Hypothyroidism
Conditions
Keywords
Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit
Brief summary
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.
Interventions
DEVICEQuantitative POC TSH Kit
A drop (approximately 30 microliter \[mcL\]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.
DEVICEQualitative POC TSH Kit
A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.
DEVICEThird generation TSH Kit
One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Suspected hypothyroidism subject * Willing to comply with the trial protocol * Signed informed consent document
Exclusion criteria
* Menstrual period, bleeding hemorrhoids, hematuria * Drinking or taking aspirin within 48 hours * Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability. * Subjects who are unwilling or unable to complete the trial * Subjects who do not sign informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Positive and Negative TSH Test Result | Day 1 up to Day 5 |
| Concentration of TSH in Whole Blood | Day 1 up to Day 5 |
Countries
China
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| POC TSH Kits + Third Generation TSH 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. | 283 |
| Total | 283 |
Baseline characteristics
| Characteristic | POC TSH Kits + Third Generation TSH Kit |
|---|---|
| Age, Continuous | 42.99 Years STANDARD_DEVIATION 12.52 |
| Sex: Female, Male Female | 181 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 283 |
| serious Total, serious adverse events | 0 / 283 |
Outcome results
Primary
Concentration of TSH in Whole Blood
Time frame: Day 1 up to Day 5
Population: The FAS included all enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| POC TSH Kits + Third Generation TSH Kit | Concentration of TSH in Whole Blood | POC TSH kits | 7.38 Milli international units per liter | Standard Deviation 8.49 |
| POC TSH Kits + Third Generation TSH Kit | Concentration of TSH in Whole Blood | Third generation kit | 30.18 Milli international units per liter | Standard Deviation 41.94 |
Primary
Number of Participants With Positive and Negative TSH Test Result
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| POC TSH Kits + Third Generation TSH Kit | Number of Participants With Positive and Negative TSH Test Result | Third generation kit (Negative) (n=283) | 162 Participants |
| POC TSH Kits + Third Generation TSH Kit | Number of Participants With Positive and Negative TSH Test Result | POC TSH kits (Positive) (n=282) | 103 Participants |
| POC TSH Kits + Third Generation TSH Kit | Number of Participants With Positive and Negative TSH Test Result | POC TSH kits (Negative) (n=282) | 179 Participants |
| POC TSH Kits + Third Generation TSH Kit | Number of Participants With Positive and Negative TSH Test Result | Third generation kit (Positive) (n=283) | 121 Participants |