Samples – Requirements, Logistics and Compatibility

What are the sample volume requirements?

Human Sample Volume Requirements
MAP Volume Required
Serum or plasma Other fluids*
Human DiscoveryMAP® 650 µL 3 mL
Human ExplorerMAP™ 300 µL 800 µL
HumanMAP® 150 µL 650 µL
Human CardiovascularMAP® 200 µL 700 µL
Human AngiogenesisMAP® 250 µL 500 µL
Human InflammationMAP® 50 µL 300 µL
Human ImmunoMAP® 200 µL 650 µL
Human NeuroMAP™ 100 µL 500 µL
Human MetabolicMAP® 50 µL 300 µL
Human KidneyMAP® 50 µL 350 µL
Human CytokineMAP® A 50 µL 125 µL
Human CytokineMAP® B 50 µL 125 µL
Vectra® DA** 300 µL n/a

* Cerebrospinal fluid, urine, tissue culture supernatants,  bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings, etc.

** Serum is the only accepted sample type for Vectra DA testing. If MAP and Vectra DA testing services are requested, please provide a separate electronic sample manifest and sample aliquot for Vectra DA testing. All Vectra DA testing is performed at Crescendo Biosciences, Inc.

Simoa™ Services
Biomarker LLOQ*
(Serum and Plasma)
LLOQ*
(Undiluted Samples)
Volume Required
Serum or plasma Other fluids**
Amphiregulin (AR) 0.24 pg/mL 0.06 pg/mL 100 µL 150 µL
B Lymphocyte Chemoattractant (BLC, CXCL-13) 0.64 pg/mL 0.064 pg/mL 50 µL 150 µL
Granulocyte Colony-Stimulating Factor (G-CSF) 0.59 pg/mL 0.059 pg/mL 50 µL 150 µL
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) 0.036 pg/mL 0.009 pg/mL 100 µL 150 µL
Growth/differential factor 11 (GDF-11) 5.00 pg/mL 1.25 pg/mL 100 µL 150 µL
Interferon alpha (IFN-alpha) 0.11 pg/mL 0.055 pg/mL 150 µL 150 µL
Interferon beta (IFN-beta) 0.16 pg/mL 0.04 pg/mL 100 µL 150 µL
Interferon gamma (IFN-gamma) 0.019 pg/mL 0.0095 pg/mL 150 µL 150 µL
Interleukin-1 beta (IL-1 beta) 0.031 pg/mL 0.016 pg/mL 150 µL 150 µL
Interleukin-2 (IL-2) 0.050 pg/mL 0.025 pg/mL 150 µL 150 µL
Interleukin-5 (IL-5) 0.052 pg/mL 0.026 pg/mL 150 µL 150 µL
Interleukin-6 (IL-6) 0.091 pg/mL 0.0046 pg/mL 50 µL 150 µL
Interleukin-10 (IL-10) 0.037 pg/mL 0.0092 pg/mL 100 µL 150 µL
Interleukin-12 Subunit p40 (IL-12p40) 7.30 pg/mL 0.730 pg/mL 50 µL 150 µL
Interleukin-17A (IL-17A) 0.048 pg/mL 0.012 pg/mL 100 µL 150 µL
Interleukin-31 (IL-31) 0.024 pg/mL 0.006 pg/mL 100 µL 150 µL
Kidney Injury Molecule-1 (KIM-1) 3.10 pg/mL 0.155 pg/mL 50 µL 150 µL
Neurofilament Light Chain (NF-L) 1.00 pg/mL 0.25 pg/mL 120 µL 200 µL
Tumor Necrosis Factor-alpha (TNF-α) 0.078 pg/mL 0.020 pg/mL 100 µL 150 µL

* Lower limit of quantitation (LLOQ) represents the lowest amount of an analyte that can be quantitatively determined with acceptable precision. LLOQ is determined by performing 2-fold serial dilutions of Standard to be tested in triplicate over three runs. The percent coefficient of variation (CV) is calculated for each of the dilution replicates, and the LLOQ is determined as the concentration at which the CV is 30%.

