Bioline ™

PRODUCT CATALOG
INFECTIOUS DISEASES | TOXICOLOGY
ONCOLOGY | WOMEN’S HEALTH | ELISA
TABLE OF CONTENTS
INFECTIOUS DISEASES.......................................................... 4–45
TOXICOLOGY.............................................................................. 46-47
ONCOLOGY............................................................................... 48–49
WOMEN’S HEALTH................................................................... 51–53
ELISA ............................................................................................. 54–56

Bioline™ PRODUCT CATALOGUE | 3

 RAPID DIAGNOSTIC TEST

INFECTIOUS
DISEASES
CHAGAS LEPTOSPIRA
CHOLERA LYMPHATIC FILARIASIS
DENGUE MALARIA
ENTEROVIRUS 71 NOROVIRUS
H.PYLORI ONCHOCERCIASIS
HANTAAN VIRUS ROTA & ADENO VIRUS
HAT RSV
HAV SALMONELLA
HBV STREP A
HCV SYPHILIS
HIV TB
HIV/SYPHILIS DUO TETANU
INFLUENZA A&B TSUTSUGAMUSHI
LEGIONELLA ZIKA
LEISHMANIA

Bioline™ PRODUCT CATALOGUE | 4

 INFECTIOUS DISEASES

Bioline CHAGAS Ab ™

ANTIBODIES TO TRYPANOSOMA CRUZI TEST

Bioline™ Chagas Ab test is an immunochromatographic test for the detection of
antibodies to Trypanosoma cruzi test in human serum, plasma or whole blood.
• Serological antibody test for a fast and easy diagnosis of the disease
• Specimen : Serum, plasma or whole blood (100 μl)
• Test result : 15 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 99.3 %, Specificity 100 % (vs. ELISA)

MATERIALS PROVIDED
• Test device

SIMPLE PROCEDURE

1 Add Specimen
Dispense 100 μl of serum,
plasma or whole blood into
RESULTS INTERPRETATION

the specimen well "S". NEGATIVE

C T

Micropipette POSITIVE
Wait 15 mins. C T

15
MIN
C T INVALID

Chagas Ab
Chagas Ab C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Chagas Ab 49FK10 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 5

INFECTIOUS DISEASES

Bioline CHOLERA Ag O1/O139

™

V. CHOLERAE O1/ O139 ANTIGEN TEST

Bioline™ Cholera Ag O1/O139 test is a rapid immunochromatographic assay for
qualitative detection of Vibrio cholera O1/O139 in human fecal specimens.
• Easy to use, convenient and clean test
• Specimen : Solid fecal specimen (about 50 mg) or liquid fecal specimen (300 μl)
• Test result : 15 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 100 %, Specificity 100 % (vs. Culture)

MATERIALS PROVIDED
• Test device • Specimen collection dropper for
• Specimen collection tube with liquid fecal specimens
extraction buffer • Patient identification label
• Specimen collection swab for solid
fecal specimens

SIMPLE PROCEDURE

1 Open the
cap of the
specimen
2 Insert swab
specimen 3 Assemble
dropping cap
and open the
4 Add Specimen
RESULTS
INTERPRETATION
Insert the swab Dispense 3 drops. Negative
collection specimen or transfer nozzle cap
liquid specimen. C O139 O1
tube
Cholera O1 Ag
Positive
C O139 O1

Cholera O139
C O139 O1
Ag Positive

Cholera O1
C O139 O1
/O139 Ag
Or Wait 15 mins. Positive

Invalid

15
MIN
C O139 O1 C O139 O1

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Cholera Ag O1/O139 44FK30 Device Fecal 20T/Kit

Bioline™ PRODUCT CATALOGUE | 6

 INFECTIOUS DISEASES

Bioline DENGUE DUO ™

SIMULTANEOUS DENGUE NS1 Ag & IgG/IgM AB TEST

Bioline™ Dengue Duo is immunochromatographic assay designed to
detect both dengue virus NS1 antigen and IgG/IgM antibodies against
dengue virus in human whole blood, serum or plasma.
• Ideal diagnostic tool to cover all clinical stages from acute phase to
convalescence phase
• Presumptive differentiation between primary & secondary dengue
infections
• Easy to use rapid test (Test result : 15~20 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-30 °C

ITEM DENGUE NS1 Ag TEST DENGUE IgG/IgM TEST

Position Left side Right side
Use Detection of dengue virus NS1 antigen Detection of IgG and IgM antibodies to dengue virus
The presumptive diagnosis between primary and
Purpose Diagnosis of early acute dengue infection
secondary dengue infection.
Sensitivity 92.4 % 94.2 %
Specificity 98.4 % 96.4 %
Compared method RT-PCR ELISA

MATERIALS PROVIDED
• Test device • Capillary pipette for dengue IgG/IgM test
• Assay diluent for Dengue IgG/IgM test • Disposable dropper for dengue NS1 Ag test

SIMPLE PROCEDURE

1 Add Specimen
Add specimen (NS1 Ag-3 drops,
IgG/IgM-10 μl) into the specimen
2 Add Assay Diluent
Dispense 4 drops of assay
diluent into the round well.
RESULTS INTERPRETATION
C M G C M G C M G
IgG/IgM

well. NS1 Ag
Dengue IgG/IgM
C T C T C T
Dengue NS1 Ag Dengue IgG/IgM Assay Negative NS1 Positive IgG Positive
Diluent

C M G C M G C M G
IgG/IgM
Wait 15-20 mins.
NS1 Ag
C T C T C T
IgM Positive NS1/IgM IgG/IgM

15-20
Positive Positive
INVALID
MIN C M G C M G C M G C M G

IgG/IgM
NS1 Ag
C T C T C T C T

The presence of any test line, no matter how faint, the result is
considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue Duo 11FK45 Combo-Device Serum/Plasma/Whole Blood 10T/Kit

Dengue Duo 11FK46 Combo-Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 7

 INFECTIOUS DISEASES

Bioline DENGUE NS1 Ag

™

DENGUE NS1 ANTIGEN TEST

Bioline™ Dengue NS1 Ag test is an in vitro immunochromatographic, assay
designed to detect Dengue virus NS1 antigen in human serum, plasma or whole
blood.
• Diagnosis of early acute dengue infection from 1 day onset of fever
• Specimen : Serum, plasma or whole blood (100 μl)
• Test result : 15~20 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 92.4 %, Specificity 98.4 %

MATERIALS PROVIDED
• Test device
• Disposable dropper

SIMPLE PROCEDURE

1 Add Specimen
Dispense 3 drops (100 μl) of serum,
plasma or whole blood into the round
RESULTS INTERPRETATION

NEGATIVE
specimen well "S".
C T

POSITIVE
C T
Wait 15-20 mins.

C T INVALID
15-20
Chagas Ab
MIN
Chagas Ab
C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue NS1 Ag 11FK50 Device Serum/Plasma/Whole blood 25T/kit

Bioline™ PRODUCT CATALOGUE | 8

 INFECTIOUS DISEASES

Bioline DENGUE IgG/IgM

™

DENGUE IgG/IgM ANTIBODY TEST

Bioline™ Dengue IgG/IgM test is a solid phase in vitro
immunochromatographic test for the qualitative and differential detection
of IgG and IgM antibodies to dengue virus.
• Differential detection of IgG and IgM antibodies
• Dengue IgG/IgM : Serum / Plasma (5 μl)
• Dengue IgG/IgM WB : Whole blood / Serum / Plasma (10 μl)
• Test result : 15~20 minutes
• Detection of Dengue IgG/IgM Ab against all serotypes; DEN-1,2,3 and 4.
• Presumptive differentiation between primary & secondary dengue
infections
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-30 °C
• Performance:
- Bioline™ Dengue IgG/IgM: Sensitivity 94.6 %,
Specificity 96.5 % (vs.ELISA test)
- Bioline™ Dengue IgG/IgM WB: Sensitivity 94.2 %,
Specificity 96.4 % (vs. ELISA test)

MATERIALS PROVIDED
• Bioline™ Dengue IgG/IgM : Test device, Assay diluent, Capillary pipette (5 μl)
• Bioline™ Dengue IgG/IgM WB : Test device, Assay diluent, Capillary pipette (10 μl)

SIMPLE PROCEDURE

1 Add Specimen
Add specimen into the
specimen well.
2 Add Assay Diluent
Dispense 4 drops of assay
diluent into the round well.
RESULTS INTERPRETATION

NEGATIVE
C M G

Dengue Dengue IgG/ IgG POSITIVE

IgG/IgM (5 μl) IgM WB (10 μl) Assay C M G

Diluent
IgM POSITIVE
Wait 15-20 mins. C M G

IgG and IgM POSITIVE

C M G

15-20
MIN
INVALID

C M G C M G

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue IgG/IgM 11FK10 Device Serum/Plasma 25T/Kit

Dengue IgG/IgM WB 11FK20 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 9

INFECTIOUS DISEASES

Bioline EV71 IgM ™

IgM ANTIBODIES TO ENTEROVIRUS 71 TEST

Bioline™ EV71 IgM test is a rapid, qualitative and differential detection of IgM
antibodies to Enterovirus 71 in human serum or plasma.
• Early diagnosis of acute EV 71 infection
• Differential detection of IgM antibody
• Easy to use: No need of any equipment
• Test result: 15~20 minutes
• Specimen: serum, plasma (5 μl)
• Shelf life and storage temperature: 18 months from the date of manufacturing at
1-30 °C

MATERIALS PROVIDED
• Test device • Assay diluent
• Capillary pipette (5 μl)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of serum or
plasma into the specimen
2 Add Assay Diluent
Dispense 3-4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
well "1".
C T

Capillary Micropipette POSITIVE

pipette
Assay C T
Diluent Wait 15-20 mins.

INVALID
15-20 C T
MIN

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

EV71 IgM 43FK50 Device Serum/Plasma 25T/Kit

Bioline™ PRODUCT CATALOGUE | 10

 INFECTIOUS DISEASES

Bioline H.PYLORI ™

H.PYLORI ANTIBODY TEST

Bioline™ H.pylori test is a rapid test for the qualitative detection of
antibodies of all isotypes (IgG, IgM, IgA, etc.) specific to Helicobacter
pylori in human serum or plasma.
• Detection of all isotypes (IgG, IgM, IgA) antibodies against H.pylori
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 2-30 °C
• Performance: Sensitivity 95.9 %, Specificity 89.6 % (vs. ELISA)
• Specimen : Serum, Plasma

MATERIALS PROVIDED
• Test device/Multi-device • Assay diluent

SIMPLE PROCEDURE

1 2
Add Specimen Add Assay Diluent
Dispense 10 μl of serum or Dispense 3 drops of the assay RESULTS INTERPRETATION
plasma into the specimen diluent. NEGATIVE
well "S".
C T

Device Multi Device POSITIVE

Device Multi Device
Assay Assay Wait 10 mins. C T
Diluent Diluent

10
MIN
C T INVALID

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

H.pylori 04FK10 Device Serum/Plasma 30T/Kit

H.pylori 04FK11 Multi-Device Serum/Plasma 10Tx10/Kit

Bioline™ PRODUCT CATALOGUE | 11

INFECTIOUS DISEASES

Bioline H.PYLORI Ag ™

H.PYLORI ANTIGEN TEST

Bioline™ H.pylori Ag kit is a rapid, qualitative test for the detection of
Helicobacter pylori antigen in human fecal specimens.
• Easy to use
• No need of any equipment
• Test result: 10 -15 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 98.4 %, Specificity 100 % (vs. respiratory test and CLO
test)
• Specimen: Fecal specimens

MATERIALS PROVIDED
• Test device • Specimen collection swab
• Specimen collection tube • Disposable dropper
• Assay diluent • Disposable dropping cap

SIMPLE PROCEDURE

1 Add
Assay Diluent 2 Insert swab
specimen 3 Assemble
dropping cap 4 Add Specimen
RESULTS
INTERPRETATION
Transfer Insert the swab Assemble Dispense 3 drops.
assay diluent into the specimen dropping cap NEGATIVE
twice. collection tube and on the specimen
swirl the swab at collection tube.
least 10 times. C T

POSITIVE
X2 Up
to the fill
C T
line
X10
Wait 10-15
mins. INVALID

10-15
MIN
Chagas Ab
Chagas Ab C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

H.pylori Ag 04FK20 Device Fecal 20T/Kit

Bioline™ PRODUCT CATALOGUE | 12

 INFECTIOUS DISEASES

Bioline HANTAANVIRUS
™

HANTAAN VIRUS ANTIBODY TEST

The Bioline™ Hantaanvirus test is rapid, qualitative detection of IgG,
IgM,
IgA antibodies to Hantaan virus in human serum, plasma or whole
blood.
• Disease: Hemorrhagic fever with renal syndrome (HFRS)
• Specimen : Serum, Plasma (10 μl) / Whole blood (20 μl)
• Test result : 15~20 minutes
• Shelf life and storage temperature: 18 months from the date of
manufacturing at 1-30 °C
• Performance: Sensitivity 96 %, Specificity 94 %

MATERIALS PROVIDED
• Test device
• Assay diluent

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of serum,
plasma, or 20 μl of whole
2 Add Assay Diluent
Dispense 3-4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
blood into the specimen
well "S". C T

POSITIVE
Device Multi Device Device Multi Device
C T
Assay Assay
Diluent Diluent
Wait 15-20 mins.

C T INVALID
15-20
MIN
C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Hantaanvirus 17FK10 Device Serum/Plasma/Whole blood 30T/Kit

Hantaanvirus 17FK11 Multi-Device Serum/Plasma/Whole blood 10Tx10/Kit

Bioline™ PRODUCT CATALOGUE | 13

INFECTIOUS DISEASES

Bioline HAT ™

T.B.GAMBIENSE ANTIBODY (VSG) TEST

The Bioline™ HAT is an immunochromatographic test for rapid, qualitative
detection of antibodies specific to variable surface glycoprotein (VSG) LiTat 1.3
and LiTat 1.5 of Trypanosomes brucei gambiense (T.b.gambiense ) in human serum,
plasma or whole blood.
• Affordable, easy and rapid testing of suspected HAT patients
• Test results: 15 - 20 minutes
• Specimen: Serum, plasma or whole blood
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-40 °C
• Performance: Sensitivity 98 %, Specificity 87 % (vs. Microscopic examination)

MATERIALS PROVIDED
• Test device • Alcohol swab
• Assay diluent • Lancet
• Capillary pipette (20 μl) (for fingerstick)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of serum, plasma,
or 20 μl of whole blood into the
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS INTERPRETATION

Negative
specimen well "S". C 2 1

T.b. gambiense VSG LiTat

1.3 antibodies
C 2 1
Positive
T.b. gambiense VSG LiTat
Capillary Micropipette C 2 1
1.5 antibodies
Assay Positive
pipette Diluent Wait 15-20 mins.
T.b. gambiense VSG LiTat
1.3 and LiTat 1.5 antibodies
C 2 1
Positive

15-20 Invalid
MIN
C 2 1 C 2 1

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HAT 53FK10 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 14

 INFECTIOUS DISEASES

Bioline HAT 2.0 ™

T.B.GAMBIENSE ANTIBODY (ISG&VSG) TEST

Bioline™ HAT 2.0 is an immunochromatographic test for rapid,
qualitative detection of antibodies of all isotypes (IgG, IgM, IgA)
specific to invariable surface glycoprotein (ISG) or variable surface
glycoprotein (VSG) of Trypanosoma brucei gambiense (T.b. gambiense)
in human serum, plasma or whole blood.
• Affordable, easy and rapid testing of suspected HAT patients
• Test results: 15 - 20 minutes
• Specimen: Serum, plasma or whole blood
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance:
- Device: Sensitivity 97.5 %, Specificity 84.0 % (vs. Microscopic
examination)
- Multi-device: Sensitivity 91.0 %, Specificity 96.5 % (vs. Microscopic
examination)

MATERIALS PROVIDED
• Test device / Multi-device • Alcohol swab
• Assay diluent • Lancet
• Capillary pipette (20 μl) (for fingerstick)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of serum,
plasma, or 20 μl of whole blood
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS
INTERPRETATION
into the specimen well "S". Negative
C 2 1

T.b. gambiense ISG Positive

C 2 1

T.b. gambiense VSG

Device Multi-Device Positive
C 2 1
Assay
Diluent
Assay
Diluent
Wait 15-20 mins.
T.b. gambiense ISG and
VSG Positive
C 2 1

15-20 Invalid
MIN
C 2 1 C 2 1

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HAT 2.0 53FK20 Device Serum/Plasma/Whole Blood 25T/Kit

HAT 2.0 53FK21 Multi-Device Serum/Plasma/Whole Blood 10Tx10/Kit

Bioline™ PRODUCT CATALOGUE | 15

INFECTIOUS DISEASES

Bioline HAV IgG/IgM ™

HEPATITIS A VIRUS ANTIBODY TEST

Bioline™ HAV IgG/IgM rapid test is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM
antibodies to Hepatitis A virus in human serum or plasma.
• Differential detection of IgG and IgM antibodies
• Specimen: Serum, plasma (5 μl)
• Test result: 20 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing
at 1-30 °C
• Performance: Sensitivity 97.6 %, Specificity 98.0 %

MATERIALS PROVIDED
• Test device
• Assay diluent
• Capillary pipette (5 μl)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of specimen
into the specimen well.
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
C M G

IgG POSITIVE
Wait 20 mins. C M G

IgM POSITIVE
C M G
Assay
Micropipette Capillary pipette
20
Diluent
IgG/IgM POSITIVE
C M G
MIN
INVALID

The presence of any test line, no matter how C M G C M G

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HAV IgG/IgM 13FK10 Device Serum/Plasma 25T/Kit

Bioline™ PRODUCT CATALOGUE | 16

 INFECTIOUS DISEASES

Bioline ™

HEPATITIS B SERIES
HEPATITIS B VIRUS TEST

HBsAg, HBsAg WB
Bioline™ Hepatitis tests are intended for professional use as
an aid in the diagnosis of hepatitis B. Highly sensitive, specific
immunochromatographic assays for detection of HBsAg.

HBsAg HBsAg WB
SPECIMEN Serum, Plasma Serum, Plasma, Whole blood
SENSITIVITY 100 % 100 %
SPECIFICITY 100 % 100 %

MATERIALS PROVIDED
• Test device

SIMPLE PROCEDURE

1 Add Specimen
Dispense 100 μl of specimen into the specimen well.
RESULTS INTERPRETATION

NEGATIVE
HBsAg HBsAg WB Wait 20 mins. C T

POSITIVE
C T

20
MIN INVALID
Chagas Ab
Chagas Ab
C T

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HBsAg 01FK10 Device Serum/Plasma 30T/Kit

HBsAg WB 01FK10W Device Serum/Plasma/Whole blood 30T/Kit

Bioline™ PRODUCT CATALOGUE | 17

INFECTIOUS DISEASES

Bioline HCV ™

HEPATITIS C VIRUS ANTIBODY TEST

Bioline™ HCV test is a immunochromatographic rapid test for the
qualitative detection of antibodies specific to HCV in human serum,
plasma or whole blood.
• Recombinant HCV Core, NS3, NS4, NS5 Ag used as capture materials
• Specimen: Serum, Plasma, Whole blood
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-30 °C
• Performance: Sensitivity 99.3 %, Specificity 98.1 %
MATERIALS PROVIDED
• Test device / Multi-device / Strip
• Assay diluent
• Option : Lancet, alcohol swab, capillary pipette (for fingerstick)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of specimen into the
specimen well.
Capillary pipette Micropipette Multi Device
2 Add Assay Diluent
Dispense 4 drops of the assay
diluent.
Device Multi Device
RESULTS
INTERPRETATION

Assay Assay
Diluent Diluent

NEGATIVE

C T

Wait 5-20 mins.

