Quantitative BK Virus Detection Kit（Real-time PCR）

BK病毒定量检测试剂盒（定量PCR法）

【Background】

BK-Virus belongs to the polyomavirus family of double stranded non-enveloped DNA viruses. BK-strain viral infections are a well known complication in immunosuppressed transplant recipients, called as BK-virus nephropathies (BKN). Immunosuppression, such as Tacrolimus, cyclosporine, etc. might possibly promote BKN by more pronounced activation of polyomavirus. BKN has a major impact on graft function and survival in patients. It has no specific clinical signs and symptoms. So an objective and specific diagnostic technique to detect BK-Virus is currently needed.

【Technical Principal】

At time of diagnosis, all patients were excreting viral inclusion bearing cells in the urine (so-called decoy cells), and BK-Virus DNA could be detected in the plasma by PCR. These latter findings constitute a clinical risk profile, which can help with patient management. Both objectives can be achieved with the help of surrogate markers. High risk patients (i.e. those coming out of rejection episodes and being treated with tacrolimus and/or mycophenolate mofetil) should be regularly screened. The screening should include the search for decoy cells (i.e. viral inclusion bearing cells) in urine cytology preparations, and PCR analyses on plasma samples (searching for BK-Virus DNA). If both tests are positive on repeat, a graft biopsy should be performed to establish a definitive diagnosis of BKN.

【Clinical Application】

- Patient screening period: to diagnose BKN early (before interstitial fibrosis and tubular atrophy have occurred):

- Patient monitoring period: to treat with low-dose immunosuppresive regimens long enough to achieve viral clearance.

Currently, specific anti viral drugs to treat BKN are not available. The only therapeutic approach to overcome viral nephropathy is to lower baseline immunosuppression in the hope that the host immune system will then clear the virus. During the low-dose immunosuppressive period, plasma PCR tests are of special help to monitor for viral clearance. If PCR results turn negative it is fair to assume that viral nephropathy has resolved. Viral resolution might be confirmed in a protocol graft biopsy. This approach is useful for patient management, since the duration of low-dose immunosuppression, which might trigger rejection episodes, can be optimized.

Simple: all reagents in ready-to-use test vials

Convenient: Utilizes urine, serum or plasma

Accurate: Excellent correlation with Western blot test

Sensitive & Specific: Surrogate biomarkers with Real Time Quantitative PCR technique offer a high specificity and sensitivity.