** 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.

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 designated “other fluids” 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 Myriad RBM, most orders are completed within 10 business days for MAP testing and 20 business days for Simoa testing. Longer times are required if a minimum number of samples is not submitted for certain MAPs or Simoa assays.

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 QNS (quantity not sufficient) results.

What is the minimum number of samples that can be sent?

Our MAP and Simoa services require at least 50 samples be sent in one batch for testing. Smaller numbers of samples can be submitted but the normal turnaround is no longer valid. Samples will be tested when at least 50 are accumulated. The InflammationMAP does not have a sample minimum.

How should samples be shipped to Myriad RBM?

Samples should be shipped to Myriad RBM on dry ice via overnight courier. If shipping via FedEx, please select Priority Overnight delivery to ensure the package is delivered during standard business hours. It is preferable to have samples arrive in a tube containing sufficient volume for all testing and a barcode to help speed the check-in process.

Kalyn Sowell
Myriad RBM, Inc
3300 Duval Road
Austin, TX 78759
Phone: (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.

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

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 courier you would like us to use and the account number to which this may be billed.

Can Myriad RBM properly dispose samples should I not want them returned?

Yes, samples to be disposed are placed into appropriately labeled and prepared Biohazard containers for routine pickup and destruction.

Can Myriad RBM store samples?

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.

What is the recommended protocol for tissue homogenization?

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.

What is Myriad RBM’s holiday schedule?

Myriad RBM’s offices will be closed on the following dates:

Date Holiday
Monday, January 1, 2018 New Year’s Day
Monday, January 15, 2018 Martin Luther King Jr. Day
Monday, February 19, 2018 President’s Day
Friday, March 30, 2018 Good Friday
Monday, May 28, 2018 Memorial Day
Tuesday, July 3, 2018 Day Before Independence Day
Wednesday, July 4, 2018 Independence Day
Monday, September 3, 2018 Labor Day
Thursday, November 22, 2018 Thanksgiving Day
Friday, November 23, 2018 Thanksgiving Holiday
Monday, December 24, 2018 Christmas Eve
Tuesday, December 25, 2018 Christmas Day
Monday, December 31, 2018 New Year’s Eve

MAP and Simoa 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. It is our practice to test samples in single determination unless otherwise specified on the sample submission form.

Can Myriad RBM do GLP testing?

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.

Can Myriad RBM test clinical samples?

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

Can Myriad RBM receive samples from central labs, CRO's, or other clinical sites?

Yes, Myriad RBM can receive samples from facilities capable of shipping them to our facility as part of a clinical study. We request samples be sent in batches of 50 samples minimum rather than as they are collected.

How are Myriad RBM assays validated?

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.

Can analytes be added that are not part of our standard service offerings?

Yes, products can be customized by adding or removing analytes, Contact your local sales representative to discuss custom analyte testing, reporting, and development.

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 Non-Human Primate samples?

Many assays found in the human products have been tested using non-human primate samples, showing that many of the human assays can detect the corresponding non-human primate 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.

Does Myriad RBM have data for common animal models/disease states?

No.

Where can I find an up-to-date list of any important changes to Myriad RBM's assays?

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

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 custom reporting upon request.

Upon request, Myriad RBM can provide result data in a flat, vertical format, more conducive to database processing where each data row represents a single result. The data file is a text file with each data point separated by a pipe (|) character.

Please contact your sales representatives or clientservices@myriadrbm.com for more details regarding custom reporting capabilities and pricing.

How will samples be identified in my standard data report?

Unless otherwise specified by the client, Myriad RBM’s receiving personnel will use the simplest unique identifier printed on the sample’s label and on the electronic Excel manifest. For instance, if a barcode is present on the sample’s label, then the barcode will be used as the sample identifier in the standard data report.

How will data be delivered to me?

Myriad RBM’s standard data reports are delivered as excel files via secure e-mail. If an alternate transfer method of delivery is required, please contact our Client Services team at clientservices@myriadrbm.com.

What does LLOQ mean?

The lower limit of quantitation (LLOQ) is the concentration at the lower standard curve range at which the coefficient of variation (CV) is 30%. The LLOQ represent the lowest amount of analyte that can be detected accurately. The LLOQ is determined by 2-fold dilutions of Standard 5 for 8 dilutions and assaying the samples in triplicate over three different runs. The CV is calculated and plotted against concentration. The LLOQ is interpolated from this plot, and multiplied by the dilution factor.

What does LDD mean?

The least detectable dose (LDD) is the concentration of target analyte that produces a signal that can be distinguished from that produced by a blank. The LDD is determined by adding three standard deviations to the average of the signal for twenty replicate determinations of the standard curve blank. This value is converted to concentration as interpolated from the standard curve and multiplied by the dilution factor used for the assay.

What does NR on the report mean?

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

What does QNS Mean?

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

What does < LLOQ mean in the report?

It is our standard practice to report data falling below the LLOQ value as

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 may not a good choice, 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.

Can the data report be customized?

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

How many significant figures will be reported for my data?

For all measurements less than 100, we will report two significant digits. If the result is greater than or equal to 100, we will report three significant digits.

How are the Myriad RBM Ranges included in my data report calculated?

The ranges shown at the top of Myriad RBM’s standard data reports are available for serum, EDTA-plasma, and urine sample types only, when applicable. We do not report or provide ranges for any other types of samples. The Myriad RBM range is determined based on the testing of approximately 100 apparently healthy individuals and no assumption is made about the samples having a normal distribution. The range comprises the middle 95%, with the highest and lowest 2.5% of the samples excluded for each given assay.

Where can I find a summary of the reporting changes made in August 2012?

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

Can Myriad RBM accommodate demographic reconciliation?

Yes, if demographic data has been included as unique field either on the Excel lab report or in a custom data file, then demographic data reconciliation can be performed. Myriad RBM aims to complete reconciliation requests within 3 business days, however large volume requests may take more time.

Reconciliation requests must be formally documented, preferably in an Excel spreadsheet containing a cumulative list of all requests for a project. The request should include the following pieces of information: person making the request, request date, sample identification as applicable (barcode, subject, visit, time point), value to change, old value, new value, reason for change. Myriad RBM will note the date each change was made to our database and will return the document when each reconciliation cycle is completed.

Can result data be delivered in a custom format?

Yes. This brochure describes the available formatting options. Please contact your sales representative for a price quote.

Secure Email Data Transfers

All standard data reports will be sent securely beginning in April 2016

How will secure messages be delivered

Incoming secure messages will be delivered as a standard email from our reporting group with a subject line containing your order number “Order # 123456”.

How do I view my secure message?

The email will contain a link to your secure message, “Click here to view your secure message from Myriad RBM, Inc.” Upon clicking the link, your message and attachment(s) will be displayed.

How do I access attachments sent to me in my secure message?

Once your message is displayed, attachments are opened by clicking the attachment name. If the program is known, the attachment is opened automatically; unknown programs open in a new browser window. You may also be presented with a pop up box giving you the option to open or save the attachment to your own network drive.

How do I reply to a secure message?

When viewing the secure message, you will see a ‘Reply’ button that you can use to respond to the email.

How long is the secure message accessible?

Messages will expire 30 days after receipt.

What happens if I need to retrieve my data after 30 days?

The data will need to be resent. Contact our Client Services team at clientservices@myriadrbm.com to request a resend of the data.

Why is my data being sent securely?

Data is sent securely to help protect sensitive information contained within the report.

How is my data secured?

Attachments are transmitted using 256-bit SSL encryption.

What do I do if I'm having problems viewing the secure message in my browser?

Click here for troubleshooting information.

TruCulture

Does Myriad 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.

How should TruCulture Tubes be thawed prior to use?

Thaw the required number of TruCulture tubes for 1 hour at room temperature, in a non-styrofoam or insulating rack. Never thaw the tubes at >37°C. After thawing, TruCulture tubes cannot be refrozen and should be discarded if blood is not drawn within 24 hours.

What is the recommended incubation time for TruCulture Tubes?

