Shenzhen A&E Health Technology Co.

, Ltd
Add: 1008 No.7 Wuhe Road, Wuhe Community, Bantian Street, Longgang District,
Shenzhen
Ph: +8618680372609 Whatsapp/Skype/Zalo/Viber: +86186803726089

* WB/S/P-Whole blood, Serum or Plasma; "*"-standard value;

1.1 Fertility Rapid Tests-Women's Healthcare Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
Premature rupture of the
IGFBP-1
RFPROM amniotic membranes (PROM) Vaginal Secretions 25ng/ml See Insert Cassette 20T CE
(PROM)
Test
RFfFNC fFN Fetal fibronectin Test Vaginal Secretions See Insert See Insert Cassette 20T CE
RFVPHC Vaginal pH Vaginal pH Test Vaginal Secretions 3.8~4.5 See Insert Panel 50T CE
Bacterial Vaginosis Rapid Test
RFBTVC BV Vaginal Secretions 7.8U/ml 100% 0.986 Solution 50T CE
(Sialidase)
Trichomonas Vaginalis (T.V)
RFWTVC TV Vaginal Secretions See Insert See Insert Cassette 20T CE
Antigen Rapid test

1.2 Fertility Rapid Tests-TORCH Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
IgG Antibody to Toxoplasma
RF411C TOXO IgG Serum/Plasma 91.60% 98.50% Cassette 25T ISO13485
Gondii Test
IgM Antibody to Toxoplasma
RF421C TOXO IgM Serum/Plasma 98.20% 99.30% Cassette 25T ISO13485
Gondii Test
IgG Antibody to Cytomegalo
RF511C CMV IgG Serum/Plasma 90.00% 97.30% Cassette 25T ISO13485
Virus Test
IgM Antibody to Cytomegalo
RF521C CMV IgM Serum/Plasma 96.15% 98.21% Cassette 25T ISO13485
Virus Test
IgG Antibody to Rubella Virus
RF611C RUB IgG Serum/Plasma 91.40% 97.70% Cassette 25T ISO13485
Test
IgM Antibody to Rubella Virus
RF621C RUB IgM Serum/Plasma 95.00% 99.10% Cassette 25T ISO13485
Test
IgG Antibody to Herpes Simples
RF711C HSV IgG Serum/Plasma 96.20% 95.00% Cassette 25T CE
Virus Type 1&2 Test
IgM Antibody to Herpes Simples
RF721C HSV IgM Serum/Plasma 94.70% 94.30% Cassette 25T CE
Virus Type 1&2 Test
IgG and IgM Antibodies to
IgG:91.6% IgG:98.5%
RF401C TOXO IgG/IgM Toxoplasma Gondii 3-line Test or Serum/Plasma Cassette 25T ISO13485
IgM:98.2% IgM:99.3%
duo test
IgG and IgM Antibodies to
IgG:91.6% IgG:98.5%
RF402C TOXO IgG/IgM Toxoplasma Gondii 3-line Test or Combo(WB/S/P) Cassette 25T ISO13485
IgM:98.2% IgM:99.3%
duo test
IgG and IgM Antibodies to
IgG:97.3% IgG:97.4%
RF501C CMV IgG/IgM Cytomegalo Virus 3-line Test or Serum/Plasma Cassette 25T ISO13485
IgM:96.15% IgM:98.21%
duo test
IgG and IgM Antibodies to
IgG:91.4% IgG:97.7%
RF601C RUB IgG/IgM Rubella Virus 3-line Test or duo Serum/Plasma Cassette 25T ISO13485
IgM:94.3% IgM:98.3%
test
IgG and IgM Antibodies to
IgG:96.2% IgG:95.0%
RF701C HSV IgG/IgM Herpes Simples Virus Type 1&2 Serum/Plasma Cassette 25T CE
IgM:94.7% IgM:94.3%
3-line Test or duo test
ToRCH IgG TOXO IgG, CMV IgG, RUB IgG,
RF011C Serum/Plasma See Insert See Insert Cassette 25T ISO13485
Combo HSV1/2 IgG Combo Test
ToRCH IgM TOXO IgG, CMV IgG, RUB IgG,
RF021C Serum/Plasma See Insert See Insert Cassette 25T ISO13485
Combo HSV1/2 IgM Combo Test

