Testosterone FIA Test

Testosterone is an anabolic steroid synthesized primarily by Leydig cells in the testes of males, the ovary of females, and adrenal glands of both sexes.

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

Working range: 0.2-20.0 ng/mL

  1. Precision

Intra-lot Precision

Intra-lot precision was determined by testing of TES reference materials using 10 test devices from the same lot. CV ≤ 15%.

Inter-lot Precision

Inter-lot precision was determined by testing of TES reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

  1. Accuracy

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

  1. Linearity

A serial concentration of TES reference materials at 0.2-20.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.

  1. Specificity
Crossed FactorsConcentrationTest Result
Progesterone500 ng/mL< 0.2 ng/mL
Estradiol100 ng/mL< 0.2 ng/mL
Cortisol500 ng/mL< 0.2 ng/mL
Aldosterone500 ng/mL< 0.2 ng/mL
Estriol100 ng/mL< 0.2 ng/mL
17α-Estradiol500 ng/mL< 0.2 ng/mL
Oestrone50 ng/mL< 0.2 ng/mL

Reagents and Materials provided:

  1. Individually sealed foil pouches containing:
    • One test device
    • 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