- Home
- IVD
- By Technology Types
- By Diseases Types
- By Product Types
- Research
- Resource
- Distributors
- Company
| Product Name | Polymerase chain reaction (PCR) HIV-1 assay kit |
| Catalog No. | PI-00126 |
| Description | Polymerase chain reaction (PCR) HIV-1 assay kit is an in vitro reverse transcription polymerase chain reaction assay kit for the detection and quantification of human immunodeficiency virus type 1 (HIV-1) RNA. |
| Testing Time | <115 min |
| Application | This product detects and quantifies human immunodeficiency virus type 1 (HIV-1) RNA. |
| Operating Temperature | Store at 4-30°C. |
| Transportation Condition | Transportation at room temperature. |
| Technology | RT-PCR |
| Probe Design | Partially double stranded DNA probe design |
| Target Region | Dual target: integrase and LTR |
| Lower Limit of Quantitation (LLOQ) | 20 Copies/mL |
| Precision | SD≤0.19 log IU/mL |
| Sample Input Volume | 600 µL |
Human Immunodeficiency Virus Type 1 (HIV-1) remains a major global public health challenge, with millions of new infections reported annually. As a retrovirus that targets and impairs the human immune system, untreated HIV-1 infection progresses to Acquired Immunodeficiency Syndrome (AIDS), leaving individuals vulnerable to life-threatening opportunistic infections and cancers.
The accurate and timely detection of HIV-1 is critical at every stage of the disease continuum:
Early Infection Diagnosis: During the "window period" (the time between HIV exposure and the development of detectable antibodies), antibody-based tests may yield false-negative results. PCR-based assays that detect HIV-1 RNA directly can identify infections as early as 7–10 days post-exposure, enabling prompt initiation of care and reducing the risk of onward transmission.
Treatment Monitoring: For individuals on antiretroviral therapy (ART), maintaining viral suppression (often defined as HIV-1 RNA levels below the limit of detection) is key to preserving immune function, preventing disease progression, and eliminating the risk of sexual transmission. Quantitative PCR assays provide precise measurements of viral load, allowing clinicians to assess treatment efficacy, detect virological failure (e.g., due to drug resistance), and adjust therapy regimens in a timely manner.
Epidemiological Surveillance: Large-scale screening using reliable HIV-1 detection tools helps public health authorities track infection trends, identify high-risk populations, and design targeted prevention and intervention strategies.
Traditional HIV-1 detection methods, such as enzyme-linked immunosorbent assays (ELISAs) for antibodies or Western blotting for confirmation, have limitations—including the inability to detect early infections and lack of quantitative data. In contrast, reverse transcription polymerase chain reaction (RT-PCR) technology addresses these gaps by amplifying and detecting HIV-1 RNA directly from clinical specimens. Our Polymerase Chain Reaction (PCR) HIV-1 Assay Kit leverages advanced RT-PCR principles, combined with optimized probe design and dual-target detection, to meet the rigorous demands of clinical diagnostics, treatment monitoring, and research applications. It adheres to global quality standards and is designed to deliver consistent, reliable results across diverse laboratory settings.
Rapid Testing Workflow: Delivers accurate detection and quantification results in less than 115 minutes, significantly reducing turnaround time compared to many conventional RT-PCR kits. This efficiency is critical for urgent clinical decisions, such as initiating early ART or assessing acute infections.
Dual-Target Detection Design: Targets two conserved regions of the HIV-1 genome—integrase and long terminal repeat (LTR). These regions are selected for their low mutation rates, ensuring the kit can detect a wide range of HIV-1 subtypes (including common Group M subtypes and rare variants) and minimizing the risk of false negatives caused by viral genetic drift or drug-resistant mutations.
High Sensitivity and Precision: Boasts a Lower Limit of Quantitation (LLOQ) of 20 Copies/mL, enabling the detection of very low viral loads—essential for confirming viral suppression in treated patients. Additionally, it maintains high precision with a standard deviation (SD) of ≤0.19 log IU/mL, ensuring consistent results across repeated tests and reducing inter-assay variability.
Convenient Storage and Transportation: Can be stored at 4–30°C and transported at room temperature. This eliminates the need for expensive cold-chain logistics during shipping and simplifies inventory management for laboratories, especially those in resource-limited settings where refrigeration infrastructure may be limited.
Partially Double-Stranded DNA Probe Technology: The kit uses a specialized partially double-stranded DNA probe, which enhances hybridization specificity to the target HIV-1 RNA sequences. This design reduces non-specific binding and background signals, improving the accuracy of detection and quantification even in specimens with high levels of contaminating nucleic acids.
Flexible Sample Compatibility: Requires a sample input volume of 600 μL, which is compatible with common clinical specimen types (e.g., serum, plasma) and standard nucleic acid extraction protocols. This flexibility allows seamless integration into existing laboratory workflows without the need for specialized sample processing equipment.
Superior Detection Coverage: The dual-target (integrase and LTR) design ensures robust detection of diverse HIV-1 variants, including subtypes that may evade single-target kits due to mutations. This advantage is particularly valuable in regions with high HIV-1 genetic diversity, ensuring no missed infections.
Reliable Performance in Challenging Specimens: The optimized RT-PCR reaction system and probe design provide strong resistance to interference from common specimen contaminants, such as hemoglobin (from hemolyzed samples), bilirubin (from jaundiced patients), and lipids (from hyperlipidemic samples). This ensures accurate results even from specimens that may compromise the performance of less robust kits.
User-Friendly Operation: The kit is designed for ease of use, with pre-optimized reagents that minimize the need for manual reagent preparation or complex adjustments. This reduces the risk of human error (e.g., pipetting mistakes, incorrect reagent ratios) and lowers the technical barrier for laboratory staff, making it suitable for both experienced and novice users.
Cost-Effective Logistics: Room-temperature transportation and a broad storage temperature range (4–30°C) eliminate the costs associated with cold-chain shipping (e.g., dry ice, temperature-monitoring devices) and reduce the risk of reagent degradation during transit. This makes the kit more accessible to laboratories in remote or low-resource areas.
Quantitative Accuracy for Treatment Monitoring: With an LLOQ of 20 Copies/mL and high precision (SD ≤0.19 log IU/mL), the kit provides the level of quantitative accuracy required to monitor viral load trends in patients on ART. Clinicians can reliably assess whether viral load is suppressed, increasing, or decreasing, and make data-driven decisions about therapy adjustments.
For in vitro diagnostic use.
|
There is no product in your cart. |
Copyright © 2025 Alta DiagenoTech. All rights reserved.
