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CHINA
Daan Gene Co., Ltd. Of Sun Yat-Sen University
19 Xiangshan Road, Science Park, High & New Technology
Development District, Guangzhou, GuangDong, P. R. China, 510665
Tel: +86 20 32290789
Fax: +86 20 32068352
Marketing Email: marketing@daangene.com
Sales Email: orders@daangene.com
Website: http://en.daangene.com

CANADA
Daan Diagnostics Ltd.
#200- 5050 Kingsway, Burnaby, B.C., Canada, V5H 4H2
Tel: 604.451.7588
Fax: 604.451.7587
Email: orders@daangene.com
Website: http://www.daandiagnostics.com

ELISA

EB

EB and Nasopharyngeal Carcinoma

ELISA Kits
Features
Product applicability is flexible. The equipment requirement is simple and could be manual. It could be
carried out in basic medical institutions.
The unique core technology is adopted in product preparation and beyond the diagnosis efficiency of
general enzyme reagent.
The product has strong operation controllability.

Advantages
The sensitive degree is high and fast with strong specificity
Sample pretreatment is relatively simple
Lower degree of instrumentation is needed.
It's suitable for site monitoring and a large number of samples screening

Epidemiology, serology, and molecular biology data verified that

there is a close relationship between EBV infection and NPCS.
It is verified that there is DNA of EB virus in the cancer cells of
nasopharyngeal carcinoma patients , by in situ hybridization,
most cancer cells present to be positive by small RNA (EBERs)
in nuclear of cell, positive by nuclear antigens (EBNA 1).
There is EB virus in tumor cells of patients with nasopharyngeal
carcinoma (NPC), a set of EB virus antibody, the level of EBV
antibody of the serum rise generally, it can distinguish between
NPC and healthy carriers. (Werner Henle et al., 1976)
The EBV to be classed as the first kind of carcinogen by the world health organization (WHO)
international cancer alliance in 1997.

Clinical Performance Evaluation of EBNA1 IgA Kits

Sensitivity
The sensitivity studies of HCV have been made on a panel of 738 positive samples. DAAN HCV has
presented a 99.8% sensitivity on true HCV positive panels.

Specificity
The specificity of HCV has been determinated on blood donors samples (2318 samples tested)
and on hospitalized patients (348 samples tested). The specificity calculated is 98.9% and
98.5% respectively.

Precision
Assay reproducibility of HCV was determined by assaying 3 specimens in replicates of 10 on 2 consecutive runs using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the
coefficient of variation (%CV) were calculated. The mean signal to cut-off ratio (S/CO) is defined as the
Mean Sample Absorbance divided by the calculated Cut-Off value.
Intra-assay Precision

Inter-assay Precision

Hospital

NPC sample (n)

300

61

90

270

Non NPC sample (n)

Sensitivity

200

85

80

200

92%

91%

93%

93%

Specificity

93%

94%

94%

93%

The Process Parameters of EB Virus Antibody Diagnostic Kits

Parameters

VCA IgA01 (DAAN)

Na1 IgA (DAAN)

Sample dilution ratio

Change colour

1:20
yes

1:20
yes

1:100
yes

Incubation time

75 min

75 min

75 min

37C

37C

18-24C

rCut-off

rCut-off

rOD

>90%

88%

Sample

S/CO

S.D.

%CV

S/CO

S.D.

%CV

9.332

0.149

8.0

9.853

0.150

7.6

Incubation condition

8.1

Result

9.1

Specificity and sensitivity

2
3

5.362
2.531

0.088
0.044

8.2
8.6

5.107
2.602

Intra-assay Precision

0.083
0.047

85%

Inter-assay Precision

Control

Mean

S.D.

%CV

Mean

S.D.