1.3 Fertility Rapid Tests-Hormone Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
human Chorionic Gonadotropin
RF100S2 HCG (hCG) Test; Early Detection Urine 25 mIU/mL >99% 2.5mm Strip 50T CE
Pregnancy Test
RF100S3 HCG Early Detection Pregnancy Test Urine 25 mIU/mL >99% 3mm Strip 50T CE
RF100S4 HCG Early Detection Pregnancy Test Urine 25 mIU/mL >99% 4mm Strip 50T CE
RF100C3 HCG Early Detection Pregnancy Test Urine 25 mIU/mL >99% 3mm Cassette 25T CE
RF100C4 HCG Early Detection Pregnancy Test Urine 25 mIU/mL >99% 4mm Cassette 25T CE
Pregnancy Ultra-Sensitive
RF1011S2 HCG-Ultra Serum/Urine 10 mIU/mL >99% 2.5mm Strip 50T CE
Cobmo Test
Pregnancy Ultra-Sensitive
RF1011S3 HCG-Ultra Serum/Urine 10 mIU/mL >99% 3mm Strip 50T CE
Cobmo Test
Pregnancy Ultra-Sensitive
RF1011S4 HCG-Ultra Serum/Urine 10 mIU/mL >99% 4mm Strip 50T CE
Cobmo Test
Pregnancy Ultra-Sensitive
RF1011C3 HCG-Ultra Serum/Urine 10 mIU/mL >99% 3mm Cassette 25T CE
Cobmo Test
Pregnancy Ultra-Sensitive
RF1011C4 HCG-Ultra Serum/Urine 10 mIU/mL >99% 4mm Cassette 25T CE
Cobmo Test
Pregnancy Test for
RF100SB4 HCG-OTC Professional&Self-testing Urine 25*/10mIU/mL >99% Strip 1T CE
1Test/Kit
 Pregnancy Test for Professional
RF100CB4 HCG-OTC Urine 25*/10mIU/mL >99% 4mm Cassette 1T CE
& Self-testing 1Test/Kit
Pregnancy Test for Professional 4mm
RF100MB4 HCG-OTC Urine 25*/10mIU/mL >99% 1T CE
& Self-testing 1Test/Kit Midstream
Pregnancy Test for Professional 5.5mm
RF100MB5 HCG-OTC Urine 25*/10mIU/mL >99% 1T CE
& Self-testing 1Test/Kit Midstream
Pregnancy Test for Professional 6mm
RF100MB6 HCG-OTC Urine 25*/10mIU/mL >99% 1T CE
& Self-testing 1Test/Kit Midstream
Luteinizing Hormone (LH) Test;
Ovulation Test for 25*/40*
RF200SB4 LH Urine >99% *4mm Strip 5T CE
Professional&Self-testing mIU/mL
5Tests/Kit
Ovulation Test for
25*/40*
RF200CB4 LH Professional&Self-testing Urine >99% 4mm Cassette 5T CE
mIU/mL
5Tests/Kit
Ovulation Test for
25*/40* 4mm
RF200MB4 LH Professional&Self-testing Urine >99% 5T CE
mIU/mL Midstream
5Tests/Kit
Ovulation Test for
25*/40* 5.5mm
RF200MB5 LH Professional&Self-testing Urine >99% 5T CE
mIU/mL Midstream
5Tests/Kit
Ovulation Test for
25*/40* 6mm
RF200MB6 LH Professional&Self-testing Urine >99% 5T CE
mIU/mL Midstream
5Tests/Kit
Follicle Stimulating Hormone
RF300S FSH Urine 25 mIU/mL 94% Strip 100T CE
(FSH) Test; Menopause Test
Follicle Stimulating Hormone
RF300C FSH Urine 25 mIU/mL 94% Cassette 25T CE
(FSH) Test; Menopause Test

2.1 Infectious Disease Rapid Tests-Hepatitis Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
HIV/HCV/HBsA HIV 1/2 Ab,HCV Ab, HBsAg and
RI400C Serum/Plasma See Insert See Insert Cassette 25T ISO13485
g/SYP Syphilis Combo Test
HBsAg, HBsAb, HBcAb, HBeAb,
RI201C HBV Serum/Plasma See Insert See Insert Cassette 25T ISO13485
HBeAg 5-in-1 Test
IgM Antibody to Hepatitis A
RI101S HAV IgM Serum/Plasma 98.50% 98.10% Strip 50T CE
Virus Test
IgM Antibody to Hepatitis A
RI101C HAV IgM Serum/Plasma 98.50% 98.10% Cassette 25T CE
Virus Test
IgM Antibody to Hepatitis E
RI001S HEV IgM Serum/Plasma 99.10% 99.40% Strip 50T CE
Virus Test
IgM Antibody to Hepatitis E
RI001C HEV IgM Serum/Plasma 99.10% 99.40% Cassette 25T CE
Virus Test
Antibodies to Hepatits C Virus
RI301S Anti-HCV Serum/Plasma 98.10% 98.90% Strip 50T ISO13485
Test
Antibodies to Hepatits C Virus
RI301C Anti-HCV Serum/Plasma 98.10% 98.90% Cassette 25T ISO13485
Test
Antibodies to Hepatits C Virus
RI302S Anti-HCV Combo(WB/S/P) 98.10% 98.90% Strip 50T ISO13485
Combo Test
Antibodies to Hepatits C Virus
RI302C Anti-HCV Combo(WB/S/P) 98.10% 98.90% Cassette 25T ISO13485
Combo Test
RI221S HBsAg Hepatits B Surface Antigen Test Serum/Plasma 1.0ng/ml 99.50% Strip *50T/100T ISO13485
RI221C HBsAg Hepatits B Surface Antigen Test Serum/Plasma 1.0ng/ml 99.50% Cassette 25T ISO13485
Hepatits B Surface Antigen
RI222S HBsAg Combo(WB/S/P) 1.0ng/ml 99.50% Strip 50T ISO13485
Cobmo Test
Hepatits B Surface Antigen
RI222C HBsAg Combo(WB/S/P) 1.0ng/ml 99.50% Cassette 25T ISO13485
Combo Test
Antibodies to Hepatitis B Surface
RI211S HBsAb Serum/Plasma 96.00% See Insert Strip 100T ISO13485
Antigen Test
Antibodies to Hepatitis B Surface
RI211C HBsAb Serum/Plasma 96.00% See Insert Cassette 25T ISO13485
Antigen Test
RI231S HBcAb Hepatitis B core Antibody Test Serum/Plasma 99.00% See Insert Strip 100T ISO13485
RI231C HBcAb Hepatitis B core Antibody Test Serum/Plasma 99.00% See Insert Cassette 25T ISO13485
RI241S HBeAb Hepatitis B e Antibody Test Serum/Plasma 99.00% See Insert Strip 100T ISO13485
RI241C HBeAb Hepatitis B e Antibody Test Serum/Plasma 99.00% See Insert Cassette 25T ISO13485
RI251S HBeAg Hepatitis B e Antigen Test Serum/Plasma 99.00% See Insert Strip 100T ISO13485
RI251C HBeAg Hepatitis B e Antigen Test Serum/Plasma 99.00% See Insert Cassette 25T ISO13485

2.2 Infectious Disease Rapid Tests-Gastrointestinal Disease Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE

RI411S H.Pylori Ab Helicobactor Pylori Antibody Test Serum/Plasma 97.10% 97.80% Strip *50T/100T CE

