RACING     

2024
                       

Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Huangpu District,
510700, Guangzhou, P.R. China
Tel: (+86) 400-830-8768
E-mail: sales@wondfo.com.cn © 2024 Guangzhou Wondfo Biotech Co., Ltd.
Website: en.wondfo.com All rights reserved Rev. A1 Rel.: 2024/04/15
 Stock Code: 300482.SZ

WONDFO
PROFILE
Founded in 1992, headquartered in Guangzhou science city,
Wondfo focuses on the R&D, manufacturing, sales and
service of POCT (Point-of-care testing) industry, providing
professional rapid diagnosis and chronic disease management
solutions.

Wondfo has 9 technology platforms. Our rapid diagnostic

devices and reagents cover a wide range, including cardiovascular
diseases, diabetes, renal functions, respiratory, fertility, DOA,
infections, tumor etc. Our products have been distributed to
over 150 countries and regions.

In 2015, Wondfo was listed on Shenzhen Stock Exchange,

becoming the first public POCT company in China.

5
R&D Centers

POCT
30+
Years in POCT

3000+
Employees
 WONDFO PRODUCT LINES
Immunofluorescence
Platform
Diabetes & Kidney Disease ;
Craniocerebral Injury ; Inflammation ;

Dry Chemistry Thyroid Function ;

Cardiovascular ;
Fertility ;
Tumor ;
Platform Coagulation ; Others Molecular Diagnostics
Organophosphates Pesticides Poisoning ; Platform
Trauma / Anemia ; Blood Glucose ;
Blood Lipid ; Myocardial Enzyme; Pathogenic Microorganism Nucleic
Liver Function ; Kidney Function ; Acid Detection;
Pancreatitis ; Alcoholism Tumor Gene Detection;
Circulating Tumor Cell Detection

Electrochemistry
Pathology
Platform PRODUCT
Coagulation Function;
Platform
Metabolites; LINE Immunohistochemistry;
In Situ Hybridization;
Blood Gas;
Electrolytes; Automatic Pathological Staining
Hematology

Chemiluminescence Colloidal Gold

Platform Platform
Inflammation; Respiratory Tract;
Infectious Disease; Infectious Disease Screening;
Anemia; Tropical Infectious Diseases;
Bone metabolism; Fertility;
Allergy; STDs;
Tumor; Digestive Tract;
Fertility; Cardiac Markers
Cardiovascular;
Thyroid Function

Cardiovascular Diabetes Respiratory Renal Injury

8
Trademark Patent Certificate MAJOR FIELDS
280+ 240+
NMPA CE
610+ 420+
Registered Trademarks Valid Patents 70+ 13
CLIA WAIVED MDALL

2
WHO PQ
Fertility DOA Infection Tumor
PRODUCT PORTFOLIO

Immunofluorescence Colloidal Gold

TM

TM

Anti-CC
S 1 0P0β
Ra pid Quan titative
C ontents
1. 25 individual
F or F inecare
F IA Meters
TM T es t
■ Tes t C artridge s ea led pouches Use On ly
■ Des iccant , ea ch containing:
2. ID Chi p Pouc h
3. Le aflet W 297P0001
4. 25 Pi pettewith Ins tructions For
5. 25 Detection Ti ps (for 100 μL Use
Buf fer Tub trans fer pipette YYY Y- MM-DD
es s et)
YY YY- MM-DD

Re v. A1 Re
l. : 2023/03/03

TM

Anti-CCP
Chip
ID
-CCP
Anti
Code:

Anti-CCP

Coagulation Chemiluminescence

Blood Gas Molecular

2019-nCoV/Flu Test

Dry Chemistry Immunohistochemistry

CONTENTS
Qualitative Rapid Diagnostic Family 09 Quantitative Detection Family 15

Fertility Tests 10 Drug of Abuse Tests 12

Electrochemistry Platform 15 Fully-auto Chemiluminescence 33
HCG Pregnancy Test
Multi-Drug Tests
LH Ovulation Test Optical Coagulation Analyzer (OCG-102) SmarLumi™ FC-2000/2100
DOA Tests (Urine)
FSH Urine Test Thrombelastography Analyzer (TLT-101)
DOA Tests (Oral Fluid)
Sperm Concentration Test Blood Gas Analyzer (BGA-102)
Automatic Blood Gas Analyzer (Ucare-6000) Molecular Diagnostics Platform 35
Tumor Marker Tests 14
Infectious Disease Tests 11
PSA Prostate Specific Antigen Test Immunofluorescence Platform 20 Molecular Diagnostic Solutions
HBsAg Hepatitis B Surface Antigen Test Real-Time PCR Assay Test Menu
FOB Fecal Occult Blood Test
HBsAb Hepatitis B Surface Antibody Test U-Card Dx™ Molecular Diagnostic System
HBV Hepatitis B Virus Test FinecareTM platform 21
Other Rapid Tests 14
HCV Hepatitis C Virus Test FinecareTM FIA Meter Plus (FS-113)
HAV Hepatitis A Virus Test Troponin I Test FinecareTM FIA Meter II Plus SE (FS-114) Immunohistochemistry Platform 40
HIV 1/2 Test (2 lines) FinecareTM FIA Meter III Plus (FS-205)
HIV 1/2 Test (3 Lines) FinecareTM FIA Meter Automatic (FS-301) PA-3600 Fully Automated IHC Staining Instrument
HIV 1/2 Oral Mucosal Transudate Test
HIV-HCV-HBsAg-Syphilis Test New FinecareTM platform 25
Dry Biochemistry Platform 45
HIV-HCV-HBsAg Test
Finecare™ FIA Meter X1 (FS-1000)
Syphilis Test
Finecare™ FIA Meter X2 (FS-2000) Dry Chemistry Analyzer (DC-101)
Chlamydia Test
Finecare™ FIA Meter X2 PLUS (FS-2100)
Gonorrhea Test
Malaria P.f Test
Malaria P.f/Pan Test Mono-test Chemiluminescence 28 Wondfo COVID-19 diagnostic solution 48
Malaria P.f/P.v Test
H. Pylori Antigen Test ACCRE 8
H. Pylori Antibody Test ACCRE 90
ACCRE 160
Adenovirus Antigen Test
Rotavirus Antigen Test
Combined Adenovirus Antigen and Rotavirus Antigen Test
EV71 IgM Antibody Test
Flu A&B Test

9
Strep A Test
MP IgM Antibody Test
CP IgM Antibody Test
Dengue NS1 Antigen Test
              
Dengue IgG/IgM Antibody Test
Combined Dengue NS1 Antigen and Dengue IgG/IgM Antibody Test

Colloidal Gold Immunofluorescence Electrochemistry

Chemiluminescence Molecular Diagnostics Dry Biochemistry

Instrument Biological Raw Material Pathology

 Qualitative Rapid          

Fertility Tests

· Other colors of Midstream

caps are available.

· Reliable original equipment

manufacturer, high-quality
C
T

service is provided.

Sperm Concentration Test Kit Pregnancy & Ovulation tests

Product Cat. No. Specimen Width Format Sensitivity Qualification

W1-S Urine 3.5mm Strip 25mIU/mL 0123

, CLIA WAIVED, NMPA
W1-S(20mIU) Urine 3.5mm Strip 20mIU/mL 0123

W1-S(10mIU) Urine 3.5mm Strip 10mIU/mL 0123

, CLIA WAIVED, NMPA
W001-S1HJ(20mIU)1 Urine 2.5mm Strip 20mIU/mL 0123

W1-C Urine 4.0mm Cassette

25mIU/mL , CLIA WAIVED, NMPA
W1-CI Urine 3.5mm Cassette 0123

W1-C(20mIU) Urine 4.0mm Cassette

20mIU/mL
W1-CI(20mIU) Urine 3.5mm Cassette 0123

W1-C(10mIU) Urine 4.0mm Cassette

10mIU/mL , CLIA WAIVED, NMPA
W1-CI(10mIU) Urine 3.5mm Cassette 0123

W1-M Urine 6.0mm Midstream

W1-MII Urine 5.0mm Midstream
W1-MIII Urine 6.0mm Midstream 25mIU/mL 0123
, CLIA WAIVED, NMPA
W1-M4 Urine 3.5mm Midstream
HCG Test W1-M6 Urine 6.0mm Midstream
W1-M(20mIU) Urine 6.0mm Midstream
W1-MII(20mIU) Urine 5.0mm Midstream
W1-MIII(20mIU) Urine 6.0mm Midstream 20mIU/mL 0123

Qualitative Rapid
W1-M4(20mIU) Urine 3.5mm Midstream
W1-M6(20mIU) Urine 6.0mm Midstream
W1-M(10mIU) Urine 6.0mm Midstream
W1-MII(10mIU) Urine 5.0mm Midstream
W1-MIII(10mIU) Urine 6.0mm Midstream 10mIU/mL 0123 , CLIA WAIVED, NMPA
Urine Midstream

Diagnostic Family
W1-M4(10mIU) 3.5mm
W1-M6(10mIU) Urine 6.0mm Midstream
W1-S3P Urine/ Serum 3.5mm Strip
25mIU/mL , CLIA WAIVED
W001P0720 Urine/ Serum 3.5mm Strip
W1-C3P Urine/ Serum 4.0mm Cassette
25mIU/mL , CLIA WAIVED
W001P0721 Urine/ Serum 4.0mm Cassette
W2-S Urine 3.5mm Strip 25mIU/mL 0123
, CLIA WAIVED, NMPA
W2-C Urine 4.0mm Cassette
25mIU/mL , CLIA WAIVED, NMPA
W2-CI Urine 3.5mm Cassette 0123

W2-M Urine 6.0mm Midstream

LH Test W2-MII Urine 5.0mm Midstream
25mIU/mL 0123
, CLIA WAIVED, NMPA
W2-M4 Urine 3.5mm Midstream
W2-M6 Urine 6.0mm Midstream
W52-S Urine 3.5mm Strip 25mIU/mL 0123
, NMPA

FSH Test W52-C Urine 4.0mm Cassette 25mIU/mL 0123

, NMPA
W52-M Urine 6.0mm Midstream 25mIU/mL 0123
, NMPA
Sperm Concentration Test W121-C Semen 4.0mm Cassette 15×10 /mL 0123
, NMPA

10
 Infectious Disease Tests DOA Urine Tests

Category Cat. No. Test Item Specimen Format Sensitivity Qualification

W003 HBsAg WB/S/P Cassette/Strip 5.0 IU/mL NMPA

W004 HBsAb WB/S/P Cassette/Strip 30 mIU/mL NMPA
HBV(HBsAg, HBsAb,
Hepatitis W040-P WB/S/P Panel / NMPA
HBeAg, HBeAb, HBcAb)

W005 HCV WB/S/P Cassette/Strip 2 NCU/mL NMPA

Cassette Strip Panel
W071 HAV-IgM S/P Cassette /

W752 HIV 1/2 (2 lines) WB/S/P Cassette / ; NMPA

0123

W006 HIV 1/2 (2 lines) WB/S/P Cassette/Strip / NMPA

WHO Pre-qualified;
W006-P HIV 1/2 (2 lines) WB/S/P Cassette /
NMPA
W006P00XX
(58~60) HIV 1/2 (2 lines) (Self-Test) Fingerstick WB Cassette / WHO Pre-qualified
HIV
W050-C HIV 1/2 (3 lines) WB/S/P Cassette /
HIV 1/2 Oral Mucosal
W063-C Cassette / NMPA
Oral Mucosal Transudate Transudate

W026-C HIV-HCV-HBsAg-Syphilis WB/S/P Cassette / NMPA

W094-C HIV-HCV-HBsAg WB/S/P Cassette / NMPA

W034 Syphilis WB/S/P Cassette/Strip 2 NCU/mL ; NMPA

STD Female Endocervical Swab/
W35-C Chlamydia Male Penile Swab/Male Urine Cassette 5×10 IFU/mL 0123
; NMPA
Female Endocervical Swab/
W036 Gonorrhea Male Penile Swab Cassette 1×10 CFU/mL ; NMPA

W037 Malaria HRP2 (P.f) WB Cassette/Strip 100 p/μL ; NMPA

T-Cup Q-Cup T-Cube
Malaria W054 Malaria HRP2/pLDH (P.f/Pan) WB Cassette 100 p/μL ; NMPA
W056 Malaria HRP2/pLDH (P.f/P.v) WB Cassette 100 p/μL
W028 H. Pylori Antigen Feces Cassette/Strip /

W038 H. Pylori Antibody S/P Cassette/Strip /

Enteric W133 ADV Feces Cassette / ; NMPA

Infection
W112 RV Feces Cassette / ; NMPA
Multi-Drug Tests
W134 ADV-RV Feces Cassette / ; NMPA
W141 EV71 WB/S/P Cassette / ; NMPA
Product Cat. No. Format Test items Specimen Sensitivity Qualification
Flu A: 5.1x10 TCID50/mL
W059 Flu A&B Nasal Swab Cassette ; NMPA
Flu B: 1.5x10 TCID50/mL
W20XX(2-16)-P Panel 2-16 Items Urine Variable ; CLIA WAIVED
Nasal Swab/ Flu A: 5.1x10 TCID50/mL
W059 Flu A&B Cassette ; NMPA
Throat Swab Flu B: 1.5x10 TCID50/mL W5XX(2-18)-CU2 T-Cup 2-18 Items Urine Variable ; CLIA WAIVED
Multi-Drug Urine Test
Nasal Swab/ Cassette Flu A: 5.1x10 TCID50/mL
W71-CH Flu A&B (Self-Test) ; NMPA W5XX(2-18)-CU3 Q-Cup 2-18 Items Urine Variable
Throat Swab Flu B: 1.5x10 TCID50/mL 0123

Respiratory Strep A Swab Cassette 1.5x10 CFU/mL W6XX(2-10)-CU6 T-Cube 2-10 Items Oral Fluid Variable
W039 ; CLIA WAIVED Multi-Drug Oral Fluid
Infection
W039 Strep A (Self-Test) Swab Cassette 1.5x10 CFU/mL 0123

W113 MP IgM WB/S/P Cassette / ; NMPA

W135 CP IgM WB/S/P Cassette / ; NMPA
W041 Dengue NS1 Antigen WB/S/P Cassette / ; NMPA
Dengue W109 Dengue IgG/IgM Antibody WB/S/P Cassette / ; NMPA

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11

W111 Dengue NS1/IgG/IgM WB/S/P Cassette / ; NMPA

 Drug of Abuse Tests (Urine) DOA Tests (Oral Fluid)

Cat. No. Product Test Item Specimen Format Sensitivity Qualification Product Test Item Specimen Format Sensitivity Qualification

W007 AMP Ampthetamine Urine Cassette/Panel/Cup 1000/500 ng/mL AMP Ampthetamine Oral Fluid T-Cube 50 ng/mL
W008 BAR Barbiturates Urine Cassette/Panel/Cup 300 ng/mL
BAR Barbiturates Oral Fluid T-Cube 60 ng/mL
W009 BZO Benzodiazepines Urine Cassette/Panel/Cup 300 ng/mL ; CLIA WAIVED
BUP Buprenorphine Oral Fluid T-Cube 5 ng/mL
W010 COC Cocaine Urine Cassette/Panel/Cup 300/150 ng/mL ; CLIA WAIVED; NMPA
BZO Benzodiazepines Oral Fluid T-Cube 30 ng/mL
W011 mAMP/MET Methamphetamine Urine Cassette/Panel/Cup 1000/500 ng/mL ; CLIA WAIVED; NMPA
COC Cocaine Oral Fluid T-Cube 20 ng/mL
Methylenedioxymethamphetamine;
W012 MDMA Urine Cassette/Panel/Cup 500 ng/mL ; NMPA
Ecstasy EDDP Ethylenediamine-dimethyphosphinic Oral Fluid T-Cube 20 ng/mL
W013 BUP Buprenorphine Urine Cassette/Panel/Cup 10 ng/mL ; CLIA WAIVED
FTY Fentanyl Oral Fluid T-Cube 30 ng/mL
W014 MOP Morphine Urine Cassette/Panel/Cup 300 ng/mL ; NMPA
MDMA Methylenedioxymethamphetamine; Ecstasy Oral Fluid T-Cube 100 ng/mL
W015 MTD Methadone Urine Cassette/Panel/Cup 300 ng/mL ; CLIA WAIVED
MET Methamphetamine Oral Fluid T-Cube 50 ng/mL
W016 OPI Opiate Urine Cassette/Panel/Cup 2000 ng/mL ; CLIA WAIVED
MTD Methadone Oral Fluid T-Cube 30 ng/mL
W017 PCP Phencyclidine Urine Cassette/Panel/Cup 25 ng/mL ; CLIA WAIVED
OPI Opiate Oral Fluid T-Cube 40 ng/mL
W018 TCA Tricyclic Antidepressants Urine Panel/Cup 1000 ng/mL
PCP Phencyclidine Oral Fluid T-Cube 10 ng/mL
W019 THC Marijuana Urine Cassette/Panel/Cup 50 ng/mL ; CLIA WAIVED
THC Marijuana Oral Fluid T-Cube 25 ng/mL
W021 OXY Oxycodone Urine Cassette/Panel/Cup 100 ng/mL ; CLIA WAIVED
OXY Oxycodone Oral Fluid T-Cube 20 ng/mL
W055 KET Ketamine Urine Cassette/Panel/Cup 1000 ng/mL ; NMPA

W057 PPX Propoxyphene Urine Cassette/Panel/Cup 300 ng/mL

Ethylenediamine-
W074 EDDP
dimethyphosphinic
Urine Cassette/Panel/Cup 100 ng/mL Tumor Marker Tests
W086 TRA Tramadol Urine Cassette/Panel/Cup 200 ng/mL
Cat. No. Test Item Specimen Format Sensitivity Qualification
W087 FTY Fentanyl Urine Cassette/Panel/Cup 20 ng/mL
W030 FOB Feces Cassette/Strip 200 ng/mL ; NMPA
W089 K2 Synthetic Cannabis Urine Panel/Cup 50 ng/mL
W030 FOB (Self-Test) Feces Cassette/Strip 50ng/mL ; CLIA WAIVED
0123

W139 COT Cotinine Urine Cassette/Panel/Cup 100 ng/mL W31-C PSA S/P Cassette / 0123

W140 ETG Ethyl Glucuronide Urine Panel/Cup 500 ng/mL

Other Rapid Tests

Cat. No. Product Format Specimen Sensitivity Qualification

W046 Troponin I Cassette WB/S/P 1 ng/mL ; NMPA

14
13
 Optical Coagulation    

OCG-102

PT,APTT,TT,FIB,ACT,PT/INR

Sample Type: Venous/Capillary whole blood

Specimen volume: 20μL
Long shelf life: 18 months
Precision: CV≤5%
Room-temperature storage: 2-30°C
Portable: Rechargeable lithium battery

Cat. No. Item Category Specification Qualification

W955 Optical Coagulation Analyzer Instrument / NMPA

W480-484 PT,APTT,TT,FIB,ACT,PT/INR Test strip 24 T/Kit NMPA

Test Items

Electrochemistry Cat. No. Item Specimen Type Test strip Volume Measuring Range Clinical Reference

    
W480 PT Citrated WB/Capillary WB 20 μL 7~90 s 10~14 s

W481 APTT Citrated WB 20 μL 18~120 s 22~38 s

W482 FIB Citrated WB 20 μL 1.5~6 g/L 2~4 g/L

W483 ACT Citrated WB 20 μL 50~600 s 80~140 s

W483P0007 ACT Fresh WB 20 μL 50~600s 80~140s

(Non-anticoagulant)

W484 TT Citrated WB 20μL 10~90 s 14~20 s

W486 PT/INR Citrated WB/Capillary WB 20μL 7~90s/0.5-9 10~14s/0.7-1.3

* Note: INR is caculated by PT.

16
17
 Thrombelastography     Blood Gas    

TLT-101 BGA-102

Fast, Accurate
● Reliable results can be obtained within 20mins~2hours Specimen type: Aeterial blood/Capillary blood

Easy to use Intelligent operation Specimen volume: 80μL

● Integrated large touch screen ● Automatic loading
Time to result: 180s
● Linux operating system ● Automatic lifting
● Immediate, intuitive reading of results ● Intelligent cover removal Portable: Built-in rechargeable battery

High throughput Patented design Suitable for Syringe and Arterial/Capillary Blood Sampler
● Four independent channels ● Small size and light weight
Good Correlation to Reference Method: R2>0.95
● Compatible with various cup types ● Six technical modules
Test cartridge is stable and effective up to 15 months
Reagent pack can be used for up to 60 days after installation

Testing Parameters

Perioperative Guidance for Monitoring of Detection of pH, pCO2, pO2, K +, Na +, Ca ++, Cl-, Hct, Glu, Lac
Bleeding Management Blood Transfusion antiplatelet therapy heparin therapy

Test Items Reportable Parameters Calculating Parameters

Thrombelastography Kaolin Test Kit

(Coagulation Method) R, K, α, MA, LY30, EPL cH+, cH+(T), pH(T), pCO2(T), pO2(T), HCO3-atd, HCO3-std, BB(B), BE(B), BE(ecf), ct CO2, Ca++(7.4), AnGap,

Thrombelastography Rapid Test Kit tHb(est), sO2(est), pO2(A-a), pO2(A-a)(T), pO2(a/A), pO2(a/A)(T), RI, RI(T), pO2/FI O2, pO2(T)/FI O2 , POP
(Coagulation Method) ACT, K, α, MA, LY30, EPL

Thrombelastography Platelet Function-AA pathway Test Kit

(Coagulation Method) AA% inhibition

Thrombelastography Platelet Function-ADP pathway Test Kit Cat. No. Test Item Specification Qualification
(Coagulation Method) ADP% inhibition

Thrombelastography Platelet Function-AA&ADP pathways Test Kit W459 pH, pCO2, pO2 25T/Kit NMPA
(Coagulation Method) AA&ADP% inhibition
W461 K +, Na +, Ca ++, Cl- 25T/Kit NMPA

R'=R(Kaolin Cup)-R（Heparinase Cup）

Thrombelastography Heparinase Test Kit
(Coagulation Method) W465 pH, pCO2, pO2, K +, Na +, CI-, Ca ++, Hct 25T/Kit NMPA

Thrombelastography Quality Control R, K, α, MA W466 pH, pCO2, pO2, K +, Na +, CI-, Ca ++, Hct , Glu, Lac 25T/Kit NMPA

18
17
 Automatic Blood Gas    

Ucare-6000

Various specifications
75/150/300-test pack

Room temperature storage

Store at 2-30°C, NO refrigeration required

Long shelf life

7 months storage or 30 days on-board life

Built-in battery
Long standby for 6 hours WITHOUT power supply

One-step blood gas analysis

All-in-one design of solution pack

One-step sample loading and code scanning

Immunofluorescence
Hands-free automatic sample aspiration

10 Testing Parameters :
pH, pCO2, pO2, K+, Na+, Cl- , Ca++, Glu, Lac, Hct
    
24 Calculating Parameters :
cH+(T), pH(T), pCO2(T), pO2(T), pO2(A-a)(T), pO2(a/A)(T), RI(T),
pO2(T)/FiO2, cH+, Ca++(7.4), HCO3-act, HCO3-std, BE(B), BB(B),
BE(ecf), AG, sO2(est), tHb(est), ctCO2, pO2(A-a), pO2(a/A), RI,
POP, pO2/FiO2
Ucare-6000 Solution Pack

12
19
 TEST MENU

Immunofluorescence
           COVID-19 Sex Hormone Tumor

● Antibody & Antigen Test ● β-HCG ● AFP
● LH ● PSA

Diabetes ● FSH ● CEA

● fPSA
Platform ● HbA1c ● Prog
● PRL
Cardiac
Kidney ● E2
● cTn I
● MAU ● Testosterone
● cTn T
● CysC ● AMH
● Myo
● NGAL
● CK-MB
● β2-MG Thyroid ● H-FABP
● T3 ● NT-proBNP
Inflammation ● T4 ● BNP
Finecare TM
FIA Meter Automatic ● PCT ● TSH ● hsCRP
FinecareTM FIA Meter III Plus (FS-301)
(FS-205) ● CRP ● fT3 ● Lp-PLA2
FinecareTM FIA Meter II Plus SE FinecareTM FIA Meter Plus
(FS-114) (FS-113) ● SAA ● fT4 ● ST2
● IL-6
Finecare TM FIA Meter series is a fluorescence immunochromatographic analysing system which can help Allergy Bone Metabolism
diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.
RA ● Total IgE ● Vitamin D
● Anti-CCP
● ASO Hypertension Thrombus
● D-Dimer
● RF ● Cortisol

Reliable Competitive Easy-to-use Brain Injury

Anemia Gastroenterology
· CE/NMPA/NGSP/IFCC · Full Test Line · LCD Touch Screen ● S100β
● Ferritin ● iFOB
Certified · Result in 3~15 mins · Multiple Language Available
● Vitamin B12 ● H.pylori Ag
· Fast and Accurate · Cost-efficient · Internal Thermal Printer Infectious Disease
· Full Traceability · Built-in Temperature Control ● Dengue NS1-Ag
· QC Available

Room Temperature Date Management Application Instrument Reagent Quality Control

· Store & Operate at 4~30°C and Transmission · Laboratory, ER, Cardiology, ICU,
· 24 Months Shelf Life · HIS/LIS Respiratory, Pediatrics, etc. Anti-CCP
S100β
Rapid
TM

TM CRP Control
Quantitative
Contents
For Finecare Test
W806P0001
FIA Meters
TM
Use Only
YYYY-MM-DD
1. 25 individual
■ Test Cartridge sealed pouches,
■ Desiccant each containing:
2. ID Chip Pouch
3. Leaflet with
4. 25 Pipette Instructions W297P0001
For Use
5. 25 Detection Tips (for 100 μL transfer
Buffer Tubes pipette set) YYYY-MM-DD
YYYY-MM-DD
FXXXXXXXXX YYYY-MM-DD
Rev . A1 Rel.:
2023/03/03

Contents:
1. 3 vials of controls with different levels:
Level 1: 1×0.5mL, Level 2: 1×0.5mL, Level 3: 1×0.5mL
2. 1 Leaflet with Instructions for Use
3. 1 Leaflet with Target Value Table
TM
3 Vials
0123 Qarad EC-REP BV, Pas 257, 2440 Geel, Belgium Ver.: 00 Rel.: 2023/06/20

Anti-CCP

p
Chi
ID
CP
ti-C
An
Code:

Anti-CCP

22
21
 DISPOSABLE REAGENT CARTRIDGES PARAMETER Cat. No. Category Specimen Volume Qualification
Test Item Diseases Specimen Type Reaction Time Measuring Range

W208 AFP Liver Cancer WB/S/P 75 μL 15 mins 5~400 ng/mL NMPA

 Serum or   
Fingerstick blood Plasma or W209 PSA Prostate Cancer WB/S/P 75 μL 15 mins 2~100 ng/mL
Tumor 0123 NMPA
Whole blood
W226 Markers CEA Cancer WB/S/P 75 μL 15 mins 1~500 ng/mL NMPA

OR ID
Chip
W230 fPSA Prostate Cancer WB/S/P 75 μL 15 mins 0.2~30 ng/mL 0123 NMPA

CRP
Chip
ID

W279P0001 iFOB Gastrointestinal bleeding Feces 6 different 5 mins 25~1000 ng/mL

Buffer
Gastroenterology parts of
W270P0001 H.pylori Ag Infectious disease Feces 10 mins Quantitative
Dropping the feces
Sampling Mixing Loading Reading W282P0001
Infections
Disease Dengue NS1 Ag Infectious disease WB/S/P 75 μL 12 mins Quantitative

W298P0001 Allergy Total IgE Allergic diseases WB/S/P 75 μL 10 mins 1~1000 IU/mL

W250 Hypertension Cortisol Cortisol disorders WB/S/P 75 μL 15 mins 50~1000 nmol/L NMPA

Cat. No. Category Test Item Diseases Specimen Type Specimen Volume Reaction Time Measuring Range Qualification W269P0001 Ferritin Iron metabolism WB/S/P 75 μL 10 mins 5 ~ 1000 ng/mL NMPA
Anemia
Markers VB12 Deficiency S/P 40μL 10 mins 80~2000pg/mL
WX01P0001 Vitamin B12

W297P0001 ASO Rheumatic fever and WB/S/P 10 μL 5 mins 20~1000 IU/mL

glomerulonephritis
W241P0002 Vitamin D Vitamin D deficiency S/P 75 μL 15 mins 5~100 ng/mL NMPA Rheumatoid
Bone W262P0001 RF Rheumatoid Arthritis WB/S/P 10 μL 5 mins 10 ~ 650 IU/mL
W241P0006/ Metabolism Arthritis
W241PP007 Vitamin D Vitamin D deficiency WB/S/P 10 μL 8 mins 5~100 ng/mL WW01P0001 Anti-CCP Rheumatoid Arthritis WB/S/P 10 μL 10 mins 3.5-300 U/mL
W207 Diabetes HbA1c Diabetes Mellitus WB 10 μL 5 mins 4.0~14.5% IFCC NGSP NMPA 2019-nCoV RBD Fingerstick or Venous
W290 20μL 15 mins Quantitative
Antibody Test WB/ S/P
W206 One Step MAU Renal Injury Urine 75 μL 3 mins 5~300 mg/L NMPA
Kideny COVID-19 COVID-19
W219 CysC Renal Injury WB/S/P 10 μL 5 mins 0.2~10 mg/L NMPA W286 2019-nCoV Antigen Test NP/ OP / 15 mins Quantitative
Function
W228 NGAL Renal Injury Urine 75 μL 15 mins 10~1500 ng/mL NMPA W278 2019-nCoV IgM/IgG Test WB/S/P 10 μL 10 mins Quantitative
Markers
Proximal Renal
W229 β2-MG Tubule Dysfunction WB/S/P 10 μL 10 mins 0.3~20 mg/L NMPA

W231 T3 Thyroid Malfunction WB/S/P 75 μL 15 mins 0.61~9.22 nmol/L NMPA

W232 T4 Thyroid Malfunction WB/S/P 75 μL 15 mins 12.87~300 nmol/L NMPA
W220 Thyroid
Function
TSH Thyroid Malfunction WB/S/P 75 μL 15 mins 0.1~100 mIU/L
0.40~50.00 pmol/L or
NMPA AUTOMATIC REAGENT KITS PARAMETER
W200 fT3 Thyroid Malfunction WB/S/P 75 μL 15 mins NMPA
0.26~32.55 pg/mL
1.00~100 pmol/L or
W259 fT4 Thyroid Malfunction WB/S/P 75 μL 15 mins NMPA
0.078~7.77 ng/dL
W225 β-HCG Fertility WB/S/P 20 μL 15 mins 2~200,000 mIU/mL NMPA
W244 LH Fertility WB/S/P 75 μL 15 mins 1~100 mIU/mL NMPA
W245 FSH Fertility WB/S/P 75 μL 15 mins 1~100 mIU/mL NMPA
W233 Sex Prog Fertility WB/S/P 75 μL 15 mins 1.5~60 ng/mL NMPA
Hormone
W246P0001 PRL Fertility WB/S/P 75 μL 15 mins 1~200 ng/mL NMPA
Markers
W247-C4P1-E E2 Fertility WB/S/P 75 μL 15 mins 9~3000 pg/mL NMPA
W248-C4P1-E Testosterone Fertility WB/S/P 75 μL 15 mins 0.2~15 ng/mL NMPA
W257P0001 AMH Fertility WB/S/P 75 μL 15 mins 0.1~16 ng/mL NMPA
W202 NT-proBNP Heart Failure WB/S/P 75 μL 15 mins 18~35000 pg/mL NMPA
W203 cTn I Myocardial Infarction WB/S/P 75 μL 15 mins 0.1~50 ng/mL NMPA
Sampling Loading Testing Reading
W204 Myo Myocardial Infarction WB/S/P 75 μL 15 mins 2.0~400 ng/mL NMPA
W205 CK-MB Myocardial Infarction WB/S/P 75 μL 15 mins 0.3~100 ng/mL NMPA
W217 H-FABP Myocardial Infarction WB/S/P 75 μL 15 mins 1~120 ng/mL NMPA
Specimen Reaction
W216 3 in 1 Myocardial Infarction WB/S/P 75 μL 15 mins Same with NMPA Category Cat. No. Test Item Diseases Measuring Range Qualification
Cardiac (cTn I/Myo/CK-MB) single items Type Time
W222 Markers BNP Heart Failure WB/P 75 μL 15 mins 5~5000 pg/mL NMPA
2 in 1 Same with
W223
(cTn I/ NT-proBNP) Myocardial Infarction WB/S/P 75 μL 15 mins single items NMPA W210P0017 PCT Sepsis WB/S/P 15 mins 0.1-100 ng/mL , NMPA
W240 hsCRP CVD WB/S/P 10 μL 3 mins 0.1~10mg/L NMPA Inflammation
100μL-WB Markers CRP
W254P0001 One Step cTnT Myocardial Infarction WB/S/P
75μL-S/P
15 mins 0.03~10 ng/mL NMPA
W201P0015 Inflammation WB/S/P 3 mins 0.5-200 mg/L , NMPA
(hsCRP+CRP)
W242 Lp-PLA2 Atherosis WB/S/P 75 μL 15 mins 10~1000 ng/mL NMPA

W243 ST2 Heart Failure WB/S/P 75μL 15 mins 10~400ng/mL Diabetes

Diabetes W207P0005 HbA1c WB 5 mins 4-14.5% , NMPA
Mellitus
W239 Brain Injury S100β Cerebral Ischemia
Markers WB/S/P 75 μL 15 mins 0.05~10 ng/mL NMPA
Cerebral Hemorrhage
15μL-WB Myocardial
W211 D-Dimer Thrombosis WB/P 5 mins 0.1~10 mg/L NMPA W203P0012 cTnI WB/S/P 15 mins 0.1-50 ng/mL , NMPA
Thrombus 10μL-P Infarction
W227 Markers 100μL-WB 15 mins
One step D-Dimer Thrombosis WB/P 75μL-S/P 0.1~10 mg/L NMPA
Cardiac Myocardial
W210/ PCT Sepsis WB/S/P 75μL-WB 15 mins 0.1~100 ng/mL NMPA Markers W205P0007 CK-MB WB/S/P 15 mins 0.3-100 ng/mL , NMPA
W210P0004 50μL-S/P Infarction
W201/ Fingerstick or Venous 8.5μL-WB 3 mins
W201P0008 CRP (hsCRP+CRP) Infection
WB/S/P 5μL-S/P 0.5~200 mg/L NMPA
Inflammation
Markers CRP:0.5~150 mg/L W202P0013 NT-proBNP Heart Failure WB/S/P 15 mins 18~35000 pg/mL , NMPA
W218 2 in 1 (CRP+PCT) Infection WB/S/P 75 μL 15 mins PCT:0.1~100 ng/mL NMPA
W221/ SAA Infection
Fingerstick or Venous 8.5μL-WB
3 mins 1 ~ 500 mg/L NMPA Thrombus
W221P0004 WB/S/P 5μL-S/P W211P0012 D-Dimer Thrombosis P/WB 5 mins 0.1-10 mg/L , NMPA
W251P0001 IL-6 Infection WB/S/P 75 μL 15 mins 3~4000 pg/mL NMPA
Markers

24
23
 Immunofluorescence
          
1 Faster to Get the Result:

Only 8mins
hs-cTnI
New Platform 2 New Items:

Support for hs-cTnI

3 Excellent CV and Accuracy with Optimized FIA Methodology

Satisfying and stable results delivered in short time

Finecare™ FIA Meter X1 Finecare™ FIA Meter X2 Finecare™ FIA Meter X2 PLUS
(FS-1000) (FS-2000) (FS-2100)
Operation Procedure

1 2 3 4

Stability Convenient
TRFIA Methodology Simple operation procedure
Lower CV higher stability Integrated handle design

Entry of test Entry of patient Sample loading Insert the cartridge

information information
Delicate design Instant results
Automatic reagent door
8 Result in 6s under quick mode
Charging indicator light Result in 8 min under standard mode Specimen Specimen Reaction Measuring
Cat. No. Category Test Item Diseases Qualification
Type Volume Time Range

hs-cTnI: 0.02 ~ 50 ng/mL

One Step hs-cTnI/ 100uL whole blood;
WS02P0001 CK-MB/Myo S/P/WB 75ul serum/plasma 8 min CK-MB: 1 ~ 80 ng/mL NMPA
Myocardial Myo:10 ~ 600 ng/mL
Infarction
Specification Large Display WS01P0001 One Step hs-cTnl S/P/WB
100uL whole blood;
8 min 0.02 - 50 ng/mL NMPA
Cardiac 75ul serum/plasma
• Dimension: 209*290*187 mm • 8-inch capacity touch screen Markers
• Weight: 3.5 kg • Intuitive user interface One Step 100μL whole blood;
WS04P0001 S/P/WB 75μl serum/plasma 8 min 18pg/mL-35000pg/mL NMPA
• Smooth operation experience NT-proBNP Heart
like smart-phone Failure
100μL whole blood;
Built-in Code Scanner WS03P0001 One Step BNP P/WB
75μl plasma 8 min 5-5000pg/mL NMPA
• No need for ID chip Thrombus One Step 100μL whole blood;
WS06P0001 Thrombosis P/WB 5 min 0.10 - 10.00mg/L FEU
• Ample batch information Connectivity Markers D-Dimer 75μl plasma

