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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 -
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 -
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 -
S3034E HCV Genotype – Hepatitis C Virus Genotype Diagnostic Kit
Blood-borne Infections (BBIs)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
Blood-borne Infections (BBIs)Brief
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HCV RNA in human serum or plasma. It is intended for use as an aid in the diagnosis of an HCV infection and observing drug efficacy. Hepatitis C is mainly caused by HCV infection and transmitted through blood. Chronic infection of HCV can lead to chronic inflammation of liver and fibrosis, and some patients may develop into liver cirrhosis, even Hepatocellular Carcinoma (HCC). It has huge harms on patients’ health and life quality, and has become a severe social and public health issue.Parameters
Product features Parameter Specimen Type Plasma Extraction Platform Advanced magnetic beads technology Genotype HCV 1-6 genotype Internal Control Lentivirus particles PCR Instrument SLAN-96P, ABI7500, Roche cobas 480 Sensitivity 12 IU/mL Linear range 25—1.0E+08 IU/mL Spec. 24T Qualification CE -
S3013E HBV fast – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit
Blood-borne Infections (BBIs)Brief
Hepatitis B Viral (HBV) DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HBV DNA in human serum or plasma. It can be used to evaluate antiviral treatment and monitor the therapeutic effect by monitoring HBV DNA baseline levels and changes in patient blood. Test results should not be taken as the only indicator for evaluation of diseases, but to be combined with patients clinical symptoms and other laboratory tests to analyze the diseases.Parameters
Product features Parameter Specimen Type Serum or plasma Extraction Platform One-tube fast test release Genotype HBV genotype A-H Internal Control Plasmid Compatible Instrument ABI7300 , Stratagene Mx3000P , Roche Light Cycler 480 , ABI7500, SLAN-96P and QuantStudio 5 Sensitivity 30 IU/mL Linear range 100—5.0E+09 IU/mL Spec. 24T, 48T -
S3118E HBV Ultra – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit
Blood-borne Infections (BBIs)Brief
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) (HBV Ultra) is an in vitro nucleic acid amplification test for the quantification of Human HBV DNA in human serum. It is intended for use as an aid in diagnosing an HBV infection and observing drug efficacy.Performance
Advanced magnetic beads technology HBV DNA detection and viral load measurement are essential for treatment decisions and patient monitoring. Sansure's HBV Ultra uses the advanced magnetic beads technology to extract HBV DNA from clinical Plasma. Our technology achieved high sensitivity and wide linear range detection to meet of clinical diagnosis and follow-up needs. Highly conservative primer probe design Sansure primers and probes target select the highly conservative S gene of HBV, which can cover A-H genotypes and avoid missed detection. High-efficient quality control system HBV Ultra uses UNG enzyme + dUTP system to remove carry-over contamination to avoid a false positive result. HBV Ultra uses Internal Control HBV Ultra uses Internal Control is the full name to whole-process the HBV extraction and amplification process to avoid false negative results.Parameters
Product features Parameter Specimen Type Plasma Extraction Platform Advanced magnetic beads technology Genotype HBV genotype A-H Internal Control Pseudoviruses PCR Instrument SLAN-96P, ABI7500, Roche cobas 480 Sensitivity 5 IU/mL Linear range 20—2.0E+09 IU/mL Spec. 48T Qualification CE
