HISCL ANTI-TP ASSAY KIT

Product description
The HISCL Anti-TP assay is an automated two-step sandwich chemiluminescence enzyme immunoassay (CLEIA) for qualitative
determination of total antibodies against Treponema pallidum (TP) in serum and plasma.
Automated Immunoassay System

Chemiluminescence Substrate Blood Screening Assays

CDP-Star

ALP-Labeled Recombinant
Anti-TP Antibodies TP Antigens
in Sample
Biotinylated Recombinant
TP Antigens
Streptavidin-Coated
Magnetic Particle Luminescence
Intensity Measurement

B/F Separation B/F Separation

Recombinant TP antigen ALP-labeled recombinant TP Chemiluminescence substrate

specifically react with anti- antigen binds with anti-TP CDP-Star used as substrate
TP antibody in sample. antibody on magnetic particle. increases the sensitivity of
the reaction.

Specifications
Reaction Time 17 minutes
Measurement Principle Two-step sandwich CLEIA
(Assay detects both IgG and IgM antibodies against TPN15, TPN17 and
TPN47 antigens)
Calibration 2-point, calibration curve is valid up to 30 days
Interpretation of Results Non-reactive : < 1.0 C.O.I
Reactive : ≥ 1.0 C.O.I
Sample Type Serum, EDTA and heparin plasma
Sample Volume 20 µL
Systems Sysmex Automated Immunoassay System - HISCL-5000, HISCL-800
Reagent on board Stability 30 days
Time to 1 Result
st
17 minutes
Throughput HISCL-5000 : 200 tests/hr HISCL blood screening assays are available in selected Asia-Pacific countries. For further enquiries, please email us at [email protected]
HISCL-800 : 100 tests/hr

Sysmex Asia Pacific Pte Ltd Sysmex (Thailand) Co., Ltd Sysmex Vietnam Co., Ltd
Tel +65 6221-3629 Fax +65 6221-3687 Tel +66 (2) 032-2536 Fax +66 (2) 116-5396 Tel +84 (8) 3997-9400 Fax +84 (8) 3997-9405
www.sysmex-ap.com www.sysmex.co.th www.sysmex.com.vn
Ordering information
Sysmex India Pvt Ltd Sysmex Philippines Inc. Sysmex Vietnam Co., Ltd (Hanoi Branch)
Tel +91 (22) 6112-6666 Tel +63 (2) 621-2460 Fax +63 (2) 621-2432 Tel +84 (4) 3776-7020 Fax +84 (4) 3776-7022
Product Name Description www.sysmex.co.in www.sysmex.com.ph www.sysmex.com.vn
HISCL Anti-TP Assay Kit 100 tests PT Sysmex Indonesia Sysmex New Zealand Ltd Sysmex Australia Pty Ltd
Tel +62 (21) 3002-6688 Fax +62 (21) 3002-6699 Tel +64 (9) 630-3554 Tel +61 (2) 9016-3040
HISCL Anti-TP Calibrator Negative : 1 ml x 1 www.sysmex.co.id www.sysmex.co.nz www.sysmex.com.au
Positive : 1 ml x 1
Sysmex (Malaysia) Sdn Bhd
Viratrol L1 : 3 ml x 3 Tel +60 (3) 5637-1788 Fax +60 (3) 5637-1688
www.sysmex.com.my
L2 : 3 ml x 3

SAP/HISCL/HISCL_BLOOD SCREENING/16102019/V2.0 www.sysmex-ap.com

HISCL HIV AG+AB ASSAY KIT HISCL HBSAG ASSAY KIT HISCL ANTI-HCV ASSAY KIT
Product description Product description Product description
The HISCL HIV Ag+Ab Assay is an automated two-step sandwich chemiluminescence enzyme immunoassay (CLEIA) for detection The HISCL HBsAg Assay is an automated two-step sandwich chemiluminescence enzyme immunoassay (CLEIA) for quantitative The HISCL Anti-HCV Assay is an automated two-step sandwich chemiluminescence enzyme immunoassay (CLEIA) for qualitative
of HIV-1 antibody, HIV-2 antibody and HIV-1 p24 antigen in serum and plasma. determination of Hepatitis B Surface Antigen (HBsAg) in serum and plasma. determination of antibodies against hepatitis C virus (HCV) in serum and plasma.

