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

Seton Healthcare Family

Status: Completed

Conditions: Scabies

Study type: Observational

Funder types: Other

Identifiers

NCT02254564

Scabies 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

17 participants in 2 patient groups

Positive Scrapings

Description:

Skin scrapings that are positive for scabies

Negative Controls

Description:

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.