RI411C H.Pylori Ab Helicobactor Pylori Antibody Test Serum/Plasma 97.10% 97.80% Cassette 25T CE
Helicobactor Pylori Antibody
RI412S H.Pylori Ab Combo(WB/S/P) 97.10% 97.80% Strip 50T CE
Combo Test
Helicobactor Pylori Antibody
RI412C H.Pylori Ab Combo(WB/S/P) 97.10% 97.80% Cassette 25T CE
Combo Test
 Helicobactor Pylori Antibody
Combo Test with individual
RI412CII H.Pylori Ab Combo(WB/S/P) 97.10% 97.80% Cassette 25T CE
buffer, safety lancet, alcohol
pad, etc.
RI424S H.Pylori Ag Helicobactor Pylori Antigen Test Stool 98.80% 98.90% Strip 20T CE
RI424C H.Pylori Ag Helicobactor Pylori Antigen Test Stool 98.80% 98.90% Cassette 20T CE
100ng/ml
RI4LFC LF (Lactoferrin) Lactoferrin Rapid Test Stool See Insert Cassette 20T CE
(10ug/g)
RI4CAL Calprotectin Calprotectin Rapid Test Stool 500ng/ml See Insert Cassette 20T CE
Calprotectin/Lactoferrin Rapid CP50ug/g
RICPLF CP/LF Stool See Insert Cassette 20T CE
Test LF10ug/g
C. Difficile Clostridium difficile glutamate
RI4GDH Stool 99.00% See Insert Cassette 20T CE
(GDH) Ag dehydrogenase antigenTest
C. Difficile Toxin
RI4TAB C. Difficile Toxin A/B Stool See Insert See Insert Cassette 20T CE
A/B
Entamoeba histolytica antigen
RI4ENT Entamoeba Stool 90.00% See Insert Cassette 20T CE
Test
RI4GIA Giardia Giardia lamblia antigen Test Stool 95.00% See Insert Cassette 20T CE
Escherichia coli O157 antigen
RIO157 E.coli O157 Stool 93.00% See Insert Cassette 20T CE
Test
V.Cholera (VC01 Vibrio Cholera (VC01 Inaba) 96.3%
RIVC011 Stool/Water See Insert Cassette 20T CE
Inaba) Rapid Test (104cfu/ml)
V.Cholera (VC01 Vibrio Cholera (VC01 Ogawa) 96.3%
RIVC012 Stool/Water See Insert Cassette 20T CE
Ogawa) Rapid Test (104cfu/ml)
V.Cholera Vibrio Cholera (VC0139) Rapid 96.3%
RIVC139 Stool/Water 97.80% Cassette 20T CE
(VC0139) Test (104cfu/ml)
Hand-foot and mouth
RIEV71 EV71 Combo(WB/S/P) 97.90% 98.60% Cassette 20T CE
disease/HFMD Test
RI104C RV Ag Rotavirus Antigen Test Stool 99.10% 99.50% Cassette 20T CE
RI204C ADV Ag Adenovirus Antigen Test Stool 99.90% 99.60% Cassette 20T CE
Rotavirus and Adenovirus RV:99.1% RV:99.5%
RI124C RV/ADV Ag Stool Cassette 20T CE
Antigens 3-line Test ADV:99.9% ADV:99.6%

2.3 Infectious Disease Rapid Tests-Respiratory Disease Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
200IU/ml,100
RIASOC ASO Antistreptolysin O Rapid Test Combo(WB/S/P) 100% Cassette 20T CE
%
Antibodies to Mycobacterium
RI501C M.TB Ab Serum/Plasma 76.60% 84% Cassette 25T CE
Tuberculosis Test
IgG and IgM Antibodies to IgG:87.2% IgG:95.6%
RI522C TB IgG/IgM Combo(WB/S/P) Cassette 25T CE
Mycobacterium Tuberculosis Test IgM:83.5% IgM:95.1%

IgG and IgM Antibodies to IgG:87.2% IgG:95.6%

RI522C TB IgG/IgM Combo(WB/S/P) Cassette 25T CE
Mycobacterium Tuberculosis Test IgM:83.5% IgM:95.1%
Group A Streptococcal Antigen 95.35% 1.0×
RI603S Strep A Ag Throat Swab See Insert Strip 20T CE
Test 105 org
Group A Streptococcal Antigen 95.35% 1.0×
RI603C Strep A Ag Throat Swab See Insert Cassette 20T CE
Test 105 org
Group B Streptococcal Antigen 90.48% 5.0×
RI604S StrepB Ag Throat Swab See Insert Strip 20T CE
Test 105 CFU
Group B Streptococcal Antigen 90.48% 5.0×
RI604C StrepB Ag Throat Swab See Insert Cassette 20T CE
Test 105 CFU
IgG antibody to Chlamydia
RICPN1 CPN IgG Combo(WB/S/P) 98.20% 98.90% Cassette 25T CE
Pneumoniae Test
IgM antibody to Chlamydia
RICPN2 CPN IgM Combo(WB/S/P) 97.94% 98.60% Cassette 25T CE
Pneumoniae Test
IgG antibody to Mycoplasma
RI901C MP IgG Combo(WB/S/P) 99.10% 98.75% Cassette 25T CE
Pneumoniae Test
IgM antibody to Mycoplasma >77% for
RI902C MP IgM Combo(WB/S/P) 99.13% Cassette 25T CE
Pneumoniae Test confirmed
RSV (long):
1.07*104
Respiratory Syncytial Virus Nasal TCID50/mL
RIRSVC RSV Ag RSV (wild): See Insert Cassette 20T CE
Antigen Test Swab/Aspiration
1.07*104
TCID50/mL
Influenza type A (including the 3.5×104
RI002S FLU A Ag Swab See Insert Strip 20T CE
subtype H1N1) antigen Test TCID50/ml
4
Influenza type A (including the 3.5×10
RI002C FLU A Ag Swab See Insert Cassette 20T CE
subtype H1N1) antigen Test TCID50/ml
FLU A: 3.5×
Influenza A and B Antigen 3-line 104 TCID50/ml
RI003S FLU A/B Ag Swab FLU B: 1.5× See Insert Strip 20T CE
Test
105 TCID50/ml
 FLU A: 3.5×
Influenza A and B Antigen 3-line 104 TCID50/ml
RI003C FLU A/B Ag Swab FLU B: 1.5× See Insert Cassette 20T CE
Test
105 TCID50/ml

