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    S3016E MP – Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit

    Brief

    Mycoplasma pneumoniae (MP) is a pathogenic microorganism between bacteria and virus. It is mainly transmitted through buccal and nasal mucus by the air causing respiratory diseases, with the highest incidence in children and adolescents. Respiratory infection has the manifestations of pharyngitis and bronchitis, with a few cases causing infection to the lung. Recently, incidence among infants and children is increasing, therefore, early diagnosis and treatment can decrease the exacerbation of acute pneumonia in children. The development of molecular biology also draws more attention to the fluorescence quantitative PCR technology for the detection of MP-DNA.   This diagnostic kit is an in vitro nucleic acid amplification test for the detection of mycoplasma pneumoniae DNA in humansputum and throat swab. It is intended for use as an aid in the diagnosis of an MP infection and providing a molecular-diagnostics-based solution.

    Parameters

    Product features Parameter
    Specimen Type Sputum and throat swab
    Extraction Platform One-tube fast release technology
    Internal Control cloning plasmid containing the target gene fragment
    PCR Instrument ABI 7500, SLAN-96P,MA-6000, Roche LightCycler 480, iPonatic S-Q31A&B,S-Q36A
    Sensitivity 400 copies/mL
    Spec. 48T, 12-P
    Qualification CE
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    S3066E 6RP – Six Respiratory Pathogens Nucleic Acid Diagnostic Kit

    Brief

    Respiratory infections are classified into the upper respiratory tract infections and lower respiratory tract infections. It refer to the pathogens that infect the nose, throat, trachea, bronchi or lungs, which principally cause diseases of tissues and organs outside the respiratory tract, manifested by fever, sore throat, cough, headache and other symptoms. The respiratory tract pathogen has the characteristics of strong infectivity, rapid spread, short incubation period and acute onset, etc. which seriously harm human health.   After respiratory infection, symptoms are mostly similar. Sansure six respiratory pathogens joint detection kits can help doctors make differential diagnosis, accurately detect the pathogens that cause symptoms, and formulate treatment plans.

    Performance

    • High sensitivity: Super-cis-nanometer magnetic bead technology; can achieve 500copies/mL
    • Accurate identification: One test presented six results ; accurate guidance for rational clinical drug use
    • Whole-process monitoring: Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) human housekeeping gene as internal standard; Monitor the whole process of sampling, nucleic acid extraction and amplification

    Parameters

    Product features Parameter
    Specimen Type Nasopharyngeal swabs
    Extraction Platform Advanced magnetic beads technology
    Internal Control lentivirus particles（GAPDH）
    PCR Instrument SLAN-96P, ABI7500, S-Q36A
    Sensitivity Influenza A virus:  2.0 TCID50/mL Influenza B virus:  2.0 TCID50/mL Respiratory syncytial virus: 500.0 copies/mL Adenovirus:  500.0 copies/mL Mycoplasma pneumonia:  500.0 copies/mL Human rhinovirus:  500.0 copies/mL
    Spec. 24T, 12P
    Qualification CE
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    S3334E AdV – Adenovirus Nucleic Acid Diagnostic Kit

    Brief

    Acute infectious disease caused by adenovirus, easily affects 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 Adenovirus Nucleic Acid 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.

    Features

    • High sensitivity: Detection sensitivity reaches 200 copies/mL.
    • Quick and easy: Perfectly match Sansure's one-tube fast Sample Release Reagent, easy to operate.
    • IC monitoring: IC(Internal Control) monitoring test process to avoid false negative results.

    Parameters

    Items 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 ABI 7500; MA-6000; SLAN-96P; QuantStudio 5; iPonatic S-Q31A&B; S-Q36A
    Sensitivity 200 copies/mL
    Qualification NMPA, CE
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    S3018E TB – Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit

    Brief

    Mycobacterium tuberculosis virus (TB) is a pathogenic bacterium that causes tuberculosis. It is likely to infect all human tissues and organs, especially the lungs to cause pulmonary tuberculosis. Early diagnosis and treatment are important for effective control of tuberculosis.   In recent years, with the development of molecular biology, nucleic acid fluorescence quantitative PCR method based on the mycobacterium tuberculosis nucleic acid has drawn more and more attention from researchers.

    Parameters

    Product features Parameter
    Specimen Type Human sputum
    Extraction Platform One-tube fast release technology
    Internal Control Cloning plasmid, without TB target sequence
    PCR Instrument ABI 7500, SLAN-96P,MA-6000, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A
    Sensitivity 1 bacterium/mL
    Spec. 48T, 12-P
    Qualification CE
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    S3310E 6LRP – Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit

    Brief

    Lower respiratory infections (LRP) remained the world’s most deadly communicable disease, ranked as the 4th leading cause of death. In 2019 it claimed 2.6 million lives. Diseases of the lower respiratory tract include acute tracheitis, bronchitis, pneumonia, chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, etc. They are caused by microbial infections such as viruses, bacteria, mycoplasma, chlamydia and legionella.   Bacteria are the main pathogens of lower respiratory tract infections, with a wide variety of pathogens and complex clinical presentations. Due to the long detection period and low positive detection rate of traditional pathogenic tests, over 62% of adults with community-acquired pneumonia have no pathogenic basis. Failure to identify the cause quickly can delay treatment, exacerbate the disease and lead to death, and increase the development of antibiotic resistance.

    Features

    • Highly efficient identification and rapid diagnosis: Six common bacteria of lower respiratory tract infections can be detected in one tube; a batch of 94 sample tests can finish in 100 minutes.
    • Accurate and reliable, high detection rate: sensitive and specific, unaffected by antibacterial drugs, full internal control monitoring to avoid false negatives, UDG enzyme + dUTP anti- contamination measures to reduce false positives.
    • Easy to operate and adaptable: automatic instruments are available, and the results can be intelligently analyzed by conventional fluorescent PCR instruments to meet the needs of medical laboratories , clinical Institutions, emergency and primary care etc.

    Parameters

    Items Parameter
    Specimen Type Sputum
    Extraction Platform Advanced magnetic beads technology
    Internal Control Plasmid
    PCR Instrument Thermofisher QuantStudio™ 5 and SLAN-96P
    Sensitivity 15 CFU/mL (Streptococcus pneumoniae) 340 CFU/mL (Legionella pneumophila) 625 CFU/mL (Haemophilus influenzae) 675 CFU/mL (Pseudomonas aeruginosa) 900 CFU/mL (Klebsiella pneumoniae) 2875 CFU/mL (Staphylococcus aureus)
    Qualification NMPA, CE
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    S3352E MPXV – Monkeypox virus Nucleic Acid Diagnostic Kit

    Brief

    Monkeypox is a disease of global public health importance as it not only affects countries in west and central Africa, but the rest of the world. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects. Transmission via droplet respiratory particles usually requires prolonged face-to-face contact, which puts health workers, household members and other close contacts of active cases at greater risk.   WHO recommends polymerase chain reaction (PCR) is the preferred laboratory test given its accuracy and sensitivity.

    Performance

    • Test time ≤ 30 min
    • Sensitivity: 200 copies/mL
    • Suitable for PCR and iPonatic

    Parameters

    Items Parameters
    Specimen Type Vesicles or pustules, nasopharyngeal swab, oropharyngeal swab, serum, whole blood
    Extraction Platform One-tube fast release technology Advanced magnetic beads technology
    Internal Control Human gene
    PCR Instrument ABI 7500, QuantStudio™ 5, LightCycler 480, MA-6000, SLAN-96P, QuantGene 9600, Portable Molecule Workstation S-Q31A&B, Portable Molecular Workstation S-Q36A
    Sensitivity 200 copies/mL
    Spec. 48 T, 12-P
    Qualification CE
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    C004E BCI – Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2)

    Brief

    The Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR) is intended for qualitative detection and screen the Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, Human Immunodeficiency Virus Type 1 (HIV-1) RNA and Human Immunodeficiency Virus Type 2 (HIV-2) RNA, in plasma and serum samples from individual human donors. Plasma and serum from all donors may be screened as individual samples. For donations, may be tested individually or be tested in pools comprised of an equal quantity of six samples.   For in vitro diagnostic use only. For professional use only.