• Wifi connection to Bi-directional LIS/HIS WS08P0001 8.5μL whole blood;

CRP
Built-in Thermal Printer • RS232 and ethernet port WS08P0002
S/P/WB 5μl serum/plasma 3 min 0.3 ~ 200 mg/L

• Real-time auto printing • 4 USB ports

100μL whole blood;
• External printer supported WS14P0001 One Step lL-6 Infection S/P/WB 75μl serum/plasma 8 min 3 ~ 4000 pg/mL
Inflammation
Markers
Linux System WSO9P1001 8.5μL whole blood;
Rechargeable Internal Battery • Smooth operation WSO9P1002
SAA S/P/WB 5μl serum/plasma 8 min 1~ 200 mg/L

• 10400 mAh battery • Security system

• 24-hour standby • Custom intelligent management module WS12P0001 One Step PCT Sepsis S/P/WB
100μL whole blood;
8 min 0.020 ~100 ng/mL
75μl serum/plasma
• Low battery alert • Multi-user management

26
25
 Mono-test Chemiluminescence

          

ACCRE CLIA Platform

ACCRE 90 ACCRE 8 *ACCRE 160

ACCRE is a series of automatic bench-top chemiluminescence immunoassay (CLIA) systems using

mono-test reagent cartridge. It provides reliable test results with less maintenance cost.

Flexible Maintenance- User-

& Efficient free friendly

Chemiluminescence Simultaneous processing of

difference parameters
No liquid path inside
600 days MTBF
Easy operation requiring
only 30-minute training

     Reliable Compact
Fast
Accuracy Design

10 mins for the first result, High sensitivity 70% smaller than traditional
Up to 120 tests/hour Wide measuring range CLIA analyzer

* Coming soon

28
25
 TEST MENU

● Available ● In Development
Nano magnetic
Sample well beads

Tumor Fertility Cardiac

Substrate

● CEA ● AMH ● cTnI

● AFP ● Progesterone ● hs cTnI
● CA125 ● Testosterone ● CK-MB
● tPSA ● Prolactin ● MYO
● CA19-9 ● LH ● BNP
● CA15-3 ● E2 ● NT-proBNP
● PGI ● FSH ● H-FABP
● PGII ● β-HCG ● ST2
● G-17 ● Inhibin B ● Lp-PLA2
Non-slip ● CA72-4 ● fTesto ● hs cTnT
handle ● HE4 ● hs-CRP
Wash
● DHEA-S
Antibody solution ● fPSA
Reading well
● CYFRA 21-1
● CA50 TORCH Thyroid
● CA242
● SCCA ● Toxo IgG ● TSH
● NSE ● Toxo IgM ● TT3
● ProGRP ● Rubella IgG ● TT4
● Rubella IgM ● FT3
● CMV IgG ● FT4
Infectious Disease
● CMV IgM ● Tg
● Dengue NS1 Ag ● HSV-1 IgG ● Anti-Tg
● Dengue IgG ● HSV-1 IgM ● Anti-TPO
● Dengue IgM ● HSV-2 IgG
● HIV
● HSV-2 IgM
● HBsAg
Allergy
● Anti-HCV
● Anti-TP ● IgE
● H.Pylori (HP) Thrombus
EXCELLENT AS CLIA EASY AS POCT ● D-dimer
Inflammation ● TM DIABETES
● TAT
● FDP ● Insulin
● ALP-APS-5 chemiluminescence ● Mono-test cartridge, ready-to-use ● PCT
● PIC ● C-Peptide
● IL-6
● t-PAIC ● INS-Ab
● Excellent reagent performance ● Avoid cross-contamination ● CRP
● SAA
● Nano magnetic particles for separation ● Short turnaround time (TAT)
Anemia Others
● Broad menu with featured items ● All-in-one design, no consumables and extra cost Bone Metabolism
● VB12 ● S100β
● Reliable calibration and quality control system ● Built-in scanner reads reagent information automatically ● 25-OH Vitamin D Total ● Folate ● ACTH
● PTH ● Ferritin ● Cortisol

30
29
 ACCRE
                     

Tisenc Wondfo Sample Sample Test Time Tisenc Wondfo Sample Sample Test Time
Category Parameter Measuring Range Qualification Category Parameter Measuring Range Qualification
Cat. No. Cat. No. Volume (μL) Type (mins) Cat. No. Cat. No. Volume (μL) Type (mins)

cTnI W121C F121C 75 S/P/WB 15 0.05-50 ng/mL , NMPA Allergy IgE W107C F107C 65 P/S 15 0.3-2500 IU/mL

hs-cTnI W122C F122C 75 S/P/WB 15 0.005-50 ng/mL , NMPA AFP W60C F60C 70 P/S 15 0.5-1000 IU/mL

MYO W123C F123C 75 S/P/WB 15 1-1000 ng/mL , NMPA CEA W85C F85C 65 P/S 15 0.2-1000 ng/mL

Cardiology CK-MB W124C F124C 75 S/P/WB 15 0.1-300 ng/mL , NMPA Tumor CA125 W104C F104C 65 P/S 15 0.6-5000 U/mL

BNP W125C F125C 75 P/WB 15 15-5000 pg/mL , NMPA CA19-9 W105C F105C 65 P/S 15 0.6-1000 U/mL

NT-proBNP W126C F126C 75 S/P/WB 15 15-35000 pg/mL , NMPA tPSA W84C F84C 65 P/S 15 0.1-100 ng/mL

H-FABP W127C F127C 75 S/P/WB 15 0.5-160 ng/mL , NMPA Ferritin W06C F06C 60 P/S 15 1-2000 ng/mL , NMPA

Thrombus D-Dimer W128C F128C 75 P/WB 15 0.045-10 μg/mL (FEU) , NMPA Anemia Folate W119C F119C 85 P/S 28 1.0-20 ng/mL , NMPA

PCT W116C F116C 75 S/P/WB 15 0.04-100 ng/mL , NMPA VB12 W118C F118C 75 P/S 35 125-2000 pg/mL , NMPA
Inflammation
Bone
IL-6 W90C F90C 75 S/P/WB 15 1.5-5000 pg/mL Metabolism 25-OH VD W120C F120C 75 P/S 40 3.0-100 ng/mL , NMPA

TSH W30C F30C 75 P/S 25 0.01-100 μIU /mL , NMPA

TT3 W31C F31C 75 P/S 25 0.3-10 nmol/L , NMPA

Thyroid TT4 W32C F32C 75 P/S 25 6.44-320 nmol/L , NMPA

FT3 W33C F33C 70 P/S 25 1.0-50 pmol/L , NMPA

Specification: 36 tests/kit
FT4 W34C F34C 70 P/S 25 2-77.2 pmol/L , NMPA
Shelf life: 18 months
FSH W41C F41C 70 P/S 15 0.2-200 mIU/mL , NMPA
Storage: 2-8°C
LH W42C F42C 70 P/S 15 0.1-200 mIU/mL , NMPA

PRL W43C F43C 70 P/S 15 4-5000 μIU/ml , NMPA Calibrator and Quality Control included in the kit.

