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    Test Kit 36

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    Respiratory Adenovirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

    BRIEF

    Acute infectious diseases caused by adenovirus easily affect the mucous membranes of the respiratory and digestive tracts, the conjunctiva of the eyes, the urinary tract and the lymph nodes. The main manifestation is an acute upper respiratory tract infection. The population is generally susceptible, mostly the children. Infants are susceptible to adenovirus pneumonia, which is severe and has a high mortality rate. The source of infection is the patient and the latent infected person. The virus is excreted from the respiratory tract and conjunctival secretions, feces and urine, and is transmitted by airborne droplets, close contact and the feces-oral route. The Respiratory Adenovirus DNA Diagnostic Kit is used for nucleic acid testing of adenovirus in patients suspected of being adenovirus infections (e.g., fever, cough, wheezing, dyspnea, bronchopneumonia, upper respiratory tract infections, lung infections, etc.) or related close contacts, and the results can be used to assist in the diagnosis of adenovirus infection and provide a molecular diagnostic basis for adenovirus infection.

    PARAMETERS

    Product features Parameter
    Specimen Type Throat swab
    Extraction Platform One-tube fast release technology Advanced magnetic beads technology
    Anti-contamination system UNG enzyme + dUTP system
    PCR Instrument ABI7500 and SLAN-96P
    Sensitivity 200 Copies/mL
    Spec. 48 T
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    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) for Self-testing

    BRIEF

    The SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) for self-testing is authorized for home use with self-collected nasal swab samples to directly detect antigen of SARS-CoV-2 virus. With the help of this kit, people without professional training can also easily acquire their COVID-19 test result within 15-20 minutes.

    PRODUCT FEATURES

    • Accurate Sensitivity 94.55%, Specificity 100%
    • Convenient No instrument needed, easy to operate
    • Fast Result available in only 15-20 min
    • Flexible Get tested anytime when you are free

    INSTRUCTION

       

    RESULT INTERPRETATION

    KIT COMPONENTS

    No. Product Name Spec.
    S3120E-1-H SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 1 Test
    S3120E-5-H SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 5 Test

    The kit components:

    •  SARS-CoV-2-Antigen Test Cassette (with desiccant)
    • SARS-CoV2 Sample Extraction Buffer
    • Specimen Collection Swab
    • Plastic Waste Bag
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    SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold)

    BRIEF

    The SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold) is intended for the qualitative detection of the SARS-CoV-2 S-RBD Antibodies in human serum, plasma and whole blood sampled from individuals after vaccination or after the infection with SARS-CoV-2.

    PRODUCT FEATURES

    INSTRUCTION

    RESULT INTERPRETATION

    ORDER INFORMATION
    No. Product Name Spec.
    S3132E-25 SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold) 25T/kit
    The kit components:
    • SARS-CoV-2 S-RBD Antibodies Test Cassette
    • Diluent Buffer
    • Blood Lancet for Single Use
    • Dropper
    • Alcohol Pad
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    SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold)

    BRIEF

    The SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold) is intended for the qualitative detection of the SARS-CoV-2 Neutralizing Antibodies in human serum, plasma and whole blood sampled from individuals after vaccination or after the infection with SARS-CoV-2.

    PRODUCT FEATURES

    INSTRUCTION

    RESULT INTERPRETATION

    ORDER INFORMATION
    No. Product Name Spec.
    S3131E-25 SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold) 25T/kit
    The kit components:
    • SARS-CoV-2 Neutralizing Antibodies Test Cassette
    • Sample Diluent Buffer
    • Blood Lancet for Single Use
    • Dropper
    • Alcohol Pad
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    SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)

    BRIEF

    The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID-19.

    PARAMETER

    • Testing time: 10-15 minutes
    • Sensitivity: 98.4%
    • Specificity: 98.1%

    KIT COMPONENTS

    No. Product Name Spec.
    S3109E-25 SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) 25 tests
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    SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

    BRIEF

    The SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) adopts latex immunochromatography technology and utilizes double-antibody-sandwich method to qualitatively detect SARS-CoV-2 antigen in human nasal, nasopharyngeal or oropharyngeal swab sampled.

    PRODUCT FEATURES

    INSTRUCTION

    RESULT INTERPRETATION

    KIT COMPONENTS

    No. Product Name Spec.
    S3120E-25 SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 25 tests
    The kit components:
    • SARS-CoV-2-Antigen Test Cassette
    • SARS-CoV2 Sample Extraction Buffer
    • Dripper
    • Extraction Tube
    • Disposable Sampler
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    iPonatic-Portable Molecule Workstation

    ,

    BRIEF

    Innovations in molecular assays—especially on the point-of-care testing (POCT) front—have spread this testing from molecular diagnostics laboratories into clinical microbiology laboratories—and now into general laboratories and even clinics and exam rooms. [1] Access to sensitive and rapid infectious disease diagnostic assays is essential for accurate diagnosis, effective treatment, and timely infection control, making POCT vital to reducing TAT.  With novel POCT on the horizon, future studies are warranted to determine cost savings, antimicrobial usage, TAT, patient impact, and how to best implement in non-microbiology clinical laboratories and clinics. [2] Sansure iPonatic (Portable Molecule Workstation) aims to subvert  traditional diagnostic mode and bring precision healthcare into thousands of households. It can provide quickly and convenient diagnosis experience for clinical emergency, health management, military safety, biological emergency and other applications.

    CORE TECHNOLOGIES

    • Rapid nucleic acid lysis at room temperature within 1 minute
    • Ultra fast amplification system in 8-45 minutes
    • Integrated automatic data analysis software
    • Results immediately printed by built-in printer

    PERFORMANCE

     

    Diagnostic results consistent with international mainstream PCR instruments

    PARAMETERS

    Model S-Q31A S-Q31B
    Detection platform Real-time PCR
    Detection module 1 amplification module 4 amplification modules
    Temperature control Liquid metal coated ceramic heating / Air cooling technology
    Heating rate ≥6.0℃ /s (from 50℃ to 95℃ )
    Cooling rate ≥2.0℃ /s (from 95℃ to 50℃ )
    Excitation light source LED
    Detector High sensitivity photodiode
    Applicable dyes FAM VIC ROX CY5
    Sensitivity Can detect single copy gene
    Electrical specification AC 100-200V 50/60Hz
    Dimension 230×284×376 mm (L×W×H) 336.5 × 280 × 435 mm (L×W×H)
    Weight 9.7Kg 13Kg

    TEST MENU

    Respiratory Infections : SARS-CoV-2, SARS-CoV-2/FluA/B, MP, ADV, BP.... HPV Infections : HrHPV, HPV 13+2, HPV 16/18, HPV 6/11.... Children's health : EBV, HCMV.... STIs : CT/UU/NG, CT, UU, NG, HSV-2.... Other test projects are under development  
    References
    [1].  Kozel TR, Burnham-Marusich AR. Point-of-care testing for infectious diseases: Past, present, and future. J Clin Microbiol 2017;55:2313-20.
    [2]. Paige M.K. Larkin,   Omai B. Garner. Molecular Point-of-Care Testing in Clinical Laboratories Laboratorians can lead a new era in rapid testing with expertise in quality control and result interpretation. Clinical Laboratory News. JUL.1.2020
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    MA-6000 Real-Time Quantitative Thermal Cycler

    BRIEF

    The MA-6000 Real-Time Quantitative Thermal Cycler has spent many years in the research and development phase, but it was worth the wait as this advanced technology will help you treat more patients and cut down your waiting times with its ability to process up to 96 samples at one time. Our new Real-Time fluorescence quantitative PCR system MA-6000 is equipped with innovative hardware, structure and optimised software to deliver higher quality results.