    Advantages

    High sensitivity
    • HBV 2.41 IU/mL
    • HCV 12.38 IU/mL
    • HIV-1 31.68 IU/mL
    • HIV-2 48.34 IU/mL
    High efficiency
    • 576 tests/ ~5h（pooling）
    • 96 tests / ~4.5h（single)
    Complete subtypes coverage
    • HBV genotypes A-H
    • HCV genotypes 1-6
    • HIV-1 group M/N/O
    • HIV-2
    Multiple results in one test
    • 4 tests in one test
    • Direct discriminative positive results
    Automated detection
    • Extraction and amplification process/li>
    • Fully automated extraction and amplification/li>
    Cost and space savings
    • One extractor + one amplifier
    • Less consumable material consumption

    Parameters

    Items C004E
    Product Name Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
    Package Specification 96 tests/kit
    Amplification Multiplex real-time PCR
    Extraction Magnetic bead method
    Sample type Plasma, Serum
    Sample Volume 960μL
    LoD (Individual testing) HBV 2.41 IU/mL; HCV 12.38 IU/mL HIV-1 31.68 IU/mL; HIV-2 48.34 IU/mL
    Storage and Validity Amplification kit: < −15°C, 12months; Extraction kit: 2 – 8°C, 12 months
    Qualification CE

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    iPonatic II— 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 innovate traditional diagnostic mode and assist precision diagnosis. 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
    Qualification CE

    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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    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
    Qualification CE
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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
    Qualification CE

    Extraction kit components

    Reagent Kit Product Name Spec.
    S10012E Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method) 48A/48B
    S10013E Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) 24T/48T
    S10016E Nucleic Acid Extraction-Purification Kit (Magnetic beads method) 24T/48T/96T
    S50016E Nucleic Acid Extraction-Purification Kit (Magnetic beads method) 48T/96T/24T/
    32T/64T

    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-contamination
    • 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
    Qualification CE

    Extraction kit components

    Cat. No. Product Description Package Registration
    S100IE Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) Specimen types: Serum or plasma 24T/48A/48B/64T CE NMPA
    S1004E Red Blood Cell Lysis Buffer 48T CE NMPA
    S1006E Multi-type Sample DNA/RNA Extraction–Purification Kit (Magnetic beads method) Specimen types: serum, plasma, throat swab, genital secretion, cervical exfoliated cells 24T/48T/96T CE NMPA
    S1001E Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) Specimen types: throat swab, herpetic fluid, anal swab, feces, etc 24T/48T CE NMPA
    S10012E Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) Specimen types: Serum or plasma 48T/96T/48A/48B CE NMPA
    S10013E Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) Specimen types: Serum or plasma 24T/48T/48A/48B CE NMPA
    S10016E Nucleic Acid Extraction–Purification Kit Specimen types: pharyngeal swabs, nasopharyngeal swabs, alveolar lavage fluid, sputum, saliva, plasma, serum, stool and anal swabs Specifications may vary depending on the extraction instruments 24T/48T/96T/24A/24B/
    48A/48B/48C/64T/96A    		 CE NMPA
    S50016E Nucleic Acid Extraction-Purification Kit Specimen types:pharyngeal swabs,nasopharyngeal swabs,oliveolar lavage uid sputum,saliva,plasma,serum,stool,oral swabs and exfoliated cells from females’ cervix,etc. Specifications may vary depending on the extraction instruments 48T/96T/12A/24A/24B/
    32A/32T/32S/48A/48B/
    48C/64A/64T/96A    		 CE NMPA
    S5006E Nucleic Acid Extraction-Purification Kit V–VI Specimen types:whole blood,serum,plasma. 48T/48A/48B/64T CE
    S5007E Nucleic Acid Extraction-Purification Kit V–VII Specimen types:cervical swab,opharyngeal swab,nasopharyngeal swabs,anal swab,rectal and vaginal swabs. 48T/96T/48A/64T/96A CE

    Available projects

    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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    S1006E 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.

