Cleartest TSH

The CLEARTEST® TSH Rapid Test is an immunological test for the qualitative detection of thyroid-stimulating hormone (TSH) in citrated blood, serum and capillary blood from the fingertip. The test is intended as an aid in the diagnosis of hypothyroidism. The test is intended for use by medically trained personnel only. The test cannot be used for diagnosis alone and should be evaluated in the context of the medical history and a laboratory confirmatory test. Hypothyroidism (latent or manifest) is a human disease with an estimated incidence of about 10 % in the population. Unrecognised, patients suffer from impairments of the cardiovascular and nervous systems, musculature, metabolism, etc. TSH (thyrotropin) plays a central role in the regulation of thyroid hormone production. Its determination is one of the most important measures in a health check. Slightly elevated TSH values can be the first sign of incipient hypothyroidism.

The test contains two monoclonal antibodies specific for human TSH, one of which is gold-labelled and one of which is fixed on the detection zone of the membrane.

The CLEARTEST® TSH detects samples from a concentration > 5 mlU/l up to a concentration of 500 mlU/l.

Performance features

Sensitivity, specificity and accuracy

TSH rapid test

• Sensitivity: 97.50 %
• specificity: 99.00 %
• Accuracy: 98.73 % (PPV)
• 98.02 % (NPV)

3 step procedure (sample collection, preparation, testing)

Test evaluation after 10 minutes

Can be performed with citrated blood, serum and capillary blood from the fingertip

Store in sealed bag at 2 - 30 °C, do not freeze.