    FEATURES

    Temperature Control Technology and Innovation MA-6000 employs a six independent temperature control module, associated with an infrared environmental scanning and monitoring system for temperature control and secured precision for the thermal block. A technologically designed thermal gradient customises twelve thermal conditions for multiple reaction actions in scientific research, maximising convenience for your research and scientific experiments. The MA-6000’s platinum sensor prevents temperature overshoot and undershoot, homogenised temperature variance which in tandem offer customers reliably excellent and repeatable data output. The World's Leading Optical Detection Technology’s Built-In Advantages A world leading technology of optical conduction and detection is applied to MA-6000. A highly functional heat-resistance optical fibre conducts full-spectrum halogen light source to samples without attenuation. The emission fluorescence signals are synchronously collected by monochrome CCD, which together with its cooling system, physically eliminate dark current on the detection array. MA-6000 ensures extraordinary detection sensitivity, extends the application of thermal cycler from nucleic acid to biotinylated protein and expands a brand-new path for multiplex diagnosis in clinical field.

    SPECIFICATIONS

    PCR Module
    Sample capacity 96×200ul tubes / 12 x 8-well PCR strips / l x 96-well plate
    Temperature range 4-100 ℃
    Maximum ramp rate 3.5 ℃/s for heating; 3.2℃/s for cooling
    Temperature accuracy ± 0. 1 ℃
    Temperature uniformity ±0.25℃
    Temperature monitoring method 6 independent zones for temperature surveillance
    Gradient capability Yes
    Excitation light source Full spectrum halogen lamp(5 years warranty)
    Excitation spectrum 380-780nm
    Excitation channels Built-in 6(including I extension channels)
    Fluorescence dyes/probes FAM / SYBR Green I / VIC / HEX / TET / Cy3 / Cy3.5 / JOE / Yellow 555 / ROX / Texas Red / Cy5 / Cy5.5 / LC Red / Tamara
    Detection channels 96 two-way heat-resistance optical fibers
    Data resolution 5.000-10.000 copies with 99.8% confidence; 1.5 times differentiation for single reaction
    Thermo Cycler
    Power supply 100-240V
    Frequency 50-60Hz
    Dimensions(WxHxD)(cm) 54.8×38.8×28.8
    Weight 23kg
    Software Win7, Win8, Win10, etc.
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    SLAN®-96P Real-Time PCR System

    FEATURES

    Precise Temperature Control System: 1. The SLAN®system adopts Peltier technology which can accurately and quickly control increases and decreases of temperature with a precision of ±0.1℃ and features long service life, no noise and no pollution, etc.; 2. Multiple-point temperature control technology ensures the uniformity between different wells. The temperature correction technology guarantees the accuracy of temperature and thus ensures the accuracy of assay result; 3. PCR tube temperature-control technology guarantees the accuracy of actual temperature of reagent in the tube and enables the SLAN®to easily adjust for different reactions using different volumes. Sensitive Photoelectric Detection System 1. High sensitivity photoelectric detector with no background noise which is fast and stable; 2. Lifetime maintenance-free ultra-bright LED cold light source with a large signal value and high stability; 3. Unique optical fiber conduction technology that greatly improves fluorescence collection efficiency and avoids fluorescence interference between neighboring tubes; 4. The system automatically selects best gain value for each tube without the need for user configuration. The SLAN®has an extremely broad measuring range for fluorescence; 5. Extremely high detection sensitivity with an extremely low fluorescence background value. It's not necessary for users to make optical correction or background correction.  

    SLAN-96P Multi-tasking Software Interface (analysis screen)

    Unique Electronic Automatic Hot Lid System 1. Flexible heating technology ensures uniform hot lid temperature; 2. The electronic automatic hot lid has an adjustment function for different 0.2ml reaction tubes to ensure even tube pressure; 3. Once the assay starts, the hot lid has automatic locking function to prevent assay failure following accidental opening. Other functions
    · Power-off protection · Automatic saving result · Export of result
    · Real-time data display · Quantitative and qualitative analysis · File encryption
    · Automatic baseline optimization · Digital filtering · Search function
    · Report sheet print and edit · Melt curve function

