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IB10 sphingotest® TSH


The IB10 sphingotest® TSH is a rapid point-of-care (POC) immunoassay for the quantitative in vitro determination of thyroid stimulating hormone (TSH) in human lithium-Heparin whole blood and plasma.

The test is designed for professional use only and may be used on sites where near patient testing is practiced.

Cat. No. IVR-IB55 | TSH (package of 10 discs)

Clinical Significance 

TSH is recognized as a sensitive indicator of thyroid status and thus the TSH assay has been widely adopted as the front-line thyroid function test (1,2,3). A normal TSH result excludes suspected thyroid disease in ambulatory patients with intact hypothalamic and pituitary function. Whereas elevated and suppressed TSH results are diagnostic of hypo- and hyperthyroidism (4). Functional sensitivity of 0.11 mIU/L and as such can be classified as a 2nd generation assay. It is able to differentiate between hyperthyroid and euthyroid conditions.

Expected Values

Reference Range(s)
Premature Infants (28-36 weeks)0.7 - 27.0 mIU/L
Term Infants (>37 weeks)1-4 days1.00 - 39.00 mIU/L
2-20 weeks1.70 - 9.10 mIU/L
5 months - 20 years0.70 - 6.40 mIU/L
Adults21-54 years0.40 - 4.20 mIU/L
55-87 years0.50 - 8.90 mIU/L
PregnancyFirst Trimester0.30 - 4.50 mIU/L
Second Trimester0.50 - 4.60 mIU/L
Third Trimester0.80 - 5.20 mIU/L

 

As a guide, the following ranges were determined. The euthyroid reference interval for IB10 sphingotest® TSH was determined as the central 95% of the measurements with human plasma samples collected from 265 apparently healthy individuals.

2.5th percentile
(mIU/L)
97.5th percentile
(mIU/L)
Median
(mIU/L)
0.253.851.43

 


 

Whole Blood vs. Plasma Comparison

All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.

 


 

Key Features

Easy Handling
Sample TypeLithium-Heparin or Citrate whole blood and plasma samples
Time to Result20 minutes
Measuring Range0.11 - 120 mIU/L
Limit of Detection0.11 mIU/L
No High Dose Hook Effectup to 8,000 mIU/L
Analyte Stability for IB10 Measurement24 hours for whole blood

 

 

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IB10 sphingotest® TSH is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of thyroid-stimulating hormone.

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References

(1) Surks et al. (1990), American Thyroid Association Guidelines for the use of laboratory tests in thyroid disorders, JAMA, DOI: 10.1001/jama.1990.03440110095035

(2) Keffer (1996), Preanalytical considerations in testing thyroid function, Clin Chem, DOI: 10.1093/clinchem/42.1.125.

(3) John et al. (1988), Evaluation of a new strategy for detection of thyroid dysfunction in the routine laboratory, Clin Chem, DOI: 10.1093/clinchem/34.6.1110

(4) Nicoloff et al. (1990), The use and misuse of the sensitive thyrotropin assays, J Clin Endocrinol Metab, DOI: 10.1210/jcem-71-3-553