300 Antibody Diagnostic Test Kit | NCT01646411

Studies
300 Antibody Diagnostic Test Kit

NCT01646411

Sponsor

The Plasma Source

Status

Unknown status

Last Update Posted

Jul 20, 2012Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Acute Bacterial Infections
Acute Viral Infections

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Jul 12, 2012

First Submission Date that Met QC Criteria

Jul 19, 2012

First Posted Date

Jul 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2012

Last Update Posted Date

Jul 20, 2012Estimated

Name	Class
Plasma Services Group	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

Acute Bacterial Infections
Acute Viral Infections

Keywords

cytomegalovirus (CMV) IgM &IgG
Lyme
Toxoplasma
Rubella
Rubeola IgM
Rocky mountain Spotted Fever IgM
Ebv IgM
Herpes
Babesia
Measles
Tetanus
Mumps
Mycoplasma
Legionella
Giardia
Syphilis
Bordetella Pertussis
H Pylori
Antibody Titre
Elevated IgG
Abnormal IgM
SLE

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
assorted acute infection		300 patients diagnosed with assorted acute infection.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IgM greater than 1xcut off value	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.	Antibody value measured within seven days of specimen collection.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current acute infection
age 18-70
male or female
any race
currently active symptoms

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with acute infection between the age of 18 and 70. Sex and race are random.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffery Flieshman, M.S immunology		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Plasma Source		Southampton	Pennsylvania	18966	United States

Condition Browse Module

MeSH Terms

ID	Term
D053307	Hyper-IgM Immunodeficiency Syndrome, Type 1
D012409	Rubella
D006561	Herpes Simplex
D008457	Measles
D013742	Tetanus
D009107	Mumps
D009175	Mycoplasma Infections
D005873	Giardiasis
D013587	Syphilis

Ancestor Terms

ID	Term
D053306	Hyper-IgM Immunodeficiency Syndrome
D004406	Dysgammaglobulinemia
D001796	Blood Protein Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided