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S3046E HIV-1 – Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit
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 |
