The RecombiLISA TSH ELISA is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (TSH) in human serum.

The RecombiLISA TSH ELISA is intended for professional use as an aid in the diagnosis of thyroid dysfunction. TSH values should not be the only factor in the determination of thyroid status, and all other available clinical and epidemiological information should be considered for an accurate diagnosis.

Recommended for use:

  • Any person presenting with signs or symptoms of hypo or hyperthyroidism
  • Any person presenting with an enlarged thyroid gland (goiter)
  • Pregnant women for first trimester screening
  • Any person requiring regular monitoring of treatment

Normally, thyroid function is first assessed by detection of TSH levels in the blood.

The monoclonal anti-TSH antibody coated on the surface of the microwells specifically recognizes the junction between the α and β subunits. The HRP-conjugated monoclonal anti-TSH antibody detects the β subunit only.

Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status.

  • Sensitivity: Detects TSH levels as low as 0.035 µIU/mL
  • Specificity: No cross reactivity detected with related hormones: FSH, LH and hCG
  • Linearity: 1:128 dilution on 36 μIU/mL sample
  • Precision: intra assay precision: CV 7.5%; inter assay precision: CV 8.0 %
  • Accuracy: R2= 0.986 against Roche TSH Chemiluminescence Immunoassay
  • Hook effect: No hook effect up to 8000 μIU/mL
  • Interference: not affected by Hemoglobin 500mg/dL, Diltiazem 15uM, Bilirubin 20 mg/dL, Erythromycin 81.6uM, Triglycerides 3g/dL, Verapamil 4.4uM, HAMA 52.5ng/mL, T3 100ng/mL, RF 215IU/mL, T4 100ug/dL, Acetaminophen 1324uM
  • Calibration: Human TSH WHO 3rd International Standards (81/565 NIBSC)
  • Calibrators: 0, 0.5, 2.0, 5.0, 10, 20, 40 µIU/mL in biological matrix
  • Shelf life: 18 months
  • Assay time: 80 minutes
  • Anti-TSH Ab coated microwells
  • TSH standard S1
  • TSH standard S2
  • TSH standard S3
  • TSH standard S4
  • TSH standard S5
  • TSH standard S6
  • TSH standard S7
  • HRP-anti-TSH conjugates
  • TMB substrate
  • Wash buffer (30X concentrate)
  • Stop solution
  • ELISA working sheet
  • Product insert

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