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Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

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ClinicalTrials.gov Identifier: NCT01921452
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypothyroidism
Interventions Device: Quantitative POC TSH Kit
Device: Qualitative POC TSH Kit
Device: Third generation TSH Kit
Enrollment 283
Recruitment Details  
Pre-assignment Details All 283 enrolled participants were analyzed using both point-of-care (POC) thyroid stimulating hormone (TSH) kits and third generation TSH kit.
Arm/Group Title POC TSH Kits + Third Generation Kit
Hide Arm/Group Description Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Period Title: Overall Study
Started 283
Completed 283
Not Completed 0
Arm/Group Title POC TSH Kits + Third Generation TSH Kit
Hide Arm/Group Description Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Overall Number of Baseline Participants 283
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants
42.99  (12.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants
Female
181
  64.0%
Male
102
  36.0%
1.Primary Outcome
Title Number of Participants With Positive and Negative TSH Test Result
Hide Description [Not Specified]
Time Frame Day 1 up to Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all enrolled participants. ‘n’ signifies number of participants who were evaluable for this measure for the specified category.
Arm/Group Title POC TSH Kits + Third Generation TSH Kit
Hide Arm/Group Description:
Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Overall Number of Participants Analyzed 283
Measure Type: Number
Unit of Measure: Participants
POC TSH kits (Positive) (n=282) 103
POC TSH kits (Negative) (n=282) 179
Third generation kit (Positive) (n=283) 121
Third generation kit (Negative) (n=283) 162
2.Primary Outcome
Title Concentration of TSH in Whole Blood
Hide Description [Not Specified]
Time Frame Day 1 up to Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all enrolled participants.
Arm/Group Title POC TSH Kits + Third Generation Kit
Hide Arm/Group Description:
Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
Overall Number of Participants Analyzed 283
Mean (Standard Deviation)
Unit of Measure: Milli international units per liter
POC TSH kits 7.38  (8.49)
Third generation kit 30.18  (41.94)
Time Frame Day 1 up to Day 5
Adverse Event Reporting Description Safety analysis set included all participants whose blood was collected.
 
Arm/Group Title POC TSH Kit + Third Generation TSH Kit
Hide Arm/Group Description Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
All-Cause Mortality
POC TSH Kit + Third Generation TSH Kit
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
POC TSH Kit + Third Generation TSH Kit
Affected / at Risk (%)
Total   0/283 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
POC TSH Kit + Third Generation TSH Kit
Affected / at Risk (%)
Total   0/283 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on the PI is that the sponsor can review the results communications prior to public release, and the sponsor can embargo communications regarding trial results if the PI does not get approval from the sponsor.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: 49-6151-72-5200
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01921452     History of Changes
Other Study ID Numbers: EMR 200125_507
First Submitted: August 9, 2013
First Posted: August 13, 2013
Results First Submitted: November 20, 2014
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014