300 Antibody Diagnostic Test Kit (Antibody 300)
| Tracking Information | |||||
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| First Received Date ICMJE | July 12, 2012 | ||||
| Last Updated Date | July 19, 2012 | ||||
| Start Date ICMJE | August 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
IgM greater than 1xcut off value [ Time Frame: Antibody value measured within seven days of specimen collection. ] [ Designated as safety issue: No ] Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff. Prevalence of IGM in general mid-atlantic population is less than 10% of study population. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01646411 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 300 Antibody Diagnostic Test Kit | ||||
| Official Title ICMJE | Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection | ||||
| Brief Summary | For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum collected in two 10ml sst and two 8ml edta venipuncture tubes. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with acute infection between the age of 18 and 70. Sex and race are random. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | assorted acute infection
300 patients diagnosed with assorted acute infection. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01646411 | ||||
| Other Study ID Numbers ICMJE | 300831 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | The Plasma Source | ||||
| Study Sponsor ICMJE | The Plasma Source | ||||
| Collaborators ICMJE | Plasma Services Group | ||||
| Investigators ICMJE |
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| Information Provided By | The Plasma Source | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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