Wondfo POCT Quantitative Detection Family

GUANGZHOU WONDFO BIOTECH CO., LTD.

NEW POCT SOLUTION

Wondfo POCTQuantitative Detection Family

ENTERPRISEINTRODUCTION

Guangzhou Wondfo Biotech Co., Ltd., located in Guangzhou, China, is a globally recognized fast growing POCT

manufacture and sales of rapid diagnostic reagents and related equipment in IVD (in vitro diagnostic) field.

Founded in 1992, the company is continually expanding its scale. Apart from the Guangzhou headquarters, Wondfo

also owns one overseas lab in San Diego, one branch in Chicago and other eleven overseas offices. Wondfo went

public in June, 2015 (Stock Number: 300482), and has more than 1, 300 employees with 30% of them obtained

postgraduate degrees.

As one of the earliest high-tech biological companies focusing on rapid diagnostics for toxicology, infectious diseases,

fertility, cardiovascular disease, tumor, respiratory disease, renal injury and diabetes, Wondfo has won good reputation

around the world. In addition, Wondfo has got CE certificates, FDA certificates, FSC certificates, ISO 9001:2008 and

ISO 13485:2012 quality system certification.

We are dedicated to making the world a better place by providing people with high quality products and services.

Guangzhou Wondfo Biotech Co., Ltd.

PRODUCTS

POCTFamily

series FIA Meter

CFDA

FinecareTM Ⅱ FIA Meter

FinecareTM Ⅲ FIA Meter

01Wondfo Biotech

FinecareTM Plus FIA Meter

NEW NEW

FinecareTM FIA Meter is a fluorescence immunochromatographic analysing system which can help diagnose conditions such

as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.

The FinecareTM platform provides reliable and quantitative results of various kinds of analytes in human blood or urine

within several minutes.

Test Item

Features

● Fertility

β-HCG

● Infection

PCT, CRP (hsCRP+CRP), 2 in 1 (CRP+PCT), SAA

● Cardiac

NT-proBNP, cTnI, Myo, CK-MB, H-FABP,

3 in 1 (cTnI + Myo + CK-MB),

2 in 1 (cTnI+NT-ProBNP), BNP

● Ongoing

Vitamin-D,

Progesterone,

S100β,

ST2,

Lp-PLA2,

PAPP-A,

LH, FSH

/ Portable

/ Instant result

/ Expansive menu

/ High accuracy

/ Built-in printer

/ Self-calibration

Principle

Specimen

Power adapter

Interface

Information input

Printer

Optical description

Operating temperature

Fluorescent immunochromatography

Whole Blood/ Serum/ Plasma/ Urine

100-240AC, 50-60Hz

RS232, USB, Ethernet (Direct connection to LIS / HIS)

Touch screen, barcode reader

Built-in thermal printer

Excitation light source: LED, 470 nm / Detector: 525nm Photodiode

10℃- 30℃

● Diabetes & Renal Injury

HbA1c, MAU, CysC, NGAL, β2-MG

● Tumor

AFP, PSA, CEA, fPSA

● Coagulation

D-Dimer

● Hormone

T3, T4, TSH

series FIA Meter

02 Wondfo Biotech

NEW

NEW

NEW

NEW

NEW

NEW NEW

03Wondfo Biotech

Mixing

Sampling Dropping

Reading

Detection Zone IQC Zone

Detection Zone IQC Zone

Wicking PadSample Pad

Wicking PadSample Pad

Principle and Operation

Why Choose Finecare™

Unique quick mode

Designed sampler

Information management

High accuracy

Instant result

Room temperature storage

Extra quick operating platform for large number of specimens

Powerful information management(Direct connection to LIS/HIS)

Convenient and fast. Get results in 3-15 minutes

Specially-designed sampler for smallvolume of specimen

Good correlation with wet chemistry method

Solid synthetic craft, can be stored at room temperature (4-30℃)

0. 00 20.00 40.00 60.00 80.00 100.00 120.00

0. 00

20.00

40.00

60.00

80.00

100.00

120.00

Y BRAHMS =0.180+1.006X wondfo

R2 =0.988n =417BR

AHM

S PC

T(ng

/ml)

FinecareTM FIA Meter(PCT ● ng/ml)

04 Wondfo Biotech

Test Item

ProductClass Test Item Diseases

SpecimenType

ReactionTime

LinearRange

ClinicalReference Qualification

Infection

PCT

SAA

SepsisWB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

WB/ Serum/ Plasma

15 min

15 min

0.1-100 ng/mL

1.0-300 mg/L 0-10 mg/L

CE CFDA

CE CFDA

CE CFDA

CE

CE CFDA

CE CFDA

CE CFDA

CE CFDA

CE CFDA

CE CFDA

CE CFDA

CE

CE

CE CFDA

CE CFDA

CE CFDA

CE CFDA

0-0.5 ng/mL

CRP(hsCRP+CRP) Inflammation

Infection & Inflammation

WB/ Serum/ Plasma 15 minInfection

& Inflammation

3 min 0.5-200 mg/L

CRP:0.5-150 mg/LPCT:0.1-100 ng/L

CRP:<10 mg/LPCT:<0.5 ng/L

CRP:0-10 mg/LhsCRP:0-1 mg/L

Coagulation D-Dimer Thrombosis WB/Plasma 5 min 0.1-10 mg/L 0-0.5 mg/L

Cardiac

NT-proBNP Heart Failure

Heart Failure

15 min 18-35000 pg/mL <75y, 0-300 pg/mL≥75y, 0-450 pg/mL

cTnIMyocardialInfarctionMyocardialInfarctionMyocardialInfarctionMyocardialInfarction

MyocardialInfarction

15 min 0.1-50 ng/mL 0-0.3 ng/mL

Myo 15 min 2.0-400 ng/mL 0-58 ng/mL

CK-MB 15 min 0.3-100 ng/mL 0-5 ng/mL

H-FABP 15 min 1-120 ng/mL

5-5000 pg/mL 0-100 pg/mL

0-7 ng/mL

3 in 1(cTnI/ Myo/ CK-MB)

15 minSame withsingle items

Tumor

AFP Liver Cancer Serum 15 min 5-400 ng/mL 0-20 ng/mL

PSA Prostate Cancer Serum 15 min 2-100 ng/mL 0-4 ng/mL

Diabetes&

Renal Injury

HbA1c Diabetes Mellitus WB 5 min 4.0-14.5% 4-6%

MAU Renal Injury Urine 3 min 5-300 mg/L 0-20 mg/L

CysC Renal Injury 5 min 0.2-10 mg/L 0.5-1.1 mg/L

WB/ Serum/ Plasma CE

CENGAL Renal Injury Urine 15 min 10-1500 ng/mL ≤131.7 ng/mL

β2-MG Proximal RenalTubule Dysfunction 10 min 0.3-20 mg/L 1.0-2.7 mg/L

Fertility Fertility 15 min 2-200,000 mIU/mL

CEA Cancer 15 min 1-500 ng/mL 0-5 ng/mL

NGSPIFCC

CE

CEHormone

T3 0.61-9.22 nmol/L

12.87-300 nmol/L

0.1-100 mIU/L

1.3-3.1 nmol/L

66-181 nmol/L

0.3-4.2 mIU/L

T4

TSH

β-hCG 5 mIU/mL

CE

15 min

15 min

15 min

NEW

NEW

NEW

NEW

NEW

NEW

Thyroid Malfunction

Thyroid Malfunction

Thyroid Malfunction

Same withsingle items

WB/ Serum/ Plasma

WB/ Plasma CE

CEMyocardialInfarction

BNP 15 min

2 in 1(cTnI/ NT-proBNP) 15 min



2 in 1(CRP+PCT)

Thyroid gland is the largest gland in the human body. It regulates energy metabolism in cells and organs. The thyroid gland

produces hormones thyroxine (T4) and triiodothyronine (T3), which are vital in regulating the metabolism. Production of

these hormones is stimulated by the thyroid stimulating hormone (TSH), the anterior pituitary gland hormone.

T3, T4, TSH Hormone Disorder Markers

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Parameters of FinecareTM T3, T4, TSH test

Items

Detection principle

Sample type

Sample capacity

Reaction time

Test time

T3, T4, TSH

Fluorescence immunoassay

Whole blood/Serum/Plasma

75 μL for one test

15 minutes for one test

10 seconds for one test

TSH comparision test between Wondfo and Roche

y = 0.9171x - 0.2694R² = 0.9784

N=65

-5

0

5

10

15

20

25

30

35

40

0 10 20 30 40 50

Won

dfo（

mIU

/L）

Roche（mIU/L）

TSH comparision test between Wondfo and Roche has a good clinical correlation.

Recommended Reference

Clinical application

Items

T3

T4

TSH

Detection Range

0.61~9.22 nmol/L

12.87~300 nmol/L

0.1~100 mIU/L

Source of pathology

Hypothalamus/pituitary

Hypothalamus/pituitary

Hyperthyroidism

Hypothyroidism

Disease causing conditions

Benign tumor of the pituitary (adenoma) or thyroid hormone resistance

Secondary hypothyroidism or "central" hypothyroidism

Primary hyperthyroidism i.e. Graves' disease

Congenital hypothyroidism (cretinism), Primary hypothyroidism i.e. Hashimoto's thyroiditis

TSH level

High

Low

Low

High

T3, T4 level

High

Low

High

Low

Normal Range

1.3~3.1 nmol/L

66~181 nmol/L

0.3~4.2 mIU/L

05Wondfo Biotech

NEW

Parameters of Finecare™ CRP test

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

Linear range

Clinical reference

CRP

WB / Serum / Plasma

8.5 μL / 5 μL / 5 μL

3 minutes

10 seconds

0.5-200 mg/L

CRP:0-10 mg/L / hsCRP:0-1mg/L

Compared with CRP results of 417 specimens from

DN-100 Special Protein Analyzer, Wondfo Finecare™ FIA

system has high accuracy in CRP test (R2>0,98).

Performance of CRP Rapid Quantitative Test

y = 1.0035x + 0.7457R2 = 0.9824

0.0

50.0

100.0

150.0

200.0

250.0

0 50 100 150 200 250

DN-100 Special Protein Analyzer

Fine

care

TM F

IA M

eter

The C-reactive protein (CRP) is synthesized by the liver in response to interleukin-6 and is well known as one of the

classical acute-phase reactants. It is used as a marker of inflammation and cardiovascular diseases (CVD).

CRP Infection Markers

Capillary tube for CRP

②①

③ ④

Specially-designed capillary tube for kids and

babies; convenient sampling, useful in

Pediatrics, ER and ICU.

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Finecare™ Test Procedure

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

Linear range

Clinical reference

PCT

WB / Serum / Plasma

75 μL / 50 μL / 50 μL

15 minutes

10 seconds

0.1-100 ng/mL

0-0.5 ng/mL

PCT（Procalcitonin）is a peptide precursor of the hormone calcitonin. Measurement of PCT can be used as a authoritative

marker for diagnosis and stratification of sepsis.

Parameters of Finecare™ PCT test

PCT Infection Markers

Compared with PCT results of 417 specimen from

B.R.A.H.M.S PCT LIA, Wondfo Finecare™ FIA

system has high accuracy in PCT test (R2>0.98).

Performance of Finecare™ PCT Rapid Quantitative Test

0. 00 20.00 40.00 60.00 80.00 100.00 120.00

0. 00

20.00

40.00

60.00

80.00

100.00

120.00

B.R.

A.H

.M.S

P

CT L

IA

Wondfo FinecareTM PCT

Y BRAHMS =0.180+1.006X wondfo

R2 =0.988n =417

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MixingSampling Dropping Reading

08 Wondfo Biotech

Diabetes and Diabetic Nephropathy (DN) are urgent and growing problems of the world, and that causes high and

escalating costs to the society.

HbA1c/MAU/CysC Diabetes and Renal Injury Markers

IDF chairman--- Professor Jean Claude Manbaya said: "Diabetes caused 5.1 million deaths in 2013. Every six seconds a person dies from diabetes".

Diabetes and Renal Injury Markers

Parameters of Finecare™ Diabetes and Renal Injury Tests

In 2014, an estimated 387 million people have diabetes worldwide. From 2012 to 2014, diabetes is estimated to have resulted in 1.5 to 4.9 million deaths

each year. WHO projects that diabetes will be the 7th leading cause of death by 2030.

HbA1c : HbA1c is the product of the hemoglobin combining with blood glucose in red blood cells, which can reflect the average blood glucose level over the

preceding 2-3 months.

MAU (Microalbumin) : It occurs when the kidney leaks small amounts of albumin into the urine, which is an early markers of kidney damage.

CysC : CysC is the inhibitor of cysteine proteinases, and the level of CysC indicates the stage of kidney diseases.

Test item Diseases Specimen type Specimen capacity Reaction time Linear range Clinical reference

HbA1c Diabetes Mellitus 4.0-14.5% WB 10 μL 5 min 4-6%

CysC Renal Injury WB/Serum/Plasma 5 min 0.5-1.1 mg/L0.2-10 mg/L

MAU Renal Injury Urine 3 min 0-20 mg/L5-300 mg/L

People livingwith diabetes

in 2035

WORLD

387M

WORLD

AFR 109.1%

MENA 96.2%

SEA 70.6%

SACA 59.8%

WP 46%

NAC 37.3%

EUR 22.4%

2014 2035

592M

incr

ease

55%

10 μL/10 μL/10 μL

75 μL

09Wondfo Biotech

Performance of Finecare™ Diabetes and Renal Injury Tests


Mixing

Sampling Dropping

Reading

Specially-designed capillary tube for HbA1c

① ②

③ ④

0 5 10 15 20

20.0

15.0

10.0

5.0

0.0

Wondfo

Bio

-Rad

D10

y=0.9888x+0.1215R2=0.9702

n=183

HbA1c Cutoff value: ＜6.5%

Specimen : Whole blood 10 μLReaction time: 5 min

Comparison between Wondfo One step HbA1c quantitative test kit and Bio-Rad HbA1c. The clinical correlation result (R2=0.9702) meetsthe clinical requirement.

MAU Cutoff value: < 20mg/L

Specimen : Urine 75 μLReaction time: 3 min

Comparison between Wondfo-MAU Quantitative Test Kit and QuikRead-MAU.The clinical correlation result (R2=0.9774) meetsthe clinical requirement.

0 1 2 3 4 5 6 7 8 9 10

109876543210

Randox(mg/L)

Won

dfo(

mg/

L)

y=0.9756x+0.0727R2=0.9691

CysC

Specimen: Whole blood/Serum/Plasma 10 μLReaction time: 5 min

Comparison between Wondfo CysC Quantitative TestKit and Randox CysC (Immunoturbidimetry assay, trace back IFCC). The clinical correlation result (R2=0.9691) meets the clinical requirement.

0 100 200 300 400

350300250200150100500

Orion QuikRead (mg/L)

y=0.975x+0.154R2=0.9774

Won

dfo

(mg/

L)

Level of renal injury

Mild renal injury

Moderate renal injury

Serious renal injury

Uremia

CysC Value (mg/L)

0.95<CysC<1.2

1.2<CysC<1.95

1.95<CysC<3.2

CysC>3.2

Performance comparison: Wondfo vs Bio-Rad, Orion and Randox

10 Wondfo Biotech

Cardiac markers are used in the diagnosis and risk stratification of patients with chest pain, suspected Acute Coronary

Syndrome (ACS) and Heart Failure (HF).

cTnI/H-FABP/NT-proBNP/CK-MB/Myo/3 in 1/2 in 1/BNP

Parameters of Finecare™ Cardiac Markers

Test items Specimen types Specimencapacity

Reactiontime

NT-proBNP

cTnI

CK-MB

Myo

H-FABP

BNP

Whole range CRP

3 in 1 (cTnI/CK-MB/Myo)

2 in 1 (cTnI/NT-proBNP)

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Serum/Plasma

WB/Plasma

15 min

15 min

15 min

15 min

15 min

3 min

15 min

15 min

15 min

75 μL/75 μL/75 μL

75 μL/75 μL/75 μL

75 μL/75 μL/75 μL

75 μL/75 μL/75 μL

75 μL/75 μL/75 μL

8.5 μL/5 μL/5 μL

75 μL/75 μL/75 μL

75 μL/75 μL/75 μL

75 μL/75 μL

Linear range

18-35000 pg/mL

5-5000 pg/mL 0-100 pg/mL

0.1-50 ng/mL

0.3-100 ng/mL

2.0-400 ng/mL

1-120 ng/mL

0.5-200 mg/L

Cardiac Markers

Clinical significance

＜75 years old: ＞300 ng/L, ≥75 years old: ＞450 ng/L: Indicating risk of congestive heart failure

