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Global Healthcare Medical
GHM TSH Fast Test Kit (Immunofluorescence Assay) US – Quantitative Thyroid-Stimulating Hormone Detection with 15-Minute Results, Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use(25T/Kit)
GHM TSH Fast Test Kit (Immunofluorescence Assay) US – Quantitative Thyroid-Stimulating Hormone Detection with 15-Minute Results, Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use(25T/Kit)
SKU: GHM TSH Fast Test Kit US
Brand: Global Healthcare Medical
Global Healthcare Medical GHM TSH Fast Test Kit (Immunofluorescence Assay) is a lateral flow chromatographic immunoassay designed for the in vitro quantitative determination of thyroid-stimulating hormone (TSH) in human serum and plasma samples. The kit is intended for use by healthcare professionals in the screening, clinical diagnosis, prognosis, and therapeutic effect evaluation of thyroid diseases.
Thyroid-stimulating hormone (TSH), also known as thyrotropin, is a glycoprotein hormone produced by the anterior pituitary gland that regulates the production and secretion of thyroid hormones (T3 and T4). TSH is the most sensitive marker for detecting thyroid dysfunction, as it responds to even subtle changes in thyroid hormone levels through a negative feedback mechanism. Measurement of TSH is central to the evaluation of thyroid function, including the diagnosis of hypothyroidism, hyperthyroidism, and monitoring of thyroid hormone replacement therapy.
The GHM TSH Fast Test Kit (Immunofluorescence Assay) delivers quantitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with serum and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including primary care clinics, endocrinology clinics, and clinical laboratories.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, endocrinology clinics, hospital laboratories, and clinical laboratories. The product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on fluorescence immunochromatography.
Key Features & Benefits
Immunofluorescence Assay Technology – High-Sensitivity Quantitative Detection
The GHM TSH Fast Test Kit (Immunofluorescence Assay) is based on lateral flow chromatography with immunofluorescence detection. The test utilizes two highly specific and sensitive monoclonal antibodies against human TSH, forming a double-antibody sandwich immunoassay. The fluorescent signal generated at the test line is proportional to the TSH concentration in the sample, enabling precise quantitative determination.
| Feature | Benefit |
|---|---|
| Immunofluorescence assay | High-sensitivity quantitative detection |
| Double-antibody sandwich method | Specific and reliable signal generation |
| TSH-specific monoclonal antibodies | Targeted and accurate measurement |
| Quantitative determination | Precise TSH concentration results |
Fast Results – 15 Minutes
The GHM TSH Fast Test Kit (Immunofluorescence Assay) provides quantitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and endocrinology clinics |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Wide Detection Range – 0.10–50.00 μIU/mL
The GHM TSH Fast Test Kit (Immunofluorescence Assay) US supports a detection range of 0.10–50.00 μIU/mL, accommodating a wide variety of TSH concentrations for comprehensive thyroid function assessment.
| Parameter | Specification |
|---|---|
| Detection Range | 0.10–50.00 μIU/mL |
| Specimen | Serum / Plasma |
| Test Time | 15 minutes |
| Cut-off Value | 0.27–4.20 μIU/mL |
| Storage Temperature | 4–30°C |
| Shelf Life | 24 months |
Serum / Plasma Sample Compatibility – Flexible Sample Collection
The GHM TSH Fast Test Kit (Immunofluorescence Assay) is compatible with serum and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs.
| Feature | Benefit |
|---|---|
| Serum / plasma specimens | Flexible sample collection options |
| Small sample volume required | Practical for pediatric and adult patients |
| No special equipment required | Streamlined workflow in clinical settings |
| Standard specimen handling | Convenient for routine testing |
Clinical Utility – Aid for Diagnosis and Monitoring of Thyroid Disease
The GHM TSH Fast Test Kit (Immunofluorescence Assay) is intended for use as an aid in the screening, clinical diagnosis, prognosis, and therapeutic effect evaluation of thyroid diseases. The test provides rapid quantitative TSH determination, enabling timely clinical decision-making and supporting patient management.
TSH measurement is a key component of thyroid function testing, used to detect primary hypothyroidism, hyperthyroidism, and to monitor the effectiveness of thyroid hormone replacement therapy. The test is particularly valuable in primary care and endocrinology settings where rapid TSH results support timely clinical decisions regarding thyroid disorder diagnosis and management.
| Feature | Benefit |
|---|---|
| Thyroid disease screening aid | Supports early identification of thyroid dysfunction |
| Therapeutic monitoring support | Enables assessment of thyroid hormone replacement therapy |
| Clinical diagnosis support | Assists in the differential diagnosis of thyroid disorders |
| Rapid quantitative results | Supports timely clinical decision-making |
| Clinical versatility | Useful across primary care clinics, endocrinology clinics, and clinical laboratories |
Clinical Performance – Trusted Quantitative Accuracy
The GHM TSH Fast Test Kit (Immunofluorescence Assay) is designed to deliver reliable clinical performance. Published evaluations of fluorescence-based lateral flow immunoassays for TSH have demonstrated high sensitivity and specificity for the detection of thyroid abnormalities when compared to reference laboratory methods. In a study of 102 clinical samples, venepuncture whole-blood samples tested with a fluorescence-based TSH LFIA showed excellent sensitivity and specificity of 95.2% and 97.5%, respectively, with an overall percentage agreement of 97.1% and a Cohen's Kappa of 0.91 compared with the Roche CobasPro-c503 reference method. Serum samples demonstrated sensitivity of 90.5% and specificity of 96.3%, with strong correlation (r = 0.93) to the reference method. Fingerstick samples showed sensitivity of 85.7% and specificity of 90%, with very strong correlation (r = 0.9). These findings support the use of fluorescence-based lateral flow immunoassays for quantitative TSH measurement in point-of-care settings.
| Parameter | Specification |
|---|---|
| Sensitivity (vs. reference method) | 90.5–95.2% |
| Specificity (vs. reference method) | 96.3–97.5% |
| Overall Agreement | 95.1–97.1% |
| Correlation (r) | 0.90–0.95 |
| Reference Method | Roche CobasPro-c503 |
Performance characteristics based on published evaluations of fluorescence-based lateral flow immunoassays for TSH. A study of 102 clinical samples reported venepuncture whole-blood sensitivity of 95.2% and specificity of 97.5%, serum sensitivity of 90.5% and specificity of 96.3%, and fingerstick sensitivity of 85.7% and specificity of 90%, compared with the Roche CobasPro-c503 reference method. Reference intervals vary by laboratory and population; the cut-off value for this assay is 0.27–4.20 μIU/mL. Detection is optimal when specimens are collected and processed according to the manufacturer's instructions.
Compatible Analyzers – Seamless Integration with GHM POCT Platforms
The GHM TSH Fast Test Kit (Immunofluorescence Assay) is designed for use with compatible GHM immunofluorescence quantitative analyzers, including the GHM Getein 1100, GHM Getein 1150, GHM Getein 1160, GHM Getein 1180, GHM Getein 1200, and GHM Getein 1600 models. This compatibility ensures seamless integration into existing point-of-care testing workflows.
| Feature | Benefit |
|---|---|
| Compatible with GHM POCT analyzers | Seamless integration with existing platforms |
| GHM Getein 1100 / 1150 / 1160 / 1180 / 1200 / 1600 | Broad analyzer compatibility |
| RFID/SD card calibration | Simplified calibration process |
| Automated result reporting | Efficient workflow integration |
ISO 13485 Certified – Quality and Safety Compliance
The product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| IVD scope | Certified for in vitro diagnostic test kits |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM TSH Fast Test Kit US |
| Product Type | TSH Fast Test Kit (Immunofluorescence Assay) |
| Intended Use | In vitro quantitative determination of thyroid-stimulating hormone (TSH) in human serum and plasma samples; used in the screening, clinical diagnosis, prognosis, and therapeutic effect evaluation of thyroid diseases |
| Detection Principle | Lateral flow chromatography; immunofluorescence assay; double-antibody sandwich method |
| Target Analyte | Thyroid-Stimulating Hormone (TSH) |
| Specimen | Serum / Plasma |
| Detection Range | 0.10–50.00 μIU/mL |
| Cut-off Value | 0.27–4.20 μIU/mL |
| Test Time | 15 minutes |
| Storage Temperature | 4–30°C |
| Shelf Life | 24 months |
| Compatible Analyzers | GHM Getein 1100, GHM Getein 1150, GHM Getein 1160, GHM Getein 1180, GHM Getein 1200, GHM Getein 1600 Immunofluorescence Quantitative Analyzers |
| Application Scenario | Primary care clinic, endocrinology clinic, hospital laboratory, clinical laboratory, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system |
| Intended User | Professional healthcare use only |
| Package Options | 25 tests/kit; 10 tests/kit |
| Kit Contents | TSH test card in sealed pouch with desiccant, disposable pipette, SD card (or RFID card), instructions for use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM TSH Fast Test Kit US |
|---|---|
| Immunofluorescence assay technology | High-sensitivity quantitative detection |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Wide detection range | 0.10–50.00 μIU/mL for comprehensive TSH assessment |
| Serum / plasma compatibility | Flexible and convenient sample collection |
| Thyroid disease screening aid | Supports early identification of thyroid dysfunction |
| Therapeutic monitoring support | Enables assessment of thyroid hormone replacement therapy |
| High sensitivity and specificity | 90.5–95.2% sensitivity and 96.3–97.5% specificity vs. reference method |
| Compatible with GHM POCT analyzers | Seamless integration with GHM Getein 1100, 1150, 1160, 1180, 1200, 1600 |
| ISO 13485 certified | Quality management system compliance |
| Point-of-care compatible | Suitable for primary care clinics, endocrinology clinics, and clinical laboratories |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM TSH Fast Test Kit (Immunofluorescence Assay) US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