1 2
POSITIVE
Add Assay Diluent and Specimen Insert Strip
Dispense 4 drops of assay diluent to the Insert strip into
empty test tube, and then dispense 10μl of
serum or plasma to the test tube.
the test tube.
5-20 C T
MIN
Strip Strip
INVALID

C T

C T
The presence of any test line, no matter how
faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HCV 02FK10 Device Serum/Plasma/Whole blood 30T/Kit

HCV 02FK11 Multi-Device Serum/Plasma/Whole blood 10Tx10/Kit
HCV* 02FK16 Device Serum/Plasma/Whole blood 25T/Kit
HCV** 02FK17 Device Serum/Plasma/Whole blood 25T/Kit
HCV 02FK10CE Device Serum/Plasma/Whole blood 30T/Kit
HCV* 02FK16CE Device Serum/Plasma/Whole blood 25T/Kit
HCV** 02FK17CE Device Serum/Plasma/Whole blood 25T/Kit
HCV Fast 02FK12 Strip Serum/Plasma 25T/Kit
(*) Lancet, Capillary pipette, Alcohol swab included.
(**) Safety lancet, Capillary pipette, Alcohol swab included.

Bioline™ PRODUCT CATALOGUE | 18

 INFECTIOUS DISEASES

Bioline HIV 1/2 3.0 ™

HIV-1/2 ANTIBODY TEST

Bioline™ HIV 1/2 3.0 test is a immunochromatographic test for
the differential and qualitative detection of all isotypes (IgG, IgM,
IgA) antibodies specific to HIV-1 including subtype O and HIV-2
simultaneously, in human serum, plasma or whole blood.
• 3rd Generation Method
• Differentiated test result between HIV type I and II by clear band
formation (3-lines)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-30°C
• Performance: Sensitivity 100 %, Specificity 99.8 %

MATERIALS PROVIDED
• Test device / Multi-device • Option : Lancet, alcohol swab and
• Assay diluent capillary pipette (for whole blood)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of plasma, serum
or 20 μl of whole blood into the
specimen well.
2 Add Assay Diluent
Dispense 4 drops of the assay
diluent.
RESULTS
INTERPRETATION
NEGATIVE

C 2 1

POSITIVE
HIV-1 Positive HIV-2 Positive

C 2 1 C 2 1

Device Multi Device Device Multi Device INVALID

Assay Assay Wait 10-20 mins.
Diluent Diluent
C 2 1 C 2 1

10-20 C 2 1 C 2 1
MIN
C 2 1

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HIV 1/2 3.0 03FK10 Device Serum/Plasma/Whole blood 30T/Kit

HIV 1/2 3.0 03FK11 Multi-Device Serum/Plasma/Whole blood 10Tx10/Kit
HIV 1/2 3.0* 03FK16 Device Serum/Plasma/Whole blood 25T/Kit
HIV 1/2 3.0** 03FK17 Device Serum/Plasma/Whole blood 25T/Kit
HIV 1/2 3.0 03FK10CE Device Serum/Plasma/Whole blood 30T/Kit
HIV 1/2 3.0*** 03FK16CE Device Serum/Plasma/Whole blood 25T/Kit
(*) Lancet, Capillary pipette, Alcohol swab included. (***) Lancet, Capillary pipette included.
(**) Safety lancet, Capillary pipette, Alcohol swab included.

Bioline™ PRODUCT CATALOGUE | 19

INFECTIOUS DISEASES

Bioline HIV/SYPHILIS DUO

™

SIMULTANEOUS DETECTION OF HIV-1/2 AND

SYPHILIS ANTIBODIES TEST
Bioline™ HIV/Syphilis Duo test is a solid phase immunochromatographic assay
for the qualitative detection of antibodies to all isotypes (IgG, IgM, and IgA)
specific to HIV-1/2 and/or Treponema pallidum (TP) simultaneously in human
serum, plasma or whole blood.
• Optimal screening test for HIV and syphilis during antenatal care
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance:
- HIV: Sensitivity 99.91 %, Specificity 99.67 %
- Syphilis: Sensitivity 99.67 %, Specificity 99.72 %

MATERIALS PROVIDED
• Test device
• Assay diluent
• Option : Lancet, alcohol swab, capillary pipette

SIMPLE PROCEDURE
• Dispense plasma, serum (10 µl) or whole blood (20 μl) into the specimen well "S".
RESULTS

1 2
INTERPRETATION
Add Specimen Add Assay Diluent
NEGATIVE
Dispense 3 drops of
the assay diluent.
C SYP HIV

POSITIVE
HIV-1/2
Positive
Micropipette Capillary pipette Syphilis
Assay Positive
Diluent
Wait 15-20mins. HIV-1/2 and
Syphilis Positive
C SYP HIV

INVALID

15-20
MIN
C SYP HIV

C SYP HIV

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

HIV/Syphilis Duo 06FK30 Device Serum/Plasma/Whole blood 25T/Kit

HIV/Syphilis Duo* 06FK35 Device Serum/Plasma/Whole blood 25T/Kit
HIV/Syphilis Duo 06FK30CE Device Serum/Plasma/Whole blood 25T/Kit
HIV/Syphilis Duo* 06FK35CE Device Serum/Plasma/Whole blood 25T/Kit
(*) Lancet, Capillary pipette, Alcohol swab included.

Bioline™ PRODUCT CATALOGUE | 20

 INFECTIOUS DISEASES

Bioline INFLUENZA ANTIGEN™

INFLUENZA VIRUS TYPE A & B ANTIGEN TEST

Bioline™ Influenza Antigen test is a chromatographic immunoassay for the

differential and qualitative detection of influenza virus type A and type B antigens
directly from nasal / throat / nasopharyngeal swab or nasal/nasopharyngeal
aspirate specimens.
• Detection : Differential detection of Influenza virus type A & B
• Specimen : Human nasal swab, throat swab, nasopharyngeal swab or nasal/
nasopharyngeal aspirate
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity : 91.8%, Specificity : 98.9% (vs. Viral Culture and RT-
PCR as gold standard)

MATERIALS PROVIDED
• Test strip • Sterilized swab
• Disposable tube with rack • Control swabs: Positive and Negative
• Assay diluent • Disposable dropper

SIMPLE PROCEDURE
All swab specimens

1 2 3
RESULTS
Add Assay Diluent Add Specimen and Insert Strip
INTERPRETATION
Mix well
Up to the fill line NEGATIVE
(approximately
300μl) 5X
Wait 10-15 mins. A B C

Type A-POSITIVE
10-15
MIN
A B C

Type B-POSITIVE

Nasal aspirate, nasopharyngeal aspirate specimen or extracted specimen into transport media

1 2 3
A B C
Add Assay Diluent Add Specimen and Insert Strip
Mix well INVALID
100μl of 100μl of extracted
Assay diluent specimen Wait 10-15 mins.

10-15
MIN
A B C

The presence of any test line, no matter

how faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Nasal/Throat/Nasopharyngeal swab, Nasal/

Influenza Antigen 19FK11 Strip 10T/Kit
Nasopharyngeal aspirate
Nasal/Throat/Nasopharyngeal swab, Nasal/
Influenza Antigen 19FK12 Strip 25T/Kit
Nasopharyngeal aspirate

Bioline™ PRODUCT CATALOGUE | 21

INFECTIOUS DISEASES

Bioline INFLUENZA Ag ™

A/B/A (H1N1)
INFLUENZA VIRUS TYPE A, B AND A (H1N1)
PANDEMIC RAPID TEST
Bioline™ Influenza Ag A/B/A (H1N1) rapid test kit is a chromatographic immunoassay for
the differential and qualitative detection of Influenza virus type A, type B and A (H1N1)
antigens directly from nasal/throat/nasopharyngeal swab or nasal/nasopharyngeal aspirate
specimens.
• Detection: Differential detection of Influenza virus type A, type B and A (H1N1) antigen
(4 lines)
• Specification: The samples tested POSITIVE can be determined as influenza H1N1
positive without additional confirmation test.
• Shelf life and storage temperature: 24 months from the date of manufacturing at 1-30 °C

MATERIALS PROVIDED
• Test strip • Control swab: A positive, B positive,
• Disposable tube with rack Negative
• Assay diluent • Disposable dropper
• Sterilized swab

SIMPLE PROCEDURE
All swab specimens
RESULTS INTERPRETATION

1 Add Assay Diluent

Up to the fill line
(approximately
2 Add Specimen and
Mix well 3 Insert Strip A
(H1N1) A B C
Negative

300μl) 5X A (H1N1)
Wait 10-15 mins.

10-15 Type A
MIN

Type B

Type A&B
Nasal aspirate, nasopharyngeal aspirate specimen or extracted specimen into transport media Co-infection

1 Add Assay Diluent

100μl of
2 Add Specimen and
Mix well
100μl of extracted
3 Insert Strip

Invalid
Assay diluent specimen Wait 10-15 mins.

10-15
MIN

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Nasal/Throat/Nasopharyngeal swab,
Influenza Ag A/B/A (H1N1) 19FK31 Strip 10T/Kit
Nasal/Nasopharyngeal aspirate
Nasal/Throat/Nasopharyngeal swab,
Influenza Ag A/B/A (H1N1) 19FK32 Strip 25T/Kit
Nasal/Nasopharyngeal aspirate

Bioline™ PRODUCT CATALOGUE | 22

 INFECTIOUS DISEASES

Bioline INFLUENZA ULTRA

™

INFLUENZA VIRUS TYPE A & B ANTIGEN TEST

Bioline™ Influenza Ultra is a rapid assay to detect and distinguish influenza A and
B virus, with nasopharyngeal swab or nasopharyngeal aspirate specimens.
• Differential detection of Influenza virus type A & B
• Positive result as early as 5 mins.
• Easy to interpret results with 3 colors lines – Green, Blue, Red
• Color line and test cassette marking helps to interpret result faster and more
confidently
• Cassette test format minimizes contact with potential biohazard material
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance vs Cell Culture
SENSITIVITY SPECIFICITY
Nasopharyngeal Swab Flu A 88.5 % 98.7%
Flu B 91.5 % 98.7%
Nasopharyngeal Aspirate Flu A 93.9 % 98.9%
Flu B 91.7 % 98.9%

MATERIALS PROVIDED
• Test device • Filter cap
• Specimen extraction tube with assay • Control swab: A positive, B positive,
diluent Negative
• Sterilized swab

SIMPLE PROCEDURE

1 2
Nasopharyngeal Nasopharyngeal Nasopharyngeal Nasopharyngeal
swab Aspirate: swab Aspirate: RESULTS
Add specimen Add specimen Remove the Mix well INTERPRETATION
& mix well swab
Negative
5X C B A

Flu A
positive
C B A

Flu B
positive

3 4
Assemble the Dispense 3 drops of C B A
filter cap extracted specimens
Flu A & Flu B
positive
C B A
Wait 5-8 mins.
Invalid

5-8
MIN

C B A C B A

The presence of any test line, no matter

how faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Influenza Ultra 19FK13 Device Nasopharyngeal swab, Nasopharygeal aspirate 10T/Kit

Bioline™ PRODUCT CATALOGUE | 23

INFECTIOUS DISEASES

Bioline LEGIONELLA Ag
™

LEGIONELLA URINARY ANTIGEN TEST

Bioline™ Legionella Ag test is a rapid immunochromatographic assay for the qualitative
detection of Legionella Pneumophila Serogroup 1 antigen in urine specimen. It is used
as an aid in the presumptive diagnosis of Legionella pneumophila infection caused by
L.pneumophila serogroup 1 and to monitor the effectiveness of targeted treatment.
• Rapid detection of Legionella pneumophila serogroup 1 antigen in urine.
• Enables timely targeted treatment with correct antibiotics for Legionella pneumophila.
• Faster throughput in lab or Emergency Room
• Shelf life and storage temperature: 24 months from the date of manufacturing at 1-30 °C
• Performance: Sensitivity 95.6 %, Specificity 99.2 %

MATERIALS PROVIDED
• Test device • Disposable urine dropper
• Positive/Negative Control

SIMPLE PROCEDURE

1 Add Specimen
Dispense 3 drops (100 μl) of urine
into the specimen well "S".
RESULTS INTERPRETATION

NEGATIVE
C T

POSITIVE
Dropper Micropipette
C T
Wait 15 mins.

C T INVALID
15
MIN C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Legionella Ag 58FK10 Device Urine 25T/Kit

Bioline™ PRODUCT CATALOGUE | 24

 INFECTIOUS DISEASES

Bioline LEISHMANIA Ab
™

LEISHMANIA ANTIBODY TEST

The Bioline™ Leishmania Ab test kit is rapid immunochromatographic assay for
in vitro diagnostic use designed to detect Leishmania antibodies in human serum
or plasma.
• Easy to use rapid test : All MATERIALS PROVIDED
• Specimen : Serum, plasma (20 μl)
• Test result : 10~15 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 98.0 %, Specificity 99.5 % (vs. immune-fluorescent
assay)

MATERIALS PROVIDED
• Test strip • Capillary pipette (20 μl)
• Assay diluent • Disposable test tube

SIMPLE PROCEDURE

1 Add Assay Diluent

Dispense 3 drops of the
assay diluent.
2 Add Specimen
Dispense 20 μl of
serum or plasma
3 Insert Strip
RESULTS
INTERPRETATION

NEGATIVE

T C
Capillary
Assay
Diluent pipette
POSITIVE

T C
Wait 10-15 mins.

INVALID

10-15
MIN
T C

The presence of any test line, no matter

how faint, the result is considered
positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Leishmania Ab 47FK12 Strip Serum/Plsma 25T/Kit

Bioline™ PRODUCT CATALOGUE | 25

INFECTIOUS DISEASES

Bioline ™

LEPTOSPIRA SERIES
LEPTOSPIRA ANTIBODY TEST

MATERIALS PROVIDED
• Test device
• Capillary pipette for Leptospira IgG/IgM test (5 μl)
• Assay diluent

ITEM LEPTOSPIRA LEPTOSPIRA IgM LEPTOSPIRA IgG/IgM

Detection Qualitative detection of Qualitative detection of IgM Differential detection of IgG &
IgG antibody to Leptospira antibody to Leptospira IgM antibodies to Leptospira
interrogans interrogans interrogans
Specimen 10 μl of serum or plasma 10 μl of serum or plasma 5 μl of serum or plasma
or 20 μl of whole blood or 20 μl of whole blood
Test result 15~20 min 15~20 min 20 min
Interpreter 2 - Line 2 - Line 3 - Line
(Control/Test) (Control/Test) (Control/IgG/IgM)

SIMPLE PROCEDURE

1 Add Specimen
Add specimen into the
specimen well.
2 Add Assay Diluent
Dispense assay diluent into
the round well.
RESULTS INTERPRETATION
Leptospria, Leptospira IgM
Negative Positive

C T C T
Invalid
Leptospira Leptospira Leptospira Leptospira Leptospira
Leptospira IgM IgG/IgM Leptospira IgM IgG/IgM Leptospira IgM C T C T
Serum, plasma 10 μl Serum, plasma 3-4 drops 4 drops Wait 15-20 mins. Leptospria IgG/IgM
or whole blood 20 μl 5 μl
Leptospira Negative IgG Positive
IgG/IgM
C M G C M G
Wait 20 mins.
Assay Assay
IgM Positive IgG & IgM Positive
Diluent Diluent

C M G C M G
Invalid
15-20
MIN

C M G C M G

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Leptospira 16FK10 Device Serum/Plasma/Whole Blood 30T/Kit

Leptospira 16FK11 Multi-Device Serum/Plasma/Whole Blood 10Tx10/Kit
Leptospira IgM 16FK30 Device Serum/Plasma/Whole Blood 30T/Kit
Leptospira IgG/IgM 16FK40 Device Serum/Plasma 30T/Kit

Bioline™ PRODUCT CATALOGUE | 26

 INFECTIOUS DISEASES

Bioline ™

LYMPHATIC FILARIASIS IgG4

LYMPHATIC FILARIASIS IgG4 TEST
The Bioline™ Lymphatic Filariasis IgG4 test is a rapid, qualitative test for the
detection of IgG4 antibodies against the Wuchereria bancrofti Wb123 antigen in
human serum, plasma or whole blood
• Specimen: Whole blood, serum, plasma
• Time to results: 30 minutes. (The results are valid from 30 minutes to 24 hours.)
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-40 °C
• Performance (Reference method: ELISA)
- Sensitivity: 93.33 % (WB), 98.33 % (S/P)
- Specificity: 98.89 % (WB), 95.56 % (S/P)

MATERIALS PROVIDED
• Test device • Alcohol swab
• Assay diluent • Lancet
• Capillary pipette (10 μl) (for fingerstick)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of whole
blood, serum or plasma into
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS INTERPRETATION
NEGATIVE
the specimen well. (Nonreactive)
C T
Capillary Micropipette
pipette
Assay POSITIVE
Diluent
(Reactive)
Wait 30 mins. C T

30
MIN
C T INVALID

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Lymphatic Filariasis IgG4 61FK30 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 27

 INFECTIOUS DISEASES

Bioline MALARIA Ag P.F ™

MALARIA ANTIGEN P.F (HRP2) TEST

Bioline™ Malaria Ag P.f test is rapid, qualitative detection of HRP2
(Histidine-rich protein 2) specific to P. falciparum in human blood
specimen.
• Specific and accurate diagnosis for P. falciparum
• WHO prequalified
• Specimen : Whole blood (5 μl)
• Test result : 15 minutes (up to 30 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance: Sensitivity 99.7 %, Specificity 99.5 %

MATERIALS PROVIDED
• Test device
• Assay diluent
• Disposable specimen applicator (Capillary Pipette or Inverted cup)
• Lancet, alcohol swab

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of whole blood into the
round specimen well.
2 Add Assay Diluent
Dispense 4 drops of
assay diluent into the
square assay diluent
Dispense all of the assay
diluent from the diluent
tube into the square well
RESULTS
INTERPRETATION

well. of test device. NEGATIVE

C P.f
Assay
Inverted cup Capillary Diluent
pipette Wait 15 mins.
(up to 30 minutes) POSITIVE
C P.f

C P.v P.f C P.v P.f C P.v P.f 15

MIN INVALID
MALARIA

MALARIA

MALARIA
P.f/P.v

P.f/P.v

P.f/P.v

C P.f

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Malaria Ag P.f 05FK50 Device, Sterile lancet Whole blood 25T/Kit

Malaria Ag P.f 05FK51 Device, Safety lancet Whole blood 25T/Kit

Malaria Ag P.f 05FK52 Device (POCT), Safety lancet Whole blood 1Pack X 25/Kit

Malaria Ag P.f 05FK53 Device (POCT), Sterile lancet Whole blood 1Pack X 25/Kit

Bioline™ PRODUCT CATALOGUE | 28

 INFECTIOUS DISEASES

Bioline ™

MALARIA Ag P.F (HRP2/pLDH)

MALARIA ANTIGEN P.F (HRP2/pLDH) TEST
The Bioline™ Malaria Ag P.f (HRP2/pLDH) test is a rapid, qualitative
test for the detection of histidine-rich protein 2 (HRP2) antigen and
lactate dehydrogenase (pLDH) from Malaria P. falciparum in human
whole blood.
• Reduce false positive rates after treatment
• Useful in regions where P.f HRP2 gene deletion suspected
• WHO prequalified
• Specimen : Whole blood (5 μl)
• Test result : 15 minutes (up to 30 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance:
- P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.3 %
- P.f (pLDH) : Sensitivity 97.4 %, Specificity 99.7 %
MATERIALS PROVIDED
• Test device
• Assay diluent
• Disposable specimen applicator (Capillary Pipette or Inverted cup)
• Lancet, alcohol swab

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of whole blood into
the round specimen well.
2 Add Assay Diluent
Dispense 4 drops of
assay diluent into the
square assay diluent
Dispense all of the assay
diluent from the diluent
tube into the square well
RESULTS INTERPRETATION

NEGATIVE
C T2 T1
well. of test device.

Assay P.f (HRP2) POSITIVE

Inverted cup Capillary Diluent C T2 T1
pipette Wait 15 mins.
(up to 30 minutes) P.f (pLDH) POSITIVE
C T2 T1

P.f POSITIVE

15
C T2 T1

C P.v P.f C P.v P.f C P.v P.f

MIN
MALARIA

MALARIA

MALARIA

INVALID
P.f/P.v

P.f/P.v

P.f/P.v

C T2 T1 C T2 T1

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Malaria Ag P.f (HRP2/pLDH) 05FK90 Device, Sterile lancet Whole blood 25T/Kit

Malaria Ag P.f (HRP2/pLDH) 05FK91 Device, Safety lancet Whole blood 25T/Kit

Malaria Ag P.f (HRP2/pLDH) 05FK92 Device (POCT), Safety lancet Whole blood 1Pack X 25/Kit

Malaria Ag P.f (HRP2/pLDH) 05FK93 Device (POCT), Sterile lancet Whole blood 1Pack X 25/Kit

Bioline™ PRODUCT CATALOGUE | 29

 INFECTIOUS DISEASES

Bioline MALARIA Ag P.F/P.V ™

MALARIA ANTIGEN P.F/P.V (HRP2/pLDH) TEST

Bioline™ Malaria Ag P.f/P.v test is a rapid, qualitative test for the
detection of HRP2 (Histidine-rich protein 2) specific to Plasmodium
falciparum and Plasmodium lactate dehydrogenase (pLDH) specific to
Plasmodium vivax.
• Differential diagnosis between Plasmodium falciparum and
Plasmodium vivax
• Useful in regions where P.v and P.f are both dominant
• Differentiate P.f mono infection from P.f/P.v co-infection
• WHO prequalified
• Specimen : Whole blood (5 μl)
• Test result : 15 minutes (up to 30 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance:
- P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.5 %
- P.v (pLDH) : Sensitivity 95.5 %, Specificity 99.5 %

MATERIALS PROVIDED
• Test device • Disposable specimen applicator
• Assay diluent (Capillary Pipette or Inverted cup)
• Lancet, alcohol swab

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of whole blood into
the round specimen well.
2 Add Assay Diluent
Dispense 4 drops of
assay diluent into the
square assay diluent
Dispense all of the assay
diluent from the diluent
tube into the square well
RESULTS INTERPRETATION

NEGATIVE
C P.v P.f
well. of test device.

Assay Malaria P.f POSITIVE

Inverted cup Capillary Diluent C P.v P.f
pipette Wait 15 mins.
(up to 30 minutes) Malaria P.v POSITIVE
C P.v P.f
Mixed Infection
of P.f and P.v

15
C P.v P.f

C P.v P.f C P.v P.f C P.v P.f

MIN
MALARIA

MALARIA

MALARIA

INVALID
P.f/P.v

P.f/P.v

P.f/P.v

C P.v P.f C P.v P.f

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Malaria Ag P.f/P.v 05FK80 Device, Sterile lancet Whole blood 25T/Kit

Malaria Ag P.f/P.v 05FK81 Device, Safety lancet Whole blood 25T/Kit
Malaria Ag P.f/P.v 05FK82 Device (POCT), Safety lancet Whole blood 1Pack X 25/Kit
Malaria Ag P.f/P.v 05FK83 Device (POCT), Sterile lancet Whole blood 1Pack X 25/Kit
Malaria Ag P.f/P.v 05FK86 Device, Sterile lancet Whole blood 10T/Kit

Bioline™ PRODUCT CATALOGUE | 30

 INFECTIOUS DISEASES

Bioline MALARIA Ag P.F/P.F/P.V

™

MALARIA ANTIGEN P.F (HRP2/pLDH) & P.V

(pLDH) TEST
Bioline™ Malaria Ag P.f/P.f/P.v test is rapid, qualitative and differential
test for the detection of HRP2 and pLDH from P. falciparum and
pLDH from P. vivax in human whole blood.
• Useful in regions where P.v and P.f are both dominant
• Identify false positives by P.f HRP2 after treatment
• Useful in regions where P.f HRP2 gene deletion suspected
• Differentiate P.f mono infection from P.f/P.v co-infection
• WHO prequalified
• Specimen : Whole blood (5 μl)
• Test result : 15 minutes (up to 30 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance:
- P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.3 %
- P.f (pLDH) : Sensitivity 97.4 %, Specificity 99.3 %
- P.v (pLDH) : Sensitivity 95.5 %, Specificity 99.3 %

MATERIALS PROVIDED
• Test device • Disposable specimen applicator (Inverted cup)
• Assay diluent • Lancet, alcohol swab

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of whole
blood into the round
specimen well.
2 Add Assay Diluent
Dispense 4 drops of
assay diluent into the
square assay diluent
Dispense all of the assay
diluent from the diluent
tube into the square well
RESULTS INTERPRETATION
NEGATIVE P.v POSITIVE

well. of test device. C T3 T2 T1 C T3 T2 T1

Assay P.f POSITIVE

Inverted cup Diluent
Wait 15 mins.
C T3 T2 T1 C T3 T2 T1 C T3 T2 T1
(up to 30 minutes)
P.f and P.v POSITIVE

C T3 T2 T1 C T3 T2 T1 C T3 T2 T1

C P.v P.f C P.v P.f 15

MIN
INVALID
MALARIA

MALARIA
P.f/P.v

P.f/P.v

C T3 T2 T1 C T3 T2 T1 C T3 T2 T1 C T3 T2 T1

The presence of any test line, no matter how faint, the

result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Malaria Ag P.f/P.f/P.v 05FK120 Device, Sterile lancet Whole blood 25T/Kit

Malaria Ag P.f/P.f/P.v 05FK121 Device, Safety lancet Whole blood 25T/Kit
Malaria Ag P.f/P.f/P.v 05FK122 Device (POCT), Safety lancet Whole blood 1Pack X 25/kit
Malaria Ag P.f/P.f/P.v 05FK123 Device (POCT), Sterile lancet Whole blood 1Pack X 25/kit

Bioline™ PRODUCT CATALOGUE | 31

 INFECTIOUS DISEASES

Bioline MALARIA Ag P.F/PAN ™

MALARIA ANTIGEN P.F/PAN (HRP2/pLDH) TEST

Bioline™ Malaria Ag P.f/Pan test is rapid, qualitative and differential
test for the detection of HRP2 specific to P. falciparum and pLDH
specific to Malaria plasmodium (P.f, P.v, P.m and P.o) in human blood.
• Distinguish P.f infection from other species (P.v, P.m or P.o)
• Useful fin regions where all malaria species are circulating
• WHO prequalified
• Specimen : Whole blood (5 μl)
• Test result : 15 minutes (up to 30 minutes)
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 1-40 °C
• Performance:
- P.f (HRP2) : Sensitivity 99.7 %, Specificity 99.5 %
- Pan (pLDH) : Sensitivity 95.5 %, Specificity 99.5 %

MATERIALS PROVIDED
• Test device • Disposable specimen applicator (Capillary
• Assay diluent Pipette or Inverted cup)
• Lancet, alcohol swab

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of whole blood into
the round specimen well.
2 Add Assay Diluent
Dispense 4 drops of
assay diluent into the
square assay diluent
Dispense all of the assay
diluent from the diluent
tube into the square well
RESULTS INTERPRETATION

C Pan P.f
NEGATIVE

well. of test device.

Malaria P.f POSITIVE

Assay
Inverted cup Capillary Diluent C Pan P.f
pipette Wait 15 mins.
(up to 30 minutes) Malaria Pan POSITIVE
C Pan P.f

Malaria Mixed Infection

15
C Pan P.f

C P.v P.f C P.v P.f C P.v P.f

MIN
MALARIA

MALARIA

MALARIA

INVALID
P.f/P.v

P.f/P.v

P.f/P.v

C Pan P.f C Pan P.f

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Malaria Ag P.f/Pan 05FK60 Device, Sterile lancet Whole blood 25T/Kit

Malaria Ag P.f/Pan 05FK61 Device, Safety lancet Whole blood 25T/Kit
Malaria Ag P.f/Pan 05FK62 Device (POCT), Safety lancet Whole blood 1Pack X 25/kit
Malaria Ag P.f/Pan 05FK63 Device (POCT), Sterile lancet Whole blood 1Pack X 25/kit
Malaria Ag P.f/Pan 05FK67 Device (POCT), Sterile lancet Whole blood 1Pack X 30/kit

Bioline™ PRODUCT CATALOGUE | 32

 INFECTIOUS DISEASES

Bioline NOROVIRUS ™

NOROVIRUS ANTIGEN TEST

The Bioline™ Norovirus test is a chromatographic immunoassay for qualitative
detection of the presence of norovirus antigen (Genogroup I (GI) and Genogroup
II (GII)) in human fecal specimens. It is used as an aid in the diagnosis of
acute gastroenteritis with the symptoms of suspected gastroenteritis caused by
Norovirus.
• Easy to use
• Specimen : Fecal specimen (50-100 mg)
• Test result : 15 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 84.1 %, Specificity 96.1 % (vs realtime RT-PCR)

MATERIALS PROVIDED
• Test device • Specimen collection swab
• Specimen collection tube • Disposable dropper
• Assay diluent • Disposable dropping cap

SIMPLE PROCEDURE

1 Add
Assay Diluent 2 Insert swab
specimen 3 Assemble
dropping cap 4 Add Specimen
RESULTS
INTERPRETATION
Transfer Insert the swab Assemble Dispense 4 drops.
assay diluent into the specimen dropping cap NEGATIVE
twice. collection tube and on the specimen
swirl the swab at collection tube.
least 10 times. C T

POSITIVE
X2 Up
to the fill
C T
line
X10
Wait 15
mins. INVALID

15
Chagas Ab
Chagas Ab
MIN C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Norovirus 52FK10 Device Fecal 20T/Kit

Bioline™ PRODUCT CATALOGUE | 33

INFECTIOUS DISEASES

Bioline ONCHOCERCIASIS IgG4

™

ONCHOCERCIASIS IgG4 TEST

The Bioline™ Onchocerciasis IgG4 test is a rapid, qualitative test for the detection
of IgG4 antibody against OV16 antigen in human serum, plasma or whole blood.
• Less invasive and less painful than current diagnostic methods
• Time to results: 30 minutes. (The results are valid from 30 minutes to 24 hours.)
• Specimen: Serum, Plasma, Whole blood
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-40 °C