2.4 Infectious Disease Rapid Tests-Sexual Transmitted Diseases (STDs) Rapid Test Kits
CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
Antibodies to Human
RS120C HIV 1.2.O Immunodeficiency Virus type 1,2 Combo(WB/S/P) 100.00% 99.30% Cassette 25T ISO13485
and O Cobmo Test
Antibodies to Human
RS111S HIV 1/2 Ab Immunodeficiency Virus type 1 Serum/Plasma 99.50% 99.80% Strip *50T/100T ISO13485
and type 2 Test
Antibodies to Human
RS111C HIV 1/2 Ab Immunodeficiency Virus type 1 Serum/Plasma 99.50% 99.80% Cassette 25T ISO13485
and type 2 Test
Antibodies to Human
RS112S HIV 1/2 Ab Immunodeficiency Virus type 1 Combo(WB/S/P) 99.50% 99.80% Strip 50T ISO13485
and type 2 Combo Test
Antibodies to Human
RS112C HIV 1/2 Ab Immunodeficiency Virus type 1 Combo(WB/S/P) 99.50% 99.80% Cassette 25T ISO13485
and type 2 Combo Test
RS201S SYP (TP) Ab Syphilis (Tp) Ab Test Serum/Plasma 99.54% 99.80% Strip *50T/100T CE
RS201C SYP (TP) Ab Syphilis (Tp) Ab Test Serum/Plasma 99.54% 99.80% Cassette 25T CE
RS202S SYP (TP) Ab Syphilis (Tp) Ab Combo Test Combo(WB/S/P) 99.54% 99.80% Strip 50T CE
RS202C SYP (TP) Ab Syphilis (Tp) Ab Combo Test Combo(WB/S/P) 99.54% 99.80% Cassette 25T CE
NGH Ag Neisseria Gonorrheae (NGH)
RS303C Swab See Insert See Insert Cassette 20T CE
(Gonorrheae) Antigen Test
RS403C CHLA Ag Chlamydia Antigen Test Swab/urine See Insert See Insert Cassette 20T CE

2.5 Infectious Disease Rapid Tests-Tropical Diseases Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
100%
RI712C Malaria Pf Ag Malaria Pf Antigen Test Whole Blood Pf:98.9% Cassette 25T CE
（50pcs/ul）
Pf:100% Pf:98.9%
RI702C Malaria Pan Ag Malaria Pan Antigen Test Whole Blood Cassette 25T CE
Pv:100% Pv:99%
Malaria Pf/Pv Malaria P.f/P.v Antibody 3-line Pf:88.20% Pf:93.8%
RI732C Combo(WB/S/P) Cassette 25T CE
Ab test Pv:91.30% Pv:95.3%
Malaria Pf/Pv Pf:100% Pf:98.9%
RI742C Malaria P.f/P.v Antigen 3-line test Whole Blood Cassette 25T CE
Ag Pv:100% Pv:99.0%
Malaria Pf/PanMalaria P.f/Pan Antigen 3-line Pf:100% Pf:98.9%
RI752C Whole Blood Cassette 25T CE
Ag Rapid test Pv:100% Pv:99.0%
Ns1 Antigen to Dengue virus
RID01C Dengue Ns1 Ag Combo(WB/S/P) 95.70% 97.70% Cassette 25T CE
Test
Dengue IgG and IgM antibodies to 95.8% See 99.3% See
RID02C Combo(WB/S/P) Cassette 25T CE
IgG/IgM Dengue virus 3-line Test Insert Insert
Ns1 Antigen, IgG and IgM
Dengue
RID03C antibodies to Dengue virus Duo Combo(WB/S/P) See Insert See Insert Cassette 25T CE
Ns1+IgG/IgM
Test
IgG and IgM antibodies to
Typhoid IgG:91.6% IgG:97.5%
RI801C Salmonella typhoid and Para- Serum/Plasma Cassette 25T CE
IgG/IgM IgM:92.8% IgM:97.6%
typhoid 3-line Test
Serum/Plasma/Stoo
RI824C S.Typhi Ag Salmonella Typhi Antigen Test 98.70% 98.10% Cassette 20T CE
l
RICGSC Chagas Ab IgG anti-Trypanosoma cruzi Test Combo(WB/S/P) 94.70% 98.70% Cassette 25T CE
Chikungunya
RICHKC IgM anti-Chikungunya Virus Test Combo(WB/S/P) 96.90% 98.10% Cassette 25T CE
IgM
Chikungunya IgG and IgM antibodies to IgG:94.3% IgG:95.6%
RICIKC Combo(WB/S/P) Cassette 25T CE
IgG/IgM Chikungunya Virus Test IgM:90.3% IgM:92.5%
Filariasis IgG and IgM antibodies to IgG:92.3% IgG:99.1%
RIFILC Combo(WB/S/P) Cassette 25T CE
IgG/IgM Filariasis Virus Test IgM:99.9% IgM:99.6%
Leishmania IgG and IgM antibodies to IgG:92.9% IgG:98.6%
RILSMC Combo(WB/S/P) Cassette 25T CE
IgG/IgM Leishmania Virus Test IgM:91.2% IgM:97.9%
Leptospira IgG and IgM antibodies to IgG:99.9% IgG:99.0%
RILPTC Combo(WB/S/P) Cassette 25T CE
IgG/IgM Leptospira Virus Test IgM:90% IgM:98.6%