AMH W117C F117C 75 P/S 15 0.01-23 ng/mL , NMPA

Fertility
Progesterone W44C F44C 100 P/S 23 0.5-191 nmol/L , NMPA

Testosterone W45C F45C 100 P/S 23 0.1-15 ng/mL , NMPA

E2 W40C F40C 100 P/S 23 15-3000 pg/mL , NMPA

β-HCG W46C F46C 60 P/S 15 1-5000 mIU/mL , NMPA

32
31
 Fully-auto Chemiluminescence TEST MENU

          
● Available ● In Development

Product Features Cardiac Thrombus Craniocerebral injury

● cTnT ● TM ● S100β
Flexibility & Efficiency Smart & Accurate Machine System
● BNP ● TAT
STAT mode supported The carry-over is ≤ 0.5ppm ● MYO ● FDP Bone metabolism
Only 0.64 m2 footprint with 60 sample positions Constant 2-8℃ reagent refrigeration
● hs-cTnI ● PIC
● Lp-PLA2 ● t-PAIC ● 25-OH VD
<12 mins for the first result Needle collision protection and block detection
● CK-MB ● D-Dimer ● PTH
High throughput with 200T per hour Liquid level detection
● NT-proBNP
RFID management, easy to load reagents Automatic switching of double substrate bottles during the operation
● MPO Hypertension Pre-eclampsia
● H-FABP
● ST2 ● REN ● PLGF
Better User Experience Fully Automatic Analyzer ● Cortisol
● hs-CRP ● sFlt-1
● HCY* ● AI
Built-in touch screen operation Primary tube sampling
● A II
Bidirectional LIS communication Automatic barcode identification
● ACTH Kidney function
Visual management of consumables and reagents Automatic dilution function Inflammation ● ALD
Cuvettes loading by dumping
● NGAL
Automatic rerun
● IL-6
● PCT Gastric function Anemia
● SAA
● G-17 ● Ferritin
Specification ● PGI
Thyroid ● Folate
● PGII ● VB12
● TSH ● HP-IgG*
Model * FC-2000 FC-2100
● FT3 Fertility
Methodology Chemiluminescence Immunoassay (CLIA) ● FT4 Tumor Markers
FC-2000 ● TT3 ● AMH
Dimension 900 mm * 710 mm * 590 mm
● More reagent volume ● TT4 ● CA50 ● β-HCG
Weight 140 kg ● CA242
Larger test volume ● Anti-TPO* ● TESTO*
Throughput 200 T/h ● Anti-TG* ● CYFRA21-1 ● PROG*
● Tg* ● SCC ● E2*
Time for first result < 12 min FC-2100 ● CT* ● HE4 ● PRL*
Reagent position 15 25 ● T-Uptake* ● NSE ● LH*
● More reagent positions
● TBG* ● CA72-4 ● FSH*
Reagent specification 50 or 100 T/Bottle 25 or 50 T/Bottle More test combinations
● TRAb* ● CEA ● InhB*
Reagent refrigeration 2-8℃ on board refrigeration ● TSAb* ● CA15-3
Sample position 60 ● rT3* ● CA125 Infectious disease
● CA19-9
Sample volume 5-150 μL
TORCH ● ProGRP ● HBeAg*
Sample type Whole blood / Serum / Plasma / Urine/ Cerebrospinal fluid ● FPSA ● HBeAb*
● TOXO-IgG* ● TPSA ● HBcAb*
Test mode Batch / STAT ● TOXO-IgM* ● HBsAg*
● AFP*
Probe system Liquid level detection / Block detection / Collision protection ● Rubella IgG* ● PIVKA-II* ● HBsAb*
● Rubella IgM* ● anti-TP*
Storage capacity ≥ 60000 results
● CMV-IgG* Liver fibrosis ● HIV Ag/Ab*
Operation system Windows 10 / bidirectional LIS compatible ● CMV-IgM*, ● HCV*
Support automatic dilution
● HSV-1-IgG* ● HA* ● M. Pneumonia IgG*
Dilution function Fixed multiple dilution ● HSV-1-IgM* ● CIV* ● M. Pneumonia IgM
Exceeded linearity range remeasurement dilution ● HSV-2-IgG* ● LN* ● Chlamydia pn. IgG*
● HSV-2-IgM* ● PIIINP* ● Chlamydia pn. IgM*
* FC-2000 and FC-2100 share the same analyzer outlook.

34
33
 MOLECULAR
 ­      ­       ­  

  
Collection Extraction Amplification

Extraction Portable PCR

Flocked Swabs Instrument Instrument

● Our sterile flocked swabs ● High throughput automated ● Flexibility - Open platform with
provide optimized specimen system with magnetic bead- high capacity.
collection at a low cost. based purification. ● Flexibility - High precision,
● The swabs feature a molded ● Compact size with large Real-Time temperature control.
breakpoint that can be easily screen. ● Automated - Automatic analysis
snapped. ● Highly efficient and stable of results, no external computer
design provides optimized required.
solution. ● User-Friendly - Visual animation

Molecular Diagnostics
guides operation; quick mode
Specimen saves time.
Collection Buffer
Extraction Kit Real-Time

     PCR Assay

● Optional inactivated
and non-inactivated
preservation solutions.

36
31
 Real-Time PCR Assay Test Menu U-Card DxTM                  

Category Product Targets

2019-nCoV (N gene)
2019-nCoV PCR Assay 2019-nCoV (ORF1ab gene)
2019-nCoV (N gene) RSV A/B
2019-nCoV/FluA/FluB/RSV PCR Assay
2019-nCoV (ORF1ab gene)
Flu A MULTIPLEXED Instrument features
Flu B
2019-nCoV (ORF1ab gene) Designed for use at the point of care

RAPID
2019-nCoV 2019-nCoV/Flu/RSV PCR Assay Flu A/B Portable and fully automated instrument
RSV A/B
2019-nCoV S371L Comprehensive results with PCR curves and Ct values
2019-nCoV PCR Assay for B.1.1.529
2019-nCoV E484A
ACCURATE
Simple workflow without sample preparation
2019-nCoV (ORF1ab gene) HV69-70del
No maintenance required
K417T T478K
FULLY
2019-nCoV Variants PCR Assay 246-252del K417N Multiple data connection interface options
N501Y AUTOMATED Robust memory capability
MPXV (F3L gene)
Monkeypox Virus Monkeypox Virus PCR Assay
MPXV (N3R gene)
RSV A/B
FluA/FluB/RSV PCR Assay Flu A
Flu B
M. pneumoniae
MP/AdV/PIV PCR Assay Adenovirus
Parainfluenza virus Reagent features
Respiratory Infection
RSV A/B M. pneumoniae
Respiratory-Virus PCR Assay Flu A Adenovirus Microfluidic cartridge design
2019-nCoV/Flu Test
Flu B Parainfluenza virus
Lyophilized reagents for ambient temperature stability
S. pneumoniae M. pneumoniae
H. influenzae C. pneumoniae Closed-system design avoids contamination
Respiratory-Bacteria PCR Assay
B. pertussis L. pneumophila Multiplex detection for up to 8 targets/controls
M. tuberculosis
Tuberculosis MTB/RIF Rapidly expanding test menu
rpoB
Norovirus GI Adenovirus
GI-Virus PCR Assay Norovirus GII Astrovirus
Rotavirus Sapovirus
Gastrointestinal Shigella/EIEC Vibrio parahaemolyticus 3-STEP OPERATION
Infection GI-Bacteria PCR Assay Y. enterocolitica Salmonella
● Simple-to-use operation with on-screen guide
C. difficile PCR Assay
C. jejuni
C. difficile
E. coli O157
● Positve samples identified in as soon as 28 minutes 28~38 mins
C. trachomatis M. hominis
Sexually Transmitted N. gonorrhoeae U. urealyticum
STD PCR Assay 1 2 3
Diseases M. genitalium U. parvum
T. vaginalis 200 uL
HPV16
HPV HPV16/18 PCR Assay
HPV18

Scan Cartridge Load Sample Insert Cartridge

38
37
 Test Menu
● CE available ● RUO

Upper Respiratory Tract Sexual Transmitted Infection (STI )

● 2019-nCoV ● CT/NG ● GBS

● 2019-nCoV/Flu A/Flu B ● MG/TV ● HSV 1/2

● Monkeypox virus ● UU

● 2019-nCoV/Flu A/Flu B/RSV ● CT/NG/UU

● Flu A/Flu B/RSV ● CT/NG/MG/TV

● Strep A ● HPV 16/18 +12 highrisk

Immunohistochemistry
    

36
39
 FULLY AUTOMATED
­€     ­ ­    ‚     „  ‚    €      ‚

Independent temperature control technology for each slide

● 36 staining modules are equipped with independent heating modules.
● Temperature control range from room temperature to 101°C, accurate and uniform temperature
control, temperature fluctuation <0.5°C.

primary antibody Wave-like mixing technology

● The liquid on the surface of the slide moves in waves to improve the antigen-antibody reaction,
shorten the staining time, and ensure thorough cleaning.
● The motor drives the cover plate through the worm gear, and the cover plate can be opened to a
larger angle, which is convenient for maintenance and cleaning.

