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State Hygienic Laboratory
COVID-19 Testing

Information and Updates for
Healthcare Providers and Clinical Laboratories

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

COVID-19 Testing Hotline

For Healthcare Providers and Clinical Laboratories

(855) 374-4692

Order a Test

Healthcare providers and Clinical Labs: Click the button to order Coronavirus PCR and/or Serology tests through the SHL Web Portal.  

Electronic Test Request Form  *NEW

Don't have Web Portal access? Request access or
complete a fillable
Coronavirus (COVID-19) Form

Test Results

Results are posted to the SHL web portal as soon as they are completed, generally within 24 - 72 hours of the specimen being received at the lab. 

Don't have Web Portal access?
Results are mailed to those without web reporting upon completion.  Request web portal access for future electronic reports.  

Hours

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

Coralville Sample Drop Off Window:
2490 Crosspark Road 
Coralville, IA 52241 

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 

Diagnostic PCR Testing

UPDATED MAY 28, 2020
Testing Criteria

Diagnostic PCR tests may only be ordered by a healthcare provider. 

The State Hygienic Laboratory will perform COVID-19 testing in accordance with one of the following criteria (these criteria may broaden as the pandemic expands and additional testing resources become available).

  • Hospitalized patient (of any age) with fever or respiratory illness for diagnosis or any hospitalized patient prior to discharge to a long term care facility or other nursing care facility
     
  • Older adult (> 60 years of age) with fever or respiratory symptoms (e.g., cough, difficulty breathing) and chronic medical conditions (e.g., diabetes, heart disease, immunosuppressive medications, chronic lung disease, or chronic kidney disease)
  • Person of any age with fever or respiratory illness who lives in a congregate setting (i.e., long term care facilities, dormitories, residential facilities, correctional facilities, treatment facilities)

  • Healthcare worker, essential services personnel, first responder, or critical infrastructure worker with fever or respiratory illness (e.g., healthcare worker, fire, EMS, law enforcement, residential facility staff, food supply, and water plant operators)
     
  • Children receiving care in and staff working in childcare homes and childcare centers with fever or respiratory symptoms (e.g., cough, difficulty breathing) without alternative diagnosis
     
  • Preschool / K12 students and staff with fever or respiratory symptoms (e.g., cough, difficulty breathing) without alternative diagnosis

  • University / college students and staff with fever or respiratory symptoms (e.g., cough, difficulty breathing) without alternative diagnosis

  • Symptomatic and asymptomatic close contacts (defined as spending more than 15 minutes within 6 feet) of persons who test positive for COVID-19 infection using PCR viral testing (close contact testing should not occur until at least 48 hours after the earliest exposure to COVID-19 positive persons)

 

    For patients that DO NOT meet the testing criteria:

    Healthcare providers can test patients, as they deem appropriate for COVID-19 infection at national reference laboratories. If healthcare providers choose to test a patient through a national reference laboratory, there is no need to call IDPH for approval. The specimens should be sent directly to the reference laboratory in accordance with the laboratory’s guidance. Reference laboratories will charge patients for this testing; public health has no funding to cover the costs of these tests.

     

    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 Lab performs the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.  It received emergency use authorization (EUA) approval from the FDA on 4 Feb 2020.  

    Test performance characteristics are based on a properly collected specimen. 

    From the CDC (https://www.fda.gov/media/134922/download Page 39)

    Clinical Performance 
    “Two thousand twenty-one (2021) respiratory specimens tested negative by the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  Forty-nine (49) of the 2071 respiratory specimens tested positive by the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  17 were confirmed by genetic sequencing and/or virus culture (positive percent agreement = 17/17”.

    While these are not typical performance characteristics, there is no comparison standard for the test.  PCR is typically in the high 90% range with other tests.

    If you suspect a patient is infected with COVID-19 and the test is negative, you may repeat the test.  SHL has not seen any patients where the PCR assay was repeated and not confirmed. The chance of a poorly collected sample also cannot be ruled out. 

