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S3250E MG/MH/TV — Mycoplasma Genitalium/Mycoplasma Hominis/ Trichomonas Vaginalis DNA Diagnostic Kit
Reproductive Tract InfectionsBrief
Mycoplasma Genitalium/Mycoplasma Hominis/ Trichomonas Vaginalis DNA Diagnostic Kit (PCR-Fluorescence Probing) is a qualitative in vitro test for simultaneous detection of Mycoplasma Genitalium, Mycoplasma Hominis and Trichomonas Vaginalis 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 MG, MH, TV Internal Control β--globin gene PCR Instruments ABI7500, SLAN-96P etc. Amplification Time 70 min Sensitivity 500 copies/mL Spec. 48T Qualification CE -
S3084E CYP2C19 – Human CYP2C19 Genetic Polymorphism Detection Kit
Other InfectionsBrief
The Human CYP2C19 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) is used for the qualitative detection of genotype of three polymorphic sites for human CYP2C192 (681G > A), CYP2C193 (636G > A) and CYP2C19*17 (-806C>T) in human peripheral blood samples.Parameters
Product features Parameter Specimen Type Peripheral blood Extraction Platform Advanced magnetic beads technology PCR Instrument SLAN-96P Spec. 24T Qualification CE -
S3089E ApoE – Human ApoE Genetic Polymorphism Detection Kit
Other InfectionsBrief
This Human ApoE Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) is used for the qualitative detection of 388T>C and 526C>T genetic polymorphisms of ApoE gene in human cell.Parameters
Product features Parameter Specimen Type Peripheral blood Extraction Platform Advanced magnetic beads technology PCR Instrument SLAN-96P Spec. 24T Qualification CE -
S3187E Malaria – Plasmodium Nucleic Acid Diagnostic Kit
Other InfectionsBrief
Plasmodium is detectable in patients who has Severe anemia, respiratory distress associated with metabolic acidosis, or cerebral malaria. Positive results are indicates the presence of Plasmodium. Clinical correlation with medical history and other diagnostic information is necessary to determine patient infection status.Parameters
Product features Parameter Specimen Type Whole blood Extraction Platform Advanced magnetic beads technology PCR Instrument MA6000, SLAN-96P Spec. 24T Qualification CE -
S3333E DENV/ZIKV/CHIKV – Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit
Other InfectionsBrief
The DENV, ZIKV, and CHIKV RNA are generally detectable in serum from infected individuals. Positive results are indicative of the presence of DENV, ZIKV, and CHIKV, clinical correlation with the medical history and other diagnostic information is necessary to determine patient infection status.Parameters
Product features Parameter Specimen Type Plasma, serum Extraction Platform Advanced magnetic beads technology PCR Instrument MA6000, SLAN-96P Spec. 24T Qualification CE -
S3214E B19 – Human Parvovirus B19 DNA Nucleic Acid Diagnostic Kit
Other InfectionsBrief
The Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing) is a real-time PCR test intended for the qualitative detection of nucleic acid from Human Parvovirus B19 in plasma, serum from individuals who are suspected of B19 infection.Parameters
Product features Parameter Specimen Type Plasma, serum Extraction Platform Advanced magnetic beads technology Extraction ReagentS1006EPCR Instrument MA6000, SLAN-96P, QuantStudio 5, ABI7500, Roche 480 Sensitivity 400 copies/mL Spec. 24T, 48T Qualification CE -
S3179E HAV – Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit
Gastrointestinal Infections (GIIs)Brief
The Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a Real-time PCR test intended for the qualitative detection of nucleic acid from HAV in plasma and faeces.
Parameters
Product features Parameter Specimen Type Plasma Extraction Platform Advanced magnetic beads technology Extraction ReagentS1006EPCR Instrument MA6000, SLAN-96P, QuantStudio 5, ABI7500, Roche cobas 480, CFX96 Sensitivity 1000 copies/mL Spec. 24T Qualification CE -
SNMC0021IR HPV G14 – High-risk Human Papillomavirus DNA (14 Genotypes) Diagnostic Kit
Reproductive Tract InfectionsBrief
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, 56, 58, 59, 66, 68) present in exfoliated cells from females’ cervix. The test results can be used for identification of HPV genotypes.Parameters
This kit is intended solely for the Iranian market.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, 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 -
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 -
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 Flu A/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
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
Cat. No.Product DescriptionPackageRegistrationX1001E Sample Storage Reagent
specimen type:Cervical exfoliated cell1T/24T СЕ NMPA X1006E Sample Storage Reagent
specimen type:Cervical exfoliated cell25T/50T/100T/200T/300T/400/500T CE NMPA X1011E Sample Storage Reagent XI
specimen types:oral and nasopharyngeal swabs24T/48T/96T CE NMPA N101E Urine Sample Collector 1T/40T CE NMPA -
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
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence probing) is intended for quantitative detection of the HIV-1 Virus RNA in human EDTA plasma specimens and used as an aid for diagnosis of HIV infection or carrier.
Test results shall not be used as the only indicator for clinical diagnosis, and a comprehensive analysis of the condition must be conducted in combination with the patient's clinical manifestations and other laboratory tests.
The kit MUST NOT be used for blood screening.
For in vitro diagnostic use only. For professional use only.Features
Patented Modified-Capture Probe Assay – Using exclusive modified super-paramagnetic nano-beads to adsorb 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 HIV-1 RNA loss. Dual Targets The LTR and pol gene regions were selected as targets for HIV detection to reduce the risk of false-negative results and improve assay sensitivity. High Sensitivity The limit of detection was 25 IU/mL, meeting international guidelines for HIV-1 detection. Internal Control The use of an internal control during extraction and amplification ensures process validity and reduces the likelihood of false-negative results.Parameters
Items Parameter Specimen Type Plasma Extraction Platform Advanced magnetic beads technology Group HIV-1 Group M, O and N 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 ORDER INFORMATION
Cat. No. Product Name Spec. S3046E Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 48T S1001E Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) 24T Related Instruments
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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, S-Q36A Sensitivity Influenza A virus: 2.0 TCID50/mL Influenza B virus: 2.0 TCID50/mL Respiratory syncytial virus: 500.0 copies/mL Adenovirus: 500.0 copies/mL Mycoplasma pneumonia: 500.0 copies/mL Human rhinovirus: 500.0 copies/mL Spec. 24T, 12P Qualification CE -
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
The Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR) is intended for qualitative detection and screen the Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, Human Immunodeficiency Virus Type 1 (HIV-1) RNA and Human Immunodeficiency Virus Type 2 (HIV-2) RNA, in plasma and serum samples from individual human donors. Plasma and serum from all donors may be screened as individual samples. For donations, may be tested individually or be tested in pools comprised of an equal quantity of six samples. For in vitro diagnostic use only. For professional use only.Advantages
High sensitivity- HBV 2.41 IU/mL
- HCV 12.38 IU/mL
- HIV-1 31.68 IU/mL
- HIV-2 48.34 IU/mL
- 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
- 4 tests in one test
- Direct discriminative positive results
- Extraction and amplification process/li>
- Fully automated extraction and amplification/li>
- One extractor + one amplifier
- Less consumable material consumption
Parameters
Items C004E Product Name Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR) Package Specification 96 tests/kit Amplification Multiplex real-time PCR Extraction Magnetic bead method Sample type Plasma, Serum Sample Volume 960μL LoD (Individual testing) HBV 2.41 IU/mL; HCV 12.38 IU/mL HIV-1 31.68 IU/mL; HIV-2 48.34 IU/mL Storage and Validity Amplification kit: < −15°C, 12months; Extraction kit: 2 – 8°C, 12 months Qualification CE Related Instruments
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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