Chemiluminescence Substrate Chemiluminescence Substrate Chemiluminescence Substrate

CDP-Star CDP-Star CDP-Star

HBs Antigen
ALP-labeled Anti-Human
HIV-1 p24 Antigen in Sample ALP-labeled Anti-HBs Anti-HCV Antibody IgG Monoclonal Antibody
in Sample ALP-Labeled Monoclonal Antibody in Sample
Anti-HIV Antibody ALP-Labeled Anti- Biotinylated Anti-
HIV Antigen
in Sample HIV-1 p24 Antibody HBs Monoclonal Biotinylated
Biotinylated Anti- HCV Antigen-
HIV-1 p24 Antibody Antibody HCV Antigen
HIV Antigen-Coated Streptavidin-Coated Coated Magnetic
Luminescence Luminescence Particle Streptavidin Luminescence
Magnetic Particles Magnetic Particle
Streptavidin Intensity Measurement Intensity Measurement Intensity Measurement

B/F Separation B/F Separation B/F Separation B/F Separation B/F Separation B/F Separation

Human recombinant HIV-1 p24 Human monoclonal HIV-1 p24 antibody Chemiluminescence substrate Monoclonal anti-HBs antibodies (mouse) ALP-labeled anti-HBs monoclonal Chemiluminescence substrate HCV antigen biotinylated (R1) corresponding to HCV ALP-labeled anti-human IgG Chemiluminescence substrate
monoclonal antibody along used in step 2 reaction increases the CDP-Star used as substrate react specifically with HBs antigen in the antibodies (mouse) specifically bind CDP-Star used as substrate core & NS4 regions and HCV antigen-coated magnetic monoclonal antibody (mouse) CDP-Star used as substrate
with HIV-1 and HIV-2 antigen specificity of reaction. increases the sensitivity of sample in the step 1 reaction. to HBs antigen on magnetic particle. increases the sensitivity of particle (R2) corresponding to HCV NS3 region react binds with anti-HCV antibody increases the sensitivity of
are used in step 1 reaction. the reaction. the reaction. specifically with anti-HCV antibody in the sample. on magnetic particle. the reaction.

Specifications Specifications Specifications

Reaction Time 17 minutes Reaction Time 17 minutes Reaction Time 17 minutes
Measurement Principle Two-step sandwich CLEIA Measurement Principle Two-step sandwich CLEIA Measurement Principle Two-step sandwich CLEIA
(Assay detects antibodies against HIV-1 gp41 (recombinant), HIV-1 gp41 (peptide), Calibration 6-point, calibration curve is valid up to 30 days (Assay detects antibodies against Core, NS3 and NS4 regions)
HIV-2 gp36 (peptide), HIV-1 sub.O (peptide) antigens). Calibration 2-point, calibration curve is valid up to 30 days
Measurement Range 0.03 to 2,500 IU/mL
Calibration 2-point, calibration curve is valid up to 30 days Specimen with HBsAg value exceeding measuring range may be diluted at 1:40 Interpretation of Results Non-reactive : < 1.0 C.O.I
Interpretation of Results Non-reactive : < 1.0 C.O.I automatically using the dilution function Reactive : ≥ 1.0 C.O.I
Reactive : ≥ 1.0 C.O.I Interpretation of Results Non-reactive : < 0.03 IU/mL Sample Type Serum, EDTA and heparin plasma
Sample Type Serum, EDTA and heparin plasma Reactive : ≥ 0.03 IU/mL Sample Volume 20 µL
Sample Volume 30 µL Sample Type Serum, EDTA and heparin plasma Systems Sysmex Automated Immunoassay System - HISCL-5000, HISCL-800
Systems Sysmex Automated Immunoassay System - HISCL-5000, HISCL-800 Sample Volume 20 µL Reagent on board Stability 30 days
Reagent on board Stability 30 days Systems Sysmex Automated Immunoassay System - HISCL-5000, HISCL-800 Time to 1 Result
st
17 minutes
Time to 1st Result 17 minutes Reagent on board Stability 30 days Throughput HISCL-5000 : 200 tests/hr
Throughput HISCL-5000 : 200 tests/hr Time to 1st Result 17 minutes HISCL-800 : 100 tests/hr
HISCL-800 : 100 tests/hr Throughput HISCL-5000 : 200 tests/hr
HISCL-800 : 100 tests/hr

Ordering information Ordering information Ordering information

Product Name Description Product Name Description Product Name Description
HISCL HIV Ag+Ab Assay Kit 50 tests HISCL HBsAg Assay Kit 100 tests HISCL Anti-HCV Assay Kit 100 tests
HISCL HIV Ag+Ab Calibrator Negative : 1 ml x 1 HISCL HBs Ag Calibrator 6 levels (C0, C1, C2, C3, C4, C5, HISCL Anti-HCV Calibrator Negative : 1 ml x 1
Positive : 1 ml x 1 1 ml each) Positive : 1 ml x 1
HISCL HIV Ag+Ab Control HIV Negative Control : 3 ml x 2 Viratrol L1 : 3 ml x 3 Viratrol L1 : 3 ml x 3
HIV Ag Positive Control : 3 ml x 2 L2 : 3 ml x 3 L2 : 3 ml x 3
HIV Ab Positive Control : 3 ml x 2 HISCL Diluent 20 ml x 1