Frequently Asked Questions

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.

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.

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

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

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

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.

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.

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

No.

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.

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.

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.

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.

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.

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.

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%.

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.

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

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.

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.

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

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.

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

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.

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.

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

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

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

Please contact Client Services at RBM_ClientServices@iqvia.com 

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.

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.

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.