• Performance:
RDT RDT
WHOLE BLOOD PLASMA/SERUM
POSITIVE NEGATIVE POSITIVE NEGATIVE
Positive 60 14 Positive 64 11
Skin snip Skin snip
Negative 1 103 Negative 1 101
Sensitivity 81.1 % (60/74) Sensitivity 85.3 % (64/75)
Specificity 99.0 % (103/104) Specificity 99.0 % (101/102)

MATERIALS PROVIDED
• Test device • Alcohol swab
• Assay diluent • Lancet
• Capillary pipette (10 μl) (for fingerstick)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of whole
blood, serum or plasma into
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
the specimen well.
C T
Capillary Micropipette
Assay
pipette Diluent POSITIVE
Wait 30 mins. C T

30
MIN
C T INVALID

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Onchocerciasis IgG4 61FK10 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 34

 INFECTIOUS DISEASES

Bioline ONCHO/LF IgG4 BIPLEX

™

ONCHOCERCIASIS IgG4 AND

LYMPHATIC FILARIASIS IgG4 TEST

The Bioline™ Oncho/LF IgG4 biplex test is a rapid, qualitative test for the
detection of IgG4 antibodies against the Onchocerca volvulus Ov16 and Wuchereria
bancrofti Wb123 antigens in human serum, plasma or whole blood
• Specimen: Whole blood, serum, plasma
• Time to results: 30 minutes. (The results are valid from 30 minutes to 24 hours.)
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-40 °C
• Performance (Reference method: ELISA) :
- Sensitivity: Oncho 92.42 % (WB), 98.48 % (S/P) and LF 81.48 % (WB), 95.06 % (S/P)
- Specificity: Oncho 100 % (WB), 97.48 % (S/P) and LF 99.31 % (WB), 95.83 % (S/P)

MATERIALS PROVIDED
• Test device
• Assay diluent
• Capillary pipette (10 μl) (for fingerstick)
• Alcohol swab
• Lancet

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of whole
blood, serum or plasma into
2 Add Assay Diluent
Dispense 4 drops of the
assay diluent.
RESULTS INTERPRETATION
Negative
the specimen well. (Nonreactive)
C O L

Lymphatic Filariasis
Reactive
C O L

Capillary Micropipette Onchocerciasis

Assay Reactive
pipette Diluent C O L
Wait 30 mins. Onchocerciasis and
Lymphatic Filariasis
C O L
Reactive

30
MIN
Invalid

C O L C O L

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Oncho/LF IgG4 biplex 61FK20 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 35

INFECTIOUS DISEASES

Bioline ROTAVIRUS ™

ROTAVIRUS ANTIGEN TEST

Bioline™ Rotavirus test is an immunochromatographic assay for the detection
of Group A rotavirus in human fecal specimens. The test utilizes two kinds of
antibody in a solid phase sandwitch immunochromatography to detect group
specific proteins, including the major inner capsid protein, present in Group A
rotaviruses.
• Early detection of rotavirus antigen group A all serotype
• Convenient and clean test
• Specimen: Fecal specimens
• Shelf life and storage temperature: 18 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity : 94 %, Specificity 98.3 % (vs. RT-PCR)

MATERIALS PROVIDED
• Test device • Specimen collection swab
• Specimen collection tube • Disposable dropper
• Assay diluent • Disposable dropping cap

SIMPLE PROCEDURE

1 Add
Assay Diluent 2 Insert swab
specimen 3 Assemble
dropping cap 4 Add Specimen
RESULTS
INTERPRETATION
Transfer Insert the swab Assemble Dispense 3-4
assay diluent into the specimen dropping cap drops. NEGATIVE
twice. collection tube and on the specimen
swirl the swab at collection tube.
least 10 times. C T

POSITIVE
X2 Up
to the fill
C T
line
X10
Wait 10-20
mins. INVALID

10-20
MIN
C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Rotavirus 14FK10 Device Fecal 20T/Kit

Bioline™ PRODUCT CATALOGUE | 36

 INFECTIOUS DISEASES

Bioline ROTA/ADENO ™

ROTA/ADENO VIRUS ANTIGEN TEST

Bioline™ Rota/Adeno test is a rapid immunochromatographic assay for qualitative
detection of the presence of rotavirus or adenovirus antigen in human fecal
specimens.
• Differentiation of test result by clear band formation (3-lines)
• Specimen : Fecal specimens
• Test result : 20 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance:
- Rotavirus: Sensitivity 99.3 %, Specificity 99.5 % (vs. RT-PCR)
- Adenovirus: Sensitivity 97 %, Specificity 100 % (vs. RT-PCR)

MATERIALS PROVIDED
• Test device • Specimen collection swab
• Specimen collection tube • Disposable dropper
• Assay diluent • Disposable dropping cap

SIMPLE PROCEDURE

1 Add
Assay Diluent 2 Insert swab
specimen 3 Assemble
dropping cap 4 Add Specimen
RESULTS
INTERPRETATION
Transfer Insert the swab Assemble Dispense 3-4 drops.
assay diluent into the specimen dropping cap Negative
twice. collection tube and on the specimen C R A
swirl the swab at collection tube.
least 10 times. Adenovirus
Positive
C R A

Rotavirus
Positive
X2
C R A
Up
to the fill
line
X10 C R A
Adenovirus
and
Rotavirus
Wait 20
Positive
mins.
Invalid

20
MIN
C R A C R A

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Rota/Adeno 14FK20 Device Fecal 20T/Kit

Bioline™ PRODUCT CATALOGUE | 37

INFECTIOUS DISEASES

Bioline RSV ™

RSV (RESPIRATORY SYNCYTIAL VIRUS) ANTIGEN TEST

Bioline™ RSV test is an immunochromatographic assay for qualitative detection of
respiratory syncytial virus (RSV) in NPS (Nasopharyngeal secretion/aspirations).
• Specimen: NPA (Nasopharyngeal Aspirate)
• Test result in 15 minutes
• Shelf life and storage temperature: 21 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 92.3 %, Specificity 93.3 % (vs. culture)

MATERIALS PROVIDED
• Test strip • Extraction buffer
• Disposable test tube, dropper

SIMPLE PROCEDURE

1 Add Assay
Diluent
Add 200 - 250 μl of
extraction buffer.
2 Add Specimen &
Mix Well
Add 200 - 250 μl of
specimen.
3 Insert Strip
RESULTS
INTERPRETATION
Negative

T C

Up to Positive
Up to the Fill
the Fill line Wait 10 mins. Wait 15 mins.
line T C

Invalid
10
MIN
15
MIN

T C

The presence of any test line, no matter

how faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

RSV 40FK12 Strip Nasopharyngeal Aspirate 25T/Kit

Bioline™ PRODUCT CATALOGUE | 38

 INFECTIOUS DISEASES

Bioline ™

SALMONELLA TYPHI IgG/IgM FAST

SALMONELLA TYPHI IGG/IGM TEST

Bioline™ Salmonella typhi IgG/IgM Fast test is an immunochromatographic assay for the
rapid, qualitative and differential detection of IgG and IgM antibodies to Salmonella typhi
in human serum, plasma or whole blood.
• Differential antibody detection: IgG and IgM antibodies
• Test result : 15 - 30 minutes
• Specimen : Serum, Plasma or Whole blood
• Shelf life and storage temperature: 24 months from the date of manufacturing at 2-30 °C
• Performance: (vs. Blood culture)
- Sensitivity : IgG-64.9 %, IgM-94.6%, IgG+IgM-100 %
- Specificity : IgG-88.3 %, IgM-92.2%, IgG+IgM-85.7 %

MATERIALS PROVIDED
• Test strip • Disposable loop (1 μl)
• Assay diluent • Disposable test tube

SIMPLE PROCEDURE

1 2 3
Add Assay Diluent Add Specimen Insert Strip
RESULTS INTERPRETATION
Dispense 4 drops of the Dispense 1 μl of
Negative
assay diluent. specimen.
G M C

IgG Positive
(previous typhoid fever
G M C
Assay infection or re-infection)
Diluent
IgM Positive
(acute typhoid fever)
G M C

Wait 15-30 mins.

IgG/IgM Positive
(acute typhoid fever in the
G M C
middle stage of infection)
Invalid
15-30
MIN

G M C G M C

The presence of any test line, no matter how faint, the

result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Salmonella typhi IgG/IgM Fast 15FK12 Strip Serum/Plasma/Whole blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 39

INFECTIOUS DISEASES

Bioline STREP A ™

GROUP A STREPTOCOCCAL ANTIGEN STRIP TEST

Bioline™ Strep A strip test is a immunochromatographic assay for the qualitative
detection of group A streptococcal antigens directly from throat swabs or confirmation of
presumptive Group A Streptococcal colonies recovered from culture. The assay detects
either viable or nonviable organisms directly form throat swabs or culture colonies within
5 - 10 minutes.
• Specimen : Throat swab
• Test result : 5 - 10 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at 1-30 °C
• Performance: Sensitivity 87.3 %, Specificity 95.8 % (vs. culture method)

MATERIALS PROVIDED
• Test strip • Disposable test tube
• Extraction Reagent A, B • Positive / Negative control
• Sterile throat swab

SIMPLE PROCEDURE

1 Add Reagent

Add 3 drops of reagent

2 Add Specimen &
Mix Well
Keep the swab in the test tube for
3 Insert Strip
RESULTS
INTERPRETATION

A+B 1 minute. The swab can remain in the NEGATIVE

test tube for up to 15 minutes.

x5-10
T C

A B POSITIVE
Wait 1 min. Wait 5-10 mins.
T C

INVALID
1
MIN
5-10
MIN

T C

The presence of any test line, no matter

how faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Strep A 45FK12 Strip Throat swab 25T/Kit

Bioline™ PRODUCT CATALOGUE | 40

 INFECTIOUS DISEASES

Bioline SYPHILIS 3.0 ™

SYPHILIS ANTIBODY TEST

Bioline™ Syphilis 3.0 test is a solid phase immunochromatographic
assay for the qualitative detection of antibodies of all isotypes (IgG,
IgM, IgA) against Treponema pallidum (TP) in human serum, plasma
or whole blood.
• Qualitative immunochromatographic assay
• No need for preprocessing and equipment
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 2-30 °C
• Performance: Sensitivity 99.3 %, Specificity 99.5 % (vs TPHA)

MATERIALS PROVIDED
• Test device / Multi-device / Strip
• Assay diluent
• Option: Lancet, alcohol swab, capillary pipette

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of plasma, serum
or 20 μl of whole blood into the
specimen well.
2 Add Assay Diluent
Dispense 4 drops of the assay
diluent.
Device Multi Device
RESULTS
INTERPRETATION

Device Multi Device Assay Assay

Diluent Diluent

NEGATIVE
C T

Wait 5-20 mins.

1 2
POSITIVE
Add Assay Diluent and Insert Strip
Specimen Insert strip into 5-20 C T
the test tube. MIN
Add 10μl of serum or plasma or 20μl of whole
blood and 4 drops of assay diluent to the empty Strip
test tube. And then, mix well.
Strip

C T INVALID

C T

The presence of any test line, no matter how

faint, the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Syphilis 3.0 06FK10 Device Serum/Plasma/Whole blood 30T/Kit

Syphilis 3.0 06FK11 Multi-Device Serum/Plasma/Whole blood 10Tx10/Kit
Syphilis Fast 3.0 06FK12 Strip Serum/Plasma/Whole blood 25T/Kit
Syphilis 3.0* 06FK13 Device Serum/Plasma/Whole blood 25T/Kit
Syphilis 3.0** 06FK16 Device Serum/Plasma/Whole blood 25T/Kit
Syphilis 3.0*** 06FK17 Device Serum/Plasma/Whole blood 25T/Kit
(*) Lancet, Capillary pipette included. (***) Safety lancet, Capillary pipette, Alcohol swab included.
(**) Lancet, Capillary pipette, Alcohol swab included.

Bioline™ PRODUCT CATALOGUE | 41

INFECTIOUS DISEASES

Bioline TB Ag MPT64 ™

IDENTIFICATION OF MYCOBACTERIUM TUBERCULOSIS

COMPLEX
Bioline™ TB Ag MPT64 is a rapid immunochromatographic test for the
identification of the M.tuberculosis complex.
• Simple, rapid assay using mouse monoclonal anti-MPT64
• Rapid discrimination between the M. tuberculosis complex and other
mycobacterium
• Identification of the M. tuberculosis complex in combination with culture
systems based on liquid media
• Specimen : Solid cultures (colony, condensation fluid) or liquid cultures
• Shelf life and storage temperature: 18 months from the date of manufacturing at
1-30 °C
• Performance: Sensitivity 98.6 %, Specificity 100 % (vs. Isolated culture method)

MATERIALS PROVIDED
• Test device
• Extraction buffer (for specimen preparation using solid cultures)

SIMPLE PROCEDURE
Liquid cultures & Solid cultures (Condensation fluid of slant agar tubes)

1 2
Collect Specimen Add Specimen RESULTS
INTERPRETATION
100 μl of 100 μl of condensation
liquid cultures fluid NEGATIVE
Wait 15mins.

OR C T
15
MIN

POSITIVE

Solid cultures (Colony) C T

1 Add extraction
buffer (200 µl) 2 Collect
Specimen 3 Mix Specimen
4 Add Specimen
100 μl of condensation fluid
Wait 15mins.
INVALID

x5 C T
15
MIN
C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

TB Ag MPT64 08FK50 Device Liquid cultures / Solid cultures 25T/Kit

Bioline™ PRODUCT CATALOGUE | 42

 INFECTIOUS DISEASES

Bioline TETANUS ™

TETANUS ANTIBODY TEST

Bioline™ Tetanus test is a rapid immunochromatographic assay for qualitative
detection of tetanus antibody in serum, plasma or whole blood.
• Specimen : Serum, Plasma or Whole blood
• Detection limit : 100 mIU/ml (serum, plasma), 200 mIU/ml (whole blood)
• Point of care test in the emergency room
• Detection of tetanus antibody (IgG/IgM) before anti-tetanus toxoid
immunoglobulin treatment
• No interfering reactivity with hemoglobin, bilirubin or triglyceride
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance : Bioline™ Tetanus vs ELISA
- Sensitivity : Serum 96.5 %, Whole blood 94.8 %
- Specificity : Serum 87 %, Whole blood 89.1 %

MATERIALS PROVIDED
• Test device • Assay diluent
• Disposable droppers or Microsafe
tube (30 μl)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 30 μl of whole
blood, serum or plasma into
2 Add Assay Diluent
Dispense 3-4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
the specimen well "S".
C T

Microsafe tube Micropipette

or dropper (whole blood, POSITIVE
(whole blood) plasma or serum) C T
Assay
Diluent Wait 10 mins.

10
MIN
C T INVALID

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Tetanus (Disposable droppers) 42FK10 Device Serum/Plasma/Whole Blood 25T/Kit

Tetanus (Microsafe tubes) 42FK20 Device Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 43

INFECTIOUS DISEASES

Bioline TSUTSUGAMUSHI
™

SCRUB TYPHUS ANTIBODY TEST

The Bioline™ Tsutsugamushi test is a solid phase,

immunochromatographic assay for the rapid, qualitative detection of
IgG, IgM or IgA antibodies to Orientia tsutsugamushi in human serum,
plasma or whole blood.
• Disease: Scrub Typhus
• Specimen : Serum, Plasma (10 μl) / Whole blood (20 μl)
• Test result : 10~15 minutes
• Shelf life and storage temperature: 18 months from the date of
manufacturing at 1-30 °C
• Performance: Sensitivity 99 %, Specificity 96 %

MATERIALS PROVIDED
• Test device
• Assay diluent

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of serum,
plasma, or 20 μl of whole
2 Add Assay Diluent
Dispense 3-4 drops of the
assay diluent.
RESULTS INTERPRETATION

NEGATIVE
blood into the specimen
well "S". C T

POSITIVE
Device Multi Device Device Multi Device
C T
Assay
Diluent
Assay
Diluent
Wait 10-15 mins.

C T INVALID
10-15
MIN
C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Tsutsugamushi 18FK10 Device Serum/Plasma/Whole blood 30T/Kit

Tsutsugamushi 18FK11 Multi-Device Serum/Plasma/Whole blood 10Tx10/Kit

Bioline™ PRODUCT CATALOGUE | 44

 INFECTIOUS DISEASES

Bioline ZIKA IgM ™

ZIKA IgM ANTIBODY TEST

The Bioline™ Zika IgM test is an in vitro immunochromatographic assay for the
qualitative detection of IgM antibodies to Zika virus in human serum, plasma or
venous whole blood.
• Specimen : Serum, plasma or whole blood (10 μl)
• Test result : 15 minutes
• Shelf life and storage temperature: 18 months from the date of manufacturing at
2-30 °C
• Performance: Sensitivity 90.8 %, Specificity 98.3 % (vs. ELISA)

MATERIALS PROVIDED
• Test device • Alcohol swabs
• Capillary pipette (10 μl) • Lancets
• Assay diluent

SIMPLE PROCEDURE

1 Add Specimen
Dispense 10 μl of serum, plasma
and whole blood into the specimen
2 Add Assay Diluent
Dispense 4 drops of assay
diluent into the round well.
RESULTS INTERPRETATION

well "S". NON-REACTIVE

C T

C T Zika IgM REACTIVE

Micropipette Capillary pipette
Assay
Diluent
Wait 15 mins. C T

15
MIN
C T INVALID

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Bioline™ Zika IgM 12FK21 Device, Safety lancet Serum/Plasma/Whole Blood 25T/Kit

Bioline™ Zika IgM 12FK26 Device, Sterile lancet Serum/Plasma/Whole Blood 25T/Kit

Bioline™ PRODUCT CATALOGUE | 45

 Bioline ™

TOXICOLOGY
AMP MET
COC MET/THC
DOA MULTI 5 MOP
DOA MULTI 6 THC
MDMA

Bioline™ PRODUCT CATALOGUE | 46

 TOXICOLOGY

Bioline DOA ™

DRUG OF ABUSE TEST

Bioline™ DOA test is a rapid and immunochromatographic
assay designed for qualitative detection of drug metabolite
in human urine at a cut-off concentration.
• Established as a guideline by U.S. NIDA
• No instruments needed
• Shelf life: 24 months from the date of manufacturing
• Storage temperature :
- 1~30 °C (MDMA, DOA Multi 5, DOA Multi 6),
2-30 °C (MET, MOP, AMP, COC, THC, MET/THC)
Item MET THC MOP COC AMP MDMA
11-nor-∆9-THC-9- Morphine , Opiates, Benzoylecgonine 3,4-Methylenedioxy-N-
Detection D-Methamphetamine D-Amphetamine
COOH (marijuana) Heroin (cocaine) Methylamphetamine
Cut-off 1000 ng/ml 50 ng/ml 300 ng/ml 300 ng/ml 1000 ng/ml 500 ng/ml
Sensitivity 100 % 100 % 100 % 100 % 100 % 100 %
Specificity 100 % 100 % 100 % 100 % 100 % 95.2 %

MATERIALS PROVIDED
• Test device / Multi-device • Disposable dropper

SIMPLE PROCEDURE

1 Add Specimen
Dropper method Dipping method
RESULTS INTERPRETATION
MET/THC MOP, AMP,
COC, MDMA
Dispense 3-4 drops Immerse the test device vertically into Negative
(MDMA, DOA 5 the urine specimen for 10 seconds. Negative
and DOA6: 3 drops) After 10 seconds, bring out the C T M
of urine into the test device, place on flat surface. C T
Positive
specimen well "S".
MET

THC Positive
Wait 5 mins. MET/THC
C T M C T

MAX.urine Invalid Invalid

level
5
MIN

C T M C T M C T

The presence of any test line, no matter how faint, the

result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE PACK SIZE PRODUCT CAT. NO. TYPE PACK SIZE
MOP 50FK10 Device 25T/Kit MET/THC 50FK60 Device 25T/Kit
MET 50FK20 Device 25T/Kit
MDMA 50FK100 Device 25T/Kit
AMP 50FK30 Device 25T/Kit
DOA Multi 5 50FK150 Multi-Device 1Tx10/Kit
COC 50FK40 Device 25T/Kit
THC 50FK50 Device 25T/Kit DOA Multi 6 50FK130 Multi-Device 1Tx10/Kit

Bioline™ PRODUCT CATALOGUE | 47

Bioline ™

ONCOLOGY
FOB

Bioline™ PRODUCT CATALOGUE | 48

 ONCOLOGY

SD BIOLINE FOB
FECAL OCCULT BLOOD TEST
SD BIOLINE FOB test is a rapid qualitative test for the detection of
human blood hemoglobin in human fecal specimens.
• No cross reaction with animal blood, Vitamin C and Sucrose
• Specimen : Fecal
• Detection Limit : 50 ng/ml of human blood hemoglobin
• Test result in 10 minutes
• Shelf life and storage temperature: 24 months from the date of
manufacturing at 2-30 °C
• Performance:
- Sensitivity : 98 %, Specificity : 98.5 %

MATERIALS PROVIDED
• Test device / Multi-device
• Specimen collection tube with assay diluent
• Storage and transport bag for specimen container

SIMPLE PROCEDURE

1 Insert swab
specimen 2 Mix
well 3 Open the cap
4 Add specimen
RESULTS
INTERPRETATION
Insert the Shake Loosen green Dispense 3 drops
applicator stick and mix cap the lower of the assay NEGATIVE
into the well part of the diluent.
specimen specimen
collection tube collection tube Device Multi- C T
Device

POSITIVE

C T
Wait 10 mins.
INVALID

10 MIN
Chagas Ab
Chagas Ab C T
The presence of any test line, no matter how faint,
the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

SD BIOLINE FOB (Fecal Occult Blood) 25FK10 Device Fecal 25T/Kit

SD BIOLINE FOB (Fecal Occult Blood) 25FK12 Multi-Device Fecal 10Tx5/Kit

Bioline™ PRODUCT CATALOGUE | 49

 Bioline ™

WOMEN’ S HEALTH
CHLAMYDIA
RUBELLA IgG/IgM

Bioline™ PRODUCT CATALOGUE | 50

 WOMEN’S HEALTH

Bioline CHLAMYDIA ™

CHLAMYDIA ANTIGEN TEST

Bioline™ Chlamydia test is a solid phase immunochromatographic assay for the
rapid, qualitative detection of Chlamydia antigen directly from endocervical swab,
cytology brush specimens.
• All materials provided, with ready to use reagent
• Shelf life and storage temperature: 18 months from the date of manufacturing at
2-30 °C
• Performance: Sensitivity 93.1 %, Specificity 98.8 % (vs. culture)

MATERIALS PROVIDED
• Test device
• Reagent A (Extraction solution)
• Reagent B (Neutralization solution)
• Sterile swab and transport tube
• Disposable dropper

SIMPLE PROCEDURE

1 Add
Reagent A 2 Add Specimen and
Extraction 3 Add
Reagent B RESULTS
INTERPRETATION
Transfer 300 μl of Reagent A. Insert the patient swab into the tube. Transfer 600 μl of Reagent B.

Up to the Up to the NEGATIVE

fill line
X10 X10 fill line

C T
Wait
2 mins.

POSITIVE

4 Mix
Specimen 5 Assemble
dropping cap 6 Add Specimen
C T
Assemble dropping Dispense 3 drops of the
cap on the specimen extracted specimen. Wait 15 mins.
collection tube.
X10
INVALID
15
MIN

C T

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Chlamydia 09FK10 Device Endocervical swab, Cytology brush 25T/Kit

Bioline™ PRODUCT CATALOGUE | 51

WOMEN’S HEALTH

Bioline RUBELLA IgG/IgM

™

RUBELLA IgG/IgM TEST

Bioline™ Rubella IgG/IgM test is a solid phase immunochromatographic assay
for the rapid, qualitative and differential detection of IgG and IgM antibodies to
rubella virus in human serum or plasma.
• Indicator of immune status or confirmation of recent rubella infection
• Specimen : Serum or Plasma
• Test result : 20 - 30 minutes
• Shelf life and storage temperature: 24 months from the date of manufacturing at
1-30 °C
• Performance:
- Sensitivity : IgG 99.14 %, IgM 98.33 %
- Specificity : IgG 91.55 %, IgM 97.64 %

MATERIALS PROVIDED
• Test device • Assay diluent
• Capillary pipette (5 μl)

SIMPLE PROCEDURE

1 Add Specimen
Dispense 5 μl of serum or
plasma into the specimen
2 Add Assay Diluent
Dispense 3-4 drops of the
assay diluent.
RESULTS INTERPRETATION

Negative
well "S". C M G

Rubella IgG
Positive
C M G
Capillary Micropipette
pipette Rubella IgM
Assay Positive
C M G
Diluent Wait 20-30 mins.
Rubella IgG/IgM
Positive
C M G

20-30
MIN Invalid

C M G C M G

The presence of any test line, no matter how faint,

the result is considered positive.

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Rubella IgG/IgM 07FK20 Device Serum/Plasma 25T/Kit

Bioline™ PRODUCT CATALOGUE | 52

 Bioline ™

ELISA KIT
ENZYME LINKED
IMMUNOSORBENT ASSAY KIT
DENGUE IgG CAPTURE ELISA
DENGUE IgM CAPTURE ELISA
DENGUE NS1 Ag ELISA
ONCHOCERCIASIS IgG4 ELISA

Bioline™ PRODUCT CATALOGUE | 53

ELISA TEST
ENZYME LINKED IMMUNOSORBENT ASSAY KIT

Bioline ™

DENGUE IgG CAPTURE ELISA

In primary infection with the dengue virus, IgG antibody appears a few
days after IgM. IgG antibodies are produced at a lower level compared
to IgM but will persist for many years after infection.
In secondary infections, IgG response may rise quickly before
or simultaneously with an IgM response and will become the
predominant immunoglobulin isotype in secondary infections.
• Suitable marker for secondary dengue infection
• High accuracy with all dengue serotypes (DEN1,2,3, and 4)
• Simple and easy to use: All necessary reagents included in the kit
• Shelf life and storage temperature: 18 months from the date of manufacturing at 2-8 °C
• Performance: Sensitivity 98.8 %, Specificity 99.2 %

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue IgG Capture ELISA 11EK10 Microplate Serum 96 wells/Kit

Bioline ™

DENGUE IgM CAPTURE ELISA

In primary infection with the dengue virus, IgM antibody becomes
detectable about five days after disease onset, when circulating virus
declines in the blood. IgM level rises quickly to peak at about 2 weeks
and declines to undetectable levels after 2-3 months
In secondary infections, IgM response is typically at a lower level
compared to that in a primary infection.
• Early diagnosis of dengue infection (especially in primary dengue
infection)
• High accuracy with all dengue serotypes (DEN1,2,3, and 4)
• Simple and easy to use: All necessary reagents included in the kit
• Shelf life and storage temperature: 18 months from the date of manufacturing at 2-8 °C
• Included in the WHO Bulk Procurement Scheme
• Performance: Sensitivity 96.4 %, Specificity 98.9 % (vs. HAI test)

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue IgM Capture ELISA 11EK20 Microplate Serum 96 wells/Kit

Bioline™ PRODUCT CATALOGUE | 54

 ELISA TEST
ENZYME LINKED IMMUNOSORBENT ASSAY KIT

Bioline ™

DENGUE NS1 Ag ELISA

The presence of circulating non-structural glycoprotein (NS1) indicates
Viremia. If sufficient virus is present, NS1 can be detectable in a patient’s
blood from day 0 to day 5 following disease onset. The detection of NS1
antigen is therefore useful as a test of early acute infection.
• Early diagnosis of dengue infection
• High accuracy with all dengue serotypes (DEN1,2,3, and 4)
• Simple and easy to use: All necessary reagents included in the kit
• Shelf life and storage temperature: 18 months from the date of
manufacturing at 2-8 °C
• Performance: Sensitivity 93.3 % (87.4 - 96.6 %), Specificity 98.9 % (96.0 - 99.7 %)

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Dengue NS1 Ag ELISA 11EK50 Microplate Serum 96 wells/Kit

Bioline ™

ONCHOCERCIASIS IgG4 ELISA

Bioline™ Onchocerciasis IgG4 ELISA is an Enzyme-linked immunosorbent
assay for the qualitative detection of human onchocerciasis IgG4 antibody
against Ov16 antigen.
• To ensure analysis of larger quantities of specimens in the event of large
outbreaks or serosurveys
• Simple and easy to use: All necessary reagents included in the kit
• Shelf life and storage temperature: 12 months from the date of
manufacturing at 2-8 °C
• Performance: Sensitivity 86.9 % , Specificity 100.0 %

ORDERING INFORMATION
PRODUCT CAT. NO. TYPE SPECIMEN PACK SIZE

Serum, Plasma, and

Onchocerciasis IgG4 ELISA 61EK11 Microplate 480 wells/Kit
DBS

Bioline™ PRODUCT CATALOGUE | 55

MEMO

GLOBALPOINTOFCARE.ABBOTT
 MEMO

GLOBALPOINTOFCARE.ABBOTT
MEMO

GLOBALPOINTOFCARE.ABBOTT
Reference
1. Sensitivity and Specificity are extracted from the Instruction for use of each product.

Product not available in all countries, and is subject to regulatory approval in regulated countries.
Please check with your local sales representative regarding availability in your area.

GLOBALPOINTOFCARE.ABBOTT
© 2021 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their
respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model.
COL-02941-02, 12/21