    SPECIFICATIONS

    Product model SLAN-96P
    Sample capacity 96 wells (dual 48/48 reaction module)
    Sample size 15-50mL
    Consumable 0.2mL PCR tubes, 8-tube strips, 48-well plates
    Parallel running mode Dual reaction blocks/running 2 tests independently
    Temperature range 4-99°C
    Max ramp rate 4.0°C/sec
    Temperature accuracy ±0.1°C
    Temperature uniformity ±0.1°C
    Thermal cycling system Peltier-based system
    Temperature control mode Tube control/block control
    Light Source LED (maintenance-free)
    Detector High sensitivity photoelectric sensor
    Sensitivity 1 copy
    Linearity range 100-1010
    Resolution Can discriminate between 1000 copies and 2000 copies
    Excitation CH1 470nm    CH2 530nm    CH3 580nm CH4 630nm   CH5/CH6   custom-made
    Emission CH1 510nm    CH2 565nm    CH3 620nm CH4 665nm   CH5/CH6   custom-made
    Dyes and probes CH1 FAMTM /SYBRGreen®   CH2 VIC®/HEX/J0ETM /TET CH3 ROX/TexasRed®   CH4 CY5TM
    Hot-lid 30°C~108°C (default105°C, adjustable) electronic automatic hot-lid
    Power supply 230VAC, 50Hz
    Power consumption 850VA
    Dimensions 380mm x 520mm x 250mm (WxDxH)
    Weight 18Kg
    Communication RS232, USB
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    Natch 48 Nucleic Acid Extraction System

    EXTREMELY SIMPLE WORKFLOW

    SPECIFICATIONS

    Instrument model Natch 24/48/96
    Sample type Serum, plasma, whole blood, secretions, exfoliated cells, tisues, throat swabs, anal swabs, urine, feces, etc.
    Extraction technology Advanced magnetic beads technology
    Sample type Volume 1-96 tests/batch
    Extraction Time 10-60 minutes each batch
    Working volume 30-2000uL
    Recovery rate of magnetic beads ＞95%
    Blending mode Vortex omnidirectional liquid mixing
    Temperature control range Adjustable from roomtemperature to 125℃
    Operation 7-inch touch screen
    Storage Up to 120 groups of programs can be used.
    size and weight 655x655x520 mm (L x W x H), weight: 65kg

    EXTRACTION KIT COMPONENTS

    No. Spec. Product Name
    S10016E 48T/kit Nucleic Acid Extraction-Purification Kit (Magnetic beads method)

    AVAILABLE PROJECTS

    Sexually Transmitted Diseases : CT, NG, UU, HSV-2, HSV I/2 Women's Health : hrHPV and hrHPV genotyping Respiratory Tract Disease : 6RP, TB, MP, RSV, ADV, BP Gastrointestinal Diseases : HFMD Prenatal and Postnatal care : CMV, EBV Public Health : SARS-CoV-2, Influenza A/B, HINI, H7N9 Customerized Projects
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    Natch CS2 Fully Automated Nucleic Acid Extraction System

    EXTREMELY SIMPLE WORKFLOW

    FEATURES

    1. EFFICIENT ANTI-CONTANMINATION
    • Well-organized countertop layout
    • Sample area is separated from clean area
    • Effective UV decontamination
    • Anti-contanmination function of moving path
    2. SUPER MAGNETIC, EFFECTIVE ADSORPTION
    • Super 3-D magnetic adhesion technology
    • Permanent magnetic mode
    • 117 magnetic racks, 4 magnetic bars in each well
    3. EXCELLENT SAMPLE ADDITION FUNCTION
    • Automatic liquid level detection
    • Clot detection
    • Tip detection
    • Air-prof detection
    4. EASY-TO-USE SOFTWARE
    • Preset programs, one-key selection
    • Prompt the placement of reagents
    • Display the status of reagents and consumables
    • Real-time display of remaining time
    • Show real-time experimental procedures
    • Permits LIS compatibility

