BK Virus (CE)
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- Rapid detection of all clinically relevant subtypes
- High priming efficiency
- Accurate controls to confirm extraction, and assay validity
- Lyophilised components for ambient shipping
- Highly specific detection profile
The genesig Real-Time PCR BK Virus Kit (CE) is CE-IVD marked and intended for in vitro diagnostic use in Europe.
Available for direct shipping to United Kingdom
ABOUT THIS PRODUCT
The genesig Real-Time PCR BKV Kit (CE) is intended to be used on the Applied Biosystems 7500 Real-Time PCR System, Bio-Rad CFX Real-Time PCR Detection System, and Roche LightCycler 480 Instrument II, to achieve quantitative detection of BKV DNA extracted from blood plasma and urine from immunocompromised patients in association with the designated extraction instrument and kits:
- Automated extraction - Roche MagNA Pure 24 and Roche MagNA Pure 24 Total NA Isolation Kit (for plasma and urine samples)
- Manual extraction - QIAGEN QIAamp® DNA Mini Kit (for plasma samples), or QIAGEN QIAamp® Viral RNA Mini Kit (for urine samples)
Quantification Standards in the kits are calibrated against the First World Health Organization International Standards for Virus Nucleic Acid Amplification Techniques (NIBSC code 14/212), and demonstrate the kit has strong levels of sensitivity and specificity performance, as well as allowing harmonisation of results across labs.
Background to BK virus
The BK virus infection is very common, and in most of cases is asymptomatic. In symptomatic cases, patients develop blurred vision, cough, blood in urine, weight gain, general cold and fever like symptoms. It has been suggested around 80% of the population will have been infected at some point in their lifetime. The virus will remain latent and the hosts immune system should be able to keep the virus persistently latent.
For immunocompromised patients including post-transplantation individuals, the virus can cause serious damage while the patient is in a vulnerable state. Its known to cause BK virus associated nephropathy (BKVAN, also known as PVAN) which leads to loss of 80% of kidney grafts. It’s also associated with urethral stenosis, and in hematopoietic stem cell transplant (HSCT) recipients with hemorrhagic cystitis (HC). Furthermore, BKV employs several potentially oncogenic mechanisms to promote its replication in human cells and had been linked to the development of malignancies. Therefore, monitoring of viral load alongside medication regimes is of the upmost importance for patients’ health and well-being.
The genesig Real-Time PCR BKV Kit (CE) is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BK virus (BKV) DNA. The probe system is based on the standard hydrolysis probe system known as TaqMan® Technology. The BKV specific probe is labelled with the FAM fluorophore and the internal control is labelled with VIC fluorophore.
The assay includes an Internal Control to identify possible PCR inhibition, to measure extraction purity and to confirm the integrity of PCR run.
Quantification Standards (QS) are included that contain standardised concentrations of BKV specific DNA. These Quantification Standards were calibrated against the 1st World Health Organisation International Standard for BK Virus for Nucleic Acid Amplification Techniques (NAT) (NIBSC code 14/212). The Quantification Standards can be used as positive controls, or to generate a standard curve, which can be used to determine the concentration of BKV specific DNA in a sample.
The analytical sensitivity was defined as the lowest concentration of analyte that could be reliably detected with 95% confidence. This was assessed across 3 clinical specimens over 3 days producing at least 30 replicates for each sample type and extraction system combination:
- The analytical sensitivity for both plasma and urine samples extracted with the MagNA Pure 24 Total NA Isolation Kit was found to be 70 IU/ml.
- The analytical sensitivity for plasma samples extracted with the QIAamp DNA Mini Kit was found to be 80.63 IU/ml.
- The analytical sensitivity for urine samples extracted with the QIAamp Viral RNA Mini Kit was found to be 161.25 IU/ml.