>0.3 ng/mL:High risk of MI

>5 ng/mL:High risk of MI

>58 ng/mL:High risk of MI

≥7 ng/mL: High risk of MI, combined with other clinical data

hsCRP<1mg/L：Low CVD riskhsCRP 1.0～3.0 mg/L：Moderate CVD risk hsCRP＞3.0 mg/L：High CVD riskCRP＞10 mg/L：Infection or inflammation

cTnI<0.3 ng/mL & CK-MB<5 ng/mL & Myo<58 ng/mL: initial exclusion of MI

● Cardiology Dept., EU, ICU, CCU and Operating Room

● Others: Laboratory, Respiratory Medicine, Cardiothoracic Surgery, Geriatric Hospital

Applications

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Same withsingle items Same with single items

11Wondfo Biotech

Performance of Finecare™ Cardiac Markers Rapid Quantitative Test

Performance comparison between Finecare™ FIA Rapid Quantitative Test system and Roche shows FinecareTM has high accuracy (R2>0.98), which can satisfy the clinical requirement.


Mixing

Sampling Dropping

Reading

0 25.0 50.0 75.0 100.0

100.0

75.0

50.0

25.0

0.0

Wondfo (CK-MB)

Roc

he

y=0.9888x+0.1215R2=0.9802

n=483

For cardiac markers testing, time means life

● Early diagnosis of AMI

● Risk assessment, stratification and prognosis of ACS

● Estimation of Myocardial Infarct Size

● Early judgment of ACS

● Therapeutic decision-making of ACS

Signification of Combined Diagnosis

Con

cent

ratio

n

The markers concentration after AMI (h)0 10 20 30 40 50 60

cTnI

CK-MBMYO

h-FABP

Normal level

Diagnosis suggestion of myocardial injury markers

＜2h H-FABP+Myo

2-6h H-FABP+Myo+cTnI+CK-MB

4-8h cTnI+CK-MB

＞8h cTnI

12 Wondfo Biotech

Parameters of Finecare™ D-Dimer test

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

D-Dimer

Whole blood / Plasma

15 μL / 10 μL

5 minutes

10 seconds

D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. It is

useful in the diagnostic evaluation of thrombotic diseases.

D-Dimer

Performance of D-Dimer

0 2 4 6 8 10 12

12

10

8

6

4

2

0

y=0.9844x+0.005R2=0.9507

Siemens (mg/L)

Won

dfo

(mg/

L)

Comparison test of D-Dimer whole blood specimen between Wondfo and Siemens

Compared with 365 test results of D-Dimer specimens conducted by Siemens, Wondfo Finecare™, shows good correlation. (R2 = 0.9507)

Coagulation Markers

Clinical significance: Efficiency of clinical diagnosis, treatment and diagnosis pathway can be optimized based on the following 3 aspects: D-Dimer screening

during clinical early phase (disease with symptoms of dizziness, chest pain and dyspnea, MI, pulmonary embolism, cerebral infarction, etc.), treatment

evaluation (MI, cerebral infarction, etc.), monitoring and prognosis of chronic diseases (Tumor).

Clinical Application

Pathway 1

Pathway 2

DizzinessChest painDyspnea

DizzinessChest painDyspnea

Tumor prognosis, management of life quality

Differentiating tumor stage

D-Dimer≥0.5mg/LPulmonary embolismCerebral infarction MI

Appropriate dosage: D-Dimer level increase then decrease until normal.

Inappropriate dosage: D-Dimerlevel increases then remains still or slowly decreases.

