No, the Shipping and Receiving Department of the University of Iowa handles all of our package/mail receiving, and they are closed on Saturday and Sunday. 

• If you draw a sample on a Friday, please hold the sample until Monday and then ship it out.  
• Frozen serum and plasma samples must be kept in a -80°C freezer and then shipped overnight on the following Monday on at least 5 pounds of dry ice.  
• Whole blood samples should be refrigerated until Monday and then sent on a cool pack.

The Joint Commission National Patient Safety Goal #1 is to improve the accuracy of patient identification by using at least two (2) patient identifiers when providing care, treatment, or services. The Molecular Otolaryngology & Renal Research Laboratories (MORL) uses multiple patient identifiers to verify the correct patient is matched with the correct specimen and the correct order for the testing services. As a specimen is received at the MORL, the referral laboratory medical record number (MRN)/accession number, patient first and last name, patient age, and date of birth are verified by comparing the labels on the specimen tube or container with the MORL requisition form and any paperwork which accompanies the specimen to be tested. When discrepancies are identified, MORL will call the referring laboratory to verify discrepant information to assure we are performing the correct testing for the correct patient. When insufficient or inconsistent identification is submitted, MORL will recommend that a new specimen be obtained.

3-5 cc EDTA whole blood is required for genetic testing.  

The “Specimen Required” section of each requisition form includes the preferred volume. Preferred volume has been established to optimize testing and allows the laboratory to quickly process specimen containers, present containers to instruments, perform test, and repeat test, if necessary. Since patient values are frequently abnormal, repeat testing, dilutions, or other specimen manipulations often are required to obtain a reliable, reportable result. Our preferred specimen requirements allow expeditious testing and reporting.

When venipuncture is technically difficult or the patient is at risk of complications from blood loss (e.g., pediatric, or intensive care patients), smaller volumes may be necessary. Specimen minimum volume is the amount of sample necessary to provide a clinically relevant result as determined by the Molecular Otolaryngology and Renal Research Laboratories (MORL). When patient conditions do not mandate reduced collection volumes, we ask that our clients submit preferred volume to facilitate rapid, cost-effective, reliable test results. Submitting less than preferred volume may negatively impact quality of care by slowing turnaround times (TAT), increasing the hands-on personnel time (and therefore cost) required to perform test.

The MORL make every possible effort to successfully test your patient’s specimen. If you have concerns about submitting a specimen for testing, please call MORL at 319-335-6623 or email your question to morl@uiowa.edu. Our staff will discuss the test and specimen you have available. While in some cases specimens are inadequate for desired test, in other cases, testing can be performed using alternative techniques or sample type.

Please contact the MORL at 319-335-6623 or morl@uiowa.edu and provide the following information:  The name, address and telephone number of the responsible party for the air bill, a completed test requisition form, audiograms, clinic notes pertaining to the patient’s hearing loss, a medical pedigree showing any family history of hearing loss, and reports from any temporal bone imaging studies. 

Sample requirements depend on the test(s) being ordered. 

Specimens must have two person-specific identifiers on the patient label. Person-specific identifiers include:

· Sample specific accession number

· Patient's first and last name

· Unique identifying number (for example, medical record number)

· Date of birth

Specimens are considered mislabeled when there is a mismatch between the person-specific identifiers on the specimen and the information accompanying the specimen. This information might include a requisition form or additional paperwork.

In addition, if a handwritten name and a label are on the container, the information must match exactly. For example, "Rebecca" does not match "Becky." When insufficient or inconsistent identification is submitted, a new specimen may be required.

We do not partner with any laboratories. In order to get a referral for a blood draw or saliva collection you will need to ask your physician.

• All FROZEN samples must be processed and frozen down to -80°C immediately after collection
• Processing instructions for FROZEN samples can be found on page 3 of the MORL- Kidney Testing Requisition Form 
• Sample cryovials type must be clearly labeled as to type (either serum or plasma)
• Cryovials should be put in zip lock bags and completely covered in dry ice to keep the sample frozen until it arrives in the lab
• FROZEN samples should be shipped overnight on at least 5 lbs of dry ice
  • Monday – Friday deliveries ONLY 
    • No Weekend Deliveries

If samples arrive thawed they will be REJECTED.

For more information regarding samples click here. 

All tests are unique in their testing requirements. To avoid specimen rejection or delayed turnaround times, please check the “Specimen Required” for each test noted in the requisition form. You will be notified of rejected or problem specimens upon receipt.

Please review the following conditions prior to submitting a specimen to MORL:

• Sample collection, processing, and handling requirements

• Serum/ EDTA Plasma drawn at least 14 days post PLEX

• A previous bone marrow transplant from an allogenic donor will interfere with genetic testing. Contact the MORL for instructions for testing patients who have received a bone marrow transplant.