    SPECIFICATIONS

    Instrument model S-S13A
    Sample type Serum, plasma, whole blood, secretions, exfoliated cells, tissues, nasopharyngeal swab, oropharyngeal swab, urine, feces, etc.
    Sample tube specifications Compatible with various original sample tubes
    Extraction Principle one-tube fast release technology (OT) Advanced magnetic beads technology (MB)
    Sample type Volume OT: 1-96 tests/batch; MB: 1-96 tests/batch
    Extraction Time OT of 96 tests ≤ 30 minutes; MB of 96 tests ≤ 90 minutes
    Pipetting range 10~1000 μL
    Level detection Pressure detection / capacitance detection, automatic detection of liquid level
    Clot detection Pressure detection, automatic detection of liquid aspiration and liquid clogging
    Sample loading function Automatic liquid level detection Clot detection Tips detection Air-prof detection
    Magnetic field control Permanent magnet mode Patented design Super 3-D magnetic adhesion technology
    Blending mode Vortex omnidirectional liquid mixing
    Temperature control range Adjustable from room temperature to 100℃
    UV disinfection Timed opening and closing
    Barcode Scanning Sample scanning system Supported multiple barcodes
    Language Simplified Chinese / English
    Display Method 10.4 inches touch screen
    Communication Interface USB, RS232, network ports, HDMI
    Dimensions and Weight 1320×850×1600mm (LxWxH), weight: 350Kg
    Power supply Input: AC 100-240V 50/60Hz 350 VA

    EXTRACTION KIT COMPONENTS

    No. Spec. Product Name
    S1013E 48T/kit Sample Release Reagent
    S1014E 24T/Kit, 48T/kit Sample Release Reagent
    S1002E 24T/kit Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method)
    S1006E 48T/kit Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method)
    S10016E 48T/kit Nucleic Acid Extraction-Purification Kit (Magnetic beads method)

    AVAILABLE PROJECT

    Hepatitis and AIDS : HBV, HCV, HIV Sexually Transmitted Diseases : CT, NG, UU, HSV-2, HSV I/2 Women's Health : hrHPV and hrHPV genotyping Respiratory Tract Disease : 6RP, TB, MP, RSV, ADV, BP Gastrointestinal Diseases : HFMD Prenatal and Postnatal care : CMV, EBV Public Health : SARS-CoV-2, Influenza A/B, HINI, H7N9 Customerized Projects
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    Multi-type Sample DNA/RNA Extraction-Purification Kit

    BRIEF

    Multi-type Sample DNA/RNA Extraction-Purification Kit (Suprall extraction reagent) is an innovative product based on Sansure advanced magnetic beads technology platform , which can accomplish the unified extraction of nucleic acids in various gene detection applications and samples to provide comprehensive solutions for nucleic acid extraction , can be applied in infectious disease diagnosis, genetic disease screening, birth defect prevention, tumor screening, individualized diagnosis and treatment, detection of disease susceptibility genes, sequencing services and other fields.  

    Fully Automated Nucleic Acid System

    KIT COMPONENTS

    No. Product Name Spec.
    S1006E Multi-type Sample DNA/RNA Extraction-Purification Kit 24T/kit
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    Nucleic Acid (DNA/RNA) Extraction or Purification Kit

    BRIEF

    Nucleic Acid (DNA/RNA) Extraction or Purification Kit developed based on Sansure advanced magnetic beads technology platform，using exclusive modified super-paramagnetic nano-beads to absorb sample DNA/RNA , only needs a simple step of washing to obtain high purity nucleic acid, combined with the "DNA/RNA elution-free " technology and integrated high-efficient amplification system, to achieve DNA/RNA amplification detection with magnetic beads.

    Fully Automated Nucleic Acid System

    Table-automated Nucleic Acid System

    KIT COMPONENTS

    No. Product Name Spec.
    S1002E Nucleic Acid (DNA/RNA) Extraction or Purification Kit 24T/kit
    S10011E Nucleic acid extraction（DNA/RNA) or purification kit 24T/Kit, 48T/kit
    S10016E Nucleic Acid Extraction-Purification Kit 48T/kit, 96T/kit
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    Sample release reagent

    BRIEF

    Sample release reagent developed based on the Sansure one-tube fast release technology platform. Adopting Sansure patent nucleic acid release technology, can quickly lyse pathogens at room temperature, no need heating, centrifuging or replacing tubes, the sample DNA/RNA can be extracted quickly through simple operations. Sample Release Reagent is used for the pretreatment of nucleic acids, to release the nucleic acids from specimens, then the released nucleic acids can be used for clinical in vitro diagnosis or used for the detection through equipment.  

