Frequently Asked Questions

Human Sample Volume Requirements

MAP	Volume Required
	Serum or plasma	Other fluids*
Human DiscoveryMAP® 250+	750 µL	2.5 mL
Human DiscoveryMAP® 175+	500 µL	2 mL
Human OncologyMAP®	500 µL	2 mL
HumanMAP®	120 µL	650 µL
Human CardiovascularMAP®	100 µL	350 µL
Human AngiogenesisMAP™	200 µL	500 µL
Human InflammationMAP®	100 µL	200 µL
Human KidneyMAP®	100 µL	350 µL
Human MetabolicMAP®	100 µL	350 µL
Human TruCulture® MAP	100 µL	200 µL (TruCulture® Supernatant)
Human CytokineMAP A	50 µL	100 µL
Human CytokineMAP B	50 µL	100 µL
Human IP-10MAP	50 µL**	N/A
Human SMA-MAP	100 µL	300 µL

*Cerebrospinal fluid, urine, tissue culture supernatants,  bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings, etc.
**Plasma only. Plasma should be collected in BD P700 tubes, specialized vacutainers that are pre-loaded with DPPIV inhibitors, to prevent extra-corporeal cleavage of IP-10

Rodent Sample Volume Requirements

MAP	Volume Required
	Serum or plasma	Other fluids*
RodentMAP®	70 µL	300 µL
Rat MetabolicMAP®	70 µL	300 µL
Rat KidneyMAP®	70 µL	150 µL urine, 300 µL all other
Mouse CytokineMAP A	50 µL	100 µL
Mouse CytokineMAP B	50 µL	100 µL
Mouse CytokineMAP C	50 µL	100 µL

*Cerebrospinal fluid, urine, tissue culture supernatants,  bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings, etc.
If your volumes are not sufficient, please contact Myriad RBM for other options and information.

If your volumes are not sufficient, please contact Myriad RBM for other options and information.

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.

Once samples have been released for testing by Myriad 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.

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 (quantity not sufficient) results.

Our MAP services 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 Smaller numbers of samples can be submitted but the normal two week turnaround is no longer valid.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.

Samples should be shipped to Myriad RBM on dry ice via overnight courier to:

Kalyn Sowell
Myriad RBM, Inc
3300 Duval Road
Austin, TX 78759
512-835-8026

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.

Please reference our Human Sample Collection, Handling and Shipping Guidelines.

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.

No, but we have recommendations that we can provide upon request. Please e-mail info@myriadrbm.com to receive more information about our recommended storage facilities.

Tissue samples should be collected, weighed, and added to lysis buffer (100 mg of tissue per 900 µL 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 nitrogen 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 the supernatant.

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.

Myriad RBM 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.

Yes, in fact, our assays are validated to clinical laboratory standards. We have been CLIA accredited since 2006.

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.

Myriad RBM’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.

Contact your local sales representative to discuss custom analyte testing, reporting, and development. Validated ELISA assays can be performed to complete a testing menu.

Yes, custom analyte selections are available. Please contact your sales representative for pricing and volume requirements.

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.

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.

No.

You can view any changes to our assays on our change log.

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@myriadrbm.com for more details regarding custom reporting capabilities and pricing.

The LLOQ (Lower Limit of Quantitation) is the lowest concentration of an analyte in a sample that can be reliably detected and at which the total error meets the laboratory’s requirements for accuracy. In our case, the laboratory’s requirement for accuracy is the concentration of an analyte at which the coefficient of variation of replicate standard samples is 30%.

The LDD (Least Detectable Dose) is the concentration interpolated by the mean plus 3 standard deviations of 20 standard diluent blank readings.

NR stands for Not Reported. All reports including NR values will contain comment boxes explaining why measurements for an analyte have not been reported.

QNS means Quantity Not Sufficient for analysis. QNS is routinely used when there is not ample sample volume for testing.

LLOQ is the lowest concentration of an analyte in a sample that can be reliably detected and at which the total error meets the laboratory’s requirements for accuracy. Therefore, “< LLOQ" means that the analyte is either not detected or detected but can't be reliably quantified.

Regulatory agencies do not currently provide guidelines for data analysis regarding which specific numbers should be assigned to values that are < LLOQ. The following are methods that have been used in practice.

1. If the data all come from a single lot of reagents, we can assign some percentage of LLOQ to values, such as 50% of LLOQ. FDA reviewers consider that 0 is not a good choice here, since we are not sure that there is absolutely no analyte in the sample.
2. If the data come from multiple lots, the LLOQs might be different for the lots. A potential problem arises when a different LLOQ is used for each lot. For example, suppose that cases are run with one lot, and controls are run with a different lot. If the LLOQ in the case lot is higher than that in the control lot, the apparent separation between cases and controls would be artificially increased. It would be desirable to use a single derived LLOQ across multiple lots, for example, by taking the average of LLOQs or the weighted average of LLOQs based on numbers of samples.

Yes. Please contact your sales representative for a price quote.

For all measurements less than 10, we will report up to two significant digits. If the result is greater than 10, no digits beyond the decimal place will be reported. For example, 0.004238 would be reported as 0.0042, 4.2380 would be reported as 4.2, and 42.38 would be reported as 42.

Click here for a summary of the changes made to Myriad RBM’s biomarker data reports in August of 2012.

Kits are not provided for any sample collection except TruCulture®.

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.

Other stimulants are available, but require a custom manufacturing lot and a commitment to purchase a minimum number of tubes.

Ready to Order Stimulants	Major Target Cells
Lipopolysaccharide (LPS)	Monocytes, T-cells
Made to Order Stimulants	Major Target Cells
Staphylococcal Enterotoxin type B (SE-B)	Th1>>Th2
LPS + SE-B	Monocytes, T-cells and Th1>>Th2
Anti-CD-3 antibody	Th1>Th2 (~ 1 out of 6 donors does not respond to this type of stimulus in whole-blood)
Anti-CD3 antibody + Anti-CD28 antibody	Th1, Th2, regulatory T cells (~ 1 out of 6 donors does not respond to this type of stimulus in whole-blood)
SE-B + Anti-CD28 antibody	Th1>Th2
Zymosan	Granulocytes, monocytes