3. Cardiac Markers Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
99.4%
RC102C cTn-I Cardiac Tropnin I Test Combo(WB/S/P) 99.10% Cassette 25T CE
(0.5ng/mL)
 99.9%
RC202C MYO Myoglobin (MYO) Test Combo(WB/S/P) 97.50% Cassette 25T CE
(50ng/mL)
MB isozyme of Creatine Kinase 99.9%
RC302C CK-MB Combo(WB/S/P) 99.40% Cassette 25T CE
(CK-MB) Test (5ng/mL)
C-Reactive Protein (CRP) Semi- 98.4%
RC402C CRP Combo(WB/S/P) 97.30% Cassette 25T CE
Quantitative Test (3~10ng/mL)
RC502C PCT Procalcitonin Test Combo(WB/S/P) 98.70% 99.00% Cassette 25T CE
99.9%
RC602C D-dimer D-dimer Test Combo(WB/S/P) 0.982 Cassette 25T CE
(400ng/mL)
Heart Type Fatty Acid-Binding 89.9% (8
RC702C H-FABP Combo(WB/S/P) 90.70% Cassette 25T CE
protein (H-FABP) Test ng/mL)
Heart Type Fatty Acid-Binding
RC802C H-FABP/cTNI protein (H-FABP) and Cardiac Combo(WB/S/P) See Insert See Insert Cassette 25T CE
Tropnin I Test
H-FABP and
H-FABP, Myoglobin, CK-MB and
Myoglobin/CK- 8/50/5/0.5ng/
RC902C cardiac Troponin I (cTnI) Combo Combo(WB/S/P) See Insert Cassette 25T CE
MB/Troponin I mL
Rapid Test
Combo
Cardiac Myoglobin, MB isozyme of
Myoglobin/CK- Creatine Kinase, Cardiac Tropnin
RC002C Combo(WB/S/P) 50/5/0.5ng/mL See Insert Cassette 25T CE
MB/Troponin I I Combo Rapid Test 3-in-1
Combo Cassette

4. Tumor Markers Rapid Test Kits

CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
99.1%
RT101S AFP Alpha-fetoprotein Cobmo Test Serum/Plasma 98.90% Strip 50T CE
(20ng/mL)
99.1%
RT101C AFP Alpha-fetoprotein Cobmo Test Serum/Plasma 98.90% Cassette 25T CE
(20ng/mL)
99.1%
RT102S AFP Alpha-fetoprotein Cobmo Test Combo(WB/S/P) 98.90% Strip 50T CE
(20ng/mL)
99.1%
RT102C AFP Alpha-fetoprotein Cobmo Test Combo(WB/S/P) 98.90% Cassette 25T CE
(20ng/mL)
Carcinoma Embryonic Antigen 98.5%
RT201S CEA Serum/Plasma 98.50% Strip 50T CE
Combo Test (5ng/mL)
Carcinoma Embryonic Antigen 98.5%
RT201C CEA Serum/Plasma 98.50% Cassette 25T CE
Combo Test (5ng/mL)
Carcinoma Embryonic Antigen 98.5%
RT202S CEA Combo(WB/S/P) 98.50% Strip 50T CE
Combo Test (5ng/mL)
Carcinoma Embryonic Antigen 98.5%
RT202C CEA Combo(WB/S/P) 98.50% Cassette 25T CE
Combo Test (5ng/mL)
Fecal Occult Blood (Hemoglobin) 50ng*/200ng/
RT304S FOB Feces See Insert Strip 20T CE
Test mL
Fecal Occult Blood (Hemoglobin) 50ng*/200ng/
RT304C FOB Feces See Insert Cassette 20T CE
Test mL
RT501S TF Transferrin Test Feces 10ng/ml See Insert Strip 20T CE
RT501C TF Transferrin Test Feces 10ng/ml See Insert Cassette 20T CE
HB-200ng/ml
RT601C FOB/TF Hemoglobin and transferrin Test Feces See Insert Cassette 20T CE
TF-10ng/ml
98.7%
RT401S PSA Prostate Specific Antigen Test Serum/Plasma 98.60% Strip *50T/100T ISO13485
(4ng/mL)
98.7%
RT401C PSA Prostate Specific Antigen Test Serum/Plasma 98.60% Cassette 25T ISO13485
(4ng/mL)
98.7%
RT402S PSA Prostate Specific Antigen Test Combo(WB/S/P) 98.60% Strip 50T ISO13485
(4ng/mL)
98.7%
RT402C PSA Prostate Specific Antigen Test Combo(WB/S/P) 98.60% Cassette 25T ISO13485
(4ng/mL)
Prostate Specific Antigen Semi- 98.7%
RT403C PSA Semi-Q Combo(WB/S/P) 98.60% Cassette 25T ISO13485
Quantitative 3-line Test (4~10ng/mL)