%CV

PC

1.907

0.120

6.3

1.872

0.107

5.7

NC

0.009

0.005

0.011

0.006

CA IgA (Abroad)

ELISA

TRFIA

Time-resolved Fluorescence Immunoassay

ELISA Products

Principle
Hepatitis Virus
DA-E-HV 001

Hepatitis A Virus (HAV) IgM

96

DA-E-HV 002

Hepatitis A Virus (HAV) IgM Ab

96

DA-E-HV 003

Hepatitis B Virus Surface Antigen (HBsAg)

96

CFDA

DA-E-HV 004

Hepatitis B e-Antigen (HBeAg)

96

CFDA

DA-E-HV 005

Hepatitis B Surface Antibody (Anti-HBs)

96

CFDA

DA-E-HV 006

Hepatitis B Core Antibody (Anti-HBc)

96

CFDA

DA-E-HV 007

Hepatitis B e-Antibody (Anti-HBe)

96

CFDA

DA-E-HV 008

Hepatitis C Virus (HCV) IgG

96

DA-E-HV 009

Hepatitis C Virus (HCV)

96

DA-E-HV 010
DA-E-HV 011

Hepatitis D Virus (HDV) Antigen

Hepatitis D Virus (HDV) IgG

96

DA-E-HV 012

Hepatitis D Virus (HDV) IgM

96

DA-E-HV 013

Hepatitis E Virus (HEV) IgG

96

DA-E-HV 014

Hepatitis E Virus (HEV) IgM

96

DA-E-HV 015

Hepatitis G Virus (HGV) IgG

96

Eu atom has long-lived fluorescence. When exciting

light emitting laser, it can produce large stokes shift.
Dissociative enhancement technique make the
fluorescent signal improve one million times. So the
fluorescent specificity is strong.

96

Infectious Diseases
DA-E-ID 001

Human Immunodeficiency Virus Types 1 and 2 (Anti-HIV-1+2) 96

DA-E-ID 002

Human Immunodeficiency Virus (double antigen sandwich)

96

DA-E-ID 003

Epstein-Barr Virus-Nuclear Antigen-1 (EBV-NA1) IgA

96

CFDA

DA-E-ID 004

Epstein-Barr Virus (EBV) Zta IgA

96

CFDA

DA-E-ID 005

Epstein-Barr Virus (EBV) Zta IgG

96

DA-E-ID 006

Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgA

96

CFDA
CFDA

DA-E-ID 007

Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM

96

CFDA

DA-E-ID 008

EB.-NA1-lgA

96

CFDA

DA-E-ID 009

Treponema Pallidum / Syphilis (Anti-TP)

96

CFDA

DA-E-ID 0010

Dengue IgG

96

DA-E-ID 0011

Dengue IgG Ab

96

DA-E-ID 0012

Dengue IgM

96

DA-E-ID 0013

Dengue IgM Ab
Tumor Markers

96

DA-E-TM 001

Alpha-fetoprotein (AFP)

96

CE

DA-E-TM 002

Carcinoembryonic Antigen (CEA)

96

CE

Work flow(It is very similar with ELISA)

Adding sample
and analysis buffer

Data reading

Incubation

Detection

Washing

Others
DA-E-OT 001

Glucose-6-phosphate Dehydrogenase (G6PD)

32

DA-E-OT 002

One-stage Polybrene Test Kit for Cross-match (OSPT)

500

DA-E-OT 003

Three-stage Polybrene Test kit for Cross-match (TSPT)

500

Washing

Adding inhancement
solution

TRFIA

TRFIA

Time-resolved Fluoro-immunoassay Diagnostic Kits

Advantages

Long-lived fluorescence
Lanthanide chelates : 600-900s, Eu: 714s
Protein fluorescence:1-10s, fluorescence be quenched
Large stokes shifts, about 290nm
Eu: excitation light 340nm, emitting light 613nm
Ordinary fluorescein stokes shift is only 28nm
Fluorescent specificity is strong
Emission band is very narrow, about 6155nm
Dissociative enhancement technique makes the fluorescent signal improve one million times

Methodology Comparison
Compare this kit with G6PD kit of another time-resolved fluoro- immunoassay company, their correlation
is as following y = 0.807x + 0.444;r = 0.960 (n = 1066)

DR-6608 Main Parameters

Time-resolved fluorescence immunoassay method compare with one widely

-used chemiluminescence immunoassay
y = 1 .6509x - 34 .986
2
R = 0.9863

DAAN
-CEA
data comparison
AFP

3500. 00
3000. 00
2500. 00
2000. 00
1500. 00
1000. 00
500. 00
0. 00
0.000
-500. 00

500.000

10 00.000

CEA
DAAN
-CEA
data comparison

150 0.000

200 0.000

2500 .000

y = 1.0966x - 5.7415
2
R = 0.997

1200
1000
800
600
400
200
0
-200

200

400

600

800

1000

1200

TRFIA

TRFIA

TRFIA Products
Semi-auto
NO.

TRFIA Products

Full-auto
NO.

Semi-auto
NO.

Hepatitis Virus ( Quantitative detection of infectious disease )

Full-auto
NO.

Diabetes Test ( Quantitative detection )

DR-ID-A001

DR-ID-B001

HbsAg (Hepatitis B Virus Surface Antigen)

1*96

CFDA

DR-IC-A001

DR-IC-B001

DR-ID-A002

DR-ID-B002

HbsAb (Hepatitis B Surface Antibody)

1*96

CFDA

DR-IC-A002

DR-IC-B002

DR-ID-A003

DR-ID-B003

HbeAg (Hepatitis B e-Antigen)

1*96

CFDA

Prenatal Screening (Quantitative detection )

DR-ID-A004

DR-ID-B004

HbeAb (Hepatitis B e-Antibody)

1*96

CFDA

DR-PS-A001

DR-PS-A001

DR-ID-A005

DR-ID-B005

HbcAb (Hepatitis B Core Antibody)

1*96

CFDA

DR-PS-A002

DR-ID-A006

DR-ID-B006

HIV (Human Immunodeficiency Virus)

1*96

CFDA

Thyroid Screening (Quantitative detection of thyroid function )

Insulin

1*96

CFDA

C-Peptide

1*96

CFDA

hAFP (Prenatal Screening Alpha-Fetoprotein)

1*96

CFDA

DR-PS-A002

Free --hCG (Free --Human Chorionic Gonadotropin)

1*96

CFDA

DR-PS-A003

DR-PS-A003

FE3 (Free Estriol)

1*96

CFDA

DR-PS-A004

DR-PS-A004

PAPPA (Pregnancy Associated Plasma Protein-A)

1*96

CFDA
CFDA

T3 (Triiodothyronine)

1*96

CFDA

DR-PS-A005

DR-PS-A005

21 Trisome (21 Trisome and Sex Chromosome Polyploid)

1*50

DR-TR-B002

FT3 (Free Thyroid)

1*96

CFDA

DR-PS-A006

DR-PS-A006

FISH Prenatal (Prenatal Chromosome number detection 5)

1*5

CFDA

DR-TR-A003

DR-TR-B003

T4 (Thyroxine)

1*96

CFDA

DR-PS-A007

1*10

CFDA

DR-TR-A004

DR-TR-B004

FT4 (Free Thyroxine)

1*96

CFDA

CFDA

DR-TR-A005 DR-TR-B005 hTSH (Human Thyroid Stimulating Hormone)

Tumor Test ( Quantitative detection of tumor markers)

1*96

CFDA

DR-PS-A008 DR-PS-A008 FISH Prenatal (Prenatal Chromosome number detection 15) 1*20
Neonatal Screening ( Quantitative detection )
DR-NS-A001

DR-NS-B001

Neo-TSH (Thyroid Stimulating Hormone)

1*480

CE CFDA

DR-CM-A001

DR-CM-B001

AFP (Alpha-Fetoprotein)

1*96

CE CFDA

DR-NS-A002

DR-NS-B002

Neo-PKU (Phenyletonuria)

1*480

CFDA

DR-CM-A002

DR-CM-B002

CEA (Carcinoembryonic Antigen)

