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优势与特点（FAB）
- Comprehensive validation - Rigorously validated through comprehensive methodology to ensure reliable and accurate results.
- Simple and fast operation - No complicated washing steps, significantly reducing time.
- High batch consistency - Strict control over raw materials and finished product quality, ensuring a stable supply.
- Accurate and reliable results - High sensitivity with minimal matrix effects.
- High throughput capability - Support multiple product specifications, ideal for high-throughput screening.
- Fast completion - Results in just 1 hour.
产品参数（Product Specifications）
Assay Range3.906 μg/mL-500 μg/mLLimit of detection (LOD)1.75 μg/mLLimit of Quantitation (LOQ)3.906 μg/mL产品概述（Product Overview）
Human Fc Detection Kit (TR-FRET) is based on a homogeneous (no wash) competition TR-FRET technology (Time-Resolved Fluorescence Resonance Energy Transfer) to quantify human IgG or human Fc-tagged proteins within 0.5-1 hours. The kit is compatible with both natural and recombinant human IgG.
存储（Storage）
1. Unopened kit should be stored at 2℃-8℃ upon receiving.
2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.
3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
组分（Materials Provided）
IDComponentsSizeFRTQ015-C01Anti-Human IgG Fc Antibody Europium-chelate100 tests/500 testsFRTQ015-C02FA Labeled Human IgG Antibody100 tests/500 testsFRTQ015-C03Human IgG Standard200 μg/100 tests 1 mg/500 testsDB-04TR-FRET Sample Dilution Buffer, pH7.450 mL/100 tests & 500 testsDB-05TR-FRET Detection Buffer, pH7.450 mL/100 tests & 500 tests原理（Assay Principles）
This Human Fc Detection Kit (TR-FRET) is based on TR-FRET technology (Time-Resolved Fluorescence Resonance Energy Transfer). This assay uses Anti-Human IgG Fc Antibody Europium-chelate as the Donor and FA Labeled Human IgG Antibody as the Acceptor.
— When the sample does not contain human IgG or human Fc-tagged proteins, the Donor and Acceptor are in close proximity because of the binding of Anti-Human IgG Fc Antibody Europium-chelate and FA Labeled Human IgG Antibody. Upon Donor excitation with light of a specific wavelength (337nm), in addition to Donor emission (620nm), non-radiative transfer of energy occurs between Donor and Acceptor, resulting in Acceptor emission (665nm).
— When the sample contains human IgG or human Fc-tagged proteins, the components inhibit the binding between the Donor and Acceptor and thereby prevent FRET from occurring.
质量管理控制体系（QMS）
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数据展示
活性（Bioactivity）-TR-FRET
Please refer to DS document for the assay protocol.
Various concentrations of Human IgG Standard were tested by this assay. The standard curve is plotted with the standard concentration as x-axis and the Ratio as y-axis. Establish a standard curve by processing the data using computer software capable of executing a four-parameter logistic (4-PL) curve fitting.
The kit is human IgG specific and not compatible with cynomolgus IgG, mouse IgG1, mouse IgG2a, mouse IgG2b and rabbit IgG. Human IgG1, human IgG3 and IgG4 demonstrate excellent linearity within the range of 3.906-500 μg/mL, while human IgG2 is undetectable at concentrations approximately below 100 μg/mL.
This kit can be used for the quantitative detection of Fc-engineered antibodies designed for Elimination of Fc-mediated effector functions. Human IgG1 and IgG4 demonstrate excellent linearity within the range of 3.906-500 μg/mL, while human IgG2 is undetectable at concentrations approximately below 100 μg/mL. The Fc-engineered antibodies designed for half-life extension, enhancement of ADCC activity and hinge region stabilization have been validated. Relevant data are documented in the DS.
稀释线性（Dilution Linearity）
To assess the linearity of the assay, samples spiked with high concentrations of human IgG standard were serially diluted with TR-FRET Sample Dilution Buffer, pH 7.4 (DB-04), to generate samples with concentrations within the dynamic range of the assay.
批内差异（Intra-Assay Statistics）
Five samples with known concentrations were tested repeatedly 16 times within a single analytical batch to assess within-batch precision and accuracy, Intra-Assay Precision CV≤20%, Intra-Assay Accuracy Recovery: 80%-120%.
批间差异（Inter-Assay Statistics）
Five samples with known concentrations were tested repeatedly across three independent analytical batches to evaluate between-batch precision and accuracy. Inter-Assay Precision CV≤20%, Inter-Assay Accuracy Recovery: 80%-120%.
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