TSH FIA Test

The Thyroid-Stimulating Hormone (TSH) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic immunofluorescent assay for the quantitative detection of TSH in human serum or plasma, using the RaFIA system. This test is intended for in vitro diagnostic use only.

Both TSH α and β subunits are required for its biological activity. TSH stimulates the production and secretion of the metabolically active thyroid hormones, thyroxine (T4) and triiodothyronine (T3). T3 and T4 are responsible for regulating diverse biochemical processes throughout the body which are essential for normal development and metabolic and neural activity.

Abnormal TSH levels indicate thyroid functional disorders. Combined with thyroid hormone levels, hyperthyroidism or hypothyroidism can be diagnosed.

The TSH FIA Test was developed to detect circulating TSH in serum or plasma within 20 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

RANGES

  • Working range: 0.4–100.0 μIU/mL

PRECISION

  • Intra-lot Precision: Intra-lot precision was determined by testing of TSH reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of TSH reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤20%.

ACCURACY 

  • TSH control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

  • A serial concentration of TSH reference materials at 0.4-100.0 μIU/mL was tested, and the correlation coefficient (R) is ≥0.9900.

 

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Instructions for Use

Catalog #

Product

Quantity

Specimen

F1030TSH FIA Test25/kitSerum, Plasma

Other tests you might be interested in:

Catalog #

Product

Quantity

Specimen

F1000β-hCG FIA Test25/kitSerum, Plasma
F3050NT-proBNP FIA Test25/kitSerum, Plasma, Whole blood
F400PCT FIA Test 25/kitSerum, Plasma, Whole blood
F3002cTnl FIA Test25/kitSerum, Plasma
F410CRP FIA Test25/kitSerum, Plasma, Whole blood

Materials required but not provided:

Catalog #

Product

FIA-100Immunofluorescence Analyzer

Catalog #

Product

FIA-101Immunofluorescence Incubator

To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY