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  • Instrument
  • Test Kit
  • S3104E 2019-nCoV (FDA EUA) — Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit

    For in vitro diagnostic use only.

    For emergency use only.

    For Prescription Use 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.
  • S3121E SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)

    Brief

    SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay) is intended for the qualitative detection of the SARS-CoV-2/InFluA/InFluB nucleocapsid protein in human nasopharyngeal or oropharyngeal swabs. Test results will be available for reading in 15-20 minutes. Positive results indicate the presence of viral antigens. This kit is for in vitro diagnostic use.

    Features

    • Accurate LOD 80TCID50 /ml, Specificity 100%
    • Convenient No instrument needed, easy to operate
    • Fast Result available in only 15-20 min

    Instruction

    Result interpretation

    Parameters

    Qualification CE

    Kit components

    No. Product Name Spec.
    S3121E-25
    SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)
    25 Test

    The kit components:

    • SARS-CoV-2/InFluA/InFluB Antigen Test Cassette (individually in a foil pouch with desiccant)
    • Sample Extraction Buffer
    • Swab
  • 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, which will open up a new “digital and intelligent” era of molecular diagnostics.

    Features

    • Fully automated rapid testing process and “sample-in-result-out” system make test results available in as short as 8 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 kilograms (15.4 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
    AC 100-240V
    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

    Respiratory Infections : SARS-CoV-2, SARS-CoV-2/FluA/B, 6RP, TB, MP, ADV, BP.... HPV Infections : HPV13+2, HPV(15HR), HPV(genotypes), HPV 16/18, HPV 6/11.... STIs : CT/UU/NG, CT, UU, NG, HSV-2.... Children's Health : EBV, HCMV....

    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
  • 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
  • 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 S3120E-10-H, S3120E-25-H SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 1 Test, 5 Tests 10 Tests, 25 Tests

    The kit components:

    •  SARS-CoV-2-Antigen Test Cassette (with desiccant)
    • SARS-CoV2 Sample Extraction Buffer
    • Specimen Collection Swab
    • Plastic Waste Bag
  • S3132E-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.

    Features

    Instruction

    Result interpretation

    Parameters

    Qualification CE
    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
  • S3131E- 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.

    Features

    Instruction

    Result interpretation

    Parameters

    Qualification CE
    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
  • 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
  • S3120E – 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.

    Features

    Instruction

    Result interpretation

    Parameters

    Qualification CE

    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
  • 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
  • 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
  • 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.

    Parameters

    Qualification CE

    Kit components

    No. Product Name Spec.
    S1002E Nucleic Acid (DNA/RNA) Extraction or Purification Kit 24T/kit
    S10011E Nucleic acid (DNA/RNA) extraction or purification kit 24T/Kit, 48T/kit
    S10016E Nucleic Acid Extraction-Purification Kit 48T/kit, 96T/kit
  • 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
  • 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 ABI7500,SLAN-96P
    Amplification Time 100 min
    Sensitivity 1000 copies/mL
    Spec. 24T
    Qualification CE
  • 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 and Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
    Qualification CE
  • 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
  • C003E 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 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.

    Parameters

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

    Brief

    Hepatitis C Virus 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 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
    Qualification CE
  • 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 test release
    Genotype HBV genotype A-H
    Internal Control Plasmid
    Compatible Instrument ABI7300 , Stratagene Mx3000P , Roche Light Cycler 480 , ABI7500, SLAN-96P and QuantStudio 5
    Sensitivity 30 IU/mL
    Linear range 100—5.0E+09 IU/mL
    Spec. 24T, 48T
    Qualification CE
  • S3118E HBV Ultra – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit

    Brief

    Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)  (HBV Ultra) 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 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
    Qualification CE
  • 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
  • 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
  • S3360E HPV 15HR – 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit

    Brief

    15 High-risk HPV DNA Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) present in exfoliated cells from females’ cervix. The test results can be used as an aid in the diagnosis of a high-risk HPV infection.

    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 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
    Internal Control β--globin gene
    PCR Instrument ABI7500, QuantStudio 5, MA-6000, SLAN-96P, LightCycler 480, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A
    Amplification Time 70 min
    Sensitivity 1000 copies/mL
    Spec. 48T, 12-P
    Qualification CE
  • S3027E HPV G15 – High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit

    Brief

    This High-risk HPV DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) 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 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
    Internal Control β--globin gene
    PCR Instrument SLAN-96P, ABI 7500, Roche LC 480 and QuantStudioTM 5 , Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 24T/48T
    Qualification CE
  • S3057E HPV 13+2 – Human Papillomavirus DNA Diagnostic Kit

    Brief

    Base on the study results by WHO International Agency for Research on Cancer (IARC) and other international organizations, the 13 kinds of genotypes including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 are classified as high-risk HPV, and the 5 kinds of genotypes including HPV26, 53, 66, 73, 82 are classified as medium-risk HPV.   Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) chooses the above 13 kinds of high-risk genotypes and two popular kinds of medium-risk genotypes that are HPV 53 and 66 to be the target genotypes, in order to guarantee that the kit is capable of cervical carcinoma screening and risk evaluation. Moreover, it is clearly indicated that the females at the age of 30 or above who have no abnormal cervical cytology but the HPV detection is positive, especially for HPV16 and HPV18 infected females, should get vaginoscopy immediately. Therefore, the diagnostic kit can be used for detection of the 15 kinds of target genotypes and also subtype identification of HPV16 and HPV18.

