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S3055E BP – Bordetella Pertussis DNA Diagnostic Kit
Respiratory Tract InfectionsBrief
Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Pertussis spreads easily from person to person mainly through droplets produced by coughing or sneezing. The disease is most dangerous in infants, and is a significant cause of disease and death in this age group.
Sansure kit is used to detect Bordetella pertussis DNA present in the nasopharyngeal swab specimens by applying PCR fluorescence probing technique. The detection result can be used as an aid in the diagnosis of bordetella pertussis.
Parameters
Product features Parameter Specimen Types Nasopharyngeal swabTechnical PlatformFast release technologyAdvanced magnetic beads technologyAnti-contamination systemUNG enzyme + dUTP systemInternal ControlInternal control plasmidPCR InstrumentsMx3000P; ABI 7500; MA-6000; S-Q31A/S-Q31B; S-Q36ASensitivity200 copies/mLObtained CertificatesNMPA, CE-IVDD etc. -
S3174E HCoV-MERS – Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit
Respiratory Tract InfectionsBrief
The Human Coronavirus (MERS) is generally detectable in respiratory samples during the acute phase of infection. The Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) can qualitatively detect HCoV-MERS in sputum, alveolar lavage fluid, and throat swabs, the test results can be used to assist in the diagnosis of patients infected with HCoV-MERS, providing a molecular diagnostic basis for coronavirus MERS infection. The test results of this kit are for clinical reference only, and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.
Parameters
Product features Parameter Covering Genes MERS-CoV Orf1bSpecimen TypesSputum, alveolar lavage fluid, throat swabTechnical PlatformOne-tube fast release technologyAdvanced magnetic beads technologyInternal Control GeneRNase PCompatible InstrumentsABI 7500, Stratagene Mx3000P, SLAN®-96P, MA-6000, iPonatic S-Q36A/S-Q31A/S-Q31BSensitivity500 copies/mLQualificationCE -
S3104E 2019-nCoV (FDA EUA)Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
2019-nCoV (FDA EUA)For in vitro diagnostic use only.
For emergency use only.
For Prescription Use only.
Rx only.Brief
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARSCoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Performance
- One-tube/fast release technology
- Simple operation process, less specialist training
- Room temperature lysis, less contamination
- Sampling types: nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
- Internal control: human housekeeping gene RNase P
Parameters
NotesProduct 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 GenesSARS-CoV-2 ORF1ab, N geneInternal ControlRnase P genePCR InstrumentABI 7500 Real-Time PCR System LoD200 copies/mLSpec.24T, 48TQualificationFDA EUA- 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.
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S3353E FluA/Flu B – Influenza A/B Virus Nucleic Acid Diagnostic Kit
Respiratory Tract InfectionsBrief
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 pathogensInfluenza A and Influenza BSpecimen TypesOropharyngeal swabTechnical PlatformOne-tube fast release technologyAdvanced magnetic beads technologyCompatible InstrumentABI 7500; MA-6000; SLAN®-96P; QuantGene 9600; iPonatic S-Q31A/S-Q31BSensitivity200 copies/mLSpec.48T, 24-PQualificationCE -
S3363E-12-P TB and RFP – Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Fluorescence Diagnostic Kit
Respiratory Tract InfectionsBrief
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
The kit is registered in Indonesia.Product features Parameter Specimen Type Sputum Technical PlatformOne-tube fast release technologyPCR InstrumentsiPonatic Ⅲ (S-Q36A)Internal ControlRNase PLimit of detectionMycobacterium tuberculosis 1,000 Bacteria/mL;Rifampicin resistance 10,000 Bacteria/mL -
Sample Storage Reagent for SARS-CoV-2
Sample Storage ReagentBrief
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 IngredientsX1002E0.9% normal saline, Rnasin and etc.X1003ESodium chloride, Rnasin and Guanidine Thiocyanate etc. X1004ETritonTM X-100, Tween-20 and ProClinTM 300 etc.Order Information
No.Product NameCapacitySpec.X1002ESample Storage Reagent1mL48T,96T/Kit2mL24T/Kit3mL24T,48T/Kit6mL24T,48T/KitX1003ESample Release Reagent1mL48T,96T/Kit2mL24T/Kit3mL24T,48T/Kit6mL24T,48T/KitX1004ESample Storage Reagent1mL48T,96T/Kit2mL24T/Kit3mL24T,48T/Kit6mL24T,48T/Kit -
S3108E HPV G23 – Human Papillomavirus DNA (23 genotypes) Diagnostic Kit
HPV InfectionsBrief
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’ cervixTechnical 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, 82Internal Control β--globin gene PCR Instrument Stratagene ABI7500, Life Technologies QuantStudioTM 5 and SLAN-96PAmplification Time 70 min Sensitivity 400 copies/mL Spec. 24T/48TQualification CE Order Information
Ref. No.Product NameSpec.S3108EHuman Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)24T, 48T/KitS1013ESample Release Reagent48T/KitS10016ENucleic Acid Extraction-Purification Kit24T, 48T, 96T/Kit -
S3046E HIV-1 – Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit
Blood-borne Infections (BBIs)Brief
The human immunodeficiency virus (HIV) is the causative agent for the worldwide AIDS epidemic, and it has taken nearly 33 million lives worldwide. Sansure's HIV-1 RNA Quantitative Fluorescence Diagnostic Kit is intended for quantitative detection of the HIV-1 Virus RNA in human EDTA plasma specimens. Sansure's HIV-1 RNA kit received CE certificate, supporting the company to provide more quality products and services for international customers, and to help prevent and control AIDS worldwide.Performance
Patented Modified-Capture Probe Assay Using exclusive modified super-paramagnetic nano-beads to absorb DNA/RNA in the sample； Heating free: Innovative lysis solution, no heating, less aerosol contamination; Single wash step: Unique combination of inorganic and organic solutions for reduced handling steps and reduced HBV DNA loss. Dual Target LTR and GAG gene regions are selected as targets for HIV detection to avoid missed detection, which can improve detection efficiency. High Sensitivity 25 IU/mL, meeting HIV-1 infection clinic guidelines. Internal Control The HIV-1 RNA Kits uses Internal Control is the full name to whole-process the HIV-1 extraction and amplification process to avoid false negative results.Parameters
Product features Parameter Specimen Type Plasma Extraction Platform Advanced magnetic beads technology Genotype HIV-1 Group M,N,O Internal Control Pseudoviruses PCR Instrument SLAN-96P, ABI7500, Roche cobas 480 Sensitivity 25 IU/mL Linear range 50—1.0E+08 IU/mL Spec. 48T Qualification CE -
S3016E MP – Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit
Respiratory Tract InfectionsBrief
Mycoplasma pneumoniae (MP) is a pathogenic microorganism between bacteria and virus. It is mainly transmitted through buccal and nasal mucus by the air causing respiratory diseases, with the highest incidence in children and adolescents. Respiratory infection has the manifestations of pharyngitis and bronchitis, with a few cases causing infection to the lung. Recently, incidence among infants and children is increasing, therefore, early diagnosis and treatment can decrease the exacerbation of acute pneumonia in children. The development of molecular biology also draws more attention to the fluorescence quantitative PCR technology for the detection of MP-DNA. This diagnostic kit is an in vitro nucleic acid amplification test for the detection of mycoplasma pneumoniae DNA in humansputum and throat swab. It is intended for use as an aid in the diagnosis of an MP infection and providing a molecular-diagnostics-based solution.Parameters
Product features Parameter Specimen Type Sputum and throat swab Extraction Platform One-tube fast release technology Internal Control cloning plasmid containing the target gene fragment PCR Instrument ABI 7500, SLAN-96P,MA-6000, Roche LightCycler 480, iPonatic S-Q31A&B,S-Q36A Sensitivity 400 copies/mL Spec. 48T, 12-P Qualification CE -
S3066E 6RP – Six Respiratory Pathogens Nucleic Acid Diagnostic Kit
Respiratory Tract InfectionsBrief
Respiratory infections are classified into the upper respiratory tract infections and lower respiratory tract infections. It refer to the pathogens that infect the nose, throat, trachea, bronchi or lungs, which principally cause diseases of tissues and organs outside the respiratory tract, manifested by fever, sore throat, cough, headache and other symptoms. The respiratory tract pathogen has the characteristics of strong infectivity, rapid spread, short incubation period and acute onset, etc. which seriously harm human health. After respiratory infection, symptoms are mostly similar. Sansure six respiratory pathogens joint detection kits can help doctors make differential diagnosis, accurately detect the pathogens that cause symptoms, and formulate treatment plans.Performance
- High sensitivity: Super-cis-nanometer magnetic bead technology; can achieve 500copies/mL
- Accurate identification: One test presented six results ; accurate guidance for rational clinical drug use
- Whole-process monitoring: Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) human housekeeping gene as internal standard; Monitor the whole process of sampling, nucleic acid extraction and amplification
Parameters
Product features Parameter Specimen Type Nasopharyngeal swabs Extraction Platform Advanced magnetic beads technology Internal Control lentivirus particles（GAPDH） PCR Instrument SLAN-96P, ABI7500 Sensitivity Influenza A virus: 2.0 TCID50/mL Influenza B virus: 2.0 TCID50/mL Respiratory syncytial virus: 500.0 copies/mL Adenovirus: 500.0 copies/mL Mycoplasma pneumonia: 500.0 copies/mL Human rhinovirus: 500.0 copies/mL Spec. 24T Qualification CE -
S3334E ADV – Adenovirus Nucleic Acid Diagnostic Kit
Respiratory Tract InfectionsBrief
Acute infectious disease caused by adenovirus, easily affects the mucous membranes of the respiratory and digestive tracts, the conjunctiva of the eyes, the urinary tract and the lymph nodes. The main manifestation is an acute upper respiratory tract infection. The population is generally susceptible, mostly the children. Infants are susceptible to adenovirus pneumonia, which is severe and has a high mortality rate. The source of infection is the patient and the latent infected person. The virus is excreted from the respiratory tract and conjunctival secretions, feces and urine, and is transmitted by airborne droplets, close contact and the feces-oral route. The Adenovirus Nucleic Acid Diagnostic Kit is used for nucleic acid testing of adenovirus in patients suspected of being adenovirus infections (e.g., fever, cough, wheezing, dyspnea, bronchopneumonia, upper respiratory tract infections, lung infections, etc.) or related close contacts, and the results can be used to assist in the diagnosis of adenovirus infection and provide a molecular diagnostic basis for adenovirus infection.Features
- High sensitivity: Detection sensitivity reaches 200 copies/mL.
- Quick and easy: Perfectly match Sansure's one-tube fast Sample Release Reagent, easy to operate.
- IC monitoring: IC(Internal Control) monitoring test process to avoid false negative results.
Parameters
Items Parameter Specimen Type Throat swab Extraction Platform One-tube fast release technology Advanced magnetic beads technology Anti-contamination system UNG enzyme + dUTP system PCR Instrument ABI 7500; MA-6000; SLAN-96P; QuantStudio 5; iPonatic S-Q31A&B; S-Q36A Sensitivity 200 copies/mL Qualification NMPA, CE -
S3018E TB – Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit
Respiratory Tract InfectionsBrief
Mycobacterium tuberculosis virus (TB) is a pathogenic bacterium that causes tuberculosis. It is likely to infect all human tissues and organs, especially the lungs to cause pulmonary tuberculosis. Early diagnosis and treatment are important for effective control of tuberculosis. In recent years, with the development of molecular biology, nucleic acid fluorescence quantitative PCR method based on the mycobacterium tuberculosis nucleic acid has drawn more and more attention from researchers.Parameters
Product features Parameter Specimen Type Human sputum Extraction Platform One-tube fast release technology Internal Control Cloning plasmid, without TB target sequence PCR Instrument ABI 7500, SLAN-96P,MA-6000, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A Sensitivity 1 bacterium/mL Spec. 48T, 12-P Qualification CE -
S3310E 6LRP – Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit
Respiratory Tract InfectionsBrief
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
Other InfectionsBrief
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)
Blood-borne Infections (BBIs)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
- 576 tests/ 5h（pooling）
- 96 tests / 4.5h（single)
- HBV genotypes A-H
- HCV genotypes 1-6
- HIV-1 group M/N/O
- HIV-2
- Four tests for a tube of samples
- Direct discriminating positive
- Extraction and amplification process
- No need to be on duty
- 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
Respiratory Tract InfectionsBrief
The SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) for self-testing is authorized for home use with self-collected nasal swab samples to directly detect antigen of SARS-CoV-2 virus. With the help of this kit, people without professional training can also easily acquire their COVID-19 test result within 15-20 minutes.Features
- Accurate Sensitivity 94.55%, Specificity 100%
- Convenient No instrument needed, easy to operate
- Fast Result available in only 15-20 min
- Flexible Get tested anytime when you are free
Instruction
Result interpretation
Parameters
Qualification CE Kit components
No. Product Name Spec. S3120E-1-H, S3120E-5-H SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 1 Test, 5 Tests The kit components:
- SARS-CoV-2-Antigen Test Cassette (with desiccant)
- SARS-CoV-2 Sample Extraction Buffer
- Swab
- Plastic Waste Bag
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S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)
Respiratory Tract InfectionsBrief
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 -
S1006E Multi-type Sample DNA/RNA Extraction-Purification Kit
DNA/RNA Extraction ReagentsBrief
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
DNA/RNA Extraction ReagentsBrief
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
DNA/RNA Extraction ReagentsBrief
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
Gastrointestinal Infections (GIIs)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
Other InfectionsBrief
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
Other InfectionsBrief
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)
Blood-borne Infections (BBIs)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
- 576 tests/ 5h（pooling）
- 45 tests / 4.5h（single
- HBV A-H
- HCV 1-6
- HIV-1（M/N/O）and HIV-2
- Four tests for a tube of samples
- Direct discriminating positive
- Extraction and amplification process
- No need to be on duty
- 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
