One Step Hepatitis B Virus Test

HBV
HBsAg, Anti-HBs, HBeAg/HBsAg
Hepatitis B is a widespread and serious liver disease. Hundreds of millions of people, most of them
in regions with poor medical care, are chronically infected with the virus and face an elevated risk of
acquiring liver cancer.
The hepatitis B virus (HBV) is made up of an inner core surrounded by an outer capsule. The outer
capsule contains the HBsAg (surface antigen). HBeAg is also found within the core. The detection of
anti-HBs has become important in the follow up of patients with the Hepatitis B virus (HBV). It is also
important when monitoring the recipients of vaccination with recombinant and natural anti-HBs.

General Information
SD BIOLINE Hepatitis tests are intended for professional use as an aid in the diagnosis of hepatitis B.
highly sensitive, specific one step immunochromatographic assay for HBsAg, Anti-HBs, HBeAg/HBsAg.
Specimen
Detection Limit
Sensitivity
Specificity

HBsAg

Anti-HBs

Serum, Plasma, Whole blood

2ng/ml
>99%
>99%

Serum, Plasma
30mlU/ml
91.7%
98.9%

HBeAg/HBsAg
Serum, Plasma
95.5%
98.6%

Materials Provided

SD BIOLINE Test device /Multi-device /Strip

Test Procedure

Add 100 l of serum or plasma into the sample well.

Interpret test results at 20 minutes.

Interpretation

Device
HBsAg

Negative
100l

20min.

HBsAg

Positive
Positive

Multi-Device

Negative

20min.

100l

Strip

100l

or

100l

20min.

Negative

T C

Positive

T C

Ordering Information
Cat. No.

Description

Type

Pack size

Cat. No.

Description

Type

Pack size

01FK10
01FK11
01FK12
01FK10W

HBsAg
HBsAg
HBsAg Fast
HBsAg W/B

Device
Multi-Device
Strip
Device

1Tx30/Kit
10Tx10/Kit
25Tx4/Kit
1Tx30/Kit

01FK20
01FK21
01FK22
01FK60

Anti-HBs
Anti-HBs
Anti-HBs Fast
HBeAg/HBsAg

Device
Multi-Device
Strip
Device

1Tx30/Kit
10Tx10/Kit
25Tx4/Kit
1Tx30/Kit

One Step Anti Hepatitis C Virus Test

HCV
The Hepatitis C virus (HCV) is recognized as a major agent of chronic hepatitis, transfusion acquired
non-A, non-B hepatitis and liver disease throughout the world. HCV diagnostic kits detect the presence
of HCV antibodies in human serum, plasma or whole blood by immunoassay. For diagnosis of HCV
infection, recombinant proteins (Core, NS3, NS4 and NS5 protein) were used as capture materials and
coated on the membrane of an immunochromatographic (rapid) test.

General Information
SD 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
High Accuracy - Sensitivity : 100%, Specificity : 99.4%
Specimen : Serum, Plasma, Whole blood

Materials Provided

SD BIOLINE HCV test device / Multi-device / Strip

Assay diluent

Test Procedure
Interpretation

Device
Add 10l Serum,
Plasma or Whole blood

HCV

4 drop

HCV

Negative

5~20min.

HCV

HCV

Positive
Multi-Device

Positive

Negative
HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

Add 10l Serum,

Plasma or Whole blood
HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

HCV

4 drop

HCV

5~20min.

Strip
Add 10l Serum,
Plasma or Whole blood

Negative

T C

Positive

T C

4 drop

5~20min.

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

02FK10
02FK11
02FK12
02FK10W
02FK11W

HCV
HCV
HCV Fast
HCV W/B
HCV W/B

Serum/Plasma
Serum/Plasma
Serum/Plasma
Serum/Plasma/Whole blood
Serum/Plasma/Whole blood

Device
Multi-Device
Strip
Device
Multi-Device

1Tx30/Kit
10Tx10/Kit
25T/Kit
1Tx30/Kit
10Tx10/Kit

One Step HIV 1/2 Antibody Test

HIV-1/2 3.0
HIV (human immunodeficiency virus) is the virus that causes AIDS. This virus may be passed
from one person to another when infected blood, semen or vaginal secretions come
in contact with an uninfected person's broken skin or mucous membrane. In addition,
infected pregnant women can pass HIV to their baby during pregnancy or delivery as well
as through breast-feeding.

General Information
SD 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.
The 3rd Generation Method (Direct Sandwitch Method, Ag-Ab-Ag)
Relative performance in seroconversion panels as compared to the
Serum, Plasma, Whole Blood specimen
reference assay (Enzygnost HIV 1/2 plus)
Highly sensitive even to IgM during early infection stage
Differentiated test result between HIV type I and II
by clear band formation (3-lines)
Sensitivity : 100%, Specificity : 99.8%
Capture Ag : HIV-1 (p24, gp41), HIV-2 (gp36)
Evaluated by WHO (Sensitivity 100%, Specificity 99.3%)
Procured by WHO, UNICEF, etc.
Long shelf life : 24 months at room temperature

Materials Provided

SD BIOLINE HIV-1/2 test device / Multi-device/ strip/ POCT

Assay diluent
Optional : Lancet, alcohol swab and capillary pipette (20l / drop)

Test Procedure
Interpretation
HIV-1/2

HIV-1/2

HIV-1
Positive

HIV-1/2

5~20min.

HIV-1/2

HIV-2
Positive

HIV-1/2

Negative
HIV-1/2

Invalid
See the insert for detailed interpretation

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

03FK10
03FK10S
03FK11
03FK12
03FK13
03FK16

HIV 1/2 3.0

HIV 1/2 3.0
HIV 1/2 3.0
HIV 1/2 Fast
HIV 1/2 POCT
HIV 1/2 3.0

S/P/WB
S/P
S/P
S/P
WB
S/P/WB

Device
Device
Multi-Device
Strip
POCT (*)
Device (*)

1Tx30/Kit
1Tx30/Kit
10Tx10/Kit
25T/Kit
1T/Kit
1Tx25/Kit

(*) Lancet, Capillary pipette included.

One Step Syphilis Antibody test

Syphilis 3.0
Syphilis is a curable sexually transmitted disease caused by the Treponema pallidum spirochete. The
route of transmission of syphilis is almost always by sexual contact. However, there are examples of
congenital syphilis via transmission from mother to child in utero.

General Information
SD 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).
The optimal choice for mass screening program
One step qualitative immunochromatographic assay
No need preprocessing and equipment
Specimen : Serum, Plasma, Whole Blood
Room temperature storage
Evaluated by WHO with excellent performance
Recombinant TP, 15kDa, 17kDa antigen used as captures and detectors

Performance Characteristics
Reference
Method

SD BIOLINE Syphilis 3.0 test

Positive
Negative
152
1
1
209
153
210

Results
Positive
Negative

TPHA Results
Total Results

Sensitivity : 99.3% (vs TPHA)

Total Result
153
210
363

Specificity : 99.55% (vs TPHA)

Materials Provided

SD BIOLINE Syphilis 3.0 test device / Multi-device / Strip

Assay diluent

Test Procedure
Interpretation

Device

Syphilis

Serum, Plasma 10l or

Whole blood 20l

Negative
3~4 drop

Syphilis

5~20min.

Syphilis

Syphilis

Positive

Multi-Device
Positive

Negative
Syphilis

Syphilis

Syphilis

Syphilis

Syphilis

Syphilis

Syphilis

Syphilis

3~4 drop

Syphilis

Syphils

Syphils

Syphils

Syphils

Syphils

Syphils

Syphils

Syphils

Syphils

Syphils

Syphilis

Serum, Plasma 10l or

Whole blood 20l

5~20min.

Syphils

Strip
Serum / Plasma
10l

3~4 drop

5~20min.

Negative

T C

Positive

T C

Ordering Information
Cat. No.

Description

Type

Specimen

Pack size

06FK10
06FK11
06FK12

Syphilis 3.0
Syphilis 3.0
Syphilis Fast 3.0

Device
Multi-Device
Strip

S/P/WB
S/P/WB
S/P

1Tx30/Kit
10Tx10/Kit
25T/Kit

One Step Chlamydia Antigen Test

Chlamydia
Chlamydia trachomatis is a bacterium which causes a sexually transmitted infection(STI).
Chlamydia is very common disease, which should be taken very seriously. The most
worrying effect of a chlamydial infection in women is that of potential fertility problems
(PID, infertility, etc.), due to inflammation of the fallopian tubes or cervix. The disease is
particularly common among young people.

General Information
SD BIOLINE Chlamydia test is a solid phase immunochromatographic assay for the rapid, qualitative detection of
Chlamydia antigen directly from endocervical swab, cytology brush specimens.
Antigen Detection : Therapeutic Drug Monitoring
Easy to test : All materials provided, Ready to use reagent

Performance Characteristics (vs. culture)

SD BIOLINE Chlamydia

Sensitivity

Specificity

93.1%

98.8%

Materials Provided

SD BIOLINE Chlamydia test device

Reagent A (Extraction solution)
Reagent B (Neutralization solution)
Sterile swabs and transport tubes
Disposable droppers

Test Procedure
1 Reagent A

2 Extraction

3 Add 600 l of
Reagent B

(300l / tube)

Up to the fill line

600 l

Interpretation
Positive
Chlamydia

4 Neutralization 5

Discard the swab

Assemble dropping cap

on the buffer bottle

7 Add 4 drops of

15min.

extracted sample

Negative
Chlamydia

InvaIid

4 drops

Chlamydia
Chlamydia

Ordering Information

Cat. No.

Description

Specimen

Type

Pack size

09FK10

Chlamydia

Endocervical swab, Cytology brush

Device

1Tx25/Kit

One Step Malaria Ag (pLDH) Test

Malaria Ag
Malaria is a serious, sometimes fatal, parasitic disease characterized by high fevers, shaking
chills and flu-like illness, and is caused by a parasite that is transmitted from one human
to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more
than 90 countries worldwide, and it is estimated that there are over 500 million clinical
cases and 2.7 million malaria-caused deaths per year, 75% of them are African children.
The infection with P. falciparum, if not promptly treated, may be fatal.

General Information
SD BIOLINE Malaria Ag test is a rapid, qualitative test for the detecting of Plasmodium lactate dehydrogenase (pLDH), an
enzyme produced both in the sexual and asexual forms of parasite.
Differential diagnosis between Plasmodium falciparum and the other Plasmodium species (P.vivax, P.ovale,
P. malariae )
Specimen : Whole blood (5l)
1RMP?EC0MMKRCKNCP?RSPC\!
Sensitivity : 96.8% (P.f), 95.5% (non-P.f)
Specificity : 99.5%
Useful to monitor the infection development after drug therapy

Materials Provided

SD BIOLINE Malaria Ag test device

Assay diluent

Disposable sample applicator

Option : Lancet, alcohol swab

Test Procedure
Interpretation

Clean the patient's finger.

The alcohol MUST be dried before
pricking, or test may not work.

Prick the patients finger with

the lancet to get blood.

1. With a 5 capillary pipette, draw blood to black line.

2. Take a disposable specimen loop (5) provided, dip the
circular end of a loop into the blood specimen.

Malaria Ag
1. P.f
2. Pan

Malaria Ag
1. P.f
2. Pan

2
5

Blo

od

1. Add 5 of drawn blood into round sample well.

2. Add 5 of drawn blood into round sample well
touching sample pad.

Add 4 drops of assay diluent

into the square assay diluent well.

Or
Black line

Or

Blo

Interpret test results in 20~30 minutes.

Malaria Pan
Positive

Malaria Ag
1. P.f
2. Pan

Malaria
Mixed Infection

Malaria Ag
1. P.f
2. Pan

20~30 mins

Dispense
Malaria Ag
1. P.f
2. Pan

Caution :
Dont read test results after 30 minutes.
Reading too late can give false results.

* Use Loop : Let the circular end of the loop on the pad and
press it slightly.

Malaria Ag
1. P.f
2. Pan

od

2
Dispense

Malaria P.f
Positive

Malaria Ag
1. P.f
2. Pan

Negative

Invalid

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

05FK40

Malaria Ag

Whole Blood

Device

1Tx25/Kit

One Step Malaria Ag P.f(HRP-II), P.v (pLDH) Test

Malaria Ag P.f
Malaria Ag P.v
Malaria is a serious, sometimes fatal, parasitic disease characterized by high fevers, shaking
chills and flu-like illness, and is caused by a parasite that is transmitted from one human
to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more
than 90 countries worldwide, and it is estimated that there are over 500 million clinical
cases and 2.7 million malaria-caused deaths per year, 75% of them are African children.
The infection with P. falciparum, if not promptly treated, may be fatal.

General Information

Item

Malaria Ag P.f

Malaria Ag P.v

Detection
Target species
Sensitivity
Specificity

HRP-II (Histidine-Rich Protein II)

P. falciparum
99.7%
99.5%

pLDH ( Plasmodium Lactate Dehydrogenase)

P. vivax
95.5%
99.5%

Specimen : Whole blood (5l)

Test result : 20~30 minutes
1RMP?EC0MMKRCKNCP?RSPC\!

Materials Provided
Item

Malaria Ag P.f

Malaria Ag P.v

Component

SD BIOLINE Malaria Ag P.f test device,

Assay diluent, Disposable sample applicator

SD BIOLINE Malaria Ag P.v test device,

Assay diluent, Disposable sample applicator

Option

Lancet, Alcohol swab

Test Procedure

Clean the patient's finger.

The alcohol MUST be dried before
pricking, or test may not work.

Prick the patients finger with

the lancet to get blood.

1. With a 5 capillary pipette, draw blood to black line.

2. Take a disposable specimen loop (5) provided, dip the
circular end of a loop into the blood specimen.

Interpretation

2
5

Or

Positive
Blo

od

1. Add 5 of drawn blood into round sample well.

2. Add 5 of drawn blood into round sample well
touching sample pad.

Add 4 drops of assay diluent

into the square assay diluent well.

Black line

Blo

od

Interpret test results in 20~30 minutes.

2
Dispense

Or

Negative

20~30 mins

Dispense

Invalid
Caution :
Dont read test results after 30 minutes.
Reading too late can give false results.

* Use Loop : Let the circular end of the loop on the pad and
press it slightly.

Ordering Information

Cat. No.

Description

Specimen

Type

Pack size

05FK50
05FK70

Malaria Ag P.f
Malaria Ag P.v

Whole Blood
Whole Blood

Device
Device

1Tx25/Kit
1Tx25/Kit

One Step Malaria Ag P.f/Pan (HRP-II/pLDH) Test

Malaria Ag P.f/Pan
Malaria is a serious, sometimes fatal, parasitic disease characterized by high fevers, shaking
chills and flu-like illness, and is caused by a parasite that is transmitted from one human
to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more
than 90 countries worldwide, and it is estimated that there are over 500 million clinical
cases and 2.7 million malaria-caused deaths per year, 75% of them are African children.
The infection with P. falciparum, if not promptly treated, may be fatal.

General Information
SD BIOLINE Malaria Ag P.f/Pan test is a one step, rapid, qualitative and differential test for the detection of HRP-II
(Histidine-rich protein II) specific to P. falciparum and pLDH (Plasmodium lactate dehydrogenase) Pan specific to P. species
in human blood sample.
Differential diagnosis between Plasmodium falciparum and the other Plasmodium species (P.vivax, P.ovale,
P. malariae)
Specimen : Whole blood (5l)
Test result : 20~30 minutes
1RMP?EC0MMKRCKNCP?RSPC\!
Sensitivity : 99.7% (P.f), 95.5% (non-P.f)
Specificity : 99.5%
Maximized sensitivity and specificity

Materials Provided

SD BIOLINE Malaria Ag P.f/Pan test device

Assay diluent

Disposable sample applicator

Option : Lancet, alcohol swab

Test Procedure
Interpretation

Clean the patient's finger.

The alcohol MUST be dried before
pricking, or test may not work.

Prick the patients finger with

the lancet to get blood.

1. With a 5 capillary pipette, draw blood to black line.

2. Take a disposable specimen loop (5) provided, dip the
circular end of a loop into the blood specimen.

Malaria Ag P.f/Pan
1. P.f
2. Pan

Malaria Ag P.f/Pan
1. P.f
2. Pan

2
5

Blo

od

1. Add 5 of drawn blood into round sample well.

2. Add 5 of drawn blood into round sample well
touching sample pad.

Add 4 drops of assay diluent

into the square assay diluent well.

