BK-Q Real-Time PCR Kit

Product Overview

BK virus (BKV) belongs to the family of Polyomavirus. It is one of the most common latent viral infections in humans. Most individuals acquire the infection during childhood, after which the virus remains dormant within the urinary tract and kidneys for life. While BK virus generally remains asymptomatic in healthy individuals, reactivation can occur in immunocompromised patients, particularly kidney transplant recipients, hematopoietic stem cell transplant patients, and individuals receiving immunosuppressive therapy.

The BK-Q Real-Time PCR Kit from Genes2Me is a highly sensitive molecular diagnostic assay designed for the qualitative detection of BK virus DNA in blood, serum, and plasma samples. Utilizing advanced TaqMan-based Real-Time PCR technology, the assay provides rapid and accurate identification of BK virus, enabling clinicians and laboratories to support early diagnosis, monitor at-risk patients, and improve treatment outcomes.

Targets:

BK Virus (BKV) DNA

Technology:

Real-Time PCR (TaqMan)

Detection:

Qualitative detection of BK Virus DNA (Detected / Not Detected)

Sample Type:

Blood, Serum, Plasma

Certification:

CE-IVD

How the Assay Works

The BK-Q Real-Time PCR Kit employs real-time polymerase chain reaction (PCR) technology for the amplification and detection of BK virus DNA. The assay utilizes BK virus-specific primers and fluorescent hydrolysis probes targeting conserved genomic regions of the virus to ensure accurate and specific detection.

During amplification, BK virus DNA is detected through the FAM fluorescence channel, while an Internal Control (IC) is simultaneously monitored through the HEX channel. The Internal Control helps to identify potential inhibitory substances that may affect assay accuracy. Positive and negative controls are incorporated into every run to validate assay performance and ensure confidence in test results.

Why Molecular Testing Matters for BK Virus Detection

BK virus infection is often difficult to diagnose based solely on clinical symptoms because viral reactivation may initially occur without obvious signs of disease. In transplant recipients and other immunocompromised patients, delayed diagnosis can lead to progressive kidney damage, treatment complications, and increased risk of graft failure.

Real-Time PCR has become the preferred laboratory method for BK virus detection because it provides rapid turnaround times, excellent analytical performance, and reliable detection even at low viral concentrations. Molecular testing offers a highly sensitive and specific method for identifying BK virus DNA directly from patient samples, enabling earlier intervention and more effective clinical monitoring.

Key Features & Benefits

Sensitive Detection of BK Virus

Accurately detects BK virus DNA with a limit of detection as low as 100 copies/mL, enabling reliable identification of low-level viral loads.

High Diagnostic Accuracy

Delivers exceptional performance with high clinical sensitivity and clinical specificity, supporting confident clinical decision-making.

Built-in Internal Control

Integrated Internal Control monitors extraction efficiency and PCR performance, ensuring result reliability and reducing the risk of false negatives.

Excellent Specificity with No Cross-Reactivity

Designed to specifically detect BK virus without cross-reactivity to related viruses such as JC Virus, SV40, and HSV, ensuring accurate results.

Broad Instrument Compatibility

Validated across major real-time PCR platforms including QuantStudio™, CFX96™, LightCycler® 480, and RapiCycler 96, offering seamless laboratory integration.

Applications

Clinical & Hospital Laboratories: Provides reliable molecular detection of BK virus in patients presenting with suspected viral reactivation, renal dysfunction, or unexplained urinary tract complications.
Immunocompromised Patient Management: Assists in the diagnosis and monitoring of BK virus infection in patients receiving immunosuppressive therapies, oncology treatments, or other immune-modulating medications.
Reference & Specialized Diagnostic Laboratories: Offers a standardized molecular testing solution for high-throughput BK virus screening and confirmatory testing.
Research & Epidemiological Studies: Supports investigations into BK virus prevalence, viral reactivation patterns, and disease progression among high-risk patient populations.

Analytical Performance

Analytical sensitivity of 100% and Analytical specificity of 100% for BK virus DNA detection.
No observed cross-reactivity against JC Virus (JCV), Simian Virus 40 (SV40), or Herpes Simplex Virus (HSV).
Clinical sensitivity of 98% and clinical specificity of 99%.
Limit of Detection (LOD) of 100 copies/mL.
Ct cut-off value of ≤35 for positive result interpretation.
Overall assay accuracy of 99% with excellent linearity (R² = 0.998).

Commercial Name	Old Cat No.	New Cat No.	Pack Size
BK-Q Real-Time PCR Kit	G2M705421	G610010	50 Tests

Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

Product Overview

How the Assay Works

Why Molecular Testing Matters for BK Virus Detection

Sample Type & Reporting Output