Sample Management

SampleManagementNew

From the point of receipt, all study specimens receive HistoGeneX chain of custody specimen care, which exceeds standard industry practices. Our pathology origins guide our decision-making when we examine specimens, select proper conditions and we have the experience to anticipate emerging issues arising from shipment, logistics and other pre-analytical variables. 

HistoGeneX handles tissue, blood and all derivatives of bone marrow specimens. We fully track all parent-child specimen relationships for example blocks to slides, and slides to DNA/RNA. 

We track each specimen until laboratory analysis is completed or the sample has been assigned a permanent storage location. End to end specimen custody is managed through our H-LIMS, which we have configured and fine-tuned, based on our years of clinical trial management experience. 

HistoGeneX project management team diligently monitors sites’ compliance with requisition documentation, and specimen collection. When deviations occur, we activate our Data and Sample Clarification processes through direct communication with the clinical sites.

We promptly repatriate all specimens to your specification, or we provide long term storage in our restricted-access, humidity-monitored and temperature-controlled facilities.

Alternatively we will destroy specimens upon request according to our standard operating procedures.

Specimen Management and Storage

  • Manage all specimen handling activity, from receipt to storage, repatriation or destruction
  • Comply with all industry standards relating to temperature, humidity and security
  • Monitor storage facilities and apparatus using automated, calibrated systems with sensors and alarm escalation on a 24/7 notice
  • Respond and rectify any alarms related to sample integrity

 

SPECIMEN RECOMMENDATIONS

For IHC Biomarker Analysis

  • Number of Slides (per biomarker). Minimum 3 slides. Preferred 5 slides (1 for HE evaluation, 1 for target analyte, the remaining are back up slides for re-testing or additional testing). 

Slides or Blocks

  • Formalin-fixed, paraffin-embedded tissue blocks are preferred. We will prepare the unstained slides per our SOP.
  • If blocks are unavailable, send a minimum of 3 unstained slides in a slide case.
  • Please provide one slide case per sample. Do not combine multiple samples (e.g. from one site) in a single slide case.

 

Slide Labeling

  • Label the slide case with the Study ID and at least one unique patient identifier (e.g. Patient ID, screening ID, accession number). For the slides, label the frosted end of the slide with pencil, or a heat stable, acid and xylol-resistant pen.
  • The label should contain the study ID, patient identifier, slide number and local pathology ID.
  • Avoid using an adhesive label as this may detach during our procedures.

 

Glass Slides

  • Use SuperFrost UltraPlus slides to minimize loss of sections during the IHC staining protocol.

 

Sample Manifest

  • Complete an inventory sheet (e.g. Laboratory Request Form or Electronic Manifest) which we will reconcile with actual shipped specimens. Attention: if local pathology ID is provided, please make sure that this ID matches the ID on the block or as completed on the unstained slides. 

 

Bone Marrow Biopsy Decalcification

BoneStation

          • This automated system caught our attention. Using it to decalcify, we successfully completed downstream applications - IHC, FISH, Special Stains, H&E and DNA/RNA.
          • It uses no acids, using an EDTA and a proprietary MolDecal chemistry. In our hands, it was superior to the "gold standards" below. For more information and data, please contact us.
          • This system is available for clinical trial use.