HIV-1 Real Time PCR Kit

AIDS, or acquired immune deficiency syndrome, is caused by the Human Immunodeficiency Virus (HIV). First reported in 1981 in the United States, AIDS has become a major worldwide epidemic. By killing or impairing cells of the immune system, HIV progressively destroys the body’s ability to fight infections and certain cancers. Individuals diagnosed with AIDS are susceptible to life-threatening diseases called opportunistic infections, which are caused by microbes that usually do not cause illness in healthy people. HIV-1 is classified as a lentivirus in a subgroup of retroviruses. The genetic material is single-stranded RNA. HIV converts its RNA into DNA and inserts into the host cell’s DNA. Two closely related retroviruses, HIV-1 and HIV-2, have been identified as causing AIDS in different geographic regions. HIV-1 causes most cases of AIDS in the Western Hemisphere, Europe, Asia, and Central, South, and East Africa; HIV-2 is the principal agent of AIDS in West Africa and appears less virulent than HIV-1. At the end of 2016, there were approximately 36.7 million people living with HIV according to WHO. CDC has estimated that approximately 40,000 persons become infected with HIV each year. Measuring human immunodeficiency virus type 1 (HIV-1) RNA in plasma has enabled the pathophysiology of the infection to be studied, and this parameter, which directly reflects viral replication, is the main prognostic factor for the evolution of the disease. It is the only evidence for mother-to-child transmission, since maternal antibodies present in infant serum hamper antibody-screening assays. The HIV-1 RNA level is the most valuable marker for predicting disease progression in nontreated patients and is highly useful for evaluating the effectiveness of antiretroviral drug therapy

ViroGene HIV-1 1.0 Real-Time PCR Kit is based on the real-time PCR principle. The pathogen is detected using fluorescent dyes that are incorporated into oligonucleotide probes. The assay utilizes the 5’ exonuclease activity of Taq Polymerase to cleave a dual-labeled fluorescent hydrolysis probe during the extension phase of PCR

• Dual Probe Assay
  The highly mutable nature of pathogens often proves challenging in molecular assay design. Traditional qPCR assays are designed so that a single primer and probe set targets one location within the pathogen genome. However, these single-target assays often prove inadequate to detect and quantify viral targets. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, ViroGene HIV-1 RT-qPCR assay targets two regions within the pathogen genome, utilizing unique primer and probe sets for each target site( gag and LTR ) . The driving principle behind our multiple-target assay design is that when a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen, and thus reduces the likelihood of under-quantification or a false negative result.

• All kit Components are Liquid Ready to use with enhanced freeze thaw stability (> 30 times)
• Using the highest standards for choice of enzymes on our kits which can tolerates all types of inhibitors found usually in clinical samples with no effect on result quality 

• Common Internal control for a wide variety of assay
• Common Reagents and common protocols which ensures running more than one test type on the same run

• Kit components enough to perform 110 Tests , to perform calibration and QC at no Extra cost

Item Name	HIV-1
Technology	one -step RT real-time PCR
Type of Analysis	qualitative and quantitative
Target Sequence	LTR gene and gag gene
Specificity	Human immunodeficiency virus type 1 (HIV-1), 100 %
Sensitivity (LoD)	reaches up to 50.0 IU/ml with probability of 95 % (on HIV NIBSC) reaches up to 27.0 IU/ml with the probability of 95 % (on HIV NIBSC using automatic extraction MagCore NA Extractor)
Linear Range	108 – 102 IU/ml with precision of ± 0.5 log
Reporting Units	IU/µl
Conversion Factor	1 IU = 0.52 cp
Metrological Traceability	AcroMetrix® HIV-1 Panel
Extraction/Inhibition Control	Exogenous Internal Control
Validated Specimen *	plasma, serum
Storage	-20 ± 5 °C
Validated Extraction Method	ViroGene Viral RNA/DNA Extraction Kit & MagCore NA Extractor
Validated Instruments *	Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus QuantStudio™ 3 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System
Required Detection Channels	FAM, HEX
Certification	CE IVD