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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02254564

Enrollment

Registered

2014-10-02

Start date

2014-10-31

Completion date

2017-10-31

Last updated

2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scabies

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR	1 year

Countries

United States

Outcome results