1. Goldsite Diagnostics Inc.
Specialist of Specific Protein Analysis
Goldsite Diagnostics Inc.
2015

3. 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.

4. Company Pictures

5. Introduction to NEPHSTAR
Instrument
Principle
Assays
Manipulation
Technology
Clinical studies
Market Positioning
Sales Analysis

6. 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

7. 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

8. 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.

9. 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

10. 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

11. 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

12. 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

13. 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)

14. Technology Fixed-time Immunonephelometry
Precipitation
Linear range
Antigen
Heidelberger Curve

15. 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.

16. 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

17. 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

18. 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

19. 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

20. 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.

21. 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

22. 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

23. 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

24. 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

25. 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 :

26. 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 :

27. Certification

28. 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

29. 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

30. 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

31. 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

32. Thank you
Joan Huang Goldsite Diagnostics Inc. Tel: Fax: Cell: Skype: joanwong109 website: