Be DNA Certain™ that lab specimens are free from contamination and exclusively belong to the patient being evaluated. Specimen Provenance Complications (SPCs) can occur outside a controlled laboratory environment even when automation technologies are employed through the Analytic Phase of testing and meticulous operating procedures are followed. Strand Diagnostics has established the highest standard for specimen provenance testing with DNA Specimen Provenance Assay (DSPA), DNA testing. The DSPA test complements the laboratory workflow while protecting the pathology lab across the entire diagnostic testing cycle. DSPA compares a DNA profile of a patient’s reference swab to the DNA profile of the biopsy tissue(s) used in the pathology evaluation process to confirm a DNA match. A DNA match removes the doubt of specimen contamination and patient transposition errors confirming the specimen purity (i.e. free from admixture) which can otherwise alter test results.
What is the laboratory’s role in implementing the know error® system?
To simply cut and send the appropriate tissue samples (or unstained slides) to Strand Diagnostics for DSPA testing.
Hundreds of laboratories already provide specimens to Strand Diagnostics for the know error system and DNA testing. The process requires minimal disruption to the standard laboratory process—when a positive for cancer (malignant) diagnosis is rendered, two 4-micron slices should be cut from the appropriate paraffin block(s) and sent to Strand Diagnostics using the supplied transport vials from the Know Error biopsy kit. Unstained slides may be sent instead.
Know Error DSPA testing can be ordered at the time of the biopsy or after the biopsy.
Laboratory and medical professionals should order DSPA testing whenever one suspects a specimen provenance problem might exist such as:
- Areas of interest on slides or blocks
- Multiple medical samples found within the same specimen jars
- Fragments, floaters in histologic specimens
- Non-labeled specimen jars or slides
- Indiscriminate medical samples
- Resected tissue is discordant with the biopsy sample
More information about which kit is right for your laboratory can be found on our Know Error site. If you have additional questions please call Monday through Friday, 8:00 a.m. to 5:00 p.m. ET at 1-888-924-6779 and select option 2 to speak with a client services representative.