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| Name | Class |
|---|---|
| Nova Clinical Solutions, Inc. | UNKNOWN |
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The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancy Positive | Pregnant subjects within 11 weeks since the first day of last period. |
| |
| Pregnancy Negative | Non-pregnant subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Device-Strip Format | Device | Sponsor's investigational device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall percent (%) agreement | The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and negative percent agreement | The secondary endpoint is the positive percent agreement and negative percent agreement. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Healthy adult women of childbearing age.
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The study will enroll healthy adult women of childbearing age.
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| Name | Affiliation | Role |
|---|---|---|
| Rui Liu, Master | Guangzhou Wondfo Biotech Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Insitute of Clinical Research | Garden Grove | California | 92844 | United States | ||
| National Research Institute-Huntington Park |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13785019 | Result | WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. doi: 10.1530/acta.0.xxxv0261. No abstract available. | |
| 6995156 | Result | Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. doi: 10.1016/s0015-0282(16)44829-6. No abstract available. |
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| Test Device-Cassette Format | Device | Sponsor's investigational device |
|
|
| Predicate Device | Device | Commercially available device |
|
|
| Huntington Park |
| California |
| 90255 |
| United States |
| Downtown L.A. Research Center, Inc | Los Angeles | California | 90017 | United States |
| National Research Institute-Westlake | Los Angeles | California | 90057 | United States |
| National Research Institute-Panorama City | Panorama City | California | 91402 | United States |
| National Research Institute-Santa Ana | Santa Ana | California | 92704 | United States |
| 984142 | Result | Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15;126(6):678-81. doi: 10.1016/0002-9378(76)90518-4. |
| 4734160 | Result | Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by neoplasms. Ann Intern Med. 1973 Jan;78(1):39-45. doi: 10.7326/0003-4819-78-1-39. No abstract available. |
| 1117063 | Result | Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyst. J Clin Endocrinol Metab. 1975 Mar;40(3):537-40. doi: 10.1210/jcem-40-3-537. |
| 7115557 | Result | Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril. 1982 Jun;37(6):773-8. doi: 10.1016/s0015-0282(16)46337-5. |