Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings
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ClinicalTrials.gov Identifier: NCT03619798 |
Recruitment Status : Unknown
Verified August 2018 by Silver Lake Research Corporation.
Recruitment status was: Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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Condition or disease | Intervention/treatment |
---|---|
Diagnoses Disease | Device: HemoTypeSC |
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings: a Multi-Center |
Actual Study Start Date : | August 3, 2018 |
Estimated Primary Completion Date : | August 31, 2018 |
Estimated Study Completion Date : | December 31, 2018 |

- Device: HemoTypeSC
Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood
- Positive for Hemoblogin A, S, or C [ Time Frame: Immediate (investigational test) to one week (reference test) ]
- Negative for Hemoglobin A, S, or C [ Time Frame: Immediate (investigational test) to one week (reference test) ]
- Positive for Hemoglobin AA, AS, AC, SS, SC, or CC [ Time Frame: Immediate (investigational test) to one week (reference test) ]
- Negative for Hemoglobin AA, AS, AC, SS, SC, or CC [ Time Frame: Immediate (investigational test) to one week (reference test) ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Agrees to be enrolled (or has parent/guardian approval to be enrolled)
Exclusion Criteria:
- Previous sickle cell screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619798
Contact: Erik Serrao, PhD | 3103872866 | eserrao@silverlakeresearch.com |
United States, California | |
Silver Lake Research Corporation | Recruiting |
Azusa, California, United States, 91702 | |
Contact: Erik Serrao 310-387-2866 eserrao@silverlakeresearch.com |
Responsible Party: | Silver Lake Research Corporation |
ClinicalTrials.gov Identifier: | NCT03619798 |
Other Study ID Numbers: |
HTSC111 |
First Posted: | August 8, 2018 Key Record Dates |
Last Update Posted: | August 8, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia, Sickle Cell Hemoglobin C Disease Anemia, Hemolytic, Congenital Anemia, Hemolytic |
Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |