Frequently Asked Question

What sample types are acceptable?

Serum, plasma, urine, cell culture supernatants, CSF, and BALF are accepted for most Luminex and Simoa assays. Serum and plasma are accepted for Olink testing. For Alamar NULISA testing, serum, plasma and CSF are accepted. Serum and plasma are accepted for MSD. 

Other fluids are accepted for specific assays. Please email client services with specific questions

What is the standard turnaround time for receiving results?

Once samples have been released for testing by IQVIA Laboratories Protein Biomarkers, most orders are completed within 10 business days for MAP testing and 25-30 business days for Simoa testing. Longer times are required if a minimum number of samples is not submitted for certain MAPs or Simoa assays. Turnaround time for Olink testing is 6-10 weeks. Ask about turnaround times for other platforms. 

How will data be delivered to me?

IQVIA Laboratories Protein Biomarkers standard data reports are delivered as Excel files via secure e-mail. If an alternative transfer method of delivery is required, please contact our Client Services team.

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, 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 are 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 IQVIA Laboratories Protein Biomarkers?

Samples should be shipped to IQVIA Laboratories Protein Biomarkers 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.

IQVIA Laboratories Protein Biomarkers

Receiving Department 
3300 Duval Road
Austin, TX 78759
Phone: (512) 835-8026

What tube types are accepted? 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.

What happens to samples after testing?

Samples will be disposed of using standard procedures unless requested otherwise. If samples should be returned, please indicate on sample submission form. Please include the courier you would like us to use and an account number for billing. 

Samples are not stored long-term at our IQVIA Laboratories Protein Biomarkers lab, but we can provide recommendations upon request.  Please email client services to receive more information about 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 IQVIA's US holiday schedule?

IQVIA Laboratories Protein Biomarkers will be closed on the following dates:

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

Yes, IQVIA Laboratories Protein Biomarkers 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 assays validated?

The multi-analyte profiles (MAPs) perfromed at IQVIA Laboratiories Protein Biomarkers 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 samples be tested using a subset of the MAPs?

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

What is the standard report format?

Data is transmitted via secure email to the recipient(s) listed on the Sample Submission Form. The standard report format is an Excel® spreadsheet. We can also upload data to data management sites and provide custom reporting upon request.

Upon request, IQVIA Laboratories Protein Biomarkers 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 email client services 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, IQVIA Laboratories Protein Biomarkers' 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.

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 represents 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. 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%.

Can data reports be customized?

Yes. Please contact your sales representative to discuss your needs.

How many significant figures will be reported in data resulted from IQVIA Laboratories Protein Biomarkers?

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 IQVIA Laboratories Protein Biomarkers ranges included in my data report calculated?

The ranges shown at the top of our 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. Our 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.

Can IQVIA Laboratories Protein Biomarkers 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. Our team 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 and reason for change. Our team will note the date each change was made to our database and will return the document when each reconciliation cycle is completed.

What kits are provided by IQVIA Laboratories Protein Biomarkers to clinical sites for sample collection?

TruCulture collection kits will be supplied to customers with a valid TruCulture quote number. Ancillary system components such as butterfly needles and priming tubes can be included when requested.

Our IQVIA Laboratories Protein Biomarkers lab does not provide any other collection kits. 

Sites are responsible for any costs related to shipment of collected samples. 

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. Adhere to any study-defined times 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.

What stimulants can be added to TruCulture tubes?

TruCulture tubes can be customized with 20 validated stimulants. Requests for null tubes and LPS (lipopolysaccharide) tubes are typically shipped within 2 weeks. Tubes with other stimulants are typically delivered within 6-8 weeks after receipt of purchase order. 

Customer tubes can be delivered upon request. Out team can evaluate your stimuli of interest for sterility, solubility, dose response, short- and long-term stability, and reproducibility. Contact our TruCulture Client Service Team for more information.

What sample types are accepted?

Serum and plasma are accepted for Olink Explore HT, Target 48 and Target 96 panels. Other sample types may also be acceptable, please contact our Client Services team for confirmation.

What is the required sample volume?

One aliquot of 40μl dedicated to Target 48 or Target 96 testing is requested. A dedicated aliquot of 80μl is requested for Explore HT. Ask client services about volumes for other panels. 

What is the turnaround time for data?

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

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

IQVIA Laboratories Protein Biomarkers 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.

Whose kits are you using?

We use Olink-produced kits.

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

Any number of samples can be sent; but testing is purchased based on the multiples noted below: 

For Target 48, services must be purchased in multiples of 40 samples per batch (ie, 40, 80, 120, etc.)

For Target 96, services must be purchased in multiples of 88 samples per batch. 

For Explore HT, services must be purchased in multiples of 172 samples per batch. 

What are ULOQ, LOD, LLOQ, and LQL?

• ULOQ (Upper Limit of Quantitation) - defined as the highest analyte concentration on the calibration curve where the coefficient of variation (CV) and the relative error are both < 30%

• LOD (Limit of Detection) - defined as three fixed standard deviations above average for the negative controls. Results below the LOD will be more variable than results above the LOD. 
  

• LLOQ (Lower Limit of Quantitation) - defined as the lowest analyte concentration on the calibration curve where the coefficient of variation (CV) and the relative error are both < 30%.
• LQL (Lowest Quantifiable Level) - defined as the value used as the lower limit, LLOQ (default) or plate LOD, when plate LOD > LLOQ.

What are NaN, 'no data' and QNS?

• NaN (not a number) - data that is below the lowest parameter in the 4PL curve fit model and cannot be calculated.

• No Data - the failure of assay or sample where the plate passed quality control parameters.

• QNS (quantity not sufficient) - the sample quality is not sufficient for testing.