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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POC TSH Kits + Third Generation TSH Kit | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative POC TSH Kit | Device | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono Limited, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27605368 | Derived | Wang T, Sheng S, Ruan M, Yan J, Gu J, Jiang Y, Gao Y, Lu H. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther. 2016 Nov;33(11):2001-2011. doi: 10.1007/s12325-016-0401-y. Epub 2016 Sep 7. |
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All 283 enrolled participants were analyzed using both point-of-care (POC) thyroid stimulating hormone (TSH) kits and third generation TSH kit.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Qualitative POC TSH Kit | Device | 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. |
|
| Third generation TSH Kit | Device | 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. |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Positive and Negative TSH Test Result | The FAS included all enrolled participants. 'n' signifies number of participants who were evaluable for this measure for the specified category. | Posted | Number | Participants | Day 1 up to Day 5 |
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| Primary | Concentration of TSH in Whole Blood | The FAS included all enrolled participants. | Posted | Mean | Standard Deviation | Milli international units per liter | Day 1 up to Day 5 |
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Day 1 up to Day 5
Safety analysis set included all participants whose blood was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POC TSH Kit + 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. | 0 | 283 | 0 | 283 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | 49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Title | Measurements |
|---|---|
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| Third generation kit (Negative) (n=283) |
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