    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 16+18+31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
    Internal Control β--globin gene
    PCR Instrument ABI7500, MA-6000, SLAN-96P, QuantGene 9600 , iPonatic S-Q31A&B, S-Q36A
    Amplification Time 70 min
    Sensitivity 1000 copies/mL
    Spec. 48T,  24-P
    Qualification CE
  • S3002E HSV-2 – Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit

    Brief

    Herpes Simplex Virus Type 2 (HSV-2) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of HSV-2- DNA in samples such as male urethral swab and female cervical swab. The detection result can be used as an aid in the diagnosis of an HSV-2 infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

    Parameters

    Product features Parameter
    Specimen Type Genital tract secretions.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen HSV-2
    Internal Control Recombinant plasmid
    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
  • S3004E UU – Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit

    Brief

    The Ureaplasma Urealyticum (UU) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of UU-DNA in samples such as male urethra swab and female cervical swab. The detection result can be used as an aid in the diagnosis of a UU infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

    Parameters

    Product features Parameter
    Specimen Type Genital tract secretions.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen UU
    Internal Control Recombinant plasmid
    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
  • S3003E NG – Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit

    Brief

    Neisseria Gonorrhoeae (NG) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of NG-DNA in samples such as male urethral swab and female cervical swab. The detection result can be used as an aid in the diagnosis of an NG infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

    Parameters

    Product features Parameter
    Specimen Type Genital tract secretions.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen NG
    Internal Control Recombinant plasmid
    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
  • 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
  • S3001E CT – Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit

    Brief

    Chlamydia Trachomatis (CT) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) applies to detect CT DNA in specimens like reproductive tract secretion. The detection result can be used for aiding diagnosis of CT infection, which provides molecular diagnosis base for early diagnosis of venereal disease and for preliminary screening of venereal disease high-risk groups.

    Parameters

    Product features Parameter
    Specimen Type genital tract secretions.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen CT
    Internal Control Recombinant plasmid
    PCR Instrument ABI 7500, Roche LC480,Stratagene Mx3000P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
    Qualification CE
  • S3050E CT/UU/NG – Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit

    Brief

    Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) is a qualitative in vitro test for simultaneous detection of Chlamydia Trachomatis, Ureaplasma Urealyticum and Neisseria Gonorrhoeae DNA in sterile calcium alginate swab specimens from male urinary tract secretion and female genital tract secretion by applying real-time fluorescence quantitative PCR technique, which can provide molecular diagnosis evidence for the early diagnosis of related sexually transmitted diseases and initial screening of high-risk STD population.

    Parameters

    Product features Parameters
    Specimen Type genital tract secretions.
    Technical Platform One-tube fast release technology Advanced magnetic beads technology
    Target pathogen CT, UU, NG-DNA
    Internal Control β--globin gene
    PCR Instruments ABI7500,SLAN-96P
    Amplification Time 70 min
    Sensitivity 400 copies/mL
    Spec. 48T
    Qualification 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
  • S3122E SC2 Mut2 – SARS-CoV-2 Mutation Nucleic Acid Diagnostic Kit

    Brief

    The SARS-CoV-2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is used to identify whether the virus contains mutation sites N501Y and HV 69-70del in nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluids, saliva and sputum from patients who have been diagnosed with SARS-CoV-2 infection.

    Performance

    • ARMS-PCR: Accurate detection of N501Y, HV 69-70delmutation sites
    • Ultra fast: Optimize testing procedures, amplification time only 60min
    • High sensitivity: Detection sensitivity reaches 200 copies/mL
    • Internal control: Rnase P, Monitor the whole process (Sampling, Extraction and Amplification )

    Parameters

    Product features Parameters
    Specimen Type Nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, saliva and sputum
    Extraction Platform One-tube fast release technology / Advanced magnetic beads technology
    Target Genes N501Y, HV 69-70del, N gene
    Internal Control Rnase P gene
    PCR Instrument SLAN-96P, ABI7500, QuantStudio 5
    Sensitivity 200copies/mL
    Spec. 24T/48T
    Qualification CE
  • S3124E SC2 Mut5 – Detection Kit for 5 Mutations of SARS-CoV-2

    Brief

    Detection Kit for 5 Mutations of SARS-CoV-2, detects 5 SARS-CoV-2 variants, including E484K, K417N, P681H, N501Y and HV 69-70del, which covers Most Worrying Mutations.

    Performance

    • More comprehensive: Accurate detection of 5 mutation sites
    • Ultra fast: Optimize testing procedures, amplification time only 60min
    • High sensitivity: Detection sensitivity reaches 200 copies/mL
    • Internal control: Rnase P, Monitor the whole process

    Parameters

    Product features Parameters
    Specimen Type Oropharyngeal swab, sputum, alveolar lavage fluid, nasopharyngeal swab and saliva
    Extraction Platform Advanced magnetic beads technology
    Target Genes E484K, K417N, P681H, N501Y, HV 69-70del, N gene
    Internal Control Rnase P
    PCR Instrument SLAN-96P, ABI7500, QuantStudio 5
    Sensitivity 200copies/mL
    Spec. 24T/48T
    Qualification CE
  • S3113E SC2/FluA/B – SARS-CoV-2 and Influenza A/B Virus Nucleic Acid Diagnostic Kit

    Brief

    Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Elder people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.   Sansure COVID-19 diagnostic solutions are used to directly detect  the presence of viral RNA, which will be detectable in patients before antibodies form or symptoms of the disease are present, which means the test results can tell whether or not that someone gets virus very early on in their illness. This kit can also joint-detect RNA of influenza A virus and influenza B virus.

    Parameters

    Product features Parameters
    Specimen Type Oropharyngeal swab, sputum
    Extraction Platform One-tube fast release technology Advanced magnetic beads technology
    Target Genes SARS-CoV-2:ORF 1ab, N gene; influenza A:M gene; influenza B:NP gene
    Internal Control Rnase P gene
    PCR Instrument ABI7500, SLAN-96P, MA-6000, QuantGene 9600, iPonatic S-Q31A&B,S-Q36A
    Sensitivity 200 copies/mL
    Spec. 24T, 48T, 24-P
    Qualification CE
  • S3123E SC2 Tri – SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit

    Brief

    COVID-19 is an infectious disease caused by a newly discovered coronavirus named SARS-CoV2.   Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Elder people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.   The SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is used for qualitative detection of the ORF1ab,N and E genes of SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, saliva and sputum from patients with SARS-CoV-2 infection, suspected cases with SARS-CoV-2 infection and other patients requiring diagnosis or differential diagnosis of SARS-CoV-2 infection.

    Performance

    • Performance upgrade: ORF 1ab, N, E genes, three targets
    • High sensitivity: 200 copies/ml (one-tube fast release technology), 50 copies/ml (advanced magnetic beads method)
    • Time saving: the amplification time was 60min, and the extraction time was the shortest 30min

    Parameters

    Product features Parameters
    Specimen Type Nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, saliva and sputum
    Extraction Platform One-tube fast release technology Advanced magnetic beads technology
    Target Genes ORF 1ab, N, E gene
    Internal Control Pseudovirus containing internal control gene fragments
    PCR Instrument SLAN-96P, ABI7500, QuantStudio 5, iPonatic S-Q31A&B
    Sensitivity 200 copies/mL (Sample Release Reagent ); 50 copies/mL (Nucleic Acid Extraction-Purification Kit )
    Spec. 24T, 48T, 96T, 12-P
    Qualification CE
  • S3148E SC2/Flu/RSV – SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit

    ,

    Brief

    The SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative Diagnostic of nucleic acid from SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple in the nasopharyngeal swabs and oropharyngeal swabs from individuals.

     

    As the seventh coronavirus that infects humans, the SARS-CoV-2 can cause fever, fatigue, dry cough, dyspnea and other symptoms. In severe cases, it can cause acute respiratory distress syndrome, septic shock, and even death. At the same time, the SARS-CoV-2 has a strong spreading ability and has a wide range. Influenza virus (Influenza virus) can cause acute respiratory infections, with clinical manifestations of fever, headache, myalgia, fatigue, rhinitis, sore throat and cough. Influenza viruses can aggravate underlying diseases (such as heart and lung diseases) or cause secondary bacterial pneumonia or primary influenza viral pneumonia. The elderly and people with various chronic diseases or physical weakness are prone to severe complications and mortality higher after infecting influenza. Respiratory syncytial virus (RSV) belongs to the Pneumovirus genus of the Paramyxoviridae family. It mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months, as well as rhinitis , Cold and other upper respiratory tract infections in older children and adults.

    Parameters

    Product features Parameter
    Covering pathogens
    SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus
    Specimen Types
    Nasopharyngeal swab and oropharyngeal swab
    Technical Platform
    One-tube fast release technology
    Advanced magnetic beads technology
    Internal Control
    RNase P gene
    Compatible Instrument
    ABI 7500; MA-6000; SLAN®-96P; iPonatic S-Q31A/S-Q31B/S-Q36A
    Sensitivity
    500 copies/mL.
    Qualification
    CE
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