Or
Black line

Or

Blo

Interpret test results in 20~30 minutes.

Malaria Pan
Positive

Malaria Ag P.f/Pan
1. P.f
2. Pan

Malaria
Mixed Infection

Malaria Ag P.f/Pan
1. P.f
2. Pan

20~30 mins

Dispense
Malaria Ag P.f/Pan
1. P.f
2. Pan

Caution :
Dont read test results after 30 minutes.
Reading too late can give false results.

* Use Loop : Let the circular end of the loop on the pad and
press it slightly.

Malaria Ag P.f/Pan
1. P.f
2. Pan

od

2
Dispense

Malaria P.f
Positive

Malaria Ag P.f/Pan
1. P.f
2. Pan

Negative

Invalid

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

05FK60

Malaria Ag P.f/Pan

Whole Blood

Device

1Tx25/Kit

10

One Step Malaria Antigen POCT Test

Malaria Antigen POCT

Malaria is a serious, sometimes fatal, parasitic disease characterized by high fevers, shaking
chills and flu-like illness, and is caused by a parasite that is transmitted from one human
to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more
than 90 countries worldwide, and it is estimated that there are over 500 million clinical
cases and 2.7 million malaria-caused deaths per year, 75% of them are African children.
The infection with P. falciparum, if not promptly treated, may be fatal.

General Information
SD BIOLINE Malaria Antigen POCT test is a qualitative test for the detecting of malaria antigen in human blood.
Individual package including all materials
Specimen : Whole blood (5l)
Test result : 20~30 minutes
1RMP?EC0MMKRCKNCP?RSPC\!

Materials Provided

SD BIOLINE Malaria Antigen POCT test device

Assay diluent

Disposable sample applicator

Lancet, alcohol swab

Test Procedure
Clean the patient's finger.
The alcohol MUST be dried before pricking,
or test may not work.

Prick the patients finger with the lancet

to get blood.

1. With a 5 capillary pipette, draw blood to black line.

2. Take a disposable specimen loop (5) provided, dip the
circular end of a loop into the blood specimen

2
5

Blo

od

1. Add 5 of drawn blood into round sample well.

2. Add 5 of drawn blood into round sample well
touching sample pad.

Add 4 drops of assay diluent into the square

assay diluent well.

Or
Black line

Blo

od

Interpret test results in 20~30 minutes.

2
Dispense

Or

20~30 mins

Dispense

Caution :
Dont read test results after 30 minutes.
Reading too late can give false results.

* Use Loop : Let the circular end of the loop on the pad and
press it slightly.

Ordering Information

11

Cat. No.

Description

Specimen

Type

Pack size

05FK43
05FK53
05FK63
05FK73

Malaria Ag POCT
Malaria Ag P.f POCT
Malaria Ag P.f/Pan POCT
Malaria Ag P.v POCT

Whole blood
Whole blood
Whole blood
Whole blood

Device
Device
Device
Device

1T/Kit
1T/Kit
1T/Kit
1T/Kit

One Step Malaria P.f/P.v Antibody Test

Malaria P.f/P.v
Malaria is a serious, sometimes fatal, parasitic disease characterized by high fevers, shaking
chills and flu-like illness, and is caused by a parasite that is transmitted from one human
to another by the bite of infected Anopheles mosquitoes. The disease now occurs in more
than 90 countries worldwide, and it is estimated that there are over 500 million clinical
cases and 2.7 million malaria-caused deaths per year, 75% of them are African children.
The infection with P. falciparum, if not promptly treated, may be fatal.

General Information
SD BIOLINE Malaira P.f/P.v test is a qualitative immunochromatographic rapid test for detection of antibodies of all
isotypes (IgG, IgM, IgA) specific to Plasmodium falciparum and Plasmodium vivax simultaneously in human serum,
plasma or whole blood.
Detecting all antibodies (IgG, IgM, IgA) against MSP of P.f and P.v
Differentiated test results between P. falciparum and P. vivax
Specimen : Serum, Plasma, Whole Blood

Performance Characteristics
Malaria P.f

Sensitivitiy
Specificity

SD BIOLINE Malaria P.f/P.v test

Malaria P.v

87%

86%
99.5%

Materials Provided

SD BIOLINE Malaria P.f/P.v test device

Assay diluent

Test Procedure

Add 10 l of serum, plasma, or 20 l of whole blood into the sample well.

Add 3~4 drops of the assay diluent.
Interpret test results in 5~20 minutes.

Interpretation
P.v Positive
1.Malaria P.f
2.Malaria P.v

P.f Positive
1.Malaria P.f
2.Malaria P.v

Serum, Plasma 10l or

Whole blood 20l

3~4 drop

P.f/P.v Positive
1.Malaria P.f
2.Malaria P.v

1.Malaria P.f
2.Malaria P.v

5~20min.

1.Malaria P.f
2.Malaria P.v

Negative
1.Malaria P.f
2.Malaria P.v

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

05FK30

Malaria P.f/P.v

S/P/WB

Device

1Tx30/Kit

12

One Step Dengue IgG/IgM Antibody Test

Dengue IgG/IgM
Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus
mosquitoes, are widely distributed throughout the tropical and subtropical areas of the
world. There are four known distinct serotypes(dengue virus 1, 2, 3 and 4). In children,
infection is often subclincal or causes a self-limited febrile disease. However, if the patient
is infected by a different serotype repeatedly, a more severe disease, dengue hemorrhagic
fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the
most important arthropod-borne viral disease due to the human morbidity and mortality it
causes.

General Information
SD 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 serotype DEN-1, 2, 3 and 4.
Differential detection of IgG and IgM antibodies
Serum, Plasma, Whole Blood
Test result : 3-lines(IgG, IgM, control)
Highest accuracy in low titer specimen
Presumptive differentiation between primary & secondary dengue infections
Good correlation with Haemagglutination-Inhibition (HI) test
No cross reactivity with other Flavivirus group mediated and mosquitoes-borne disease
Sensitivity 94.6%, Specificity 94.1% (vs. HI test)

Materials Provided

SD BIOLINE Dengue IgG/IgM test device, Assay diluent, Capillary pipette (5l)
SD BIOLINE Dengue IgG/IgM (WB) test device, Assay diluent, Capillary pipette (10l)

Test Procedure
1. Dengue IgG/IgM

Interpretation
Positive
IgM Positive
(Primary dengue Infection)

5l

C
M
G

Dengue

C
M
G

IgG Positive
(Secondary or past dengue Infection)

4 drop
C
M
G

Up to black line
(5l)

C
M
G

Dengue

C
M
G

15~20min.

IgG and IgM Positive

(Late primary or early secondary dengue Infection)

C
M
G

2. Dengue IgG/IgM WB
Negative
Up to black line
(10l)

C
M
G

W/B

Dengue

C
M
G

Ordering Information

13

Cat. No.

Description

Specimen

Type

Pack size

11FK10
11FK20

Dengue IgG/IgM
Dengue IgG/IgM WB

Serum, Plasma
Serum, Plasma, Whole blood

Device
Device

1Tx25/Kit
1Tx25/Kit

One Step Salmonella typhi IgG/IgM Test

Salmonella typhi IgG/IgM

Typhoid fever is a serious illness caused by a bacteria called Salmonella typhi. Symptoms of Salmonella
typhi infection may be mild to severe and can include fever, headache, loss of appetite, constipation
or diarrhea, and nonproductive cough. Typhoid fever is still common in developing countries and
affects about 12.5 million persons each year. Salmonella typhi bacteria are shed in the urine or stool of
infected persons, including chronic carriers. Typhoid fever is spread by eating or drinking contaminated
food or water or by direct or indirect contact with fecal material from infected persons.

General Information
SD BIOLINE Salmonella typhi IgG/IgM rapid 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.
This test provides only a preliminary test result. Therefore more specific alternative diagnosis method must be used in
order to confirm salmonella typhi infection.
IgM : Perfect alternative of Widal test
IgG : Examination of past infection
Specific screening test for Salmonella typhi
Test result : 3-lines (IgG, IgM, Control)
Specimen : Serum, Plasma or Whole blood
Sensitivity : IgG-70% IgM-69% IgG+IgM-80%
Specificity : IgG-76% IgM-79% IgG+IgM-81%
1RMP?EC0MMKRCKNCP?RSPC\!

