State Hygienic Laboratory
COVID-19 Testing

Information and Updates for
Healthcare Providers and Clinical Laboratories


COVID-19 Testing Hotline: (855) 374-4692

3D image of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID-19)

Test Results

Results are posted to the SHL Web Portal upon completion, generally 24-72 hours from the time the specimen arrives at the lab.

web portal    

Don't have Web Portal access? Request access

Order a Test

Long Term Care Facilities and Clinical Labs must submit COVID-19 samples using the Electronic Test Request Form in the SHL Web Portal to ensure a timely result.

Electronic Test Request Form

Don't have Web Portal access? Request access

Hours

SHL is  testing 7 days a week at our Coralville location:

2490 Crosspark Road, Coralville, IA 52241 

Sample Receiving Window Hours: 
M-F: 7:00 AM to 5:00 PM 
Sat: 8:00 AM to Noon 
Sun: 8:00 AM to 10:00 AM 

Updates

Update on COVID-19 Testing at the State Hygienic Laboratory

On Monday, February 22, 2021, IDPH issued a Health Alert Network message to hospitals and local public health departments regarding updates to COVID-19 testing updates at SHL. Click for more information.

New Design for OpenELIS Web Portal on March 2

Beginning March 2, the OpenELIS Web Portal will have a new and more responsive design while still maintaining all of its current functionality. Click here for more details.

How are we doing?

Please take a few minutes to tell us how we are doing. Click to access the survey.

Long Term Care Testing Guidance *UPDATED 01/11/2021

COVID-19 Testing Guidance for Long Term Care Facilities. This content is periodically updated.

Notice to Patients

The State Hygienic Laboratory will never contact a patient to request personal information, such as address or date of birth. SHL works directly with healthcare providers. Please do not provide personal identifiers to callers requesting this information.

Diagnostic PCR Testing

UPDATED FEBRUARY 9, 2021
Testing Criteria

On Tuesday, February 9, 2021, the Iowa Department of Public Health eliminated PCR testing criteria for SARS-CoV-2 at the State Hygienic Laboratory.  SHL will accept any PCR detection test for COVID-19 infection ordered by a healthcare provider with no restrictions.

 

    Mandatory Reporting

    Per the Iowa Department of Public Health, all positive and negative results for SARS-CoV-2 testing, including but not limited to viral RNA, and all results for SARS-CoV-2 serological testing including antigen and antibody testing, are designated as reportable in Iowa.  

    IDPH Mandatory Reporting Order

    The State Hygienic Laboratory has validated multiple Molecular Diagnostic Tests for SARS-CoV-2 that previously received emergency use authorization from the FDA.  Performance characteristics for each assay are contained within the Instructions for Use as issued by the manufacturer within the links below. There are not comparison standards for these tests.  Test performance characteristics are based on specimen collection per the manufacturers recommendation.

    If you suspect a patient is infected with COVID-19 and the test is negative, you may repeat the test.  

    The State Hygienic Lab currently performs the following Molecular Diagnostic Tests for SARS-CoV-2 (EUA):  

    The State Hygienic Lab maintains the ability to perform the following Molecular Diagnostic Test for SARS-CoV-2: 

    CT Values in PCR tests

    Information on the role of CT (Cycle Threshold) values in the testing process is avaiable through the following sources:

    ORDER SPECIMEN COLLECTION KITS

    Click here to Order Specimen Collection Kits 

    • Under the "Kit Information" section of the form, insert: 
    • Type of kit: Virus Isolation and Detection Kit 
    • Comments: COVID-19 aka SARS-nCoV-2 

     

    KIT CONTENTS 

    • 1 biohazard bag
    • 1 synthetic-tipped swab  
    • 1 viral transport medium tube 
    • 1 absorbent pad

     

    Please note:  Due to fluctuating supply availability, kit components may vary. Follow storage temperature instructions indicated on the kit.  Use only the materials provided with the kits (for example, do not substitute swabs). 

     

    PRODUCT STATEMENTS

    SWABS: Due to limited supplies nationally, collection kits may include either nasopharyngeal or nares swabs depending on availability. 

    VTM: The type of Viral Transport Media in the collection kit may vary depending on availability.  Some types of media require refrigeration at 4° C until used and will be labeled accordingly.  

    QUIDEL SOFIA SARS ASSAY: Per the kit insert "To obtain accurate results, use only Copan UTM or CDC’s formulation of VTM." If your facility uses this assay and requests viral transport media from SHL, please ask for UTM (Copan or BD) or the CDC’s VTM formulation (SHL). 

    SHL VTM Non-Hazardous Product Statement

    Remel M4 Media SDS

     

    The State Hygienic Laboratory is working hard to ensure providers have the materials needed to collect specimens.  Please help us conserve these scarce resources by only ordering the number of kits immediately needed and reorder as necessary. 

    PRIOR TO COLLECTION

    • All testing for SARS-CoV-2 should be conducted in consultation with a healthcare provider. Specimens should be collected as soon as possible once a decision has been made to pursue COVID-19 testing, regardless of the time of symptom onset.
    • Store specimens at 2-8°C for up to 72 hours after collection.
    • Label all specimens with name and date of birth.  Ensure the information on the specimen matches the test request form. Unlabeled specimens will be rejected and not tested. 

     

    COLLECTION PROCEDURES

    • Collection instructions for upper and lower respiratory tract specimens are available on the CDC website.  

     

    SPECIMEN TYPES

    Preferred Specimen:
    • A nasopharyngeal (NP) swab placed into viral transport medium (VTM) is the preferred choice for swab-based SARS-CoV-2 testing. To date, the scientific literature states that nasopharyngeal specimens have the highest yield of recovery of an infected patient.
     
    Acceptable Specimen Alternatives:

           Upper respiratory

    • Oropharyngeal (OP) specimen
    • Anterior nares specimen (nasal swab) using a round foam swab
    • Mid-turbinate swab
    • Nasopharyngeal wash (collect 2-3 mL into a sterile, leak-proof, screw cap container)

           Lower respiratory

           Collect 2-3 mL into a sterile, leak-proof, screw-cap container.

    • Sputum specimens are acceptable for patients with a productive cough. Do not induce sputum collection.
    • Bronchoalveolar lavage
    • Bronchial wash
    • Endotracheal aspirate
    Acceptable Swabs:
    • Synthetic tips (e.g. polyester or dacron) with a flexible plastic shaft
    • Eswab™
    • Flocked swabs
    Acceptable Transport Medium for Swab Specimens (in order of preference):

    The screw-top transport tube should contain a minimum of  2 mL of either:

    • Viral transport medium
    • Sterile saline or phosphate buffered saline (PBS)
    • Liquid Amies transport medium

    Multiple specimens may be taken with a single swab.  If you use separate swabs from different locations, combine them into a single tube of viral transport media to help preserve testing materials.

    Not acceptable:
    • Swabs submitted in bacterial transport media (usually clear fluid)
    • Calcium alginate swabs, cotton swab
    • Swabs with wooden or aluminum shaft

    Diagnostic PCR Samples using VTM or Saline Transport Medium

    Specimen Packaging Guidance (PDF)

     

    Hologic® Panther

    SPECIMEN PACKAGING GUIDANCE (PDF)

    CAUTION - USE ONLY THE MATERIALS PROVIDED IN THE KITS.  REPLACEMENT OF MATERIALS MAY DAMAGE INSTRUMENTATION OR INVALIDATE TESTING.

    Important safety notice

    In accordance with biosafety requirements, make certain that the screw cap tightly seals the tube. Leaking samples will be rejected. 

    Samples meeting any of the following criteria will be rejected and not tested. Facilities will be alerted of a sample rejection via the SHL web portal for any facilities enrolled in online reporting or via US Mail.

    • Broken or leaking sample containers 
    • Unlabeled sample containers 
    • Samples containing swabs other than those provided in the collection kit
    • Incomplete or incorrect test request form (must be the Coronavirus COVID-19 Test Request Form)  

    Result types:
    • Detected/Positive -  2019-nCoV COVID-19 RNA was found
    • Not detected/Negative - no COVID-19 RNA was found
    • Inconclusive - 1 of the 2 targets was detected. Submission of a new specimen is recommended
    • Invalid - a result cannot be provided, generally because the specimen was poor quality

     

    Platform Analyte Name LOINC
    Thermofisher TaqPath COVID-19 real-time RT-PCR 2019 Novel Coronavirus RNA coronavirus, pcr real-time, 94309-2
    Hologic Aptima SARS-CoV-2 SARS-CoV-2 RNA coronavirus, tma-cov-2, 94559-2
         

    It is possible to use the same COVID-19 specimen for other in-house testing. Here's how: 

    • After swabbing the nasopharyngeal, place the swab in the media, cap, vortex and briefly spin down to remove liquid from the inside of the cap. 
    • Remove the minimum volume needed to do testing with a transfer pipette, being careful to not splash or drip on the outside of the tube, then re-cap. 
    • Specimens sent to SHL must have 1 - 2 mL of viral transport media. We prefer to have the swab in the tube, but it is not required. 

    Serologic Antibody Testing

    Serology Testing Criteria
    UPDATED FEBRUARY 9, 2021

    Serology tests may only be ordered by a healthcare provider. 

    On Tuesday, February 9, 2021, the Iowa Department of Public Health eliminated PCR testing criteria for SARS-CoV-2 at the State Hygienic Laboratory.  SHL will accept any serology test for COVID-19 infection ordered by a healthcare provider with no restrictions.

     
    Use of Serology Testing

    While the RT-PCR molecular test is the test to use for diagnosis of COVID-19, detection of antibodies can serve as an indirect marker of infection.  For example, if a physician is considering that there may have been a false negative PCR test, serology might be useful for a patient who has tested negative by the molecular assay, is at least 7 days post onset of symptoms and is not immunocompromised.  Serology is useful for screening of recovered COVID-19 patients for donors to convalescent plasma therapy.  As a surveillance tool, serologic testing is helpful in estimating the prevalence of past viral infection or the cumulative incidence of infection in a population. It can also help improve our understanding of disease transmission patterns and the proportion of people previously infected, among various populations.

    It is important to note that there are still many unanswered questions about when to use COVID-19 antibody testing including how detection of antibodies correlates to functional immunity and how long that immunity might last. 

     

    Mandatory Reporting

    Per the Iowa Department of Public Health, all positive and negative results for SARS-CoV-2 testing, including but not limited to viral RNA, and all results for SARS-CoV-2 serological testing including antigen and antibody testing, are designated as reportable in Iowa.  

    IDPH Mandatory Reporting Order

    The State Hygienic Laboratory has validated three serology assays with emergency use authorization from the FDA: 

    • Abbott Architect SARS-CoV-2 IgG
    • DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG
    • Beckman DxI600 SARS-CoV-2 IgM/IgG

    Whichever assay is used, the manufacturer’s reference range is included in the final report. 

    The performance characteristics of these assays can be reviewed on the FDA website:
    https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

     

    Serology collection materials are available commercially and should be acquired directly whenever possible.

    Materials required:
    • Gold or marble top serum separator tubes (SST)
    • Plastic biohazard specimen bag
    • Blood draw supplies

     

    SHL currently has a limited supply of SSTs available for order.  Please help us conserve these scarce resources by only ordering the number of kits immediately needed and reorder as necessary.  Please note that SHL kits do not include any blood draw supplies.

     

    Order Specimen Collection Kits

    • Under the "Kit Information" section of the form, insert: 
    • Type of kit: Serology Kit 
    • Comments: COVID-19

    PRIOR TO COLLECTION

    SARS-CoV-2 antibody testing should be conducted in consultation with a healthcare provider. 

    Be prepared to store specimens at 2-8°C after collection.

    Label all specimens with name and date of birth.  Ensure the information on the specimen matches the test request form.  Unlabeled specimens will be rejected and not tested. 

     

    SPECIMEN TYPES
    Preferred Specimen:
    1. Serum
      Gold or Marble Top Serum Separator Tube (SST) (clot activator w/gel)
      1 mL minimum
      Prefer to have the specimen centrifuged, but not required.  Do not need to aliquot.  
    Alternative Specimens: 

         2.  Plasma
              Green Top Lithium Heparin Tube or Purple Top K2 EDTA Tube
              1 mL minimum

         3.  Serum
              Red Top Tube
              1 mL minimum
              Prefer to have the specimen centrifuged, but not required. Must aliquot and
              send serum in a separate tube. 

