have developed semi-automatic analyzer such as Nephstar / Nephstar Plus and fully automatic analyzer, Omlipo, Astep etc. Our products have successfully entered the market of Europe, Asia and Africa and received very good feedback.
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Company Pictures
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Introduction to NEPHSTAR
Instrument Principle Assays Manipulation Technology Clinical studies Market Positioning Sales Analysis
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Specifications Principle: Fixed-time nephelometry
Light source: Red laser diode Language: English and Chinese Printer: Inlaid, Thermal Weight: 2.9kg Dimensions: 270mm x 268mm x 130mm Ambient operating temperature: 15-30℃ Power requirements: 220V±10% AC 50Hz
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Features Principle: Fixed-time immunonephelometry
Electronic pipette attached Light and small, thermal printer inlaid Intelligentized temperature control Automatic blanking, timer and mixing No need to do calibration, magnetic card provided Record management software presented which allows data transferring to computer Optimised and user-friendly operating procedure
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Principle Immunonephelometry: The amount of light scattered by insoluble complexes formed by specific reaction between soluble specific protein in samples and its respective antiserum is measured and it is directly proportional to the concentration of the protein under condition that antiserum is in excess. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.
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Principle Fixed-time Immunonephelometry: This method involves measuring intensity of light scattered at one certain point before the ‘end’ (actually the dynamic equilibrium) of Ag-Ab reaction. Remarkable time is saved compared to End-point nephelometry Nephstar employs Fixed-time Immunonephelometry
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Reagent Kits Features 29 assays covering many clinical fields
New assays in development Assays standardized against CRM470/IFCC reference materials Correlate well to Dade Behring Latex enhanced immunoassay increases sensitivity Optimized reaction conditions make antigen excess almost impossible
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Reagent Kits Features Uniform procedure
Easy dilution schemes (1/11, 1/40) Point of Care Testing (POCT) Results available within 15 to 120 seconds Broad linear ranges Rapid, accurate, easy
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Current assays IgA IgM CER C3 KAP IgG ALB AT3 C4 LAM DD PAB ASO C1IN
bCRP AAG CRP AAT mALB TRF RF APOA1 BMG HPT UsCRP APOB HbA1c
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Manipulation: Summary of Protocol
Switch On Enter Chemistry Number (e.g. 4 = IgG) Check reagent lot number (swipe card if necessary) Enter sample ID Accept dilution factor (change if necessary) Prepare Dilution (if necessary) Place sample and stirring bar in cuvette Place Cuvette in Instrument Add Antiserum + reaction buffer simultaneously using electronic pipette Wait for results to be displayed (and printed)
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Technology Fixed-time Immunonephelometry
Precipitation Linear range Antigen Heidelberger Curve
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Technology Fixed-time Immunonephelometry
Heidelberger Curve: When the amount of ab is defined and not changed, in the first stage, the precipitation formed by specific Ab-Ag reaction increases with the addition of Ag, then after the precipitation peak the precipitation decreases with further addition of Ag. Usually the amount of light scattered is proportional to the amount of precipitation.
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Technology Fixed-time Immunonephelometry
End-point nephelometry measures the light scattered at the precipitation peak, when the dynamic equilibrium of Ab-Ag reaction is reached. This process takes usually 10 to 30 minutes depending on assays. Fixed-time nephelometry measures the light scattered before the precipitation peak, when the precipitation increases most quickly. This method is much quicker, and more accurate than end-point nephelometry
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Technology Rate Nephelometry
Rate nephelometry: This method measures the peak velocity of varying intensity of scattered light by Ag-Ab complexes. Usually the peak velocity is reached within one minute after Ab meets Ag. This method is the most rapid. Its disadvantages are necessity to filter all reagents, many requirements for detectors and time interval chosen for monitoring
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Technology Latex-enhanced Immunonephelometry
This method utilizing immunoparticles (antibody covalently coupled to polystyrene particles) provides increased sensitivity as compared with conventional assays, and allow the determination of proteins present in low concentrations. And some tiny undetectable particles with conventional methods become measurable after coupled to latex
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Technology Antigen Excess
Antigen excess resulting in much lower values than actual is a common problem for all immunonephelometric or immunoturbidimetric methods. Some walkaway fully automatic instruments like Beckman Immage and BN II utilize a pretest to detect antigen excess, which consumes time and also reagents thus adds to cost of the customers
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Technology Antigen Excess
Goldsite conducted numerous studies and got known of the highest possible concentrations of each assay in the routine clinical determinations. And in line with these possible high values the reaction condition of each assay is optimized to ensure that antibody is always in excess. For example, CRP concentrations of less than 6000 mg/L will not result in misled low values due to antigen excess.