• Lack of hemolysis/lipemia

• Correct specimen type (EDTA plasma, serum, citrated plasma, whole blood) drawn for requested testing

• Specimen volume

• Patient information requested

• Proper identification of patient/specimen

• Specimen container (metal-free, separation gel, appropriate preservative, etc.)

• Transport medium

• Temperature (ambient, frozen, refrigerated)

Whole Blood Sample Stability for DNA extraction

EDTA Whole Blood is stable for 7 days at room temperature and 4 months in the refrigerator

Saliva Collection Kits and Buccal Swabs Sample Stability
Per the manufacturer, samples collected following the instructions with the OGR-500 saliva collection kits are stable at room temperature for several years and with the OCD-100 buccal swabs stable up to 80 days.  Both of these kits can be shipped at room temperature.

Frozen Serum, EDTA Plasma and Citrate Plasma Sample Stability

Serum or plasma samples must be frozen to below -80°C immediately after separation from cells. These samples remain viable for at least six months when stored at -80°C or shipped on dry ice.

Please visit our test menu here for ordering tests. Please contact the MORL Administration team at morl@uiowa.edu or by telephone at 319-335-6623 if you have any questions regarding ordering genetic testing.

No, a licensed and qualified healthcare provider must order testing.

Please send all prior testing information, audiograms, and pedigrees with the testing requisition form or email the MORL at morl@uiowa.edu

Cancellations received prior to test setup will be honored at no charge. Requests received following test setup cannot be honored. A report will be issued automatically and charged appropriately.

There are four broad groups of tests that are required for a comprehensive evaluation of the complement system: functional assays, biomarker assays, autoantibody assays, and genetic testing.

• Functional assays measure overall activity of the complement system by triggering one of the initiating pathways (usually the classical and alternative) and measuring the end consequence – the generation of the membrane attack complex.  These assays fall into a few major categories: hemolytic-based assays, liposome-based assays, and enzyme-linked immunosorbent assays, or ELISAs.  Hemolytic- and liposome-based assays quantitate the ability of a particular serum sample to lyse erythrocytes or liposomes as an indirect measurement of complement activity.  ELISAs quantitate the generation of new antigens on complement component 9 that are produced when it is assembled into the membrane attack complex.

• Assays of overall complement function provide an overview of basic complement activity but lack the specificity afforded by biomarker profiling, that is to say, the direct measurement of individual complement biomarkers and their cleavage or breakdown products.

• Biomarker assays provide details on complement activity and control at a more granular level.  Complement proteins and their breakdown products can be measured in serum or urine using various methods.  Commonly measured complement proteins include C3 and C4.  C3 and C4 can be measured by most laboratories, and abnormalities can help provide initial clues to underlying complement dysregulation.  However, measurement of many other complement proteins is needed for more complete assessment of the complement system.  Some of these markers include C3b, C3c, C3d, C4b, factor B, Ba, Bb, factor D, C5, C5a, properdin, and soluble membrane attack complex, as well as the complement regulators factor H and factor I.  Measuring the levels of these biomarkers in the circulation can provide a comprehensive picture of complement activity and potentially identify sites of complement dysregulation, which are typical of some rare complement-mediated kidney diseases. 

• Despite their clinical utility, there are important challenges in interpreting a panel of complement biomarkers.  First, the complement system is complex and incompletely understood. We interpret activity and dysregulation using only a limited number of markers.  Second, some biomarkers are impacted by biological processes irrespective of the concurrent disease. Good examples are factors D and Ba, as their levels increase as kidney function decreases.  And lastly, complement biomarkers measured in the circulation may not reflect local complement activity.

The short answer is No.  Unlike Membranous Nephropathy and AntiPLAR2 – where we only just now beginning to move this direction, the biomarkers in C3G are driven by a system that has a normal function – (ie the innate immunity), as well as a disease function.  It is the combination of the biomarkers and the biopsy result that help you understand the disease characteristics of a given patient (particularly degree of underlying complement dysregulation and possible remission on targeted therapy).