Incubate all TruCulture tubes at 37˚C in the block thermostat (or equivalent) for a study-defined period of time, preferably not to exceed 48 hours. TruCulture Tubes are typically incubated for 24 hours. The study defined time should be strictly adhered to for all specimens of the same cohort. Any deviations should be noted, and it is recommended that the exact start and stop time of the cultures are recorded for each tube.

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.

Part # Stimulus Description
782-001086 Null Pure (proprietary) TruCulture media without stimulants
782-001087 Lipopolysaccharide (LPS) Bacterial endotoxin (E.coli, O55:B5) that elicits a strong innate immune response
782-001089 LPS + Staphylococcal Enterotoxin B (SEB) This combination elicits a coordinated activation of T-cells (see below) and cells of the innate immune system (see above)
782-001124 Staphylococcal Enterotoxin (SEB) Bacterial superantigen, stimulating polyclonal T-cell responses via the T-cell receptor (Th1 bias)
782-001125 anti-CD3 + anti-CD28 Two antibodies triggering T-cell activation via the signaling unit of the T-cell receptor complex (CD3) + co-activation (intensifying T-cell responses, adding activities of Th2 and Treg) via CD28
782-001126 SE-B + CD28 Bacterial superantigen, stimulating polyclonal T-cell responses via the T-cell receptor (Th1 bias) + co-activation (intensifying T-cell responses, also those of Th2) via CD28
782-001202 anti-CD3 T-cell activation via the signaling unit of the T-cell receptor complex (CD3)
782-001295 TNF-alpha Pro-inflammatory cytokine; weak activator of mediator synthesis when used alone
782-001224 Intron A (IFN-alpha) Type I interferon, modulator of for example T lymphocyte responses
782-001225 Intron A + LPS-EB high IFN-alpha modulates the response of cells of the innate immune system to LPS (see above)
782-001259 Zymosan ß-glucan particles (fractions of yeast cell walls); stimulates phagocytes
782-001261 LPS-EB high Bacterial endotoxin (E.coli, O111:B4) that elicits a strong innate immune response
782-001264 Resiquimod R848 Synthetic agonist of TLR7 and TLR8 (both responding to single-stranded RNA)
782-001269 Gardiquimod Synthetic agonist of TLR7 (responding to single-stranded RNA, for example)
782-001272 Adenosine Triphosphate (ATP) + Lipopolysaccharide (LPS-EB) in high concentration ATP modulates via purinergic receptors (such as P2X7) LPS-induced activation of cells of the innate part of the immune system
782-001273 Lauroyl-γ-D-glutamyl-meso-diaminopimelic acid (C12-iE-DAP) Dipeptide representing bacterial peptido-glycan, activator of NOD1 (intracellular pattern recognition receptor)
782-001274 Fibroblast-stimulating Lipopeptide (FSL-1) Synthetic analogue of microbial lipoprotein; agonist of TLR2/TLR6
782-001275 HKEB Heat killed preparation of the gram negative bacterium, E. Coli O111:B4. Stimulates Toll-Like Receptor 2 (TLR2)
782-001276 HKLR Heat killed Lactobacillus rhamnosus. Stimulates TLR2
782-001277 Interferon beta (IFN-beta) Type I interferon, modulator of for example T lymphocyte responses
782-001278 Interleukin-1beta (IL-1beta) + tumor necrosis factor-alpha (TNF-alpha) 2 synergistically acting pro-inflammatory cytokines (weak to modest immune cell activation)
782-001279 Intron A + anti-CD3 + anti-CD28 IFN-alpha modulates the T-cell response to anti-CD3 + anti-CD28 (see above)
782-001280 Lipoarabinomannan from M. smegmatis (LAM-MS) Lipoglycan in mycobacterial cell walls that activates macrophages through TLR-2.
782-001281 Class A CpG oligonucleotide (ODN 2216) + LPS-EB high ODN is a synthetic oligonucleotide including CpG motifs that are common in bacterial DNA. ODN stimulates the immune system through TLR9.
782-001282 Polyinosinic:polycytidylic acid (Poly I:C) Analogue of double-stranded RNA, mimics the presence of viral infection. Activator of TLR3.
782-001291 NegCo TruCulture media without stimulants, specially formulated for premium and custom tubes.