    Parameters

    Qualification CE

    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.

    Kit components

    Cat. No. Product Description Package Registration
    S100IE Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) Specimen types: Serum or plasma 24T/48A/48B/64T CE NMPA
    S1004E Red Blood Cell Lysis Buffer 48T CE NMPA
    S1006E Multi-type Sample DNA/RNA Extraction–Purification Kit (Magnetic beads method) Specimen types: serum, plasma, throat swab, genital secretion, cervical exfoliated cells 24T/48T/96T CE NMPA
    S1001E Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) Specimen types: throat swab, herpetic fluid, anal swab, feces, etc 24T/48T CE NMPA
    S10012E Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) Specimen types: Serum or plasma 48T/96T/48A/48B CE NMPA
    S10013E Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) Specimen types: Serum or plasma 24T/48T/48A/48B CE NMPA
    S10016E Nucleic Acid Extraction–Purification Kit Specimen types: pharyngeal swabs, nasopharyngeal swabs, alveolar lavage fluid, sputum, saliva, plasma, serum, stool and anal swabs Specifications may vary depending on the extraction instruments 24T/48T/96T/24A/24B/
    48A/48B/48C/64T/96A    		 CE NMPA
    S50016E Nucleic Acid Extraction-Purification Kit Specimen types:pharyngeal swabs,nasopharyngeal swabs,oliveolar lavage uid sputum,saliva,plasma,serum,stool,oral swabs and exfoliated cells from females’ cervix,etc. Specifications may vary depending on the extraction instruments 48T/96T/12A/24A/24B/
    32A/32T/32S/48A/48B/
    48C/64A/64T/96A    		 CE NMPA
    S5006E Nucleic Acid Extraction-Purification Kit V–VI Specimen types:whole blood,serum,plasma. 48T/48A/48B/64T CE
    S5007E Nucleic Acid Extraction-Purification Kit V–VII Specimen types:cervical swab,opharyngeal swab,nasopharyngeal swabs,anal swab,rectal and vaginal swabs. 48T/96T/48A/64T/96A CE
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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.

    Parameters

    Qualification CE

    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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    S3053E EV/EV71/CA16 – Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA 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 MA-6000, SLAN-96P, ABI7500
    Amplification Time 100 min
    Sensitivity 1000 copies/mL
    Spec. 24T
    Qualification CE
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    S3014E HCMV – Human Cytomegalovirus DNA Quantitative Fluorescence 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, Stratagene Mx3000P, SLAN-96P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
    Qualification CE
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    S3015E EBV – Epstein-Barr virus DNA Quantitative Fluorescence 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
    Qualification CE
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    C003E BCI – Nucleic Acid Test Kit for HBV, HCV, HIV (Type 1+2)

    Brief

    The Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR) is intended for qualitative detection and screen the Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, Human Immunodeficiency Virus Type 1 (HIV-1) RNA and Human Immunodeficiency Virus Type 2 (HIV-2) RNA, in plasma samples from individual human donors. The detection method can be divided into single sample detection and six sample pooled detection.