Materials Provided

SD BIOLINE Salmonella typhi IgG/IgM Test Strip

Assay diluent
Disposable Loop (1l)
Disposable test tube

Test Procedure
Interpretation
IgM Positive

(acute typhoid fever)

G M C

4 drop

IgG Positive

1l

Mix well

(previous typhoid fever infection or re-infection)

G M C

15~30min.

IgG/IgM Positive (acute typhoid fever in the middle stage of infection)

G M C

Negative
G M C

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

15FK12

Salmonella typhi IgG/IgM

Serum/Plsma/Whole blood

Strip

1Tx25/Kit

14

One Step Hantaan virus Antibody Test

One Step Tsutsugamushi Antibody Test

Hantaan Virus
Tsutsugamushi
Hantaan virus are carried by rodents and are spread to human via inhalation of aerosolized virus particles
shed in the rodent feces and urine. Infection with Hantaan virus can range in severity from asymptomatic to a
severe, life-threatening illness characterized by fever, hemorrhage, and renal failure.
O. tsustsugamushi, the causative agent of scrub typhus, is transmitted to human by the bite of a larval
mite. The disease is characterized by fever, rash, eschar, pneumonitis, menigitis and disseminated intravascular
coagulation which leads to severe multiorgan failure in untreated cases.

General Information
Item
Disease

SD BIOLINE Hantaan Virus

SD BIOLINE Tsutsugamushi

Hemorrhagic fever with renal syndrome (HFRS)

Detection of IgG, IgM, IgA
antibodies to genus Hantavirus like Hantaan virus,
Seoul virus, Puumula virus, Prospect Hill virus
Human serum, plasma or whole blood

Scrub Typhus

Sensitivity

96%

99%

Specificity

94%

96%

IFA

IFA

Detection
Sample

Comparied Method

Detection IgG, IgM, IgA antibodies to Rickettsia

Tsutsugamushi
Human serum, plasma or whole blood

Materials Provided

SD BIOLINE Test device

Assay diluent

Test Procedure
Device

Interpretation

Serum, Plasma 10l or

Whole blood 20l

Positive

Hantaanvirus
15~20min.

3~4 drop

Negative

Tsutsugamushi
10~15min.
Multi-Device
Serum, Plasma 10l or
Whole blood 20l

Positive

Negative

Hantaanvirus
15~20min.

3~4 drop

Tsutsugamushi
10~15min.

Ordering Information

15

Cat. No.

Description

Specimen

Type

Pack size

17FK10
17FK11
18FK10
18FK11

Hantaan virus
Hantaan virus
Tsutsugamushi
Tsutsugamushi

S/P/WB
S/P/WB
S/P/WB
S/P/WB

Device
Multi-Device
Device
Multi-Device

1Tx30/Kit
10Tx10/Kit
1Tx30/Kit
10Tx10/Kit

One Step Leptospira Antibody Test

Leptospira
Eptospirosis occurs worldwide but is most common in temperate or tropical climates. It is an occupational
hazard for many people who work outdoors or with animals, for example, farmers, sewer workers,
veterinarians, fish workers, dairy farmers or military personnel. It is a recreational hazard for campers or those
who participate in outdoor sports in contaminated areas and has been associated with swimming, wading, and
whitewater rafting in contaminated lakes and rivers. The incidence is also increasing among urban children.

General Information
Leptospira

Item

Detection

Sample
Interpreter

Leptospira IgM

Leptospira IgG/IgM

Qualitative detection of IgG

antibody to Leptospira
interrogans

Qualitative detection of IgM

antibody to Leptospira
interrogans

Differential detection of IgG &

IgM antibodies to Leptospira
interrogans

10ul of serum or plasma

or 20ul of whole blood

10ul of serum or plasma

or 20ul of whole blood

5ul of serum or plasma

2 - Line
(Control/Test)

2 - Line
(Control/Test)

3 - Line
(Control/IgG/IgM)

Easy to use : no need of any instrument

Test result: 20 minutes

Materials Provided

SD BIOLINE Leptospira, Leptospira IgM, Leptospira IgG/IgM test device

Capillary pipette (IgG/IgM)

Assay diluent

Test Procedure
Leptospira / Leptospira IgM

Interpretation
Serum, Plasma 10l or
Whole blood 20l

3~4 drop

15~20min.

Leptospria
Leptospira IgM

Leptospria IgG/IgM

IgG/IgM
IgG/IgM

Leptospira

Invalid

20min.

C
M
G

IgG/IgM

Leptospira

C
M
G

IgG/IgM

Leptospira

C
M
G

IgG/IgM

Leptospira

C
M
G

Or

Leptospira

C
M
G

5l
4 drop

IgG/IgM

C
M
G

Negative

Invalid

Up to black line
(5l)

Leptospira

IgM Positive

IgG/IgM

Negative

Leptospira IgG/IgM

Leptospira

IgG Positive
C
M
G

Positive

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

16FK10
16FK11
16FK30
16FK40

Leptospira
Leptospira
Leptospira IgM
Leptospira IgG/IgM

S/P/WB
S/P/WB
S/P/WB
S/P/WB

Device
Multi-Device
Device
Device

1Tx30/Kit
10Tx10/Kit
1Tx30/Kit
1Tx30/Kit

16

One Step Influenza Virus Type A & B Antigen Test

One Step Influenza Virus Type A / H5 Antigen Test

)NUENZA!G
)NUENZA(
Influenza, commonly known as "flu", is a highly contagious viral infection of the respiratory tract. It
affects both sexes and all age groups, but its highest incidence is in children. Outbreaks tend to occur
in the winter and early spring when as many as 40% of children can become infected. There are three
types of influenza viruses. Type A is usually responsible for the large influenza epidemics. Type A is
constantly changing, with new strains appearing regularly.
Influenza types A are divided into subtype H (hemagglutinin) and N (neuraminidase). The subtype H
has H1~H15 types and the subtype N has N1~N9. Especially H1N1, H3N2, H2N2, H5N1 are important
to a human infection.

General Information
Item
Detection

Influenza Antigen Test

Differential detection of Influenza
virus type A & B

Infuenza H5 Test
Detection of Influenza virus type A subtype H5

Sample

Human nasal swab, throat swab, nasopharyngeal

swab or nasal/nasopharyngeal aspirate

Human nasal swab, throat swab, nasal/tracheal

aspirate

Accuracy

Sensitivity (91.8%), Specificity 98.9% vs. Viral

culture and RT-PCR as gold standard

Detecting all of H5N1 bird flu samples isolated from

human in 2006, 2005, 2004 in Vietnam

Materials Provided

SD BIOLINE Influenza Ag Test strip, Disposable tubes with rack, Assay diluent, Sterilized swab, Control swab, Disposable dropper
SD BIOLINE Influenza H5 Test strip, Disposable tubes with rack, Assay diluent, Sterilized swab, Control swab, Disposable dropper

Test Procedure
Methods of Sample Collection

Influenza Ag
Influenza H5

Influenza Ag
Influenza H5

Influenza Ag

Influenza Ag
Influenza H5

Influenza Ag

Influenza H5

Interpretation
Influenza Ag
A B C

Negative
A B C

Type A-Positive
A B C

Type B-Positive
A B C

10~15min.

Type A/B-Positive

Influenza H5
T C

Negative
T C

H5-Positive

Ordering Information

17

Cat. No.

Description

Type

Pack size

19FK12
19FK22

Influenza Virus A & B Antigen Test

Influenza Virus H5 Antigen Test

Strip
Strip

1Tx25/Kit
1Tx25/Kit

One Step Respiratory Syncytial Virus Test

RSV
RSV is the most common respiratory virus in infants and young children. It infects virtually
all infants by the age of two. In most infants, the virus causes symptoms resembling those
of the common cold. In infants born prematurely and/or with chronic lung disease, RSV can
cause a severe or even life-threatening disease. Prior to the introduction of Synagis, RSV
disease resulted each year in over 125,000 hospitalizations. There was a high mortality risk
in approximately 2 percent of those infants.

General Information
SD BIOLINE RSV test is an immunochromatographic assay for qualitative detection of respiratory syncytial virus (RSV) in
NPS (Nasopharyngeal secretion/ aspirations).
Specimen: NPS (Nasopharyngeal secretion/ aspirations)
Test result in 15minutes

Performance Characteristics (vs. culture)

SD BIOLINE RSV

Sensitivity

Specificity

92.3%

93.3%

Materials Provided

SD BIOLINE RSV test strip

Disposable test tubes, droppers
Extract buffer

Test Procedure
Interpretation

15min.

Negative

T C

Positive

T C

Invalid

T C
T C

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

40FK12

RSV Test

NPS

Strip

1Tx25/Kit

18

One Step Group A Streptococcal Antigen Rapid Test

Strep A
GAS (Group A streptococcus) is one of the most important causes of acute upper
respiratory track infection. Hardly diagnosis and treatment of Group A Streptococcal
pharyngitis has been shown to reduce the severity of symptoms and serious compications
such as rheumatic fever and glomerulonephritis. Conventional identification procedures
for GAS from throat swabs involve the isolation and subsequent identification of viable
pathogen techniques that require 24~48 hours or longer for results.

General Information
SD BIOLINE Strep A rapid test is a chromatographic immunoassay 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 : 10 minutes

Performance Characteristics (vs. culture method)

Sensitivity
87.3%

SD BIOLINE Strep A

Specificity
95.8%

Materials Provided

SD BIOLINE Strep A test strip

Extraction Reagent A, B
Sterile throat swab

Disposable test tube

Positive / Negative control

Test Procedure
Interpretation

5~10min.

Negative

T C

Positive

T C

Invalid

T C
T C

Ordering Information

19

Cat. No.

Description

Specimen

Type

Pack size

45FK12

Strep A

Throat swab

Strip

1Tx25/Kit

One Step TB Antibody Test

TB
TB W/B
TB IgG/IgM
Tuberculosis (TB) is a disease caused by bacteria called Mycobacterium tuberculosis. The
bacteria can attack any part of your body, but they usually attack the lungs. Morbidity of
tuberculosis has been decreasing but recently HIV-associated tuberculosis and multi-drug
resistant tuberculosis are on the rise. It's not easy to detect TB disease at the beginning of
infection since there are few symptoms. Tuberculin skin test or chest X-ray can be used to
screen TB. However, these methods require complex procedures or may not confirm that
a person has TB disease. Serologic test can overcome these disadvantages with its simple
and rapid method.

General Information
SD BIOLINE Rapid TB Test is an in vitro immunochromatographic test for the detection of antibodies to Mycobacterium
tuberculosis in human serum, plasma or whole blood.
Easy to test : No technician and equipment needed
No cross reactivity with other species of Mycobacterium
Good supplementary or substitutional test for X-ray screening or sputum culture examination

TB

Item

TB W/B

TB IgG/IgM

Simultaneous detection of all Simultaneous detection of all

antibodies (IgG, IgM, IgA) to antibodies (IgG, IgM, IgA) to
M.tuberculosis
M.tuberculosis

Detection

Sample

10l of serum or 20l of whole

blood
96.4%
98.2%

100l of serum

Sensitivity
Specificity

98.2%
99.6%

Differential detection of IgG and

IgM (3-lines)
10l of serum or plasma
96.4%
98.2%

Materials Provided

SD BIOLINE TB test device

SD BIOLINE TB IgG/IgM test device, Assay diluent

SD BIOLINE TB WB test device, Assay diluent

Test Procedure
TB

Interpretation

100l

15min.

TB

TB

C
G
M

Positive

TB IgG/IgM
TB IgG Positive
TB
IgG/IgM

TB W/B

TB
TB WB

TB IgM Positive
3~4 drop
C
G
M

15min.

TB W/B

TB W/B

Negative

TB IgG/IgM Positive

Invalid

C
G
M

15min.

TB Negative
TB
IgG/IgM

3~4 drop

Serum / Plasma
10l

TB
IgG/IgM

C
G
M

TB IgG/IgM

TB
IgG/IgM

Serum 10l or
Whole blood 20l

TB
IgG/IgM

C
M
G

TB
IgG/IgM

C
M
G

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

08FK10
08FK20
08FK30

TB
TB W/B
TB IgG/IgM

Serum
Serum/Whole blood
Serum/Plasma

Device
Device
Device

1Tx30/Kit
1Tx30/Kit
1Tx25/Kit

20

Identification of Mycobacterium tuberculosis Complex

TB Ag MPT64
Tuberculosis is a highly infectious disease caused by Mycobacterium tuberculosis and
potentially fatal disease of human. Biochemical, immunological and molecular biological
characterization of Mycobacterium tuberculosis has led to the identification of several
antigens which may be useful in the development of improved diagnostic methods in
order to discriminate between the M. tuberculosis complex and mycobacteria other than
M. tuberculosis (MOTT bacilli). M. tuberculosis has been known to secrete more than 33
different proteins. One of the predominant proteins, MPT64 was found in the culture fluid
of only strains of the M. tuberculosis complex.

General Information
SD BIOLINE TB Ag MPT64 is a rapid immunochromatographic identification test for the M. tuberculosis complex.
Simple, rapid assay using mouse monoclonal anti-MPT64
Rapid discrimination between the M. tuberculosis complex and MOTT bacilli
Identification of the M. tuberculosis complex in combination with culture systems based on liquid media
Sample: Colony, Condensation fluid(Solid cultures) or Liquid cultures
Test result: 15minutes

Materials Provided

SD BIOLINE TB Ag MPT64 test device

Extraction buffer (for sample preparation from solid cultures)

Test Procedure
Solid cultures
[Colony]

2
200 of
extraction
buffer

100

5x

7PSUFYJOH

Interpretation

[Condensation fluid of slant agar tubes]

Positive

TB Ag MPT64

Negative

100

100 of
condensation
fluid

TB Ag MPT64

Liquid cultures

Invalid

TB Ag MPT64

TB Ag MPT64

100

100 of
liquid
cultures

Ordering Information

21

Cat. No.

Description

Specimen

Type

Pack size

08FK50

TB Ag MPT64

Liquid cultures / Solid cultures

Device

1Tx25/Kit

One Step H.pylori Antibody Test

H.pylori
Helicobacter pylori (H. pylori) is a spiral-shaped bacterium and that is found in the gastric
mucous layer or adherent to the epithelial lining of the stomach. H. pylori causes more than
90% of duodenal ulcers and up to 80% of gastric ulcers. Approximately two-thirds of the
world's population is infected with H.pylori.The immunochronomatographic techinques for
the detection of antibodies specitic to H. pylori has substantially resolved these problems.

General Information
SD 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, plasma or whole blood.
Detection of all isotypes (IgG, IgM, IgA) antibodies against H.pylori
High Accuracy - Sensitivity : 95.9%, Specificity : 89.6%
Specimen : Serum, Plasma, Whole Blood

Materials Provided

SD BIOLINE H. pylori test device/multi-device

Assay diluent

Test Procedure

Add 10 l of serum/plasma or 20 l of whole blood into the sample well.

Add 3 drops of the assay diluent.
Interpret test results at 10 minutes.

Interpretation
Device
H.pylori

Negative

3drop
H.pylori

10min.

H.pylori

H.pylori

Positive

Multi-Device

Positive

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

H.pylori

3drop

Negative

10min.

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

04FK10
04FK11

H.pylori
H.pylori

S/P/WB
S/P

Device
Multi-Device

1Tx30/Kit
10Tx10/Kit

22

One Step H.pylori Antigen Test

H.pylori Ag
Helicobacter pylori (H. pylori) is a spiral-shaped bacterium that found in the gastric mucous
layer or adherent to the epithelial lining of the stomach. H. pylori causes more than 90% of
duodenal ulcers and up to 80% of gastric ulcers. Approximately two-thirds of the world's
population is infected with H.pylori.The immunochronomatographic techinques for the
detection of antibodies specitic to H. pylori has substantially resolved these problems.

General Information
SD BIOLINE H.pylori Ag test is a rapid immunochromatographic assay for the detection of Helicobacter pylori in human fecal
specimens.
Simple and easy to collect specimen : Non invasive test
Sample: 50mg of stool
Detection limit: 4ng/ml
Test result: 10 minutes

Materials Provided

SD BIOLINE H.pylori Ag test device

Sample collection tube with assay diluent
Sample collection swab
Disposable dropper

Test Procedure

Interpretation
Negative
H.pylori Ag

Take a portion of fecal

(about 50mg) from a
stool sample.

Insert the swab into the sample

collection tube and swirl the
swab at least 10 times.

Discard the swab while

squeezing the swab
against the wall of tube.

Positive
H.pylori Ag

Invalid
H.pylori Ag

4drops

10min.