1*96

CE CFDA

DR-NS-A003

DR-NS-B003

CE CFDA

CA125 (Cancer Antigen 125)

1*96

CFDA

Neo-G6PD (Glucose-6-phosphate Dehydrogenase) 1*480

Quantitative detection of parasite

DR-TR-A001

DR-TR-B001

DR-TR-A002

DR-PS-A007

FISH Prenatal (Prenatal Chromosome number detection 10)

DR-CM-A003

DR-CM-B003

DR-CM-A004

DR-CM-B004

CA19-9 (Cancer Antigen 19-9)

1*96

CE CFDA

DR-PA-A001

DR-PA-B001

Liver Fluke (Enzyme-linked assay)

1*96

CFDA

DR-CM-A005

DR-CM-B005

NSE (Neuron-Specific Enolase

1*96

CFDA

DR-PA-A002

DR-PA-B002

Blood Fluke (Enzyme-linked assay)

1*96

CFDA

DR-CM-A006

DR-CM-B006

CA153 (Cancer Antigen 153)

1*96

CE CFDA

DR-PA-A003

DR-PA-B003

Plasmodium Falciparum (Gold-labelled detection)

1*96

DR-CM-A007

DR-CM-B007

CA50 (Cancer Antigen 50)

1*96

CFDA

DR-PA-B004

Plasmodium Falciparum/Vivax (Gold-labelled detection)

DR-CM-A008

DR-CM-B008

CA242 (Cancer Antigen 242)

1*96

CFDA

DR-PA-A004
Others

DR-CM-A009

DR-CM-B009

tPSA (Total Prostate Specific Antigen)

1*96

CFDA

DR-OT-A001

DR-OT-B001

Ferritin

1*96

CFDA

DR-CM-A010

DR-CM-B010

fPSA (Free Prostatic Specific Antigen)

1*96

CFDA

DR-OT-A002

DR-OT-B002

Pepsinogen I

1*96

CFDA

DR-CM-A011

DR-CM-B011

2-MG (Beta-2-microglobulin)

1*96

CFDA

DR-OT-A003

DR-OT-B003

Pepsinogen II

1*96

CFDA

DR-CM-A012 DR-CM-B012 Cyfra-211 (Cytokeratin Fragment-211)

Hormone Test ( Quantitative detection - Hormone test )

1*96

CFDA

Instrumentations and Consumables

DR-HO-A001

DR-HO-B001

hCG (Human Chorionic Gonadotropin)

1*96

DR-HO-A002

DR-HO-B002

DR-HO-A003

DR-HO-B003

DR-HO-A004

DR-CO-001

903 Imported filter paper (For screening and blood collection)

1000

CFDA

DR-CO-002

1000 ul reagent plus sample probe

960

-hCG (-Human Chorionic Gonadotropin) 1*96

CFDA

DR-CO-003

1001 ul reagent plus sample probe

500

LH (Luteinizing Hormone)

1*96

CFDA

DR-CO-004

Wash Concentrate

8*250ml

DR-HO-B004

FSH (Follicle Stimulating Hormone)

1*96

CFDA

DR-CO-005

Enhancement Solution

8*250ml

DR-HO-A005

DR-HO-B005

PRL (Prolactin)

1*96

CFDA

DR-CO-006

6606 system

1Set

DR-HO-A006

DR-HO-B006

hGH (Human Growth Hormone)

1*96

CFDA

DR-CO-007

6608 system

1Set
1Set

DR-HO-A007

DR-HO-B007

Testosterone

1*96

CFDA

DR-CO-008

6609 system

DR-HO-A008

DR-HO-B008

Progesterone

1*96

CFDA

DR-CO-009

6610 Pre-processing system

1Set

DR-HO-A010

DR-HO-B010

E2 (Estradiol)

1*96

CFDA

DR-CO-010

6611 Pre-processing system

1Set

DR-HO-A012

DR-HO-B012

SHBG (Sex Hormone Binding Globulin)

1*96

CFDA

DR-CO-011

6620 Pre-processing system

1Set

CFDA
CFDA