    Fully Automated Nucleic Acid System

    iPonatic Portable Molecule Workstation

    KIT COMPONENTS

    No. Product Name Spec.
    S1011E Sample Release Reagent 48T/kit
    S1013E Sample Release Reagent 48T/kit
    S1014E Sample Release Reagent 24T/Kit, 48T/kit
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    EV/EV71/CA16 Diagnostic Kit

    BRIEF

    Hand-foot-and-mouth disease is a common childhood disease caused by enteroviruses. Most of the patients will have a fever and get vesicle rash in the mouth or on the hand and foot. A few patients will get cephalomeningitis, cerebritis, neurogenic pulmonary edema and myocarditis, etc. Some patients may get sequelae of this disease or even death. The viruses that can cause hand-foot-and-mouth disease include Coxsackievirus, new-type enterovirus and ECHO virus, of which the most common types are Coxsackievirus A16 and Enterovirus 71. The laboratory diagnosis methods mainly include virus isolation, nucleic acid detection, etc. The Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing) is intended to detect Enterovirus, Coxsackievirus A16 and Enterovirus 71 in throat swab by applying real-time quantitative PCR technique. The detection results can be used to distinguish Coxsackievirus A16 and Enterovirus 71.

    PARAMETERS

    Product features Parameter
    Specimen Type throat swab
    Technical Platform Advanced magnetic beads technology
    Target pathogen EV, EV71, CA16
    Internal Control Lentivirus
    PCR Instrument ABI7500,SLAN-96P
    Amplification Time 100 min
    Sensitivity 1000 copies/mL
    Spec. 24T
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    HCMV Diagnostic Kit

    BRIEF

    Human cytomegalovirus (HCMV), also called cell inclusion body virus, is a double helix DNA virus and belongs to β genus of herpes virus family, which causes infected cells to enlarge and has a huge intranuclear inclusion. The ways of infection of HCMV is mainly through contact, blood transfusion, intrauterine and birth canal, and the infections are commonly found in fetus, newborns, pregnant women, etc. If the pregnant women are infected, it may cause their newborns congenital monstrosity. When the organism immune deficiency or immune system is under inhibitory state, people can be easily infected by HCMV, such as the patients receiving immunosuppressive therapy after transplantation of organ, the patients receiving malignant tumor chemotherapy and AIDS patients, etc. If these patients are infected by HCMV, it usually causes high mortality and serious diseases. Clinical tests suggest that HCMV infection hasn’t specific manifestations and it causes harm to multiple organs, especially the liver and lung. A statistical analysis of positive and negative rate of HCMV in various kinds of clinical indications shows HCMV infection is probably related with various diseases, such as Cytomegalovirus hepatitis, Infant hepatitis syndrome, liver dysfunction, pneumonia, Bronchitis, Upper respiratory tract infections, enteritis, enterocolitis, diarrhea, hematemesis, heart failure, etc. The Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of HCMV DNA in human urine, serum and peripheral blood samples. It is intended for use as an aid in the diagnosis of an HCMV infection and for observing drug efficacy.

    PARAMETERS

    Product features Parameter
    Specimen Type urine, serum, and peripheral blood.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen HCMV
    Internal Control cloning plasmid
    PCR Instrument ABI7500, Roche LC 480 and Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
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    EBV Diagnostic Kit

    BRIEF

    Epstein-barr virus (EBV) is known to be the first virus that is definitely related with human tumors. EBV infection mainly causes infectious mononucleosis in children and tumor-related diseases such as Burkitt’s lymphoma, lymphoid tissue hyperplasia in immunocompromised individuals, primary lymphoma, empyema associated lymphoma, T-cell lymphoma, NK cell lymphoma/leukemia, Hodgkin’s disease, nasopharyngeal carcinoma, stomach cancer, lymphoid epithelial tissue cancer, smooth muscle tumors, etc. The Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of Epstein-Barr Virus (EBV) DNA in peripheral blood. Test result can be used as an aid in the diagnosis of an EBV infection and in observation of drug efficacy.

