Quality Control (QC)
ProteoGenex has developed a strict Quality Control Program to ensure that the human specimens it provides are continually checked for quality throughout their collection, processing, storage, and shipment.
Quality Control in Collection
Collection to shipment, all human biological specimens are handled using sterile techniques.
All samples are handled as potentially infectious. Clients are warned if specimens contain any known infectious agent.
Clinical Data Quality Control
All data is cross-referenced with patient charts and reviewed for accuracy and completion.
All data is ensured to correspond with pathology information provided by the collection site.
Informed Consent is obtained from each and every donor before blood or tissue sampling.
All identifying patient information is redacted from all pathology reports and summarizing clinical spreadsheets.
Donors are anonymized and specimens are re-identified with a Sample ID number.
Quality Tissue Collection
A representative piece of tissue is cut off and used to prepare representative paraffin embedded tissue blocks and an H&E slide.
- Each tissue specimen undergoes strict Pathology QC (see below)
- Low quality tissues and tissues with high necrosis content are discarded.
Each tissue sample is cut into ~0.5 – 1.0g fragments.
Each fragment is snap frozen individually in liquid nitrogen within 30 to 60 minutes of surgical excision.
Tissue specimens are pre-frozen before they are placed in tubes to assure that they do not stick to the tubes.
All tubes are pre-labeled for accuracy in specimen identity.
RNA Quality Control
All fresh frozen samples collected by ProteoGenex are quality assured by total RNA extraction
- Samples are cut from fresh frozen specimens on dry ice for RNA testing
- RNA is extracted using Trizol reagent
- RNA is analyzed using the Agilent 2100 Bioanalyzer
- Samples are ensured to have an RNA Integrity Number (RIN) of 7 or higher
Pathology Quality Control
H&E slides are prepared from every fresh frozen and FFPE tissue block collected for ProteoGenex.
- Each H&E slide is reviewed by a certified pathologist to confirm tissue identity and appropriate histology and to ensure that the representative cellular components are present in the collected tissue specimen.
- Each H&E slide is ensured to match the confirmed diagnosis in the pathology report
For tumor tissues, only specimens with ≥60% tumor cells will be acceptable for shipping to clients (unless requested otherwise).
Pathologists pass or reject specimens as research quality.
Quality Blood Collection
Blood samples are processed and frozen at -80°C within 4 hours after blood draw.
Plasma samples are double spun to ensure proper blood fractionation.
Serum and plasma samples are checked for hemolysis after processing.
- Hemolyzed samples are discarded and not stored for distribution.
Quality Control in Storage
ProteoGenex ensures that all frozen specimens are kept frozen and never allowed to thaw.
Frozen Tissue Storage
Frozen tissue specimens are stored in liquid nitrogen (-190°C).
Liquid nitrogen levels are maintained daily.
FFPE Tissue Storage
FFPE tissue specimens are stored at room temperature under temperature controlled conditions.
Blood and Biofluid Samples
All frozen blood and biofluids are stored in Ultra Low -80°C Freezers.
Freezer temperatures are regularly monitored and recorded.
All serum and plasma samples are checked for quality and volume before shipment.
Quality Control in Shipment
After a Purchase Order is placed, ProteoGenex will contact the client to coordinate a shipment date. Specimens will not be shipped without confirmation of shipment.
At the time of shipment, applicable carrier tracking numbers for shipment will be provided by email to the client.
All FFPE tissues are checked to confirm pathology and identity before shipment.
All frozen samples are shipped on dry ice or in vapor phase liquid nitrogen.
ProteoGenex suggests that PBMCs and BMMCs be shipped at -190°C in vapor phase liquid nitrogen.
FFPE tissue specimens are shipped at ambient temperature, unless requested otherwise.
The following items are included in every shipment:
- A packing slip including a list of samples
- Labeled specimens in appropriate packing materials
- One representative H&E slide is included with all FFPE specimens.
- Complete clinical information, pathology reports, and any other applicable data are sent electronically at time of shipment.