High-Sensitivity Human Growth Hormone for GH Deficiency & Acromegaly Diagnosis
The Sekbio hGH CLIA Bulk Reagent enables quantitative measurement of human Growth Hormone — a pulsatile pituitary hormone essential for growth, body composition, and metabolic regulation. Required for GH deficiency diagnosis in children and adults, acromegaly diagnosis and monitoring, and GH replacement therapy assessment.
One-step sandwich on the AE chemiluminescence platform. Near-zero blank signal, CV ≤3.0% (n=10), and thermostability <10% deviation at 37°C/7d confirm suitability for GH provocation testing where low-end precision is critical at the <1 ng/mL decision zone.
Reaction: 30 µL Ra + 15 µL sample + 30 µL Rd, 15 min incubation, wash, read RLU after Pre-Trigger/Trigger.
| Calibrator (ng/mL) | RLU Run 1 | RLU Run 2 | RLU Run 3 | Avg RLU | S/N |
|---|---|---|---|---|---|
| 0 (Blank) | 124 | 156 | 150 | 143 | — |
| 0.5 | 28,402 | 26,913 | 24,962 | 26,759 | 187 |
| 1 | 52,933 | 52,781 | 52,007 | 52,574 | 367 |
| 10 | 543,195 | 539,229 | 524,454 | 535,626 | 3,737 |
| 30 | 1,524,980 | 1,511,527 | 1,511,487 | 1,515,998 | 10,577 |
| 50 | 2,370,790 | 2,275,603 | 2,375,330 | 2,340,574 | 16,330 |
| Near-zero blank (143 RLU). S/N = Avg RLU / Blank RLU. | |||||
| QC Level (ng/mL) | Avg Conc (ng/mL) | SD | CV |
|---|---|---|---|
| 0.5 (Low) | 0.50 | 0.013 | 3.0% |
| 10 (Mid) | 9.30 | 0.26 | 2.8% |
| Acceptance criterion: CV ≤10%. | |||
Signal deviation vs. Day 0 reference ≤7.18% across all calibrator levels — confirming stability for ambient-temperature shipping and on-instrument use.
| Calibrator (ng/mL) | Day 0 Avg RLU | 37°C/7d Avg RLU | Deviation |
|---|---|---|---|
| 0.5 | 26,759 | 25,321 | −5.4% |
| 1 | 52,574 | 50,120 | −4.7% |
| 10 | 535,626 | 497,181 | −7.2% |
| 30 | 1,515,998 | 1,407,566 | −7.2% |
| Criterion: all within ±10% | — | ✓ Pass | |
| 37°C/7d ≈ accelerated 6-month ambient storage model. | |||
GH stimulation testing (ITT, glucagon, arginine). Peak GH <3 ng/mL (severe) or <9 ng/mL (partial) thresholds require precision at the low end of the range.
GH nadir <1 ng/mL on OGTT suppression confirms cure/control. Near-zero blank and CV ≤3% enable accurate nadir determination at the critical decision threshold.
Serial tracking during recombinant GH therapy. Target GH/IGF-1 normalization requires precision across the 0.1–5 ng/mL therapeutic monitoring range.
Ra magnetic bead + Rd AE bulk reagent for CLIA analyzer integration. Thermostability data supports ambient shipping claims for regulatory submissions.
Full technical specifications, performance data, and OEM pricing available on request.