    PARAMETERS

    Product features Parameter
    Specimen Type peripheral blood.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen EBV
    Internal Control cloning plasmid
    PCR Instrument ABI7500, Roche LC 480 and Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
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    Nucleic Acid Test Kit for HBV, HCV, HIV(Type1+2)

    BRIEF

    Nucleic Acid Test Kit for HBV,HCV,HIV(Type1+2), is based on real-time fluorescence PCR technology and used for nucleic acid qualitative detection of HBV, HCV, HIV1+2 in plasma. This kit is intended for use as a blood donor screening test to detect HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA in pooled or individual sample from healthy blood donors, blood donors of various components (red blood cells, platelets and plasma) and other types of blood donors. All plasma to be tested can be screened as individual samples or tested in pools after mixing with each equal aliquots according to routine serological screening results HBV, HCV and HIV samples. For the pooled sample showed positive test results, carry out individual testing, the individual test result should be used as the final test result of this sample. The test results of this diagnostic kit can distinguish reactivity of between HBV, HCV and HIV.

    ADVANTAGES

    High sensitivity
    • HBV 3IU/mL
    • HCV 10IU/mL
    • HIV 45IU/mL
    High efficiency
    • 576 tests/ 5h（pooling）
    • 45 tests / 4.5h（single
    Complete subtypes coverage
    • HBV A-H
    • HCV 1-6
    • HIV-1（M/N/O）and HIV-2
    Single pipe joint inspection
    • Four tests for a tube of samples
    • Direct discriminating positive
    Automated detection
    • Extraction and amplification process
    • No need to be on duty
    Cost and space savings
    • One extractor + one amplifier
    • Less consumable material consumption

    FEATURES

    Sample preparation and extraction in one module Fully automatic sample preparation and nucleic acid extraction in one module to build up a integrated reaction system Flexible testing mode 6 pooling sample testing or individual donor testing (IDT) supported Advanced magnetic beads technology Nanometer-level beads enable beads-in-PCR amplification ensuring maximum nucleic acid template Patented magnetic beads lateral suction technology Thorough waste liquid removal allows minimal magnetic beads loss Sophisticated sample information processing Automatic recognition of the sample barcode & sample tracking and archiving table generation available High throughput 558/45 samples result output in one time Minimal system maintenance time Less than 20 minutes startup with fewer maintenance tasks Excellent accuracy A total number of 105,124 blood bags which confirmed as negative by serological testing were tested against some referential screening kits. 15 false-negative results in reference tests were found.
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    HCV RNA Genotype Diagnostic Kit

    BRIEF

    By applying real-time PCR technology, the Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing) is designed for qualitative identification of HCV genotypes (including genotypes 1b, 1, 2, 3, 4, 5 and 6) from HCV RNA positive samples. The test results can be used as an aid in the identification of HCV genotypes and determination of an appropriate therapeutic treatment indicated for the above listed gentoypes. The results can be used only for clinical reference, and cannot be used as the only evidence for adjusting therapeutic drugs. Clinical symptoms and other laboratory test results should also be considered to comprehensively determine the patients treatment.

    PARAMETERS

    Product features Parameter
    Specimen Type serum
    Extraction Platform Magnetic beads technologies
    Genotype 1b, 1(1b, 1a), 2 (2a), 3 (3a, 3b), 4 (4a), 5 (5a), 6 (6a)
    Internal Control Plasmid
    PCR Instrument Mx3000P,Slan 96P
    Sensitivity 1000 IU/mL
    Spec. 12T
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    HCV RNA Diagnostic Kit (MB)

    BRIEF

    Hepatitis C Viral (HCV) RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HCV RNA in human serum or plasma. It is intended for use as an aid in the diagnosis of an HCV infection and observing drug efficacy. Hepatitis C is mainly caused by HCV infection and transmitted through blood. Chronic infection of HCV can lead to chronic inflammation of liver and fibrosis, and some patients may develop into liver cirrhosis, even Hepatocellular Carcinoma (HCC). It has huge harms on patients’ health and life quality, and has become a severe social and public health issue.

