Specialist of Specific Protein Analysis

Goldsite Diagnostics Inc.

2015
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
1999.

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.
Company Pictures
 Introduction to NEPHSTAR

– Instrument
– Principle
– Assays
– Manipulation
 Technology
 Clinical studies
 Market Positioning
 Sales Analysis
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
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
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.
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
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
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
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

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)
Technology

Fixed-time Immunonephelometry
Precipitation

Linear
range

Antigen
Heidelberger Curve
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.
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
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
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
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
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.
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 5.76-7.24 10 6.34 2.21
Randox L2 13.3 11.3-15.3 10 13.66 1.2
Randox L3 19.6 16.7-22.5 10 20.01 2.41
Cliniqa L1 6.72 6.048-7.392 10 6.65 2.82
Cliniqa L2 12.6 11.34-13.86 10 12.5 2.08
Cliniqa L3 18.5 16.65-20.35 10 18.72 3.19
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 0.752-0.912 10 0.81 2.53
Randox L2 1.68 1.43-1.93 10 1.65 1.22
Randox L3 2.49 2.12-2.86 10 2.56 1.13
Cliniqa L1 0.703 0.633-0.773 10 0.68 2.23
Cliniqa L2 1.51 1.36-1.66 10 1.53 2.01
Cliniqa L3 2.24 2.02-2.46 10 2.29 1.85
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 19.9-28.7 10 23.5 1.15

Randox L2 53.1 45.1-61.1 10 52.9 1.85
Randox L3 77.4 65.8-89 10 73.9 2.18
Cliniqa L1 15 13.5-16.5 10 16.2 2.05
Cliniqa L2 30.3 27.27-33.33 10 31.2 2.01
Cliniqa L3 66.9 60.21-73.59 10 67.9 1.59
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 234 187-281 10 215 2.15
Randox L3 375 300-450 10 361 2.06
Cliniqa L1 90 81-99 10 94 3.56
Cliniqa L2 236 212.4-259.6 10 240 2.22
Cliniqa L3 331 297.9-364.1 10 340 2.51
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 : B
Correlation: Beckman Immage / Nephstar
Nephstar(Y)

2.4
2.2
Complement 3 (g/L)
y=0.995x+0.012 r=0.976
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4

0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4
Beckman Immage (X)
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 :
B
Nephstar CRP

200
Correlation BN II (X) / Nephstar (Y)
CRP (mg/L)
y=0.967x+0.394 with r=0.989
150

100

50

0
0 50 100 150 200
BN II CRP
Certification
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
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
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
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
Thank you

Joan Huang
Goldsite Diagnostics Inc.
Tel:0086-755-26890807
Fax: 0086-755-26890799
Cell:0086-18926012882
Skype: joanwong109
website: www.goldsite.com.cn
Email: export@goldsite.com.cn