H. pylori Ag

H.pylori Ag

Assemble dropping cap

on the buffer bottle

Add 4 drops into the sample

well (S) of test device.

Ordering Information

23

Cat. No.

Description

Specimen

Type

Pack size

04FK20

H.pylori Ag

fecal

Device

1Tx20/Kit

One Step Rotavirus Antigen Test

Rotavirus
Rotavirus is the most common cause of severe, dehydrating diarrhea among children
worldwide. Scientists have described seven rotavirus groups (A to G). Only groups A, B,
and C infect humans. Group A, which has multiple strains, causes the majority of childhood
infections. Although human of all ages are susceptible to rotavirus infection, children 3
to 24 months of age account for the vast majority of severe infections. A person with
rotavirus diarrhea often excretes large amounts of virus, which can spread readily through
contaminated hands. Rotavirus, a hearty virus that survives easily in the environment, can
also be transmitted through contaminated objects, water or food.

General Information
SD BIOLINE Rotavirus test is an immunochromatographic assay for the detection of Group A rotavirus in 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
Sensitivity : 94%, Specificity 98.3% (vs. RT-PCR)
1RMP?EC0MMKRCKNCP?RSPC\!

Materials Provided

SD BIOLINE Rotavirus test device

Sample collection tube with assay diluent
Sample collection swab

Test Procedure

Interpretation
Positive

Take a portion of fecal

(about 50mg) from a
stool sample.

Insert the swab into the sample

collection tube and swirl the
swab at least 10 times.

Discard the swab while

squeezing the swab
against the wall of tube.

ROTAVIRUS

Negative
ROTAVIRUS

4drops

10~20min.
InvaIid

ROTAVIRUS

ROTAVIRUS

Assemble dropping cap

on the buffer bottle

Add 4 drops into the sample

well (S) of test device.

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

14FK10

Rotavirus

fecal

Device

1Tx20/Kit

24

One Step Rota/Adeno virus Antigen Test

Rota/Adeno Ag
Rotaviruses are one of the major causes of pediatric gastroenteritis and diarrhea.
Untreated rotavirus infection may result in severe illness with dehydration and disturbances
of the body's normal electrolyte balance, especially in babies and preschool children.
Adenoviruses have been implicated in a wide range of clinical diseases affecting mainly
the respiratory, ocular and the gastrointestinal systems of the human. Some adenovirus
serotypes are enteric and have emerged as a major source of pediatric gastroenteritis.

General Information
SD BIOLINE Rota/Adeno Ag test is a rapid immunochromatographic assay for qualitative detection of the presence of
rotavirus or adenovirus antigen in human fecal samples.
Differentiation of test result by clear band formation(3-lines)
Specimen : Fecal specimens
Test result: 10 minutes

Materials Provided

SD BIOLINE Rota/Adeno Ag test device

Sample collection tube with assay diluent
Sample collection swab

Test Procedure

Interpretation
Adenovirus Positive

Take a portion of fecal

(about 50mg) from a
stool sample.

Insert the swab into the sample

collection tube and swirl the
swab at least 10 times.

Discard the swab while

squeezing the swab
against the wall of tube.

1. ADENOVIRUS
2. ROTAVIRUS

Rotavirus Positive
1. ADENOVIRUS
2. ROTAVIRUS

10min.

Negative

Rota/Adeno Ag

1. ADENOVIRUS
2. ROTAVIRUS

Assemble dropping cap

on the buffer bottle

Add 4 drops into the sample

well (S) of test device.

Ordering Information

25

Cat. No.

Description

Specimen

Type

Pack size

14FK20

Rota/Adeno virus

fecal

Device

1Tx20/Kit

One Step Rubella IgG/IgM Test

Rubella IgG
Rubella IgG/IgM
Rubella (commonly known as German measles or 3-day measles) is an infection that
primarily affects the skin and lymph nodes. It is caused by the rubella virus (not the same
virus that causes measles), which is usually transmitted by secretions from the nose or
throat. It can also pass through a pregnant woman's bloodstream to infect her unborn
child. As this is a generally mild disease in children, the primary medical danger of rubella
is the infection of pregnant woman, which may cause congenital rubella syndrome in
developing babies.

General Information
Rubella IgG

Rubella IgG/IgM

Description

Semi-quantitative immunochromatographic assay

Differential immunochromatographic assay

Detection antibody

Cut off

IgG
3 - Line
C2 : Control line 2 (procedual)
T : Test line
C1 : Control line 1 (10 IU/ml)
10 IU/ml (compare with C1)

Sensitivity

>99.9%

Specificity

>99.9%

Use

Indicator of immune status

Rubella IgG and IgM

3 - Line
G : IgG result line
M : IgM result line
C : Control line
IgG : 99.14%
IgM : 98.33%
IgG : 91.55%
IgM : 97.64%
Indicator of immune status or comfirmation of
recent rubella infection

Test result

Materials Provided

SD BIOLINE Rubella IgG/IgM test device, Assay diluent, Capillary pipette

SD BIOLINE Rubella IgG test device, Assay diluent, Capillary pipette

Test Procedure
Interpretation
P.vRubell
PositiveIgG/IgM

Rubella IgG Negative

Rubella IgM Positive

IgG/IgM
IgG/IgM

Rubella

IgG/IgM

C
M
G

Rubella

C2

C1

Rubella IgG

Rubella IgG/IgM Negative

C
M
G

C1T : Similar color and darkness

of "C1" and "T1"
C1<T : "T" may be darker than "C1"

Add 5l of serum or plasma into

the sample well marked "S".

Rubella

Rubella IgG/IgM Positive

C
M
G

C2

C1

Put 3~4 drops of assay diluent into

the assay diluent well round shaped.

Rubella IgG

C
M
G

Up to black line
(5l)

IgG/IgM

Rubella IgG Positive

Rubella IgG Positive

C
M
G

3~4 drop

Rubella

Rubella IgG

C2

C1

Only control bands appeared (C1&C2)

T<C1 : weaker "T" than "C1"

C
M
G

20~30min.

C2

C1

C
M
G

Or

Rubella IgG

5l

Rubell IgG

Ordering Information
Cat. No.

Description

Specimen

Type

Pack size

07FK10

Rubella IgG

Serum/Plasma

Device

1Tx25/Kit

07FK20

Rubella IgG/IgM

Serum/Plasma

Device

1Tx25/Kit

26

One step Tetanus Antibody Test

Tetanus
Tetanus is an acute, often fatal, disease caused by a neurotoxin produced by Clostridium
tetani. The toxin causes a high rate of disease outbreak and lethality by invading the
nerve system. In case of infectious exposure from external injuries, an immunization with
tetanus toxoid or its immunoglobulin is recommended to prevent tetanus from attacking.
Also a sufficient titer level of tetanus antibody in blood is required to confirm even though
a person has a tetanus immunization history in the infant and childhood, because the
immunization may not be performed correctly or the antibody titer level declined by aging.

General Information
SD BIOLINE Tetanus test is one step, rapid immunochromatographic assay for qualitative detection of tetanus antibody in
serum, plasma and whole blood.
Specimen : Serum, Plasma and Whole blood
Detection limit : 100 mIU/ml (serum, plasma), 200 mIU/ml (whole blood)
Point of care test at emergency room
Detection of tetanus antibody (IgG/IgM) before anti-tetanus toxoid immunoglobulin treatment
Useful to determine tetanus antibody immune status :
Correctly protected - over 100mIU/ml (S/P), 200mIU (WB)
Slighty or not protected - below 100mIU/ml (S/P), 200mIU (WB)
No interfering reactivity with hemoglobin, bilirubin or triglyceride
Sensitivity 96.5%, specificity 87.0% (vs. ELISA)

Materials Provided

SD BIOLINE Tetanus test device

Assay diluent
Capillary pipette

Test Procedure
Blood specimen

Interpretation
Tetanus

Negative
Prick with the
lancet.

Draw blood into the

capillary pipette.

Tetanus

Add 1drop of blood.

Blood (by venipuncture), plasma or serum

specimen

20~30min.
Tetanus

Positive
Tetanus

Add 3~4 drops of

assay diluent.

Invalid
Tetanus

Tetanus

Take 30l of specimen

using a micropipette.

Add 30l of blood, plasma

or serum.

Ordering Information

27

Cat. No.