    PARAMETERS

    Product features Parameter
    Specimen Type serum or plasma
    Extraction Platform Advanced magnetic beads technology
    Genotype HCV 1-6 genotype
    Internal Control Lentivirus particles
    PCR Instrument ABI 7500,SLAN-96P,QuantStudio 3/5,Roche Light Cycler 480
    Sensitivity 12 IU/mL
    Linear range 25—1.0E+08 IU/mL
    Spec. 24T
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    HBV DNA Diagnostic Kit (OT)

    BRIEF

    Hepatitis B Viral (HBV) DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HBV DNA in human serum or plasma. It can be used to evaluate antiviral treatment and monitor the therapeutic effect by monitoring HBV DNA baseline levels and changes in patient blood. Test results should not be taken as the only indicator for evaluation of diseases, but to be combined with patients clinical symptoms and other laboratory tests to analyze the diseases.

    PARAMETERS

    Product features Parameter
    Specimen Type serum or plasma
    Extraction Platform One-tube fast test release
    Genotype HBV A-H genotype
    Internal Control plasmid
    Compatible Instrument ABI7500, ABI7300, Roche LC 480, Stratagene Mx3000P, Slan 96P and Slan 48P
    Sensitivity 100 IU/mL
    Linear range 500—5.0E+09 IU/mL
    Spec. 48T
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    HBV DNA Diagnostic Kit (MB)

    BRIEF

    Hepatitis B Viral (HBV) DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of Human HBV DNA in human serum. It is intended for use as an aid in diagnosing an HBV infection and observing drug efficacy.

    PERFORMANCE

    Advanced magnetic beads technology HBV DNA detection and viral load measurement are essential for treatment decisions and patient monitoring. Sansure's HBV DNA test kit (MB) uses the advanced magnetic beads technology to extract HBV DNA from clinical serum or plasma.  Our technology achieved high sensitivity and wide linear range detection to meet of clinical diagnosis and follow-up needs. Highly conservative primer probe design Sansure primers and probes target select the highly conservative S gene of HBV, which can cover A-H genotypes and avoid missed detection. High-efficient quality control system HBV DNA test kit (MB) uses UNG enzyme + dUTP system to remove carry-over contamination to avoid a false positive result. HBV DNA test kit (MB) uses Internal Control HBV DNA test kit (MB) uses Internal Control is the full name to whole-process the HBV extraction and amplification process to avoid false negative results.

    PARAMETERS

    Product features Parameter
    Specimen Type Serum，plasma
    Extraction Platform Advanced magnetic beads technology
    Genotype HBV A-H genotype
    Internal Control Lentivirus particles
    PCR Instrument ABI 7500,SLAN-96P,QuantStudio 3/5,Roche Light Cycler 480
    Sensitivity 5 IU/mL
    Linear range 20—2.0E+09 IU/mL
    Spec. 48T
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    HPV (Type 6 and 11) DNA Fluorescence Diagnostic Kit (HPV 6,11)

    BRIEF

    HPV (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of low-risk HPV (type 6/11) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (type 6/11) infection and patients with clinically suspected genital warts.

    PARAMETERS

    Product features Parameter
    Specimen Type reproductive tract secretions
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Detection types type 6, 11
    Internal Control β--globin gene
    PCR Instrument ABI7500, Roche LC480 and Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
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    HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit (HPV 16,18)

    BRIEF

    HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (Type 16 and18) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (Type 16 and18) infection, and the early screening of cervical cancer.

    PARAMETERS

    Product features Parameter
    Specimen Type reproductive tract secretions
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Detection types type 16, 18
    Internal Control β--globin gene
    PCR Instrument ABI7500, Roche LC480 and Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
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