Trial Outcomes & Findings for Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit (NCT NCT01921452)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

283 participants

Primary outcome timeframe

Day 1 up to Day 5

Results posted on

2014-11-25

Participant Flow

All 283 enrolled participants were analyzed using both point-of-care (POC) thyroid stimulating hormone (TSH) kits and third generation TSH kit.

Participant milestones

Participant milestones
Measure	POC TSH Kits + Third Generation Kit 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 Study STARTED	283
Overall Study COMPLETED	283
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	POC TSH Kits + Third Generation TSH Kit n=283 Participants 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.
Age, Continuous	42.99 Years STANDARD_DEVIATION 12.52 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 5

Population: The FAS included all enrolled participants. 'n' signifies number of participants who were evaluable for this measure for the specified category.

Outcome measures

Outcome measures
Measure	POC TSH Kits + Third Generation TSH Kit n=283 Participants 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.
Number of Participants With Positive and Negative TSH Test Result POC TSH kits (Positive) (n=282)	103 Participants
Number of Participants With Positive and Negative TSH Test Result POC TSH kits (Negative) (n=282)	179 Participants
Number of Participants With Positive and Negative TSH Test Result Third generation kit (Positive) (n=283)	121 Participants
Number of Participants With Positive and Negative TSH Test Result Third generation kit (Negative) (n=283)	162 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 5

Population: The FAS included all enrolled participants.

Outcome measures

Outcome measures
Measure	POC TSH Kits + Third Generation TSH Kit n=283 Participants 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.
Concentration of TSH in Whole Blood POC TSH kits	7.38 Milli international units per liter Standard Deviation 8.49
Concentration of TSH in Whole Blood Third generation kit	30.18 Milli international units per liter Standard Deviation 41.94

Adverse Events

POC TSH Kit + Third Generation TSH Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: 49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER