Frequently Asked Questions
Samples – Requirements, Logistics and Compatibility
- What are the sample volume requirements?
- What sample types are acceptable?
- What is the standard turnaround time for receiving results?
- Can samples be tested if my volume does not meet the standard volume requirements?
- What is the minimum number of samples that can be sent?
- How should samples be shipped to RBM?
- In what type of tubes should samples be sent? Can I send a microtiter plate?
- May I have remaining samples shipped back to me?
- Can RBM store samples?
- Do we have a recommended protocol for tissue homogenization?
MAPs and Testing Capabilities
- Are replicates necessary?
- Can RBM do GLP testing?
- Can RBM test clinical samples?
- Can RBM receive samples from central labs, CRO’s, or other clinical sites?
- How are RBM assays validated?
- Can analytes be added that are not part of a specific product?
- Can I measure a subset of the MAPs?
- Do the human MAPs cross react with monkey samples?
- How does assay performance compare to ELISA? To Luminex kits, MSD, and other multiplex platforms?
- Our CLIA certification requires that we participate in a proficiency testing survey for those assays that have a survey.
- Does RBM have data for common animal models/disease states?
Reporting
- What is the standard report format?
- What does QNS stand for?
- What does LDD stand for and how should I interpret results that fall below the LDD value?
- What is LLOQ?
- Can the data report be customized?
TruCulture
- Does RBM provide kits to clinical sites for sample collection?
- Do you provide lab supplies for the phlebotomy and transportation?
- List of Standard TruCulture™ Stimulants
Samples – Requirements, Logistics and Compatibility
What are the sample volume requirements?
| MAP | Volume Required | |
|---|---|---|
| Serum or plasma | Other fluids* | |
| Human DiscoveryMAP™ v. 1.0 | 500 µL | N/A |
| HumanMAP® v. 1.6 Antigens | 100 µL | 350 µL |
| Human PsyMAP™ v. 1.0 | 120 µL ** | 600 µL |
| Human CardiovascularMAP™ v. 1.0 | 100 µL | 350 µL |
| Human InflammationMAP™ v. 1.0 | 100 µL | 200 µL |
| Human KidneyMAP™ v. 1.0 | 100 µL | 350 µL |
| Human MetabolicMAP™ v. 1.0 | 100 µL | 350 µL |
| Human TruCulture™ MAP v. 1.1 | 100 µL | 200 µL (TruCulture™ Supernatant) |
| Human Human CytokineMAP™ A v. 1.0 | 50 µL | 100 µL |
| Human Human CytokineMAP™ B v.1.0 | 50 µL | 100 µL |
| Human Autoimmune SerologyMAP™ v. 1.0 | 40 µL | N/A |
| Human Infectious Disease SerologyMAP v. 1.0 | 40 µL | N/A |
| MAP | Volume Required | |
|---|---|---|
| Serum or plasma | Other fluids* | |
| RodentMAP® v. 2.0 Antigens | 70 µL | 300 µL |
| Rat MetabolicMAP™ v. 1.0 | 70 µL | 300 µL |
| Rat KidneyMAP™ v. 1.0 | 70 µL serum or plasma 85 µL urine |
300 µL |
| Mouse CytokineMAP™ A v. 1.0 | 50 µL | 100 µL |
| Mouse CytokineMAP™ B v. 1.0 | 50 µL | 100 µL |
| Mouse CytokineMAP™ C v. 1.0 | 50 µL | 100 µL |
What sample types are acceptable?
Serum, plasma, urine, cell culture supernatants, CSF, and BALF are our standard acceptable sample types. All other sample types will be handled as a custom service and some may not be feasible for testing.
What is the standard turnaround time for receiving results?
Once samples have been released for testing by RBM, most samples are completed within 10 business days. Longer times are required if a minimum number of samples is not submitted for certain MAPs.
Can samples be tested if my volume does not meet the standard volume requirements?
If the volume of the sample is less than the required amount (please see sample volume requirements), there may not be enough sample to test all analytes. The subsequent report may contain
What is the minimum number of samples that can be sent?
The DiscoveryMAP™, Human and Rodent MetabolicMAPs, and Custom HumanMAPs require at least 50 samples be sent in one batch for testing. Smaller numbers of samples can be submitted but the normal two week turnaround is no longer valid. The samples will be tested when at least 50 are scheduled. All other MAPs have no minimum sample numbers.
How should samples be shipped to RBM?
Samples should be shipped to RBM on dry ice via overnight courier to
Ashley Garrett
Rules-Based Medicine, Inc
3300 Duval Road
Austin, TX 78759
512-835-8026
In what type of tubes should samples be sent? Can I send a microtiter plate?
Samples may be sent in a variety of tubes including screw and snap top microcentrifuge tubes. Microtiter plates are also acceptable. Please ensure that tubes and plates are packaged and sent in such a way that evaporation or leakage does not occur during shipping.
May I have remaining samples shipped back to me?
Yes. Please indicate that you would like samples returned to you on the sample submission form. Please include the carrier you would like us to use and the account number to which this may be billed.
Can RBM store samples?
No, but we have recommendations that we can provide upon request. Please e-mail info@rulesbasedmedicine.com to receive more information about our recommended storage facilities.
Do we have a recommended protocol for tissue homogenization?
Tissue samples should be collected, weighed, and added to 9X volume of lysis buffer. Our recommended lysis buffer is 50mM Tris-HCL with 2mM EDTA, pH 7.4. If the samples are not homogenized immediately then the samples should be frozen in liquid N2 and stored at -80° C. While EDTA is a good inhibitor of divalent metal requiring proteases, you may want to minimize other protease activity by adding the following inhibitors: aprotinin, antipain, leupeptin, and pepstatin A (all at 1ug/ml) and 2mM PMSF (phenylmethylsulfonyl flouride).
Tissues may be homogenized using a Potter-Elvehjem homogenizer (Teflon pestle and glass mortar) attached to a variable-speed drill, a polytron or a tissuemizer. During the homogenization process, the tube should be submersed in an ice bath to maintain the sample at 2-8° C. Following homogenization, the tissue preparation is centrifuged for 2 minutes in a microfuge at 13,000xg. Making sure that the cell pellet is not disturbed; aspirate a minimum of 240 µL per sample to be shipped to us. The sample must be frozen immediately and if stored, placed in a -80° freezer. When you are ready to ship the samples, they must be placed in dry ice and shipped by an overnight carrier.
MAPs and Testing Capabilities
Are replicates necessary?
Replicates are not necessary as our assays use automated liquid handling and are validated to have minimal lot to lot and run to run variability.
Can RBM do GLP testing?
Rules-Based Medicine, Inc. supports GLP studies. If you would like your study conducted according to GLP guidelines, please be sure to request this from your sales representative as an additional cost is associated.
Can RBM test clinical samples?
Yes, in fact, our assays are validated to clinical laboratory standards. We have been CLIA accredited since 2006.
Can RBM receive samples from central labs, CRO’s, or other clinical sites?
Yes, typically we can upload biomarker data directly to their data management systems, but a consultation is necessary to confirm compatibility. Please contact your local sales representatives for more information.
How are RBM assays validated?
Rules-Based Medicine’s multi-analyte profiles (MAPs) have been validated to Clinical Laboratory Standards Institute (formerly NCCLS) guidelines. These are based upon the principles of immunoassay and rigorously examine the fundamental assay parameters of least detectable dose, lower limit of quantification, precision, cross-reactivity, linearity, spike-recovery, dynamic range, matrix interference, freeze-thaw stability, and short-term sample stability.
Can analytes be added that are not part of a specific product?
Contact your local sales representative to discuss custom analyte testing, reporting, and development. Validated ELISA assays can be performed to complete a testing menu.
Can I measure a subset of the MAPs?
Yes, custom analyte selections are available. Please contact your sales representative for pricing and volume requirements.
Do the human MAPs cross react with monkey samples?
Many assays found in the Human products have been tested using primate samples, showing that many of the human assays can detect the corresponding monkey analyte.
How does assay performance compare to ELISA? To Luminex kits, MSD, and other multiplex platforms?
There will most likely be discrepancies in absolute values seen between results from different platforms. For most assays, we use the recommended matched antibody pair and standard from a reliable source. Currently, no “gold standard” exists for comparing assay platforms.
Question?
Our CLIA certification requires that we participate in a proficiency testing survey for those assays that have a survey.
Does RBM have data for common animal models/disease states?
No.
Reporting
What is the standard report format?
Data is transmitted via email to the recipient(s) listed on the Sample Submission Form. The standard report format is an Excel® spreadsheet and can be viewed by clicking the link Sample Report. We can also upload data to data management sites and provide some custom reporting upon request. Please contact your sales representatives or info@rulesbasedmedicine.com for more details regarding custom reporting capabilities and pricing.
What does QNS stand for?
Quantity Not Sufficient.
What does LDD stand for and how should I interpret results that fall below the LDD value?
The Least Detectable Dose (LDD) is defined as the concentration interpolated by the mean plus 3 standard deviations of 20 standard diluent blank readings. The LDD is typically near the lower limit of quantitation. Values reported below the LDD may be used, but we urge caution in using this data as it is subject to higher imprecision. Values falling within the workable assay range (calibration curve) are reported; results below the detection ability of the assay are reported as <LOW>.
What is LLOQ?
The lower limit of quantitation (LLOQ) is defined as the point at which the Coefficient of Variation (CV) for replicate samples is 30%. It was determined by 2-fold serial dilutions of assay standards tested in triplicate over three different runs.
Can the data report be customized?
Yes. Please contact your sales representative for a price quote.
TruCulture
Does RBM provide kits to clinical sites for sample collection?
Kits are not provided for any sample collection except TruCulture™.
Do you provide lab supplies for the phlebotomy and transportation?
Phlebotomy supplies are not included for samples to be tested except when the TruCulture™ system has been ordered. Transportation, coordination and associated costs are the responsibility of the customer.
List of Standard TruCulture™ Stimulants
Other stimulants are available, but require a custom manufacturing lot and a commitment to purchase a minimum number of tubes.
| Stimulant | Major Target Cells |
| Lipopolysaccharide (LPS) | Monocytes, T-cells |
| Zymosan | Granulocytes, Monocytes |
| Anti-CD3 antibody | Th1>Th2 |
| Anti-CD3 antibody + Anti-CD28 antibody | Th1, Th2, regulatory T cells |
| Staphylococcal Enterotoxin type B (SE-B) | Th11>1>Th2 |
| LPS + SE-B | Monocytes, T-cells and Th11>1>Th2 |