CLIA · AE Platform · Sandwich Method

Estradiol (E2) CLIA Bulk Reagent

High-Precision Estradiol Quantification for Reproductive Endocrinology & ART

CLIA (AE)17β-Estradiol7–3,889 pg/mLIVF / ARTOEM
7–3,889
pg/mL Detection Range
≤2.2%
Within-Run CV
7.64
pg/mL Blank Limit
1,143×
S/N at Upper Range

Precision E2 CLIA for Fertility & Endocrine Monitoring

The Sekbio E2 CLIA Bulk Reagent enables quantitative measurement of 17β-Estradiol — the primary estrogen critical for monitoring follicular development in ART/IVF, diagnosing menstrual disorders, evaluating menopausal status, and assessing estrogen-responsive conditions.

One-step sandwich format on the AE chemiluminescence platform. Range 7.27–3,889 pg/mL spans prepubertal through IVF peak concentrations. CV ≤2.2% meets the precision required for serial E2 monitoring during ovarian stimulation cycles.

AE ChemiluminescenceSandwich Format ISO 13485OEM Bulk Reagent

Analytical Specifications

Assay FormatCLIA Sandwich (AE)
Target Analyte17β-Estradiol (E2)
Sample TypeSerum / Plasma
Detection Range7.27 – 3,889 pg/mL
Blank Limit7.64 pg/mL (avg+2SD)
CV (Low ~25 pg/mL)1.8% / 2.2%
CV (Mid ~163 pg/mL)1.7%
Reaction50µL Ra + 30µL sample + 50µL Rd, 10 min

Calibration & Precision

1 Six-Point Calibration Curve

Six calibrators from 7.27 to 3,889 pg/mL with inter-run CV 0.49–2.71% per level and S/N rising from 4.11 to 1,143.

Calibrator (pg/mL)RLU Run 1RLU Run 2RLU Run 3Avg RLUCV%S/N
7.27 (Blank)2,0072,0432,0632,0381.25%1.00
16.928,5208,1998,4288,3822.71%4.11
24.8913,58413,48913,67313,5820.49%6.67
161.15100,099101,88799,775100,5871.26%49.4
1,949.841,181,4011,201,0391,191,0311,191,1571.17%585
3,889.282,299,8102,361,6662,323,1792,328,2181.88%1,143
Blank limit (avg+2SD, n=20): 7.64 pg/mL. S/N = Avg RLU / Blank RLU.
2 Precision — Within-Run (n=10)
QC Level (pg/mL)Avg Conc (pg/mL)SD (pg/mL)CV
~25 (Low)25.040.461.8%
~163 (Mid)162.882.711.7%
n=10 replicates per level. Acceptance criterion: CV ≤10%.

Applications

IVF / ART Ovarian Stimulation

Serial E2 monitoring every 1–2 days guides gonadotropin dosing and trigger timing. 7–3,889 pg/mL and ≤2.2% CV enable precise follicular E2 tracking from basal to peak.

Menstrual Disorder & Menopause

Blank limit 7.64 pg/mL accurately captures postmenopausal and POI concentrations for HRT initiation, dose adjustment, and POI diagnosis.

Male Endocrine Evaluation

E2 in males (10–40 pg/mL) for gynecomastia, aromatase excess, and hypogonadism workup on the same CLIA platform as female panels.

CLIA Analyzer OEM

Ra magnetic bead + Rd AE bulk pair for CLIA analyzer integration. Full validation package — calibration, precision, blank limit, method comparison — for regulatory submissions.

Request E2 CLIA Reagent Datasheet

Full technical specifications, performance data, and OEM pricing available on request.

Guangming District, Shenzhen, China