MicroProfit Fluorecare Estradiol (E2) – Quantitative Immunofluorescence – 20 Test Kit
A quantitative in vitro immunochromatographic solution for determining Estradiol (E2) levels in human serum or plasma samples, optimized for combined use with the Microprofit Fluorecare Reader (model MF-T1000) dry immunofluorescence analyzer. Specifically developed to ensure analytical sensitivity and reproducibility within laboratory routines and professional diagnostic workflows.
🎯 Technology: Quantitative competitive immunoassay in fluorescence (FIA) with pre-set calibration via lot-specific ID Chip.
🧪 Sample Matrix: Human serum or plasma (treated with sodium heparin or EDTA); requires specimens free of severe hemolysis or icterus.
⏱️ Rapid Workflow: Two-phase protocol (5 minutes of pre-incubation in reaction tube and 15 minutes of thermostatic incubation at 25°C on the card) with automated reading and results available in seconds.
📊 Reliability: Extended dynamic linearity range from 20 to 4000 pg/mL (R > 0.975) with analytical sensitivity (LOD) ≤ 20 pg/mL and coefficient of variation (CV) maintained within 15%.
📦 Kit: Professional 20-test pack including 20 foil-sealed test cards with desiccant, 20 Reaction Tubes with lyophilized fluorescent antibody, 1 bottle of 1.2 mL diluent, 1 lot ID Chip, and user manual.
Fluorecare Estradiol (E2)
REF: MF-50 | SKU: 113845 | BRAND: MicroProfit
⚙️
FIA – Fluorescence
🧪
Serum / Plasma
⏱️
20 Minutes Total
📦
20 Test Kit
Scientific Description
The fluorecare E2 diagnostic kit is an advanced, standardized diagnostic aid for the rapid and quantitative determination of Estradiol (E2) concentration in human serum or plasma samples. The system is specifically developed for combined use and quantitative analysis on the Microprofit Fluorecare Reader dry immunofluorescence analyzer (model MF-T1000). The test is utilized in clinical settings as a detection support for hormonal status within defined monitoring protocols.
The analytical principle is based on a competitive immunochromatographic immunoassay method: the mixed sample migrates via capillary action along the assay. If estradiol is absent from the sample, the fluorescence-labeled detection antibody binds to the conjugated antigen in the test line (T) region, generating maximum signal intensity. When E2 is present in the sample, the analyte competes for binding with the labeled antibody; consequently, a higher concentration of estradiol in the sample leads to less binding on the test line and a weaker fluorescent signal emitted at the specific wavelength. The instrument quantifies the optical density and calculates the concentration in pg/mL using the pre-set calibration curve provided on the lot-specific ID Chip. The test is intended solely for professional in vitro use as a clinical support for Human Clinical Analysis Laboratories, Clinics, and Nursing Homes.
Execution Protocol
- Equilibrate the test card, reaction tubes, and specimens to room temperature prior to starting operational procedures.
- Power on the Fluorecare analyzer and activate the external thermostatic incubator (configured at 25°C).
- Verify exact matching between the lot number of the ID Chip inserted into the instrument and the lot number of the diagnostic kit in use.
- Open the aluminum pouch by tearing along the notch, place the card on a flat surface, and perform the test within 1 hour of opening.
- Thoroughly mix the biological specimen and diluent prior to sampling.
- Add 70 µL of sample (serum or plasma) directly into the Reaction Tube and shake thoroughly for 10 seconds.
- Add 40 µL of diluent into the same Reaction Tube, shake for an additional 10 seconds ensuring all components are incorporated into the liquid phase, and wait 5 minutes for the initial reaction phase.
- Holding the pipette vertically without generating air bubbles, draw 70 µL of the mixture and dispense into the sample well of the test card.
- Place the card into the thermostatic incubator at 25°C for a fixed incubation time of 15 minutes.
- Insert the card into the Fluorecare analyzer to initiate automated reading; the quantitative value (expressed in pg/mL) will appear on screen within seconds.
Performance Table
| Performance Parameter | Value / Technical Specification |
|---|---|
| Linearity Range (Dynamic Range) | 20 – 4000 pg/mL (R > 0.975) |
| Analytical Sensitivity (LOD) | ≤ 20 pg/mL |
| Accuracy (Relative Deviation) | Within ±15% |
| Intra-assay Precision (Within-run CV) | ≤ 15% |
| Inter-assay Precision (Between-run CV) | ≤ 15% |
| Indicative Reference Values | Men: <20-53 pg/mL | Post-menopausal women: <20-48 pg/mL |
Technical Opinion: The competitive immunofluorescence method of the Fluorecare system allows monitoring of Estradiol levels with excellent linear correlation across the entire therapeutic dynamic range. The assay’s accuracy lies in thermal standardization and the use of the paired ID Chip, which reduces analytical variability between operational runs. For professional in vitro diagnostic use only. Supply strictly reserved for Clinical Analysis Laboratories, Clinics, and Nursing Homes.
Technical Team BIOLAB Diagnostici – Laboratory Division
Biolab is the exclusive Italian distributor of MicroProfit