5.1 Drugs Of Abuses (DOAs) Urine Rapid Tests- Single Common Drug Urine Rapid Test Kits
DESCRIPTION
CAT # PRODUCT SPECIMEN CUT-OFF ACCURACY FORMAT KIT SIZE CERTIFICATE
(CALIBRATOR)
RDALCU ALC Alcohol Test Urine 0.02% B.A.C See Insert Strip 100T CE
Amphetamine Test (d- 1000*/500/300
RD101S AMP Urine See Insert Strip 100T CE
Amphetamine) ng/Ml
Amphetamine Test (d- 1000*/500/300
RD101C AMP Urine See Insert Cassette 25T CE
Amphetamine) ng/Ml
300*/200
RD201S BAR Barbiturates Test (Secobarbital) Urine See Insert Strip 100T CE
ng/mL
300*/200
RD201C BAR Barbiturates Test (Secobarbital) Urine See Insert Cassette 25T CE
ng/mL
Benzodiazepines Test 300*/500/200/
RD301S BZO Urine See Insert Strip 100T CE
(Oxazepam) 100 ng/mL
Benzodiazepines Test 300*/500/200/
RD301C BZO Urine See Insert Cassette 25T CE
(Oxazepam) 100 ng/mL
Buprenorphine Test
RDB01S BUP Urine 10*/5 ng/mL See Insert Strip 100T CE
(Buprenorphine)
 Buprenorphine Test
RDB01C BUP Urine 10*/5 ng/mL See Insert Cassette 25T CE
(Buprenorphine)
Cocaine Test (Benzoylecgonine) 300*/150/100
RD401S COC Urine See Insert Strip 100T CE
Test ng/mL
Cocaine Test (Benzoylecgonine) 300*/150/100
RD401C COC Urine See Insert Cassette 25T CE
Test ng/mL
1000*/500/300
RDK01S KET Ketamine Test (Ketamine) Urine See Insert Strip 100T CE
/100ng/ml
1000*/500/300
RDK01C KET Ketamine Test (Ketamine) Urine See Insert Cassette 25T CE
/100ng/ml
300*/100
RD501S MOP MorphineTest Urine See Insert Strip 100T CE
ng/mL
300*/100
RD501C MOP Morphine Test Urine See Insert Cassette 25T CE
ng/mL
Methamphetamine (MET/m-
1000*/500/300
RD601S MET AMP) Test (d- Urine See Insert Strip 100T CE
/ ng/mL
Methamphetamine)
Methamphetamine (MET/m-
1000*/500/300
RD601C MET AMP) Test (d- Urine See Insert Cassette 25T CE
/ ng/mL
Methamphetamine)
300*/200
RD701S MTD Methadone Test Urine See Insert Strip 100T CE
ng/mL
300*/200
RD701C MTD Methadone Test Urine See Insert Cassette 25T CE
ng/mL
Ecstasy (MDMA) Test (d,l-
500*/1000
RD801S MDMA Methylenedioxymethamphetamin Urine See Insert Strip 100T CE
ng/mL
e)
Ecstasy (MDMA) Test (d,l-
500*/1000
RD801C MDMA Methylenedioxymethamphetamin Urine See Insert Cassette 25T CE
ng/mL
e)
2000/300
RDO01S OPI Opiates Test (Morphine) Urine See Insert Strip 100T CE
ng/mL
2000/300
RDO01C OPI Opiates Test (Morphine) Urine See Insert Cassette 25T CE
ng/mL
RDP01S PCP Phencyclidine Test Urine 25 ng/mL See Insert Strip 100T CE
RDP01C PCP Phencyclidine Test Urine 25 ng/mL See Insert Cassette 25T CE
RDP02S PPX Propoxyphene Test Urine 300 ng/mL See Insert Strip 100T CE
RDP02C PPX Propoxyphene Test Urine 300 ng/mL See Insert Cassette 25T CE
Tricyclic Antidepressants Test
RDT01S TCA Urine 1000 ng/mL See Insert Strip 100T CE
(Nortriptyline)
Tricyclic Antidepressants Test
RDT01C TCA Urine 1000 ng/mL See Insert Cassette 25T CE
(Nortriptyline)
Cannabis/Marijuana Test (11- 50*/25/300/60
RD901S THC Urine See Insert Strip 100T CE
nor-Δ9-THC-9 COOH) 0 ng/mL
Cannabis/Marijuana Test (11- 50*/25/300/60
RD901C THC Urine See Insert Cassette 25T CE
nor-Δ9-THC-9 COOH) 0 ng/mL
100*/300
RDT01S TML Tramadol Test (Cis-Tramadol) Urine See Insert Strip 100T CE
ng/mL
100*/300
RDT01C TML Tramadol Test (Cis-Tramadol) Urine See Insert Cassette 25T CE
ng/mL

5.2 Drugs Of Abuses (DOAs) Urine Rapid Tests-Single New Drug Urine Rapid Test Kits
DESCRIPTION
CAT # PRODUCT SPECIMEN CUT-OFF ACCURACY FORMAT KIT SIZE CERTIFICATE
(CALIBRATOR)
Acetaminophen Test
RDACES ACE Urine 5000 ng/mL See Insert Strip 100T CE
(Acetaminophen)
Acetaminophen Test
RDACEC ACE Urine 5000 ng/mL See Insert Cassette 25T CE
(Acetaminophen)
RDACLS ACL 7-Aminoclonazepam Test Urine 300 ng/mL See Insert Strip 100T CE
RDACLS ACL 7-Aminoclonazepam Test Urine 300 ng/mL See Insert Cassette 25T CE
RDCAFS CAF Caffeine Test Urine 1000 ng/mL See Insert Strip 100T CE
RDCAFC CAF Caffeine Test Urine 1000 ng/mL See Insert Cassette 25T CE
RDCATS CAT Cathinone Test (Cathine) Urine 150 ng/mL See Insert Strip 100T CE
RDCATC CAT Cathnion Test (Cathine) Urine 150 ng/mL See Insert Cassette 25T CE
400*/150
RDCLOS CLO Clonazepam Test Urine See Insert Strip 100T CE
ng/mL
400*/150
RDCLOC CLO Clonazepam Test Urine See Insert Cassette 25T CE
ng/mL
Nicotine/Cotinine Test (Cotinine) 200*/100/50
RDCOTS COT Urine See Insert Strip 100T CE
Test ng/mL
Nicotine/Cotinine Test (Cotinine) 200*/100/50
RDCOTC COT Urine See Insert Cassette 25T CE
Test ng/mL
RDDIAS DIA Diazepam Test Urine 300 ng/mL See Insert Strip 100T CE
RDDIAC DIA Diazepam Test Urine 300 ng/mL See Insert Cassette 25T CE
2-Ethylidene-1, 5-dimethyl-3, 3- 300*/100
RDEDPS EDDP Urine See Insert Strip 100T CE
diphenylpyrrolidine Test ng/mL
 2-Ethylidene-1, 5-dimethyl-3, 3- 300*/100
RDEDPC EDDP Urine See Insert Cassette 25T CE
diphenylpyrrolidine Test ng/mL
500*/1000
RDETGS ETG Ethyl-β-D-Glucuronide Test Urine See Insert Strip 100T CE
ng/mL
500*/1000
RDETGC ETG Ethyl-β-D-Glucuronide Test Urine See Insert Cassette 25T CE
ng/mL
RDFYLS FYL Fentanyl Test (Norfentanyl) Urine 20*/10 ng/mL See Insert Strip 100T CE
RDFYLC FYL Fentanyl Test (Norfentanyl) Urine 20*/10 ng/mL See Insert Cassette 25T CE
Synthetic Marijuana Test (JWH-
RDK02S K2 Urine 50/30ng/ml See Insert Strip 100T CE
018、JWH-073)
Synthetic Marijuana Test (JWH-
RDK02C K2 Urine 50/30ng/ml See Insert Cassette 25T CE
018、JWH-073)
6-mono-aceto-morphine Test (6-
RDMAMS 6-MAM Urine 10ng/ml See Insert Strip 100T CE
MAM)
6-mono-aceto-morphine Test (6-
RDMAMC 6-MAM Urine 10ng/ml See Insert Cassette 25T CE
MAM)
RDLSDS LSD Lysergic Acid Diethylamide Test Urine 20*/50 ng/mL See Insert Strip 100T CE
RDLSDC LSD Lysergic Acid Diethylamide Test Urine 20*/50 ng/mL See Insert Cassette 25T CE
(±) 3,4-Methylenedioxy-
RDMDAS MDA Urine 500 ng/mL See Insert Strip 100T CE
Amphetamine Test
(±) 3,4-Methylenedioxy-
RDMDAC MDA Urine 500 ng/mL See Insert Cassette 25T CE
Amphetamine Test
Methylenedioxypyrovalerone
RDMDPS MDPV Urine 1000 ng/mL See Insert Strip 100T CE
Test
Methylenedioxypyrovalerone
RDMDPC MDPV Urine 1000 ng/mL See Insert Cassette 25T CE
Test
RDM01S MQL Methaqualone Test Urine 300 ng/mL See Insert Strip 100T CE
RDM01C MQL Methaqualone Test Urine 300 ng/mL See Insert Cassette 25T CE
300*/1000
RDMPDS MPD Methylphenidate Test Urine See Insert Strip 100T CE
ng/mL
300*/1000
RDMPDC MPD Methylphenidate Test Urine See Insert Cassette 25T CE
ng/mL
RDOXYS OXY Oxycodone Test Urine 100 ng/mL See Insert Strip 100T CE
RDOXYC OXY Oxycodone Test Urine 100 ng/mL See Insert Cassette 25T CE
RDTROS TRO Tropicmide Test Urine 350 ng/mL See Insert Strip 100T CE
RDTROC TRO Tropicmide Test Urine 350 ng/mL See Insert Cassette 25T CE
RDZOLS ZOL Zolpidem Test Urine 50 ng/mL See Insert Strip 100T CE
RDZOLC ZOL Zolpidem Test Urine 50 ng/mL See Insert Cassette 25T CE

5.3 Drugs Of Abuses (DOAs) Urine Rapid Tests-Multi-Drug Urine Rapid Test Kits
DESCRIPTION
CAT # PRODUCT SPECIMEN CUT-OFF ACCURACY FORMAT KIT SIZE CERTIFICATE
(CALIBRATOR)
Specimen Validity Tests (S.V.T.)
for Oxidants/PCC, Specific
Adulteration OXI,NIT,SG,GL
RDASVT Gravity, pH, Nitrite, Urine See Insert Strip 25T CE
SVT Test U,pH,CRE
Glutaraldehyde, Creatinine and
Bleach
RD02XMC- DOA 2~14-in-1 Multi-Drug 2~14 in-1 rapid test Multi-in-1
Urine Ref:Analytes See Insert 25T CE
RD12XMC Panel cassett Panel
RD02XMP~RD12XM DOA 2~12-in-1 Multi-Drug 2~12 in-1 rapid test Multi-in-1
Urine Ref:Analytes See Insert 25T CE
P panel dipping panel with with SVT Panel
RD02XCA~RD18XC DOA 2~18-in-1 Multi-Drug 2~18 in-1 rapid test
Urine Ref:Analytes See Insert Multi-in-1 Cup 25T CE
A 1-step cup 1-step cup with SVT
RD02XCB1~RD12X DOA 2~12-in-1 Multi-Drug 2~12 in-1 rapid test
Urine Ref:Analytes See Insert Multi-in-1 Cup 25T CE
CB1 2-step key cup 2-step key cup without SVT
DOA 2~12-in-1
RD02XCB2~RD12X Multi-Drug 2~12 in-1 rapid test
2-step key cup Urine Ref:Analytes See Insert Multi-in-1 Cup 25T CE
CB2 2-step key cup with SVT
with SVT

5.4 Drugs Of Abuse (DOA) Saliva Rapid Tests-Single Drug Saliva Rapid Test Kits
DESCRIPTION
CAT # PRODUCT SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
(CALIBRATOR)
RDSALC1 ALC Alcohol Test (Alcohol) Saliva 0.02% B.A.C See Insert Strip 50T CE
Amphetamine Test (d-
RDS101 AMP Saliva 50 ng/mL See Insert Strip 50T CE
Amphetamine)
RDS201 BAR Barbiturates Test (Secobarbital) Saliva 50/300 ng/mL See Insert Strip 50T CE
Benzodiazepines Test
RDS301 BZO Saliva 10/50 ng/mL See Insert Strip 50T CE
(Oxazepam)
Buprenorphine Test
RDSBUP BUP Saliva 5/10 ng/mL See Insert Strip 50T CE
(Buprenorphine)
RDS401 COC Cocaine Test (Benzoylecgonine) Saliva 20 ng/mL See Insert Strip 50T CE
RDSCOT COT Cotinine/Nicotine Test (Cotinine) Saliva 30/50 ng/mL See Insert Strip 50T CE
RDSK01 KET Ketamine Test (Ketamine) Saliva 50ng/ml See Insert Strip 50T CE
Synthetic Marijuana Test (JWH -
RDSK02 K2 Saliva 25ng/ml See Insert Strip 50T CE
018, JWH- 073)
 m-AMP, Methamphetamine Test
RDS601 MET Saliva 50 ng/mL See Insert Strip 50T CE
(d-Methamphetamine)
RDS701 MTD Methadone Test (Methadone) Saliva 30/75 ng/mL See Insert Strip 50T CE
Ecstasy Test (d,l-
RDS801 MDMA Methylenedioxymethamphetamin Saliva 50 ng/mL See Insert Strip 50T CE
e)
RDSMAM 6-MAM 6-mono-aceto-morphine Saliva 25 ng/mL See Insert Strip 50T CE
RDSOPI OPI Opiates Test (Morphine) Saliva 15/40 ng/mL See Insert Strip 50T CE
RDSOXY OXY Oxycodone Test (Oxycodone) Saliva 20/50 ng/mL See Insert Strip 50T CE
Phencyclidinen Test
RDSPCP PCP Saliva 10 ng/mL See Insert Strip 50T CE
(Phencyclidine)
12/25/50
RDS901 THC Cannabis/Marijuana Test Saliva See Insert Strip 50T CE
ng/mL
RDSTML TML(TRA) Tramadol Test Saliva 100 ng/mL See Insert Strip 50T CE