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Clinical Studies Precision Study: IgG
Cliniqa and Randox controls for IgG are measured with Nephstar IgG kit on Nephstar Taget(g/L) Norms(g/L) N Mean CV% Randox L1 6.5 10 6.34 2.21 Randox L2 13.3 13.66 1.2 Randox L3 19.6 20.01 2.41 Cliniqa L1 6.72 6.65 2.82 Cliniqa L2 12.6 12.5 2.08 Cliniqa L3 18.5 18.72 3.19
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Clinical Studies Precision Study: C3
Cliniqa and Randox controls for C3 are measured with Nephstar C3 kit on Nephstar C3 Taget(g/L) Norms(g/L) N Mean CV% Randox L1 0.832 10 0.81 2.53 Randox L2 1.68 1.65 1.22 Randox L3 2.49 2.56 1.13 Cliniqa L1 0.703 0.68 2.23 Cliniqa L2 1.51 1.53 2.01 Cliniqa L3 2.24 2.29 1.85
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Clinical Studies Precision Study: CRP
Cliniqa and Randox controls for CRP are measured with Nephstar CRP kit on Nephstar CRP Taget(mg/L) Norms(mg/L) N Mean CV% Randox L1 24.3 10 23.5 1.15 Randox L2 53.1 52.9 1.85 Randox L3 77.4 73.9 2.18 Cliniqa L1 15 16.2 2.05 Cliniqa L2 30.3 31.2 2.01 Cliniqa L3 66.9 67.9 1.59
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Clinical Studies Precision Study: ASO
Cliniqa and Randox controls for ASO are measured with Nephstar ASO kit on Nephstar ASO Taget(IU/mL) Norms(IU/mL) N Mean CV% Randox L1 120 96-144 10 118 3.21 Randox L2 234 215 2.15 Randox L3 375 361 2.06 Cliniqa L1 90 81-99 94 3.56 Cliniqa L2 236 240 2.22 Cliniqa L3 331 340 2.51
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Clinical Studies Correlation Study: C3
A correlation study was performed on 20 normal and clinical serum samples using Nephstar C3 kit on Nephstar and Beckman C3 kit on Beckman Immage. The study demonstrated a good agreement between the two systems :
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Clinical Studies Correlation Study: CRP
A correlation study was performed on 20 normal and clinical serum samples using Nephstar CRP kit on Nephstar and Behring CRP kit on Behring BN II. The study demonstrated good agreement between the two systems :
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Certification
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Market Positioning for NEPHSTAR
Routine protein analyser in small and medium sized laboratories Emergency protein analyser in larger laboratories e.g. CRP, blood CRP Gold standard test for diabetes glucose monitoring. HbA1c Specific assay system for one off or “stat” tests e.g. microalbumin in Diabetic clinic, ultrasensitive CRP in Cardiovascular clinic
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NEPHSTAR users Opportunities
Replace competitor RID and other manual and time-consuming assay methods Allow smaller labs to do own testing Remove small volume assays from large analysers, NEPHSTAR as second analyser Allow quicker testing for emergency requirements of large laboratories Allow small clinics do own stat and specific testing
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Success in different markets
NEPHSTAR has been successfully placed in many target markets Main analyser in small lab, often replacing RID or other manual techniques Second analyser in larger lab low volume assays emergency testing Analyser in specific laboratories of some areas such as Paediatric, Diabetic, Rheumatoid and Infectious diseases
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Keys to success with NEPHSTAR
Find opportunity where number of tests is high busy small laboratory shared use by several departments Generate most profit by having high kits sales per instrument >100 kits per year HbA1c sales Higher price per test means more profit per kit bCRP sales Market demand is very big due to its simpleness, quickness, high accuracy
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Thank you Joan Huang Goldsite Diagnostics Inc. Tel: Fax: Cell: Skype: joanwong109 website:
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