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.
Storage
2°C - 10°C
Performance Characteristics
1. Validity of the test 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.
Precision
The interassay variability (between tests) and the intraassay variability (within the test) were determined by testing samples with different OD values. 1. Repeatability (intraassay) The variation coefficient of intraassay is max. 8 %. It is measured for each particular lot at least on 12 parallels of the same microtiter plate. 2. Reproducibility (interassay) The variation coefficient of reproducibility is a maximum of 15 %. It is measured for each lot by comparing the wells of the same sample in several consecutive tests.
Detection Range
The measuring range is determined by the measuring capability of the spectrophotometer / colorimeter used.
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.
Citations
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Q: How many test kits are manufactured per lot# on average? What is the maximum capacity and what is the minimum?
A: We manufacture about 100 kits/lot now. The minimum capacity is 50 and the maximum is 500 kits.
Q: How about the interference studies?
A: Interference of heamoglobin (up to 50mg/ml), bilirubin (up to 10 mg/ml) and triglycerides (up to 50 mg/ml) was not proven.
Q: How about the cross-reactivity studies?
A: Detection of cross-reactive antibodies against JCV and polyomavirus SV40 in ELISA anti-BKV IgG was studied using cross saturation binding reaction with soluble antigen VLP VP1BKV (BKV-I and BKV-IV) and VLP VP1 JCV or VLP VP1 SV40 with plasma samples from patients after kidney transplantation. Results show that ELISA anti-BKV IgG kit is highly specific, detection of cross-reactive antibodies against other polyomaviruses is minimal and can occur at samples with high levels of antibodies against the tested polyomaviruses.
Q: What is the sequence of the antigen used to coat the plate.
A: Sorry, this information is a property of CD, which we cannot disclose. The antigens are virus like particles able to detect BKV I and BKV IV serotype.
Q: Is citrated plasma an acceptable sample type?
A: Regarding the citrated plasma, our kit was not tested with this type of sample. For plasma samples you can use following anti-coagulants: Heparin, EDTA.
Q: What genotype is targeted with the creative-diagnostics test method below
A: anti-BKV IgG detects antibodies against BKV1 and BKV4
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