Description

Product Overview

The PTH Test Kit is a fluorescence immunoassay designed for quantitative determination of circulating parathyroid hormone levels. PTH is a peptide hormone secreted by the parathyroid glands and plays a critical role in calcium and phosphorus metabolism. It is widely used in evaluation of hyperparathyroidism, hypoparathyroidism, chronic kidney disease and bone metabolism disorders.

Intended Use

For in vitro quantitative determination of parathyroid hormone (PTH) in human serum and plasma samples as an aid in diagnosis and monitoring of parathyroid function and calcium metabolism disorders.

Clinical Significance

PTH regulates calcium concentration in plasma and is an important biomarker in evaluation of parathyroid gland disorders, renal osteodystrophy, chronic kidney disease-related mineral imbalance and osteoporosis.

Test Principle

The assay uses double-antibody sandwich fluorescence immunoassay technology. Fluorescence-labelled monoclonal antibodies bind PTH in the sample forming immune complexes which are quantitatively detected by the analyzer.

Sample Type

Serum / Plasma

Sample Volume

100 μL

Test Time

Approximately 15 minutes

Measuring Range

6.0 – 1900.0 pg/mL

Detection Limit

≤6.0 pg/mL

Precision

Within-run Precision ≤10%
Between-lot Precision ≤15%

Expected Reference Range

15.0 – 65.0 pg/mL

Technology

Fluorescence Immunoassay (Sandwich Method)

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

Store at 4–30°C. Stable up to expiry date under recommended storage conditions.

Applications

Dialysis centres, nephrology clinics, endocrinology laboratories, hospital diagnostic departments and bone metabolism assessment programs.

Key Advantages

• Quantitative parathyroid hormone assessment
  • Supports renal and bone metabolism evaluation
  • Suitable for nephrology and endocrine testing
  • Rapid analyzer-based testing
  • High sensitivity fluorescence immunoassay