    Serology Samples

    Serology Specimen Packaging Guidance (PDF)

    Important safety notice

    In accordance with biosafety requirements, make certain that the screw cap tightly seals the tube. Leaking samples will be rejected.

       

         

        Samples meeting any of the following criteria will be rejected and not tested. Facilities will be alerted of a sample rejection via the SHL web portal for any facilities enrolled in online reporting or via US Mail.

        Result Types:

        Current methods being used are qualitative, with the interpretation of the result being most important. Interpretations are being reported according to the manufacturer’s instructions for the product used.  Results will be Positive/Reactive, Negative/Non Reactive, or Equivocal, with Cut-Off Values depending on the method used listed in the Notes Section of the final report.

        Platform   Analyte Name OpenELIS Test, Method OpenELIS Report Description Test
        LOINC/PHLIP
        Analyte
        LOINC/PHLIP
        Beckman DxI600 CoV-2 IgM Antibody cov-2 igm, cmia-beckman-igm SARS-CoV-2 IgM Antibody 94564-2 94564-2
        Beckman DxI600 CoV-2 IgG Antibody cov-2 igg, cmia-beckman-igg SARS-CoV-2 IgG Antibody 94563-4 94563-4
        Abbott Architect CoV-2 IgG Antibody cov-2 igg, cmia-abbott-igg SARS-CoV-2 IgG Antibody PLT2338 94563-4
        DiaSorin Liaison CoV-2 IgG arbitrary units (AU/mL) Result
        CoV-2 IgG arbitrary units (AU/mL) Interpretation
        cov-2 igg, clia-diasorin-igg SARS-CoV-2 S1/S2 IgG Antibody PLT2338 94505-5
        94563-4
        Other Resources:

        Beckman Coulter
        Information for Healthcare Providers
        Information for Patients

        Abbott Architect                                          
        Information for Healthcare Providers      
        Information for Patients   

        DiaSorin Liaison
        Information for Healthcare Providers
        Information for Patients

        Iowa State University Public Health Testing Services
        COVID-19 Antibody (Serology) Testing

         

        COVID-19 antibody (serology) testing can be a useful tool to assess previous COVID-19 infections.  The State Hygienic Laboratory continues to offer serologic testing for COVID-19.  Additional capacity to perform COVID-19 antibody (serology) testing for Iowans is now available at the Public Health Testing Services (PHTS) unit at Iowa State University.

        PHTS  has been established (June 2020) through the collaborative efforts of the University of Iowa’s State Hygienic Laboratory (SHL), Iowa Department of Public Health, and Iowa State University Veterinary Diagnostic Laboratory to expand COVID-19 antibody testing capacities in Iowa.

        PHTS and SHL both use COVID-19 antibody (serology) tests that have received EUA from the FDA and perform testing at no cost to the submitter. 

         

        Testing Criteria

        • A patient suspected or confirmed to have COVID-19 who is greater than 7 days post symptom onset
        • Identification of persons with an antibody response to serve as convalescent plasma donors
        • Healthcare worker, essential services personnel, first responder or critical infrastructure worker (e.g., healthcare worker, fire, EMS, law enforcement, food service worker and residential facility staff)

         

        Sample Collection Supplies

        • Blood draw materials should be acquired locally, as these materials are readily available commercially.
        • Use gold or marble-top (Serum Separator Tubes) for blood collection.  

         

        Sample Submission

               BECOME A CLIENT

                SAMPLE DELIVERY

        • PHTS utilizes Central Delivery Service of Iowa (the same courier system as SHL).
        • Request for courier pick-up for delivery to PHTS can be made by using the Central Delivery Services of Iowa website, or you can call PHTS at 515-296-3150 to request a courier pick-up. 

         

        Additional Information About PHTS

        Whole Genome Sequencing

        Whole Genome Sequencing (WGS)

        Whole genome sequencing determines the order of bases in the genome (genetic material) of an organism.  A genome consists of multiple genes which determine the characteristics of the organism.

