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  • Instrument
  • Test Kit
  • S3055E BP – Bordetella Pertussis DNA Diagnostic Kit

    Brief

    Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Pertussis spreads easily from person to person mainly through droplets produced by coughing or sneezing. The disease is most dangerous in infants, and is a significant cause of disease and death in this age group.

     

    Sansure kit is used to detect Bordetella pertussis DNA present in the nasopharyngeal swab specimens by applying PCR fluorescence probing technique. The detection result can be used as an aid in the diagnosis of bordetella pertussis.

    Parameters

    Product features Parameter
    Specimen Types
    Nasopharyngeal swab
    Technical Platform
    Fast release technology
    Advanced magnetic beads technology
    Anti-contamination system
    UNG enzyme + dUTP system
    Internal Control
    Internal control plasmid
    PCR Instruments
    Mx3000P; ABI 7500; MA-6000; S-Q31A/S-Q31B; S-Q36A
    Sensitivity
    200 copies/mL
    Obtained Certificates
    NMPA, CE-IVDD etc.
  • Natch 16S Nucleic Acid Extraction System

    Specifications

    Model
    Natch 16S
    Sample throughput
    1-16
    Extraction technology
    Magnetic bead technology
    Purification differences between wells
    CV5%
    Mixing mode
    Tip comb moving up and down to mix, 10 different mixing modes
    Extraction time
    10-60 minutes/batch
    Anti-contamination
    Built-in UV lamp and air filtration system
    Operation mode
    Touch control
    Program management
    Create, copy, delete, import, export and edit
    Display
    7-inch touch screen
    Interface
    USB
    Power supply
    Input: AC 100V-240V, 50-60Hz, 120VA
    Size
    200mm×300mm×300mm (L×D×H)
    Net weight
    8Kg

    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
  • S3174E HCoV-MERS – Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit

    Brief

    The Human Coronavirus (MERS) is generally detectable in respiratory samples during the acute phase of infection. The Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) can qualitatively detect HCoV-MERS in sputum, alveolar lavage fluid, and throat swabs, the test results can be used to assist in the diagnosis of patients infected with HCoV-MERS, providing a molecular diagnostic basis for coronavirus MERS infection. The test results of this kit are for clinical reference only, and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

    Parameters

    Product features Parameter
    Covering Genes
    MERS-CoV Orf1b
    Specimen Types
    Sputum, alveolar lavage fluid, throat swab
    Technical Platform
    One-tube fast release technology
    Advanced magnetic beads technology
    Internal Control Gene
    RNase P
    Compatible Instruments
    ABI 7500, Stratagene Mx3000P, SLAN®-96P, MA-6000, iPonatic S-Q36A/S-Q31A/S-Q31B
    Sensitivity
    500 copies/mL
    Qualification
    CE
  • S3104E 2019-nCoV (FDA EUA)Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

    For in vitro diagnostic use only.

    For emergency use only.

    For Prescription Use only.

    Rx only.

    Brief

    The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARSCoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

     

    Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

     

    Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

    Performance

    • One-tube/fast release technology
    • Simple operation process, less specialist training
    • Room temperature lysis, less contamination
    • Sampling types: nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
    • Internal control: human housekeeping gene RNase P

    Parameters

    Product features Parameters
    Specimen Type Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
    Extraction Platform Sample Release Reagent Qiagen QIAamp Viral RNA Mini Kit
    Target Genes
    SARS-CoV-2 ORF1ab, N gene
    Internal Control
    Rnase P gene
    PCR Instrument
    ABI 7500 Real-Time PCR System
    LoD
    200 copies/mL
    Spec.
    24T, 48T
    Qualification
    FDA EUA
      Notes
    • This test has not been FDA cleared or approved;
    • This test has been authorized by FDA under an EUA for use by authorized laboratories;
    • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
    • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
  • S3353E FluA/Flu B – Influenza A/B Virus Nucleic Acid Diagnostic Kit

    Brief

    Influenza Virus is a kind of RNA virus in the Orthomyxoviridae family which leading to human and animal influenza. It causes acute upper respiratory tract infection, spreads rapidly through the air and has periodic pandemics around the world. Human influenza virus are influenza pathogens which can be classified into three types, namely A, B and C. Among them, influenza A is the most harmful, while influenza B and influenza C have weak pathogenicity and are not easy to mutate.

     

    The diagnostic Kit is intended for detection of the Influenza A and Influenza B in oropharyngeal swab from individuals. The test results can be used for the auxiliary diagnosis of respiratory Influenza A/B Virus infection and provide molecular diagnostic basis for Influenza A/B Virus infection.

    Parameters

    Product features Parameter
    Covering pathogens
    Influenza A and Influenza B
    Specimen Types
    Oropharyngeal swab
    Technical Platform
    One-tube fast release technology
    Advanced magnetic beads technology
    Compatible Instrument
    ABI 7500; MA-6000; SLAN®-96P; QuantGene 9600; iPonatic S-Q31A/S-Q31B
    Sensitivity
    200 copies/mL
    Spec.
    48T, 24-P
    Qualification
    CE
  • S3363E-12-P TB and RFP – Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Fluorescence Diagnostic Kit

    Brief

    Mycobacterium tuberculosis (M. tuberculosis) is the pathogen causing tuberculosis, which can invade all organs of the whole body, and pulmonary tuberculosis caused by pulmonary involvement is the most common. Early diagnosis and treatment are crucial measures to effectively control the spread of tuberculosis.

