CLIA Variant Confirmation (PCR + Sanger)

PCR + Sanger sequencing allows you to detect or confirm mutations in genomic DNA. This technique is a reliable method for initial analysis or orthogonal confirmation of next generation sequencing, microarrays, or qPCR/dPCR results in clinical samples. Achieve clinical success in our GCP-compliant and CLIA-certified laboratory.
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Service Details

Service Level* Raw Data Files QA Oversight Variant Report Lab Director Signature Test Registration Clinical Outcome Report
CLIA Environment

CLIA Workflow (With QA)

CLIA (Full Service)

Included | Available as an add-on | Not Available

*All service levels are performed by CLIA-trained personnel in a CLIA-certified lab with CLIA-qualified equipment.

Applications

Identify or validate variants of interest in complex regions
Confirm work from patient panels or run samples to support registered tests
Orthogonal analysis of next generation sequencing, microarray, qPCR data, and dPCR
Genotype SNPs of interest in clinical samples for medical device validation

SAMPLE TO ANSWER

1. PROJECT CONSULTATION & PRIMER DESIGN

Amplicon selection and primer design to targeted regions of interest in new or existing assays

2. ASSAY DEVELOPMENT


Optimization on project-specific samples with different validation options

3. PCR & PURIFICATION


PCR amplification of genomic DNA using ideal conditions

4. SEQUENCING & DATA ANALYSIS

Bi-directional DNA sequencing per amplicon with optional variant reporting

Deliverables

All customers receive raw data as .ab1, .seq, and .phd files. A Variant Report is available as an add-on for CLIA Environment and CLIA Workflow. An optional lab director signed quality score report is available with CLIA Workflow. CLIA (Full Service) includes both reports.

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*Terms & conditions apply

REQUEST YOUR CLIA VARIANT CONFIRMATION QUOTE

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Email | Phone (1-877-436-3949, Ext. 3350)