D-Dimer＜0.5mg/L

Confirm

Scree

ning

Screening

Thrombolysis

Other tests(PCT/CRP)

Negative

Routine Monitoring Routine Monitoring

13Wondfo Biotech

Parameters of Finecare™ β-HCG test

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

Linear range

Clinical reference

β-HCG

Whole blood / Serum / Plasma

20 μL / 20 μL / 20 μL

15 minutes

10 seconds

2-200,000 mIU/mL

5 mIU/mL

Human chorionic gonadotropin (HCG) is a kind of hormone, produced by the developing placenta shortly

after conception. It’s made up of α-and β-glycoprotein dimers, and its β subunit is used for early detection

of pregnancy.

FinecareTM β-HCG Rapid Quantitative Test can detect tiny amounts of this hormone in blood.

Fertilityβ-HCG

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Performance Evaluation of β-HCG quantitative test

00

20000

20000

40000

40000

60000

60000

80000

80000

100000

100000

120000

120000

140000

140000

160000

y=1.0552x + 1138R2 = 0.9872

Abbott VS Wondfo

160000

Wondfo HCG measured value (mIU/mL)

Abbo

tt H

CG m

easu

red

valu

e (m

IU/m

L)

ApplicationHCG level trend in pregnancy under different conditions

2 4 6 8 10 12 14 16 18 20

106

105

104

103

102

10

0

HC

G le

vel (

mlU

/mL)

Gestational week

EctopicPregnancy

Miscarriage

Normalpregnancy

Trophoblastdisease

HCG level in pregnancyHCG clinical value

Early diagnosis for pregnancy

Early diagnosis for ectopic pregnancy

Efficacy evaluation for conservative treatment of ectopic pregnancy

Auxiliary diagnosis for miscarriage

Auxiliary diagnosis and efficacy evaluation for gestational trophoblastic

diseases

14 Wondfo Biotech

AFP

Compared with 629 test results of AFP specimens conducted by Roche, Wondfo Finecare™ FIA System has high accuracy in AFP test. Correlation(R2 =0.9945) can satisfy the clinical requirement.

Comparison of AFP tests between Wondfo and Roche

0 50 100 150 200 250 300 350 400 450

450400350300250200150100500

y=1.0004x+1.8538R2=0.9945

Roche-AFP

Won

dfo-

AFP

AFP (Alpha-fetoprotein) is a major plasma protein produced by yolk sac and liver during fetal development. It is

widely used to detect a subset of tumors in non-pregnant women, men and children.

Parameters of Finecare™ AFP test

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

AFP

Serum

75 μL

15 minutes

10 seconds

Tumor Markers

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Parameters of Finecare™ PSA test

Detection object

Specimen type

Specimen capacity

Reaction time

Test time

PSA

Serum

75 μL

15 minutes

10 seconds

PSA (Prostate Specific Antigen) is a protein produced by cells of prostate gland, which is a biomarker for screening

prostate cancer. It is also widely used for monitoring the recurred prostate cancer after initial treatment.

Compared with 829 test results of PSA specimens conducted by Roche, Wondfo Finecare™ FIA System has high accuracy in PSA test. Correlation (R2 =0.994) can satisfy the clinical requirement.

PSA

0 20 40 60 80 100 120

120

100

80

60

40

20

0

y=0.9997x+0.2523R2=0.994

Roche-PSA

Won

dfo-

PS

A

Comparison of PSA tests between Wondfo and Roche

Advanced methodology

Simple operation

High accuracy

Authorized certification

Immunofluorescence technology

4 steps ( sampling, mixing, dropping, reading )

IQC/EQC double quality control

CE

Wondfo Finecare™ provides you with fast,

convenient, accurate, and reliable tumor

markers quantitative rapid test as well as

powerful information management.

Tumor Markers

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Wondfo Controls are intended as an assayed quality control to monitor the precision of laboratory testing

procedures for the analytes listed in the following table.

Controls

Cat. No. Test Item Level Specification Shelf Life QualificationStorage TemperatureProduct Class

W806-L/W806-M/W806-H

W805-L/W805-N/W805-H

W818-L/W818-M/W818-H

W810-L/W810-N/W810-H

W809-L/W809-N/W809-H

W808-L/W808-N/W808-H

W817-L/W817-M/W817-H

W811-L/W811-N/W811-H

W807-L/W807-N/W807-H

W815-L/W815-M/W815-H

W814-L/W814-M/W814-H

W813-L/W813-N/W813-H

W816-L/W816-M/W816-H

W819-L/W819-M/W819-H

W812-L/W812-N/W812-H

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

0.5ml×1

12 months

12 months

12 months

18 months

12 months

12 months

12 months

12 months

12 months

8 months

12 months

18 months

12 months

12 months

12 months

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

2～8℃

Level1, Level2, Level3















CRP

PCT

CRP-PCT

CK-MB

Myo

cTnI

cTnI/CK-MB/Myo

H-FABP

NT-proBNP

AFP

PSA

MAU

CysC

β-hCG

D-Dimer

Infection

Cardiac

Tumor

Fertility

Coagulation

● Ongoing: T3, T4, TSH

Diabetes &

Renal Injury

Contents:1. Control (lyophilized): 0.5mL× 12.Leaflet with instruction for use

For in vitro diagnostic use only. For professional use only.

TM

Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City,

Luogang District, Guangzhou,

Guangdong, P.R. China 510663

Tel: 0086-20-3229-6083

Fax: 0086-20-3229-6063

Email: [email protected]

http://www.wondfo.com.cn

1 Vial

TM

Glucose Meter

Test sample

Test time

Sample volume

Hematocrit range

Storage temperature

Operating temperature

Operating relative humidity

Memory capacity

Power supply

Battery life

Dimension and weight

Capillary Whole Blood

about 10 sec

0.8 μl

30 – 50%

-20℃~55℃

6℃ - 44℃

<85%

400 most recent results

3-Volt lithium battery (CR-2032)

Approximately 1000 tests

90×58×19mm; 50g

The Extracare series blood glucose monitoring system is designed to measure the blood glucose levels in fresh

fingertip blood. The system is suitable for diabetics to monitor their blood glucose level at home by themselves

and also can be used at clinical sites by healthcare professionals.

Customized Glucose Monitoring System is also available.Customized Glucose Monitoring System is also available.

Extracare Series Blood Glucose Monitoring SystemExtracare Series Blood Glucose Monitoring System

1x Meter+

10x Strips1x Meter

under room temperature.

Authorized Distributor:

Manufactured for：

Wondfo USA Co., Ltd

825 W 75th St,

Unit B Willowbrook

IL 60527

Qarad b.v.b.a.

Volmolenheide 13

B-2400 Mol, Belgium

E C REP

Storage:

Store the meter, control solution, test strips

Operation Temperature:10-40℃

Please read user's manual carefully before testing.

This product is suitable for self-testing.

USA Technology

200 Memories200

Fast Test

Less Blood Sample

Automatic Temperature Adjust

Blood GlucoseMonitoring SystemBlood GlucoseMonitoring System

Blood GlucoseMonitoring SystemBlood GlucoseMonitoring System Blood GlucoseMonitoring System



Manufactured for：

Wondfo USA Co., Ltd

825 W 75th St,

Unit B Willowbrook

IL 60527

Qarad b.v.b.a.

Volmolenheide 13

B-2400 Mol, Belgium

E C REP

Storage:






USA Technology

100 Memories100

Fast Test

Less Blood Sample


1x Meter+

25x Strips


USA Technology

400 Memories400

Fast Test

Less Blood Sample




Manufactured for：

Wondfo USA Co., Ltd

825 W 75th St,

Unit B Willowbrook

IL 60527

Qarad b.v.b.a.

Volmolenheide 13

B-2400 Mol, Belgium

E C REP

Storage:






17Wondfo Biotech

1 Overseas Lab

1 Branch

12 Overseas Offices

OUR VISIONProvide professional product and service of rapid diagnosis and chronic disease management; pursue

better and convenient user experience; promote high-standard life and health quality; fulfill shared dream

of our staff, customers and partners.

Guangzhou

Chicago Branch

Jakarta Manila

Belo Horizonte

Delhi

San Diego Lab

Nairobi

Abuja

Cape Town

Istanbul

Moscow

BucharestFrankfurt

London

Guangzhou Wondfo Biotech Co., Ltd.Add: No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. ChinaTel: +86-20-32296083 Fax: +86-20-32296063E-mail: [email protected] Websites: www.wondfo.com.cn

Version 20160627

Documents

Wondfo POCT Quantitative Detection Family