     

    Due to the abuse of antibiotics or the insufficient course of drugs of patients, the sensitivity of patients to drugs weakens or even disappears, resulting in the decreasing or ineffective effect of drugs on pulmonary tuberculosis. According to the types of anti-tuberculosis drugs, drug-resistant tuberculosis can be divided into monoresistance pulmonary tuberculosis, polyresistance pulmonary tuberculosis, multidrug resistance pulmonary tuberculosis and extensively drug-resistant pulmonary tuberculosis. Rifampicin is one of the first-line drugs for the treatment of pulmonary tuberculosis.

     

    The Mycobacterium Tuberculosis and Rifampicin Resistance Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time polymerase chain reaction test kit intended for the qualitative detection of the nucleic acid of mycobacterium tuberculosis and rifampicin resistance mutations in human sputum samples. The test results can be used to assist in the diagnosis of TB patients and patients with an increased risk of RFP drug-resistant TB, providing a molecular diagnosis basis for infected patients.

    Parameters

    Product features Parameter
    Specimen Type Sputum
    Technical Platform
    One-tube fast release technology
    PCR Instruments
    iPonatic (S-Q36A)
    Internal Control
    RNase P
    Limit of detection
    Mycobacterium tuberculosis 1,000 Bacteria/mL;
    Rifampicin resistance 10,000 Bacteria/mL
    The kit is registered in Indonesia.
  • Sample Storage Reagent for SARS-CoV-2

    Brief

    The Sample Storage Reagent is intended for preservation and transportation of cells from human body.

     

    The Sample Storage Reagent can protect the stability of virus and intracellular nucleic acid in clinical samples in a short term and is beneficial to the transport of clinical samples.

    Kit Components

    Item No.
    Main Ingredients
    X1002E
    0.9% normal saline, Rnasin and etc.
    X1003E
    Sodium chloride, Rnasin and Guanidine Thiocyanate etc.
    X1004E
    TritonTM X-100, Tween-20 and ProClinTM 300 etc.

    Order Information

    No.
    Product Name
    Capacity
    Spec.
    X1002E
    Sample Storage Reagent
    1mL
    48T,96T/Kit
    2mL
    24T/Kit
    3mL
    24T,48T/Kit
    6mL
    24T,48T/Kit
    X1003E
    Sample Release Reagent
    1mL
    48T,96T/Kit
    2mL
    24T/Kit
    3mL
    24T,48T/Kit
    6mL
    24T,48T/Kit
    X1004E
    Sample Storage Reagent
    1mL
    48T,96T/Kit
    2mL
    24T/Kit
    3mL
    24T,48T/Kit
    6mL
    24T,48T/Kit
     
  • S3108E HPV G23 – Human Papillomavirus DNA (23 genotypes) Diagnostic Kit

    Brief

    Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (Type 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82) present in exfoliated cells from females’ cervix. The test results can be used for identification of HPV genotypes.

    Parameters

    Product features Parameter
    Specimen Type
    Exfoliated cells from females’ cervix
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Detection types
    Type 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82
    Internal Control β--globin gene
    PCR Instrument
    Stratagene ABI7500, Life Technologies QuantStudioTM 5 and SLAN-96P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec.
    24T/48T
    Qualification CE

    Order Information

    Ref. No.
    Product Name
    Spec.
    S3108E
    Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)
    24T, 48T/Kit
    S1013E
    Sample Release Reagent
    48T/Kit
    S10016E
    Nucleic Acid Extraction-Purification Kit
    24T, 48T, 96T/Kit
     
  • iPonatic III – Portable Molecular Workstation

    Brief

    iPonatic III - Portable Molecular Workstation is a new member of Sansure's iPonatic series, optimizing molecular diagnostics with its advanced capabilities. With its cutting-edge technology, iPonatic III ushers in a new "digital and intelligent" era of molecular diagnostics, empowering healthcare professionals and providing rapid and accurate results.

    Features

    • Fully automated rapid testing process and “sample-in-result-out” system make test results available in 15 - 45 minutes.
    • Pre-packaged kits significantly shorten the hands-on time and reduce the chance of contamination.
    • Rich and extendable testing menu meets the testing demands of different pathogens from every scenario.
    • Through innovative wireless connection modules, large smart screen, and flexible combination abilities, samples can be tested anytime upon arrival.
    • Only 7.2 kilograms (15.84 Pounds)
    • Benefiting from state-of-the-art “SanUI” interactive system and HD smart touch screen, the test results will be displayed directly.
    • Top international industrial design standard embodies Sansure’s distinctive design concepts.

