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

    The kit components:

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