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BK virus (BKV), a multi tumor virus widely present in the human population, typically remains in an asymptomatic latent state in healthy individuals. However, in people with low immune function, such as organ transplant recipients, AIDS patients or patients receiving immunosuppressive treatment, BKV may reactivate and replicate in large numbers. The reactivation of this virus may lead to serious clinical complications, including BK virus associated nephropathy (BKVAN), which is one of the important causes of kidney transplant failure; And hemorrhagic cystitis, especially common in bone marrow transplant patients. Therefore, accurate and timely monitoring of BKV infection status is crucial for managing high-risk patients. Traditional detection methods, such as virus DNA quantification (PCR), can evaluate the replication level of the virus, but cannot fully reflect the immune response of the body. Serological testing, especially for BKV specific IgG antibodies, provides another important evaluation dimension for clinical doctors: virus exposure history and long-term immune status. By quantitatively detecting IgG antibody levels, doctors can better understand the patient's immune background and develop more accurate treatment and follow-up strategies based on other clinical indicators.

The Anti BK Virus (BKV) IgG ELISA Detection Kit is based on the Enzyme Linked Immunosorbent Assay (ELISA) principle and uses an indirect method for quantitative detection of Anti BK Virus (BKV) IgG antibodies. The microplate of the reagent kit is pre coated with highly purified BK virus specific antigen. When the sample to be tested (such as serum, plasma, etc.) is added to the micro well, the Anti BK Virus (BKV) IgG antibody in the sample will specifically bind to the antigen coated on the micro well plate, forming an antigen antibody complex. After washing to remove unbound components, horseradish peroxidase (HRP) labeled anti human IgG antibody (secondary antibody) is added, which can specifically bind to Anti BK Virus (BKV) IgG antibody in the sample, forming an antigen antibody enzyme labeled secondary antibody complex. After washing again to remove unbound enzyme labeled secondary antibodies, substrate solution (such as TMB) is added. The HRP in the enzyme labeled substance will catalyze the substrate to undergo a color reaction, generating colored products. The color intensity is positively correlated with the concentration of Anti BK Virus (BKV) IgG antibody in the sample. Finally, add a stop buffer to terminate the reaction, and use an enzyme-linked immunosorbent assay (ELISA) reader to measure the absorbance (OD value) of each micropore at a specific wavelength. By comparing the OD value with the standard, the quantitative concentration of Anti BK Virus (BKV) IgG antibody in the sample can be calculated.
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Technical Parameters And Performance Indicators
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Performance Indicators of Reagent Kit
Widely Applicable Scenarios
| Parameter | Details |
| Product name | Anti-polyomavirus BK (BKV) IgG ELISA Kit |
| Sample | serum and plasma |
| Intended Use | The kit is intended for professional use for the qualitative and semi-quantitative detection of species-specific IgG antibodies against polyomavirus BK (BKV) in human serum and plasma. For research use only, not for use in diagnostic procedures. |
| Performance Characteristics | The OD values of the standards / control sera and the ratio of the OD values of the standards PC / CAL should be within the ranges stated in the Quality Control Certificate of the lot. The Calibrator and Controls are human sera, and as such they may show inhomogeneity, if their value in the test is significantly different from the values stated in the Certificate of analysis (see CoA - lot characteristics), consult the results with the manufacturer. |
| Sensitivity | The analytical sensitivity of the assay is defined as the mean of the sample without analyte plus three times of the standard deviation and represents the lowest detectable antibody titer. The analytical sensitivity value is determined for each kit lot and is stated in the Quality Control Certificate of that kit lot. |

Highly Sensitive and Specific
Our kit uses recombinant BKV VP1 protein that has been rigorously screened and purified as the capture antigen, minimizing non-specific binding and ensuring highly specific recognition of BKV specific IgG antibodies. Meanwhile, the optimized reaction conditions and enzyme-linked immunosorbent assay system ensure that trace antibodies can also be effectively detected, achieving excellent sensitivity.

Accurate quantitative results
Unlike traditional qualitative or semi quantitative methods, our kit provides a complete quantitative detection scheme. By establishing a standard curve using standard samples, we can directly convert the OD value of the sample into precise IU/mL or AU/mL units, providing a reliable numerical basis for clinical diagnosis and research. This quantitative capability makes it possible to dynamically monitor changes in patients' antibody levels.

Excellent repeatability
We strictly follow quality management system for production, ensuring excellent inter batch consistency for each batch of reagent kits. Internal quality control verifies the stability and repeatability of the reagent kit, ensuring that reproducible and reliable results can be obtained in different laboratories and by different operators.
The Anti BK virus (BKV) IgG ELISA detection kit is an ideal tool for clinical laboratories and research institutions to conduct BKV serological testing. It integrates high sensitivity, high specificity, precise quantification, and excellent stability, providing strong technical support for the diagnosis, risk assessment, and treatment efficacy monitoring of BKV related diseases. By combining quantitative detection of IgG antibodies with viral load monitoring, medical professionals can obtain more comprehensive information to better manage and improve the health status of high-risk patients.
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