    Parameters

    Model
    S-Q36A
    Dimension 391 mm×140 mm×368 mm (L×W×H)
    Weight
    About 7.2kg
    Channels
    FAM, VIC/HEX, ROX/Texas Red, CY5
    Duration
    15 - 45min (SARS-CoV-2)
    LOD
    200 copies/mL (SARS-CoV-2)
    Maximum heating rate
    10℃/sec
    Maximum cooling rate
    3℃/sec
    Temperature accuracy
    ±0.5°C
    Functions
    Nucleic acid extraction, amplification detection, data analysis
    Display
    Built-in 7-inch high-definition touch screen, 12.1-inch smart screen (optional)
    Interfaces/communication
    USB2.0, RJ45, Type-C, WI-FI, Bluetooth, LIS_LH7
    Input voltag
    100-240 VAC
    Power frequency
    50/60Hz
    Rated power
    160VA
    Temperature
    Operating conditions:10°C- 30°C
    Transportation and storage: -40°C- 55°C
    Humidity
    Operating conditions: 30% - 80%, non-condensing
    Transportation and storage: ≤ 93%, non-condensing
    Barometric pressure
    85.0kPa - 106.0k Pa
    Altitude
    Less than 3,000 m
    Qualification
    CE

    Test menu

    RTI:  SARS-CoV-2 (ORF1ab, N gene) SARS-CoV-2 (ORF1ab, N gene, E gene) SARS-CoV-2/Flu A/Flu B SARS-CoV-2/Flu/RSV Six Respiratory Pathogens (Flu A/Flu B/RSV/AdV/HRV/MP) Acinetobacter baumannii and Canidia albican (AB/CA) Flu A/Flu B Mycoplasma Pneumoniae (MP) Mycobacterium Tuberculosis (TB) Bordetella Pertussis (BP) Respiratory Syncytial Virus (RSV) Streptococcus Pneumoniae (SP) Carbapenemase Gene (KPC) MERS Legionella pneumophila (Lp) Adenovirus (AdV)   STI & HPV:  HPV 13+2 (Identifies HPV 16 and HPV 18, reports 13 other high risk types in pooled results) HPV 15 HR (Reports 15 high risk HPV types in pooled results) HPV 16&18 HPV 6&11 HSV-2 HSV-1&2 Mycoplasma Genitalium/Mycoplasma Hominis/Trichomonas Vaginalis (MG/MH/TV) Neisseria Gonorrhoeae (NG) Ureaplasma Urealyticum (UU) Mycoplasma Genitalium (MG)   Other infections: Epstein-Barr Virus (EBV) Group B Streptococcus (GBS) Toxigenic Clostridium difficile (CD) * Monkeypox Virus (MPXV) *

    Use scenarios

    Medical laboratories, emergency rooms, fever clinics, remote areas, CDCs, airports, customs, etc.

    *All use scenarios must comply with local regulations.
  • S3046E HIV-1 – Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit

    Brief

    The human immunodeficiency virus (HIV) is the causative agent for the worldwide AIDS epidemic, and it has taken nearly 33 million lives worldwide.​ Sansure's HIV-1 RNA Quantitative Fluorescence Diagnostic Kit is intended for quantitative detection of the HIV-1 Virus RNA in human EDTA plasma specimens. Sansure's HIV-1 RNA kit received CE certificate, supporting the company to provide more quality products and services for international customers, and to help prevent and control AIDS worldwide.

    Performance

    Patented Modified-Capture Probe Assay Using exclusive modified super-paramagnetic nano-beads to absorb DNA/RNA in the sample; Heating free: Innovative lysis solution, no heating, less aerosol contamination; Single wash step: Unique combination of inorganic and organic solutions for reduced handling steps and reduced HBV DNA loss. Dual Target LTR and GAG gene regions are selected as targets for HIV detection to avoid missed detection, which can improve detection efficiency. High Sensitivity 25 IU/mL, meeting HIV-1 infection clinic guidelines.  Internal Control The HIV-1 RNA Kits uses Internal Control is the full name to whole-process the HIV-1 extraction and amplification process to avoid false negative results.

    Parameters

    Product features Parameter
    Specimen Type Plasma
    Extraction Platform Advanced magnetic beads technology
    Genotype HIV-1 Group M,N,O
    Internal Control Pseudoviruses
    PCR Instrument SLAN-96P, ABI7500, Roche cobas 480
    Sensitivity 25 IU/mL
    Linear range 50—1.0E+08 IU/mL
    Spec. 48T
    Qualification CE
  • 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
  • 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
    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
    Qualification CE
  • 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
  • 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
  • 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
  • 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
  • C004E BCI – 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 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
    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 558/96 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.

    Parameters

    Qualification CE
  • S3120E-H-SARS-CoV-2 Rapid Antigen Test 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.

    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

    Parameters

    Qualification CE

    Kit components

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

    The kit components:

    •  SARS-CoV-2-Antigen Test Cassette (with desiccant)
    • SARS-CoV-2 Sample Extraction Buffer
    • Swab
    • Plastic Waste Bag
  • S3109E 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.

    Parameters

    Testing Time 10-15 minutes
    Sensitivity 98.4%
    Specificity 98.1%
    Qualification CE

    Kit components

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

    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
  • 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

    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 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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