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ThyroChek  //  TSH Controls

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TSH Control Set

A qualitative control (Human)

Product Number: 120-C

Store at 15 -28°C until opened.

Vitro Diagnostic Use.

INTENDED USE

TSH Control is an assayed, stable, ready to use liquid, bi-level control for use with assays designed for qualitative detec-tion of TSH.  It is intended to assist in quality control assur-ance of TSH test devices.

SUMMARY AND PRINCIPLE

This control will assist in the evaluation of proper perfor-mance of TSH test devices.

REAGENT

TSH Control is prepared using human serum with purified human TSH added to achieve the desired concentration levels and 0.1% sodium azide as a preservative.

The set consists of two vials.  Each vial contains 0.5mL of liquid controls.

STORAGE

TSH Control is stored at 15-28°C and is stable until the expiration date on the vial.  Upon opening, the vials should be used at room temperature and immediately refrigerated. Once opened, vials are stable for 30 days, refrigerated.

PROCEDURE

Controls should be used in the same manner as samples and run according to the procedure provided by the test kit manu-facturer. Read Quick Reference Instructionsincluded with kit, substituting TSH Control for fresh whole blood.

PERFORMANCE CHARACTERISTICS

TSH Control is a ready to use liquid product manufactured according to standard quality control procedures. Stability and consistency of this product is guaranteed by the manufacturer.

CAUTION

This product has been found to be non-reactive for Hepatitis-B surface antigen and other tested infectious agents. HOWEVER, this product should be handled as if potentially infectious.

This product contains sodium azide which may react with lead and copper plumbing to form potentially explosive metal azides.  On disposal, flush with a large volume of water to prevent azide build-up.

TARGET VALUES

The vial labeled Negative should yield a negative test result.  The vial labeled Positive  should yield a positive test result.

Negative 0.001uIU/ml

Positive > 5.0uIU/ml


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Publications PDF Articles on Hypothyroidism

Product Inserts

Sell Sheets

“Based on the less-than-1% discordance rate between sTSH and FT4 results, an sTSH level alone is adequate to screen outpatients for thyroid dysfunction. Ordering the sTSH alone,initially, followed by FT4 in only those cases of abnormal sTSH, will significantly decrease unnecessary testing and expense.”

Dr. Anthony J. Viera

American Academy of Family Physicians. Award winner for his study while a resident at the Family Practice Unit at the Jacksonville Naval Hospital, 2002