Independent liquid cover film technology

● works long with IHC staining
secondary antibody PA-3600 Fully Automated IHC Staining Instrument ● Improve reaction efficiency and ensure staining quality

RFID chip technology

● Reduce the pre-treatment time of the experiment, and place the reagent bottle without restriction.
● 40 reagent bottles are equipped with independent scanning antennas, and the time to identify 40

Efficient, flexible and stable reagent bottles is less than 10s. It is recognized when inserted, efficient and accurate.

                ƒ  
QR code identification technology

01 02 03 ● Using QR code technology to identify slides, slides can be placed at will

● Identify 36 slides <30s

Flexibility Optimal quality High Accuracy

RFID chip technology,
supports customization of Automatic scanning of reagent
incubation time and Staining cover plate & information to reduce manual Economical reagent design
temperature for each slide wave-like mixing technology errors and real-time monitoring
of reagent capacity ● Only needs 130 μL to cover the whole slide
● Reduce reagent residue

04 05
High workflow Uninterrupted operation
Eco-friendly design efficiency ● During operation, slides can be loaded continuously without interfering with existing
V-shape design bottom of Continuous and random slide
bottle enables small processing to optimize staining procedure.
amount of reagent residue laboratory workflow ● In the same way as stain module.

42
41
 Software Operation Interface

Clear Partition & Situation Display &

Easy Operation
High Visualization Reminding Timely

Instrument
status display

Function button

Reagent status display

Staining operation

Waste container
status display

Buffer status display

WORK PROCESS

Dewaxing

Dry Chemistry
Antigen
Bake and Staining Re-staining
Retrieval
Hydration

    
● PA-3600 Immunostaining Solution

Secondary Antibody ● PA-3600 Dewax Solution

● PA-3600 Wash Solution
Reagent System ● PA-3600 Antigen Retrieval Solution (PH9.0)
● PA-3600 Antigen Retrieval Solution (PH6.0)
43
 MAIN SPECIFICATIONS

Test channel 1
Dimension 331.5 (L) * 220.5 (W) * 153 (H) mm
Weight 2.3 kg
Screen 8 inches
Record storage 50,000
Incubation zone temperature 37 °C ±0.3°C
Thermal Printer Auto-print, Support for external printing
Power adapter AC 220 V ±22 V, 50 Hz ±1 Hz
Cable Interface USB 2.0*2, RS232 Interface*1, LIS/HIS Interface*1

ONE-STEP OPERATION

APPLICATION SCENARIOS COMPARED WITH OTHER BIOCHEMICAL ANALYZERS

46
45
 Test Parameters

WONDFO COVID-19
DIAGNOSTIC SOLUTION
 ƒ     ƒ     ­ †‡ ˆ       ‰

44
47
 COVID-19 COVID-19 PRODUCT
              ­          
*For illustrative purpose only

Incubation Period

IgM+IgG
Recovery

IgG
15 mins 2~30 °C
Levels

Virus (PCR, Antigen

IgA

IgA
Wondfo 2019-nCoV Antigen Test
15 mins 2~30 °C 0123 1/5 T
IgM Virus (For Self-testing)
IgM
Minimum detectable limit

-7 0 7 14 21 28 35 Days after onset of symptoms

15 mins 2~30 °C 20 T
First infection Symptom onset Second infection
Antigen Window Period
Testing Period
PCR

IgA
15 mins 4~30 °C 25 T
IgM

IgG

IgM+IgG
15 mins 4~30 °C 25 T
* Incubation Period: 1~14 days, mostly 3~7 days * The minimum detectable limit varies with methodology and sensitivity of test
* Antibody Window Period 5-10 days after onset of symptoms * IgG antibody test can be referred as one of discharge criteria for recovering COVID-19 patients

10 mins 4~30 °C 25 T

Molecular Test Antigen Test 10 mins 4~30 °C 25 T

FinecareTM FIA Platform
• 2019-nCoV Antigen Test
10 mins 4~30 °C 25 T
2019-nCoV
2019-nCoV
Ant ibody
Tes t (L
Colloidal Gold Platform
ateral
Flow
Met hod
C ontents )
20
:
1. 20 individual
Test cassette pouches,
Desiccant each containing: Qarad
BV
Cipalstraat
2. 20 disposable pouch 2440
Geel, 3
Belgium
3. Detection droppers
4. Leaflet b uffer
( 1*6 mL)
with instructions
for use

• 2019-noV Antigen Test

Version:
Rel.: 2020/12/23
A3

10 mins 4~30 °C 25 T
(NP/OP/Nasal/Saliva/Sputum)
ACCRE CLIA Platform
• Influenza/2019-nCoV Antigen Combo Test
• 2019-nCoV Real-time RT-PCR Assay • 2019-nCoV Antigen (CLIA)

10~30 °C

Antibody Test
U-Card DxTM 2019-nCoV/Flu Test Nasopharyngeal swab 40 mins 2~30 °C 12/24 T WG01P0001/2

FinecareTM FIA Platform ACCRE CLIA Platform

U-Card DxTM 2019-nCoV Test Nasopharyngeal swab 40 mins 2~30 °C 12/24 T WG01P0001/2
• 2019-nCoV IgM/IgG Test
• 2019-nCoV Antibody Test • 2019-nCoV IgG kit (CLIA)
U-Card Dx™ System • 2019-nCoV IgM Test • 2019-nCoV IgM kit (CLIA)
• 2019-nCoV IgG Test 2019-nCoV IgG kit (CLIA) Serum/Plasma 22 mins 2~8 °C 36/60 T W78
• 2019-nCoV/Flu Test
• 2019-nCoV Test

2019-nCoV IgM kit (CLIA) Serum/Plasma 22 mins 2~8 °C 36/60 T W77

2019-nCoV Neutralizing Serum/Plasma 15 mins 2~8 °C 36/60 T W101

Antibodies (CLIA)
ACCRE CLIA
2019-nCoV Antigen (CLIA) Nasal swab 20 mins 2~8 °C 36/60 T W94
Finecare FIATM
ACCRE CLIA Platform
Neutralizing Antibody Test Platform
• 2019-nCoV Neutralizing
• 2019-nCoV RBD Test Antibodies (CLIA)

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Vision
Racing for life

Mission
Make biotechnology benefit the public

WONDFO MASCOT – FOFO

Core Values
                                    .
We strive to achieve goals with full passion to meet every customer’s needs; we
respect every employee and give them opportunities to constantly improve
themselves; we dare to dream and act to bring success to every partner.
We pursue excellence to safeguard everyone’s health.

                            
                     .