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Frequently Asked Questions

Samples – Requirements, Logistics and Compatibility

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 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 price will be based on 50 samples.

How should samples be shipped to RBM?

Samples should be shipped to 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
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 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 RBM store samples?

No, but we have recommendations that we can provide upon request. Please e-mail rbm_clientservices@iqvia.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 RBM's holiday schedule?

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

 

Date Holiday
Tuesday, January 2, 2024 New Year’s Day
Monday, January 15, 2024 Martin Luther King Jr. Day
Monday, February 19, 2024 President’s Day
Monday, May 27, 2024 Memorial Day
Thursday, July 4, 2024 Independence Day
Monday, September 2, 2024 Labor Day
Thursday-Friday, November 28-29, 2024 Thanksgiving Day
Tuesday-Wednesday, December 24-25, 2024 Christmas Day
Wednesday, January 1, 2025 New Year's Day

 

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 RBM do GLP testing?

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

Yes, 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 RBM assays validated?

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 Luxminex kits, MSD, and either 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 RBM have data for common animal models/disease states?

No.

MAP and Simoa Testing Capabilities

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, 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 RBM_clientservices@iqvia.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, 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?

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 RBM_clientservices@iqvia.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 <LLOQ as the imprecision of the value will be greater than 30% as defined by how LLOQ values are established. The 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. 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%.

What numbers should be assigned to the values that are < LLOQ for statistical analysis?

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 data reports 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 RBM ranges included in my data report calculated?

The ranges shown at the top of 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 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 changes made to RBM's biomarker data reports in August of 2012?

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

Can 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. 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. RBM will note the date each change was made to our database and will return the document when each reconciliation cycle is completed.

Secure Email Data Transfers

(Note: All standard data reports will be sent securely with Office 365 Encryption beginning February 2022.)
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 messages?

There are 2 ways to decrypt a secure email.

  • By providing your Microsoft email account credentials to authenticate the message.
  • By selecting ‘Sign in with One-time passcode’. The passcode will be sent to you via email, you then enter this passcode and click Continue and you are able to read the message.
How do I access attachments sent to me in my secure messages?

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.

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?

Cryptographic Mode 2 is an updated and enhanced AD RMS cryptographic implementation. It supports RSA 2048 for encryption.

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

Please contact Client Services at RBM_ClientServices@iqvia.com 

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.

How Should TruCulute 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
782-001125 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
782-001202 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
782-001259 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)
782-001280 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.

Olink 

What sample types are accepted?

EDTA plasma

What is the required sample volume?

One aliquot of 40ul plasma dedicated to Olink Target 48 testing is requested.

What is the turnaround time for data?

6-10 weeks from release of the samples into the testing queue.

What is the minimum number of samples that can be sent for Olink Target 48?

Our Olink Target 48 testing service requires a minimum of 40 samples to be sent in one batch for testing. Olink Target 48 services must be purchased in multiples of 40 samples per batch (ie, 40, 80, 120, etc.)

What is the data format and how is it provided to clients?

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 RBM_clientservices@iqvia.com.

What is the application?

Olink is available for research use only. This is not validated to clinical lab standards and testing is not performed in a CLIA-certified environment.

Whose kits are you using?

We use Olink-produced kits.