PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-31

Brief Summary

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The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.

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Detailed Description

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The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.

Conditions

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Scabies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive Scrapings

Skin scrapings that are positive for scabies

No interventions assigned to this group

Negative Controls

collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1\. Male/Female of all ages whose standard clinical treatment produces one or more of the following:

* Slides from skin scrapings containing scabies mites, eggs, and/or fecal material
* Slides from skin scrapings of suspected tinea
* Slides from skin scrapings of demodex mites

Exclusion Criteria

* 1\. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes