STEMpredict™

A Standardized and Validated, 3-Day Hematopoietic Stem Cell Assay to Triage High from Low Quality Cell Therapy Products Prior to Cryopreservation

 

STEMpredict™

A 3-Day HALO® Style Assay to Triage High from Low Quality Human Hematopoietic Cells Prior to Cryopreservation

Cell Population Tissue Formulation Catalog Number Quantity
Stem Cells
Background + Stem Cells Any. Low-throughput Low serum K2-SP-1 1 Kit
Background + Stem Cells Any. High-throughput Low serum K3-SP-1 1 Kit
Stem Cells
Background + Stem Cells Any. Low-throughput Serum-Free K2SF-SP-1 1 Kit
Background + Stem Cells Any. High-throughput Serum-Free K3SF-SP-1 1 Kit

 

 

STEMpredict™: A standardized and validated ATP bioluminescence assay to predict high from low quality hematopoietic cell therapy products prior to cryopreservation

 

Download the Stem Cell Product Quality Assay Flyer  

 

A complete, predictive, hematopoietic stem cell "quality", viability and functionality umbilical cord blood and mobilized peripheral blood collection assay.
  • Separate high from low quality stem cell therapeutic products in just 3 days.
  • For umbilical cord blood and mobilized peripheral blood. Can also be used for bone marrow.
  • Fresh or frozen samples(1).
  • Accurate, single dose, cell proliferation ratio data predicts high from low growth-potential units.
  • Fully standardized and validated ATP bioluminescence readout according to FDA guidelines.
  • Profieciency testing performed during the assay standardization procedure. No addition proficiency testing required.
  • Measurement assurance parameters provide proficiency and the trust in your results.
  • Makes cell quality using TNC, viability, CD34 or CFU assays obsolete.
  • Suspension Expansion Culture™ (SEC™ Technology allows automated use of 96-well plates or 384-well plates for true high-throughput capability for large numbers of samples.
  • SEC™ Technology means more accurate dispensing, smaller sample and reagents volumes with faster (automated) setup.
  • Most rapid stem cell functional assay available.
  • Let the plate reader measure and calculate results in 5 minutes or less.
  • Everything is included in the assay kit to culture and measure stem cell quality. Just prepare and add cell sample.
  • Always reliable and reproducible results.
  • Easy to use, time efficient and cost-effective.
  • Easy to learn in just 1 day.
(1) Frozen samples produce a response 2-3 time lower than fresh samples.

Principle of ATP Bioluminescence Cell Proliferation Assays

All ATP bioluminescence assays kits from Preferred Cell Systems™ include an ATP standard(s) and controls.  Performing the ATP standard curve and controls is highly recommended. The controls are used to calibrate the luminescence plate reader and the ATP standard is used to standardize the assay. The values obtained from the standard curve and controls (see diagram below) are then compared to the measurement assurance parameters that are provided in the instruction manual. If the values obtained are within the ranges provided by the measurement assurance parameters, you, the user, have successfully performed the proficiency testing to ensure that you have not only performed the assay correctly, but that the results you obtain can be trusted.

No additional proficiency testing is required if the calibration and standardization procedure is performed. The values you obtain from each calibration and standardization can be logged and used for certification that the assay has been performed correctly and that the results are trustworthy.

Calibration and standardization of an ATP bioluminescence assay from Preferred Cell Systems™ - Measurement Assurance
 
  • Umbilical cord blood
  • Mobilized peripheral blood
  • Bone marrow
  • Purified cells from any of the above

The recommended cell purity is a mononuclear cell (MNC) fraction or higher purity. A total nucleated cell (TNC) fraction is not recommended as this contains high concentrations of cell impurities, such as red blood cells, neutrophils, platelets and other cells that dilute, mask and severely underestimate and even inhibit the detection of rare primitive stem cells.

STEM predict: How STEMpredict predicts whether a cord blood unit has high quality cord blood stem cells

Click image for larger view

STEMpredict™ for Cord Blood Stem Cells

The graph shows an example of how STEMpredict™ predicts stem cell growth, functionality and viability for umbilical cord blood cells. If cells are metabolically viable (which is not the same as being viable by dye exclusion methods), they will demonstrate cellular and mitochondrial integrity by producing intracellular ATP (iATP). The iATP concentration, in turn, directly correlates with proliferation ability. If a quantitative difference in proliferation ability between stimulated and unstimulated (background) stem cells exists, as shown in the graph, the stem cells from the product are predicted to proliferate and grow. In this way, STEMpredict™ not only detects whether the cells are metabolically viable, but also whether they will exhibit cellular functionality and proliferate. The assay therefore measures three parameters simultaneously.


This same concept and principle is applied to mobilized peripheral blood, bone marrow and purified hematopoietic cell products. It is also the cornerstone of all Preferred Cell Systems™ cellular therapeutic assays.

For Research Use Only. Not for clinical diagnostic use.

Luminescence or multimode plate reader with "glow" luminescence measuring capability. 

  • STEMpredict™ stem cell and control Master Mix
  • ATP standard
  • ATP high and low controls
  • ATP Enumeration Reagent
  • Sterile, 96- or 384-well plates for cell culture
  • Non-sterile 96-well plates (for assay calibration and standardization)
  • Sterile, adhesive foil covers to maintain sterility in unused wells

A specific video tutorial on using the STEMpredict™ is not yet available. Please scroll down and check out the QuickGuide and Technical Manual (if available). Below, are the links to perform the ATP bioluminescence readout:

How to Calibrate and Standardize an ATP Bioluminescence Assay - Part 1

How to Calibrate and Standardize an ATP Bioluminescence Assay - Part 2

Proficiency Testing of Hematopoietic Cellular Therapy Products
 

STEMpredict™ to triage and predict low from high quality stem cell products
 

Download the STEMpredict™ Technical Manual
Download the ATP Optimization Kit Protocol for First-Time Users
Download the Instrument Setup and RLU to ATP Conversion Procedure Download Certificate of Analysis (CoAs) for ATP Enumeration Reagent (ATP-ER)
Download Certificate of Analysis for ATP Stanadrds
Download Certificate of Analysis for ATP Controls
Download Certificate of Analysis of ATP Reconstitution Reagent
Download Certificate of Analysis for Sterile 96-Well Plates
Download Certificate of Analysis for Non-Sterile, 96-Well Plates
Download Certificate of Analysis for Sealing Films
Download Certificate of Analysis for IMDM

When ordering STEMpredict™, please copy the Catalog Number, click on Catalog Number Search and paste the number, followed by Search. You will be taken directly to the desired product.

 
Plate Format Catalog Number Format Number of Plates/Kit
96-well plate. 0.1mL/well assay K2-SP-1 Low serum 1
96-well plate. 0.1mL/well assay K2SF-SP-1 Serum-Free 1
384-well plate. 0.025mL/well assay K3-SP-1 Low serum 1
384-well plate. 0.025mL/well assay K3SF-SP-1 Serum-Free 1

To perform STEMpredict™, high throughput, a liquid handler (robot) is required
For bulk orders, please contact Preferred Cell Systems