    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
    Multiple results in one test
    • 4 tests in one test
    • Direct discriminative positive results
    Automated detection
    • Extraction and amplification process
    • Fully automated extraction and amplification
    Cost and space savings
    • One extractor + one amplifier
    • Less consumable material consumption

    Parameters

    Items C003E
    Product Name Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
    Package Specification 96 tests/kit
    Amplification Amplification Multiplex real-time PCR
    Extraction Magnetic bead method
    Sample type Plasma
    Sample Volume 960μL
    LoD Individual testing: HBV 3 IU/mL; HCV 10 IU/mL; HIV 45 IU/mL
    Mini-pool testing: HBV 18 IU/mL; HCV 60 IU/mL; HIV 270 IU/mL
    Storage and Validity Amplification kit: −25 to −15°C, 12months;
    Extraction kit: 2 – 8°C, 12 months
    Qualification NMPA

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    S3034E HCV Genotype – Hepatitis C Virus 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 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
    Qualification CE

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    S3119E HCV Ultra – Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit

    Brief

    Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is intended for quantitative detection of the Hepatitis C Virus RNA in human EDTA plasma specimens. The Hepatitis C Virus genotypes 1, 2, 3, 4, 5, 6, can be quantitatively detected.
    Test results shall not be used as the only indicator for clinical diagnosis, and a comprehensive analysis of the condition must be conducted in combination with the patient's clinical manifestations and other laboratory tests.
    The kit Must NOT be used for blood screening.
    For in vitro diagnostic use only. For professional use only.

    Parameters

     
    Product features Parameter
    Specimen Type Plasma
    Extraction Platform Advanced magnetic beads technology
    Genotype HCV 1-6 genotype
    Internal Control Lentivirus particles
    PCR Instrument SLAN-96P, ABI7500, Roche cobas 480
    Sensitivity 12 IU/mL
    Linear range 25—1.0E+08 IU/mL
    Spec. 24T

    Order Information

     
    Cat. No. Product Name Spec.
    S3119E-24 Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 24T
    S10013E-48 Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) 48T

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    S3013E HBV Fast – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit

    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 release
    Genotype HBV genotype A-H
    Internal Control Plasmid
    Compatible Instrument ABI7300 , Stratagene Mx3000P , Roche Light Cycler 480 , ABI7500, SLAN-96P and QuantStudio 5
    Limit of Detection 30 IU/mL
    Linear range 100—5.0E+09 IU/mL
    Spec. 24T, 48T

    Order Information

     
    Cat. No. Product Name Spec.
    S3013E Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 24T, 48T
    S1011E Sample Release Reagent 48T

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    S3118E HBV Ultra – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit

    Brief

    Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is intended for quantitative detection of the Hepatitis B Virus DNA in human EDTA plasma specimens. The Hepatitis B Virus genotypes A, B, C, D, E, F, G, H can be quantitatively detected.
    Test results shall not be used as the only indicator for clinical diagnosis, and a comprehensive analysis of the condition must be conducted in combination with the patient's clinical manifestations and other laboratory tests.
    The kit Must NOT be used for blood screening.
    For in vitro diagnostic use only. For professional use only.

    Performance

    Advanced magnetic beads technology HBV DNA detection and viral load measurement are essential for treatment decisions and patient monitoring. Sansure's HBV Ultra uses the advanced magnetic beads technology to extract HBV DNA from clinical 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 Ultra uses UNG enzyme + dUTP system to remove carry-over contamination to avoid a false positive result.   HBV Ultra uses Internal Control HBV Ultra 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 Plasma
    Extraction Platform Advanced magnetic beads technology
    Genotype HBV genotype A-H
    Internal Control Pseudoviruses
    PCR Instrument SLAN-96P, ABI7500, Roche cobas 480
    Sensitivity 5 IU/mL
    Linear range 20—2.0E+09 IU/mL
    Spec. 48T

    Order Information

     
    Cat. No. Product Name Spec.
    S3118E-48 Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 48T
    S10012E-48 Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) 48T

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    S3017E HPV 6,11 – Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit

    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,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T, 12-P
    Qualification CE
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    S3019E HPV 16, 18 – Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit

    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 and 18) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (Type 16 and 18) 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,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T, 12-P
    Qualification CE
    Read More
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