Description

Specimen

Type

Pack size

42FK10

Tetanus Test

S/P/WB

Device

1Tx25/Kit

One Step Tumor Markers Test

AFP/CEA/PSA
Alpha-fetoprotein(AFP) is one of the most well-known carcinofetal antigens.
Carcinoembryonic antigen (CEA) is a tumor-associated antigen, which is expressed largely in
gastrointestinal track tumors. Prostate-specific antigen (PSA) is the most useful tumor marker in
diagnosis of prostate cancers.

General Information
SD BIOLINE AFP, CEA, PSA tests are immunochromatographic assay designed for qualitative detection of AFP, CEA, PSA in
human serum, plasma or whole blood.
Description
Detection
Sample
Cut - Off
Sensitivity
Specificity

AFP
Alpha fetoprotein
Serum/Plasma/Whole blood
20ng/ml
100%
100%

CEA
Carcinoembryonic antigen
Serum/Plasma/Whole blood
5ng/ml
100%
99.6%

PSA
Prostate - specific antigen
Serum/Plasma/Whole blood
3ng/ml
98.6%
98.9%

Materials Provided

SD BIOLINE AFP, CEA, PSA test device / Multi-device

SD BIOLINE AFP WB, CEA WB, PSA WB test device / Assay diluent

Test Procedure
Interpretation

Device(S/P)

Negative

100l

20min.
Positive

Device(W/B)
Negative

30l

4 drop

15~20min.

Positive

Positive

Multi-Device

Negative

100l

20min.

Ordering Information
Cat. No.
20FK10
20FK11
20FK14
21FK10
21FK11
21FK20
22FK10
22FK11
22FK20

Description
AFP
AFP
AFP (W/B)
CEA
CEA
CEA (W/B)
PSA
PSA
PSA (W/B)

Specimen

S/P
S/P
S/P/WB
S/P
S/P
S/P/WB
S/P
S/P
S/P/WB

Type
Device
Multi-Device
Device
Device
Multi-Device
Device
Device
Multi-Device
Device

Pack size
1Tx30/Kit
10Tx10/Kit
1Tx30/Kit
1Tx30/Kit
10Tx10/Kit
1Tx30/Kit
1Tx30/Kit
10Tx10/Kit
1Tx30/Kit

28

One Step Fecal Occult Blood Test

FOB
The detection of fecal occult blood is important for the diagnosis of disease that results
in gastrointestinal bleeding and to screen for colorectal cancers and large adenomas that
bleed. Screening for colorectal cancer probably increases the cancer detection at an early
stage, therefore reduces the mortality.

General Information
SD BIOLINE FOB test is a rapid, qualitative test for the detection of human blood hemoglobin in human fecal specimens.
Screening occult blood in fecal
No cross reaction with animal blood
Sensitivity : 98%, Specificity : 98.5%
Specimen : Fecal
Detection Limit : 50 ng/ml of human blood hemoglobin
Test result in 5~10 minutes

Materials Provided

SD BIOLINE FOB test multi-device

Sample collection tube with assay diluent
Storage and transport bag for specimen container

Test Procedure
Interpretation
3drop

Positive

FOB

FOB

FOB

FOB

FOB

FOB

FOB

FOB

FOB

FOB

Ordering Information

29

Cat. No.

Description

Specimen

Type

Pack size

25FK12

FOB(Fecal Occult Blood)

Fecal

Multi-Device

10Tx5/Kit

FOB

FOB

FOB

FOB

FOB

Loosen green cap

the lower part
of the sample
collection tube

FOB

Shake and
mix well

FOB

Re-insert the
applicator stick
into the sample
collection tube

FOB

Insert and turn the

stick into the fecal
sample 5~6 times at
different site

FOB

Loosen
Cap

FOB

5~10min.

Negative

One Step Human chorionic gonadotropin Test

hCG
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the
developing placenta shortly after fertilization. When you are pregnant, your body will
produce special pregnancy hormone known as hCG.

General Information
SD BIOLINE hCG test is an immunochromatographic assay designed for qualitative detection of hCG in urine.
Test result: urine 3minutes / serum 5minutes
Detection : 25 mlU/ml
Specimen : Urine, Serum
Cross reactivity : No cross reactivity with 200 mlU/ml of hLH, 1,000 mlU/ml of hFSH and 1,000lU/ml of hTSH

Test Procedure
Interpretation

Device
3~4 drop

hCG

urine 3min.
serum 5min.

hCG

Non-Pregnancy
hCG

Pregnancy

Midstream

Or

Non-Pregnancy

5min.

Pregnancy

Strip

Non-Pregnancy

urine 3min.
serum 5min.

3~4 drop

T C

Pregnancy
T C

Ordering Information
Cat. No.
30FK10
30FK11
30FK12
30FK15
30FK20
30FK22

Description
hCG (Urine)
hCG (Urine)
hCG (Urine)
hCG (Urine)
hCG (Urine, Serum)
hCG (Urine, Serum)

Type
Device
Midstream
Strip
Strip
Device
Strip

Pack size
1Tx25/Kit
1T/Kit
25Tx4/Kit
1Tx25/Kit
1Tx25/Kit
25Tx4/Kit

30

One Step Fertility Hormones Test

LH / FSH
Human luteinizing hormone (hLH) is a glycoprotein hormone secreted by the anterior
pituitary. Detection of the hLH surge can aid in predicting the time of ovulation. Human
folicle stimulating hormone(hFSH) is a glycoprotein hormone secreted by the basophilic cell
of the anterior pituitany under the control of other hormone.

General Information
SD BIOLINE LH, FSH tests are immunochromatographic assay designed for qualitative detection of LH, FSH in urine.
Test results in 5~10 minutes
LH

FSH

Specimen

Urine

Urine

Cross reactivity

No cross reactivity with hFSH, TSH, hCG

No cross reactivity with hCG, LH, TSH

Test Procedure
Device (LH)

Interpretation
LH

3~4 drop

Negative
T<C : Weaker "T" than "C"

LH

10min.

LH

LH

Positive
C=T : Similar color and drkness of
"C" and "T".
C<T : "T" may be darker than the "C".

LH

Midstream
(LH, FSH)
Negative

Positive

T<C : Weaker "T" than "C"

C=T : Similar color and drkness of

"C" and "T".
C<T : "T" may be darker than the "C".

5min.

Or

Ordering Information
Cat. No.
31FK10
31FK12
32FK11

31

Description
LH (Urine)
LH (Urine)
FSH (Urine)

Type
Device
Midstream
Midstream

Pack size
1Tx25/Kit
1T/Kit
1T/Kit

One Step Drug of Abuse Test

DOA
Drug abuse has a wide range of definitions related to taking a psychoactive drug or performance
enhancing drug for a non-therapeutic or non-medical effect. Depending on the actual compound, drug
abuse may lead to health problems, social problems, physical dependence, or psychological addiction.

General Information
SD BIOLINE DOA test is a rapid, one step, 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
Item
MET
THC
MOP
COC
AMP
MDMA
Cut-off
1000ng/ml
50ng/ml
300ng/ml
300ng/ml
1000ng/ml
500ng/ml
Sensitivity
99.5%
99.4%
99.4%
99.4%
99.5%
100%
Specificity
>99%
>99%
>99%
>99%
>99%
>95.2%
DOA Multi-10
Cut-off
Cut-off
Target
Product Name
Product Name
levels
Target compound
levels
compound
(ng/ml)
(ng/ml)
THC (marijuana)
MOP
COC (cocaine)
AMP
MET

11-nor-9-THC-9-COOH
Morphine
Benzoylecgonine
D-Amphetamine
D-Methamphetamine

50
300
300
1000
1000

MDN
BZO
BAR (barbituates)
TCA (tricyclic antidepressants)
PCP

Methadone
Oxazepam
Secobarbital
Nortriptyline
Phencyclidine

300
300
1000
1000
25

Materials Provided

SD BIOLINE DOA test device / Multi-device / Strip

Disposable urine dropper

Test Procedure
Interpretation

Device

Positive

5min.

3~4 drop

Negative

Multi-Device

Negative
10seconds

Negative

5min.

Negative
Negative

MAX. urine level

Positive
Bring out, palce on flat surface.

