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

• Natch CS3 Plus — Fully Automated Nucleic Acid Processing System
• Natch CS2 — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System

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

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

Multiple results in one test

• 4 tests in one test
• Direct discriminative positive results

Automated detection

• Extraction and amplification process/li>
• Fully automated extraction and amplification/li>

Cost and space savings

• 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

• Natch S Pro — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System

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	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

Related Instruments

• Natch CS3 Plus — Fully Automated Nucleic Acid Processing System
• Natch CS2 — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System

Brief

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is intended for quantitative detection of the Hepatitis C Virus RNA in human EDTA plasma specimens. The Hepatitis C Virus genotypes 1, 2, 3, 4, 5, 6, can be quantitatively detected.
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.

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

Order Information

 

Cat. No.	Product Name	Spec.
S3119E-24	Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	24T
S10013E-48	Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)	48T

Related Instruments

• Natch CS3 Plus — Fully Automated Nucleic Acid Processing System
• Natch CS2 — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System

Brief

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is intended for quantitative detection of the Hepatitis B Virus DNA in human EDTA plasma specimens. The Hepatitis B Virus genotypes A, B, C, D, E, F, G, H can be quantitatively detected.
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.

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

Order Information

 

Cat. No.	Product Name	Spec.
S3118E-48	Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	48T
S10012E-48	Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)	48T

Related Instruments

• Natch CS3 Plus — Fully Automated Nucleic Acid Processing System
• Natch CS2 — Fully Automated Nucleic Acid Extraction System
• SLAN-96P — Real-Time PCR System