The know error® system
The know error system can be easily integrated within an existing routine clinical process, regardless of whether pathology services are performed in house or by a reference lab partner. Strand Diagnostics provides training for the medical professionals and staff involved in the collection process.Biopsy kits provided as part of the patented know error system utilize forensic principles, unique patient bar coding, and DNA Specimen Provenance Assay (DSPA) testing to confirm that surgical biopsy samples being evaluated are free from contamination and belong exclusively to the patient being evaluated. Our patented system involves three simple steps and requires minimal disruption to the standard biopsy collection process.
Before the biopsy procedure, a reference sample of DNA is taken by swabbing the inside of the patient’s cheek. The swab is then sent to Strand Diagnostics.
The patient’s biopsy specimen sample(s) are placed in bar-coded specimen containers included in the biopsy kit and sent to the pathology lab for evaluation.
If the biopsy results come back positive for cancer (malignant) a small piece of the tissue (or unstained slide) is sent to Strand Diagnostics, where a DNA test compares the (1) swab reference sample to the (2) biopsy tissue sample(s) to assure a (3) DNA match and the sample purity. The DNA match confirms the diagnosis matches the DNA of the reference sample identified as belonging to the patient and rules out specimen contamination.
Once the DSPA is completed, an electronic report (compatible with most EMR systems) is issued to summarize the findings. The turn-around-time (TAT) varies depending upon the specimen type, but reports are usually issued within 5 – 6 calendar days after receipt of both the swab/reference and tissue sample(s). If a potential non-match is indicated, the appropriate parties are notified immediately to address the issue.
More information about the patented know error system is available on our Know Error website.