Ordering Information
Cat. No.
50FK10
50FK20
50FK30
50FK40
50FK50
50FK53

Description
MOP
MET
AMP
COC
THC
THC

Type
Device
Device
Device
Device
Device
Strip

Pack size
1Tx25/Kit
1Tx25/Kit
1Tx25/Kit
1Tx25/Kit
1Tx25/Kit
1Tx25/Kit

Cat. No.
50FK60
50FK100
50FK80
50FK150
50FK130
50FK210

Description
MET/THC
MDMA
DOA Multi-3
DOA Multi-5
DOA Multi-6
DOA Multi-10

Type
Device
Device
Device
Multi-Device
Multi-Device
Multi-Device

Pack size
1Tx25/Kit
1Tx25/Kit
1Tx25/Kit
1Tx10/Kit
1Tx10/Kit
1Tx10/Kit

32

One
OneStep
StepFertility
Life Diagnostics
HormonesTest
Test

Nicotine Test
Diet Check
Quick Mite Test
Guanine Test
General Information
Nicotine

Diet Check

Quick Mite Test

Guanine Test

Discribtion

One Step Cotinine Test

(Nicotine metabolite)

One Step Test to check

body fat breakdown

Easy One Step Test to

detect house dust mite

Simple Test to detect

guanine

Specimen

Urine

Urine

Dust in sofa, mattress, bed,

carpet, etc.

Dust in sofa, mattress, bed,

carpet, etc.

Materials
provided

Test device
Disposable dropper

Test Strip

Test device
Assay diluent
Disposable swab

Test strip
Assay diluent

Test Procedure
Interpretation

Nicotine Test
3~4 drop

Nicotine

5~10min.

Positive

Nicotine

Nicotine

Negative

Quick Mite Test

High QMT Level

Negative

10min.
Low QMT Level

Diet Check

Or

1min.

Ordering Information
Cat. No.
60FK50
60FK20
60FK10
60FK30

33

Description
Nicotine Test
Diet Check
Quick Mite Test
Guanine Test

Type
Device
Strip
Device
Strip

Pack size
1Tx10/Kit
25T/Kit
1Tx2/Kit
100T/Kit

One Step Bio-Defense Pathogens and Toxins Rapid Test

Bio-Defense Pathogens
and Toxins
Bio-Defense pathogens and toxins test is a chromatographic immunoassay for the
qualitative detection of 10 kinds of biological weapons such as anthrax spores, C.
botulinum toxin A (Clostridium botulinum toxin A), Brucella spp. (B. abortus, mellitensis,
suis), Poxvirus, Ricin (Ricinus Communis L.), SEB (Staphylococcus aureus enterotoxin type B),
F. tularensis (Francesilla tularensis), Y. pestis (Yersinia pestis), V. cholerae O1 &O139 (Vibrio
cholerae O1 & O139), Salmonella typhi in environmental specimens.

General Information

Designed to detect suspected Bio-Defense pathogens and toxins in environmental samples in 20 minutes.
Developed by working with KCDC (Korean Center for Disease Control and Prevention).
Acceptance
Criteria

Cat. No.

Item

Type

Pack size

70FK10

Anthrax spore

Device

1Tx10/Kit

Detection of Bacillus anthracis spore antigen

No cross reaction with other Bacillus spp.

71FK10

Botulinum toxin

Device

1Tx10/Kit

Detection of Clostridium botulinum toxin A, antigen

No cross reactivity with other Clostridium spp.

50ng/ml

72FK10

Ricin

Device

1Tx10/Kit

Detection of Ricin from Cator bean (Ricinus

communis) antigen

50ng/ml

73FK10

SEB

Device

1Tx10/Kit

Detection of Staphylococcus aureus enterotoxin B

antigen

10ng/ml

74FK10

Tularemia

Device

1Tx10/Kit

Detection of Francesilla tularensis LPS antigen

105 CFU/ml

75FK10

Y. Pestis

Device

1Tx10/Kit

Detection of Yersinia pestis F1 antigen

No cross reactivity with other Yersinia spp.

105 CFU/ml

76FK10

Poxvirus

Device

1Tx10/Kit

Detection of Poxvirus (Variola virus, vaccinia virus)

antigen

105 CFU/ml

77FK10

Brucella

Device

1Tx10/Kit

Detection of Brucella spp. (B.abortus, mellitensis,

suis) antigen

105 CFU/ml

78FK10

V. Cholerae O1 &
O139

Device

1Tx10/Kit

Detection of Vibrio cholerae O1 & 0139 LPS antigen

No cross reactivity with other Vibrio spp.

105 CFU/ml

10 80FK10

Salmonella typhi

Device

1Tx10/Kit

Detection of Salmonella typhi antigen

105 CFU/ml

11 79FK10
12 79FK11

Characteristics

Bio-Defense Pathogens
Multi-Device 9Tx10/Kit Simultaneous detection of the above 9 items
& Toxins 9
Bio-Defense Pathogens
Multi-Device 10Tx10/Kit Simultaneus detection of the above 10 items
& Toxins 10

105 CFU/ml

same as
above
same as
above

Test Procedure
Interpretation
Positive

Negative

4 drop

5~10min.

34

One Step Blood Stain Inspection Test

One Step Semen Inspection Test

Blood Stain Inspection

Semen Inspection
Forensic rapid test by one step immunochromatographic assay for the qualitative detection
of Human Blood Stain and Human(male) Semen in environmental specimen.

General Information
Blood Stain Inspection

Characteristics
Diagnosing doubtful material as blood
Only detecting human blood (specific reactivity with human blood)
More accurate than conventional Luminol, LMG test by over 100 times
Detectable within 5~10 min. on the spot (helpful for early criminal investigation)

Semen Inspection

Diagnosing doubtful material as semen

Specific reactivity with semen
More accurate than conventional SM test by over 100 times
Detectable within 5~10 min. on the spot (helpful for early criminal investigation)

Products

Materials Provided
Semen

Blood Stain

SD BIOLINE Blood Stain Test device

Assay diluent
Sample collection swab

SD BIOLINE Semen Test device

Assay diluent
Sample collection swab

Test Procedure
Blood Stain

Interpretation
Blood Stain

Negative

5~10min.
Blood Stain

Positive

Blood Stain

Semen

Semen

Negative

5~10min.
Semen

Positive

Semen

Ordering Information

35

Cat. No.

Description

Type

Pack size

25FK21

Blood Stain Inspection

Device

1Tx5/Kit

22FK21

Semen Inspection

Device

1Tx5/Kit

Urine Chemistry

UroColor

TM

Test for Blood, Bilirubin, Urobilinogen, Ketone, Protein, Nitrite, Glucose, pH, Specific gravity,
Leucocytes and Ascorbic acid in urine.

General Information

Clear positive and negative results

Good resistance to humidity
Checking an interference in Glucose, Blood, Bilirubin, Nitrite by Ascorbic acid ingested
No color change after testing is completed
No color spread between pH and specific gravity
No interference in protein by alkali urine
Long shelf life : 24 months
Different color packages by parameters
Fast result visually or instrumentally

Ordering Information
Cat No.

Product

10UK01G
10UK01P
10UK01K
10UK01B
10UK01U
10UK02
10UK02K
10UK03
10UK03A
10UK03K
10UK03U
10UK03N
10UK04
10UK04K
10UK04S
10UK04P
10UK05
10UK05B
10UK05L
10UK05K
10UK05N
10UK06
10UK06B
10UK06U
10UK06L
10UK06NBi
10UK07
10UK08
10UK08A
10UK09
10UK09A
10UK10
10UK11

UroColor 1G
UroColor 1P
UroColor 1K
UroColor 1Bi
UroColor 1U
UroColor 2
UroColor 2K
UroColor 3
UroColor 3A
UroColor 3K
UroColor 3U
UroColor 3N
UroColor 4
UroColor 4K
UroColor 4S
UroColor 4K
UroColor 5
UroColor 5Bi
UroColor 5L
UroColor 5K
UroColor 5N
UroColor 6
UroColor 6B
UroColor 6U
UroColor 6L
UroColor 6NBi
UroColor 7
UroColor 8
UroColor 8A
UroColor 9
UroColor 9A
UroColor 10
UroColor 11

Blood

Bilirubin

Urobilinogen Ketone

Protein

Nitrite

Glucose

pH

Specific Leukocyte Vitamin C

gravity

UroColor Control
Cat. No.
11UC11

37

Description
UroColor Control Strip

Type
Positive and Negative Strip

Pack size
Positive 25T, Negative 25T