        WGS in the COVID-19 Pandemic

        Genome sequencing enabled the world to rapidly identify SARS-CoV-2 and later develop diagnostic tests and other tools for the response. Continued COVID genome sequencing will be important for public health officials to track the transmission routes of the virus globally, detect mutations quickly to prevent the spread of new strain types, identify viral mutations that can avoid detection by established molecular diagnostic assays and affect vaccine potency, and screen targets for possible COVID-19 therapeutics.

        The Importance of WGS

        There is growing concern over fast spreading, novel variants of the SARS-CoV-2 coronavirus, such as the B.1.1.7 strain originally identified in the United Kingdom.  This novel variant is more easily transmissible than other SARS-CoV-2 virus strains and infection with this strain may lead to approximately 30% higher mortality rates. 

        WGS in Iowa

        The State Hygienic Lab regularly submits positive specimens to the CDC’s National SARS-CoV-2 Strain Surveillance (NS3) program for genomic analysis.  SHL also sequences selected Iowa patient specimens per request of the Iowa Department of Public Health (IDPH) to look for potential novel variant strains, possible reinfection, or potential vaccine breakthrough.

        Requesting WGS

        IDPH is the requesting authority for all COVID genomic sequencing.  To submit specimens for sequencing surveillance, healthcare providers should call IDPH for preapproval and submission instructions at 800-362-2736. Sequencing surveillance preapprovals will be processed M-F from 8:00AM to 4:30PM.

        Patients must work with their healthcare provider. 

        More Information

        For more information see https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance.html

         

        Other

        The State of Iowa has several programs for BinaxNOW antigen cards.  If you have questions about any of these programs, please contact Alyssa Mattson at alyssa-mattson@uiowa.edu or 319-335-4454.  Please do not order supplies unless your facility has been approved and completed enrollment in advance.  

        The State Hygienic Laboratory is not able to provide patient results through the Test Iowa system.  For information about Test Iowa, please visit https://www.testiowa.com/en or contact the Test Iowa Call Center at 515-575-2131 or 844-844-1561. 

        Courier:

        SHL utilizes Central Delivery Service of Iowa for courier service. If you are a current CDS client, go to the CDS webpage to arrange a pick-up. If you are not a current CDS client, call SHL at 1-855-374-4692 for assistance. 

        Please help expedite sample pick-ups:

        • Samples must be prepared in advance of pick-up.  The CDS driver is authorized to leave the site if asked to wait for sample preparation.
        • If your facility is locked-down, please make every effort to get the driver so they are not delayed by screening lines.

        Clearly label the outer most package with:

        Clearly label the outer most package
        • To: Name of Testing Lab (e.g. SHL
        • From: Your facility name
        • COVID-19 

         

        Hand-delivery:
        Bring to the State Hygienic Laboratory Sample Drop-Off window in Coralville, IA during business hours.  A drop box is available at the Coralville lab Sample Drop-Off door for bagged specimens after hours.

         

        Shipping
        Ship overnight via UPS or FedEx following Category B shipping requirements.  For specific details about shipping “Biological Substances, Category B” through UPS or FedEx, or to order packaging and labeling materials, please contact the respective agency directly.

        • FedEx

          • FedEx webpage on “How to Ship Dangerous Goods” 

          • FedEx Dangerous Goods/Hazardous Materials Hotline: 1-800-463-3339 (say “dangerous goods”)

        • UPS

        Laboratory Biosafety Guidance: Visit https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html for the most current CDC guidance. 

        CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV) 

        Each laboratory in Iowa can prepare to receive samples for COVID-19 by doing the following: 

        • Perform a risk assessment for receiving and handling specimens from patients under investigation for COVID-19 
        • Use appropriate personal protective equipment (PPE) 
        • Ensure biological safety cabinet (BSC) certification is current 
        • Train all applicable staff on the proper use of a BSC. CDC Fundamentals of Working Safely in a Biological Safety Cabinet  
        • Refresh staff knowledge regarding Category B Packaging and Shipping 
        • Make certain that all staff follow the established disinfection protocols 
        • Remind staff of the importance of proper and regular handwashing 
        • Train staff on the signs and symptoms of COVID-19 
        • Contact the State Hygienic Laboratory with any concerns 

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        Helpful Articles

        Centers for Disease Control and Prevention 
        Iowa Department of Public Health 
        World Health Organization