Yes, we offer fee-for-service familial variant testing for the following tests: 

• Genetic Renal Panel Familial Variant Testing
• OtoSCOPE® Familial Variant Testing 
• GJB2/GJB6 (Connexin 26/30) familial

For qualified OtoSCOPE® patients with Variants of Uncertain Significance (VUS), MORL offers the HEAR VUS program which provides complimentary testing of family members. (link to the HEAR VUS page) 

• Genetic variant interpretation is complex and relies on all available clinical, phenotypic and genetic information. There is no single method, tool, or filter that reliably determines pathogenicity and so expert analysis is required.
• All genetic testing results are discussed with a multidisciplinary team of experts in hearing loss or renal disease to discuss each variant in the context of available clinical information and provide expert contextual interpretation of genetic variants.
• The MORL classifies genetic variants according to the Hearing Loss-Specific guidelines for variant interpretation set by the American College of Medical Genetics and Genomics (ACMG). 
• Members of the MORL are active members of ClinGen Expert Gene and Variant Curation panels for Hearing Loss and Complement Mediated Kidney Disease.

Establishing a genetic cause for non-syndromic hearing loss saves healthcare dollars by making additional investigational tests, such as thin-cut computed tomography of the temporal bones, unnecessary. Establishing a cause of hearing loss also allows healthcare providers to provide to their patients prognostic information, such as rate of progression of hearing loss, and meaningful genetic counseling.

We provide clinicians caring for patients and families with non-syndromic hearing loss the most accurate and comprehensive genetic testing available today.

Complement functional testing is integral to a comprehensive care approach to patients with complement-mediated kidney disease.  Defining the degree of complement activity in a given patient, as well as documenting where in the complement pathway dysregulation is the greatest, is instrumental in defining underlying disease characteristics.  This information in turn is useful for determining next steps in care (i.e. whether treatment may be discontinued or whether escalation of care should be considered).   Importantly, data support that functional complement testing may also help define risk for relapse of complement-mediated kidney disease in the renal transplant setting.   (Please see: PMID: 24088957; PMID: 25341722; PMID: 25843230; PMID: 30692664)

There are times when the Molecular Otolaryngology and Renal Research Laboratories (MORL) receive requests for testing that are incomplete. The requisition may be missing billing/payment information, or the testing is ordered on an out-of-date requisition. We may also receive testing requests where the patient or their family are noted to be paying for the testing out-of-pocket or the healthcare provider has requested that the sample(s) be held until prior authorization for the testing can be obtained. The MORL will hold clinical samples for 1 year while working with the sendout lab to get a completed requisition; waiting for pre-payment of testing from the patient or their family; waiting on insurance prior authorization; or other reasons for the hold.

One year after the requested sample and testing has been received, the MORL will cancel the order in our system, and if the testing is still desired by the healthcare provider, a new testing requisition and sample(s) will be needed.

While we are a not-for-profit lab, we must charge for testing to cover the cost of materials and staff salaries. We have the lowest rates in the country and as each gene tested requires special handling the cost varies. 

A complete list of genes we test with the CPT codes and costs are on our testing menu.

Check back frequently as new genes or tests may be added to the list.

The price for familial testing is $220 per person per gene. 

The cost is test dependent. Our test menu provides a complete list of all tests offered by the MORL and their pricing.

The Molecular Otolaryngology and Renal Research Laboratories (MORL) are committed to maintaining confidentiality of patient information. To ensure Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA) compliance for appropriate release of patient results, the MORL has adopted the following policies:

Email/Fax/Phone Inquiry Policy—One of the following unique identifiers will be required:

• Patient ID number (assigned by the MORL) along with patient name; or

• Patient name and date of birth; or

• Identification by individual that they are the “referring healthcare provider” identified on requisition form received by the MORL.

The MORL is pleased to release completed results to non-referring healthcare providers with a signed consent to release information from the patient/patient’s guardian for the specific testing ordered from the MORL.

The Molecular Otolaryngology & Renal Research Laboratories (MORL) retains all test requisitions and patient test results at a minimum for the retention period required to comply with and adhere to the CLIA and The Joint Commission requirements. A copy of the original report can be reconstructed including reference ranges, interpretive comments, flags, and footnotes upon request by the original ordering healthcare provider or with a signed consent to release information.

The Molecular Otolaryngology & Renal Research Laboratories’ (MORL) extensive test menu reflects the needs of the patients we serve. We are committed to providing the most expedient TAT possible to improve diagnosis and treatment. We consider laboratory services as part of the patient care continuum wherein the needs of the patient are paramount. In that context, we strive to fulfill our service obligations. Our history of service and our quality metrics will document our ability to deliver on all areas of service including TAT.

The MORL defines TAT as the analytical test time (the time from which a specimen is received at the testing location to time of result) required and is listed for each test as “Report Available”. TAT is monitored continuously by each clinical testing team within the MORL. For the most up-to-date information on TAT for individual tests, please visit our testing menu or contact MORL at morl@uiowa.edu or 319-335-6623.

Genetic variant classification is done with the data available at time of testing. The laboratory encourages healthcare providers to contact the laboratory at any time to learn how the classification of a particular variant may have changed over time. Review of previously reported variants is done at no charge. Please contact MORL at MORL@uiowa.edu to request current interpretation and data for variants identified in a patient’s testing.

Variant classification is done with the data available at time of testing. Evaluation and categorization of variants are performed using published American College of Medical Genetics and Genomics and the Association for Molecular Pathology recommendations as a guideline as well as MORL expert evaluation. Other gene-specific guidelines may also be considered. Variants are classified based on known, predicted, or possible pathogenicity and reported with interpretive comments detailing their potential or known significance. Hearing loss variants classified as benign or likely benign are not reported but are available upon request.

Multiple in silico evaluation tools may be used to assist in the interpretation of these results. The accuracy of predictions made by in silico evaluation tools is highly dependent upon the data available for a given gene, and periodic updates to these tools may cause predictions to change

over time. Results from in silico evaluation tools are interpreted with caution and professional clinical judgement.

Rarely, incidental findings or secondary findings may implicate another predisposition or presence of active disease. Incidental findings may include, but are not limited to, results related to the sex chromosomes.

C3G is an ultra-rare kidney disease that most frequently affects children and young adults. It may present with few obvious symptoms. Many times, findings of blood and/or protein in the urine are identified during a routine doctor appointment or while being evaluated for high blood pressure. Others present with more aggressive symptoms such as swelling and acute kidney injury. Fatigue is a frequent patient complaint.

C3G is caused by excessive activity of the alternative pathway (AP) of complement, an important part of our immune system. This is why it frequently presents for the first time after an infection – after the immune system has been activated. Once activated, the immune system of the C3G patient fails to shut down properly, and the excess activity begins to create many byproducts of complement activity (protein complexes and breakdown products) that deposit on the kidney and produce disease. Excess complement activity is why many (but not all) patients with C3G present with a low complement C3 level in the blood; C3 is being consumed (“used up”) due to dysregulation of the alternative pathway of complement.

The driver or cause of C3G is most often autoimmune (~65%), and less frequently genetic (~20%). Autoimmune proteins known as nephritic factors (C3, C5 and/or C4) are most commonly identified. They bind to and disrupt the normal function of key enzymes in the complement system. Other complement protein autoantibodies may also be present. We do not know why these proteins are made.

The diagnosis of C3G is made by finding predominantly C3 deposits (at least 2 times more than any other protein) on the immunofluorescence (IF) part of the kidney biopsy. Other diseases (i.e., post infectious glomerulonephritis) may mimic this exact biopsy pattern therefore it may be difficult to diagnose C3G when the disease first presents itself. There are two types of C3G: C3 Glomerulonephritis (C3GN) and Dense Deposit Disease (DDD).

The Complement Cascade an important part of both the innate and adaptive immune systems. The majority of circulating complement is produced by the liver however complement synthesized in the kidney is likely to have an important role in local injury.  There are several different pathways of complement activation involved in different forms of renal disease, such as the alternative pathway in atypical hemolytic uremic syndrome (aHUS) and C3 Glomerulopathy (C3G), and the classical pathway in lupus nephritis.

For more information, including diagrams, click HERE. 

Interpretating the MORL Complement-Mediate Kidney Disease Genetic and Functional Results

For more questions, please contact us at MORL@uiowa.edu

Yes! Contact the MORL through our inquiry form with all your ordering questions.

Yes! Contact the MORL through our inquiry form with all your ordering questions.

• You can make an appointment with a genetic counselor through a referral with your primary care physician, or use the "Find a Genetic Counselor" tool on the National Society of Genetic Counselors website to locate genetic counselors in your area. 
• Looking for a genetic counselor outside the United States? Visit the Transnational Alliance for Genetic Counseling to find contact information for genetic counseling organizations from around the world.

Yes, our CLIA number is 16D0966193   

1376134676

42-6004813

Yes, for more information about sending samples, please contact us at 319-335-6623 or morl@uiowa.edu

Yes, please contact us at 319-335-6623 or morl@uiowa.edu if you have questions or concerns about international shipping of samples. 

If you have any questions we would be happy to answer them for you. Please call us at 319-335-6623.

If you have any questions or concerns about this laboratory, please feel free to contact the Laboratory Director, Dr. Richard Smith at 319-356-3612.

You can also contact the Operations Manager, Jori Hendon at 319-335-3353. 

If you would like to contact the Center for Medicaid and State Operations/Survey and Certification Group, please see this brochure. 

If you are interested in being a part of our hearing loss or complement-mediated kidney disease studies, please contact Amy Weaver directly at amy-weaver@uiowa.edu or 319-335-6623.