5.5 Drugs Of Abuses (DOAs) Saliva Rapid Tests-Multi-Drug Saliva Rapid Test Kits
DESCRIPTION
CAT # PRODUCT SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
(CALIBRATOR)
DOA 2~6-in-1 Multi-Drug 2~6 in-1 saliva rapid Multi-in-1
RDSXNCA Saliva Ref:Analytes See Insert 25T CE
Saliva Cassette test cassette Cassette
DOA 2~9-in-1
Multi-Drug 2~9 in-1 saliva rapid Multi-in-1
RDS0XNM Saliva Saliva Ref:Analytes See Insert 25T CE
test midstream Midstream
Midstream
DOA 2~14-in-1 Multi-Drug 2~14 in-1 saliva rapid
RDSCBXXN Saliva Ref:Analytes See Insert Multi-in-1 Cup 25T CE
Saliva Cup test cup

5.6 Multi-in-1 Drugs Rapid Test Kits (part of frequently ordered items for reference)
CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
COC/THC 2-in- Multi-Drug 2-in-1 Urine Rapid
RDMP022 Urine See Insert See Insert 2-in-1 Panel 25T CE
1 Test Panel
MET/OPI/THC Multi-Drug 3-in-1 Urine Rapid
RDMP033 Urine See Insert See Insert 3-in-1 Panel 25T CE
3-in-1 Test Panel
AMP/COC/OPI/ Multi-Drug 4-in-1 Urine Rapid
RDMP042 Urine See Insert See Insert 4-in-1 Panel 25T CE
THC 4-in-1 Test Panel
AMP/COC/MET
Multi-Drug 5-in-1 Urine Rapid
RDMP051 /OPI/THC 5-in- Urine See Insert See Insert 5-in-1 Panel 25T CE
Test Panel
1
AMP/BZO/COC
Multi-Drug 6-in-1 Urine Rapid
RDMP063 /OPI/THC/TML Urine See Insert See Insert 6-in-1 Panel 25T CE
Test Panel
6-in-1
AMP/BAR/BZO/
COC/MET/MD
Multi-Drug 10-in-1 Urine Rapid
RDMP1001 MA Urine See Insert See Insert 10-in-1 Panel 25T CE
Test Panel
MOP/MTD/PCP
/THC 10-in-1
AMP/BAR/BZO/
COC/MDMA/M Multi-Drug 10-in-1 Urine Rapid
RDMP1002 Urine See Insert See Insert 10-in-1 Panel 25T CE
OP/MTD/OPI/T Test Panel
HC/TML 10-in-1

AMP/BAR/BZO/
COC/COT/KET/ Multi-Drug 10-in-1 Urine Rapid
RDMP1003 Urine See Insert See Insert 10-in-1 Panel 25T CE
MDMA/OPI/TH Test Panel
C/TML 10-in-1
ALC/COC/COT/
TML/BAR/KET/
Multi-Drug 10-in-1 Urine Rapid
RD001CA1 THC/ Urine See Insert See Insert 10-in-1 Panel 25T CE
Test Panel
OPI/MDMA/BZ
O 10-in-1
MET/OPI+MDM
Multi-Drug 6-in-1 Urine Rapid
RDMC061 A+COC+AMP+ Urine See Insert See Insert 6-in-1 Cassette 25T CE
Test Cassette (5 Window)
THC 6-in-1
MOP/OPI/MDM
A/PCP/COC/T
ML/BAR/BZO/A Multi-Drug 15-in-1 Urine Rapid 15-in-1 1-step
RD151CA Urine See Insert See Insert Bulk CE
MP/MET/K2/KE Test 1-step Cup Cup
T/THC/BUP/ET
G 15-in-1
AMP/BZO/COC
Multi-Drug 6-in-1 Urine Rapid 6-in-1 2-step
RD061CB2 /OPI/THC/TML Urine See Insert See Insert Bulk CE
Test 2-step key Cup key Cup
6-in-1
AMP/BZO/COC
Multi-Drug 6-in-1 Saliva Rapid 6-in-1
RDS601M /MET/OPI/THC Saliva See Insert See Insert 25T CE
Test Midstream midstream
6-in-1
COC/AMP/BZO
Multi-Drug 6-in-1 Saliva Sapid 6-in-1
RDS61CA +OPI/MET/THC Saliva See Insert See Insert 25T CE
Sest Cassette-A Cassette-A
6-in-1
 6. Other Rapid Test Kits
CAT # PRODUCT DESCRIPTION SPECIMEN SENSITIVITY ACCURACY FORMAT KIT SIZE CERTIFICATE
I+CareTM Human
HIV 1/2 Ab Immunodeficiency Virus
RSHIVCB Saliva 98.28% 99.20% Cassette 1T ISO13485
Saliva Antibodies Type 1 and 2 Saliva
Test 1Test/Kit
Human Immunodeficiency Virus
HIV 1/2 Ab
RSHIVC Antibodies Type 1 and 2 Saliva Saliva 98.28% 99.20% Cassette 20T ISO13485
Saliva
Test
Thyroid stimulating hormone
RNTSHC TSH Combo(WB/S/P) 5µlU/ml,98.1% 98.20% Cassette 25T CE
Test
RCMAUS MAU Microalbumiuria qualitative Test Urine 20ug/mL 98.00% Strip 100T CE
0-20-50-
Microalbumiuria Semi-
RCMAUC MAU Semi-Q Urine 100ug/mL 100.00% Cassette 25T CE
quantitative Test
100%
RI4RFC RF Rheumatoid Factor Rapid Test Combo(WB/S/P) 95.60% 98.00% Cassette 25T CE
Infectious Mononucleosis
RIMONC MONO Combo(WB/S/P) 99.90% 99.30% Cassette 25T CE
heterophile antibodies Test
RITETC Tetanus Tetanus Rapid Test Combo(WB/S/P) 94.10% 97.80% Cassette 25T CE