    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

     

     

    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 (using a round foam 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)

     

    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:
    • 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 JULY 10, 2020

      Serology tests may only be ordered by a healthcare provider. 

      When a physician determines that a SARS-CoV-2 antibody test is needed, the patient should meet one of the following criteria:

      • A patient suspected or confirmed to have COVID-19 who is greater than 7 days post symptom onset, or a patient exposed to a known case of COVID-19 more than 7 days in the past

      • 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) for whom knowledge of antibody production is needed

       
      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

      Due to fluctuating supply concerns, the State Hygienic Laboratory validated three different serology assays that previously received emergency use authorization from the FDA.  These include the Abbott Architect SARS-CoV-2 IgG, DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG, and the EUROIMMUN SARS-COV-2 ELISA (IgG).  Test results from all three assays provide a signal to cutoff (S/C) ratio compared to internal calibration controls and an interpretation of Positive or Negative (The Euroimmun assay also includes a Borderline interpretation). 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:

          Results will be Positive, Negative, or Borderline with Cut-Off Values depending on the method used. Cut-Off will be listed in the Notes Section of the final report.

          Platform   Analyte Name LOINC
          Abbott Architect CoV-2 IgG Index (S/C) cov-2 igg, cmia-abbott-igg,  PLT2338
          DiaSorin Liaison CoV-2 IgG arbitrary units (AU/mL) cov-2 igg, clia-diasorin-igg, PLT2338
          EuroImmun Novel 2019 Coronavirus IgG Ratio

          cov-2 igg, elisa-euroimmun-igg, PLT2338

          cov-2 iga, elisa-euroimmun-iga, PLT2337

               
          Other Resources:

          Abbott Architect                                          
          Information for Healthcare Providers      
          Information for Patients   

          EuroImmun
          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

          Other

          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. 

          Clearly label the outer most package

          Please help expedite sample pick-up: 

          • Specimens must be prepared in advance of pick-up. The CDS driver is authorized to leave the site if wait time exceeds 20 minutes. 

          • If your facility is locked-down, please make every effort to get the specimens to the driver so they are not delayed by screening lines.  

          Clearly label the outer most bag or container with:

          • 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 

          Laboratories are required to meet all CLIA and/or their accrediting agency's requirements for performing non-waived EUA COVID-19 testing.

          To meet the verification requirements, laboratories can run external quality controls for their verification plan and send the first 5 positive and 5 negatives for confirmation to the State Hygienic Laboratory.
          On those first 10 samples, laboratories will need to report "Presumptive" results until those 10 results are confirmed.

          The State Hygienic Laboratory at the University of Iowa has confirmed this will meet CLIA validation requirements for laboratories in Iowa that hold a Certificate of Compliance.

          If a laboratory holds a Certificate of Accreditation, they will need to follow their accrediting organization requirements.

          For further CLIA questions please contact Kristine Rotzoll at kristine-rotzoll@uiowa.edu.

          Click here to print

          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. 

          Overview

          The State of Iowa received a limited quantity of Abbott ID NOW™ Rapid Analyzers from FEMA for diagnostic COVID-19 testing. Instruments have been placed in clinical laboratories throughout Iowa, as designated by the Iowa Department of Public Health and according to the guidelines provided by the U.S. Federal Task Force.  These tests are designated to be used for high priority specimens requiring a rapid result and when action will be taken based on the result. Throughput for these instruments is limited and supplies are in short supply nationally. Contact the testing site in advance to ensure they are adequately prepared for sample intake and analysis. 

          Limit testing to high priority situations where the result will make an immediate difference in the care of the individual. Routine testing is available through a reference laboratory or the State Hygienic Laboratory. Samples collected for ID NOW™ analysis cannot be sent to the State Hygienic Laboratory due to the short sample holding time (see collection and packaging guidance for details).

          Collection and Packaging Guidance

          Click here for guidance

          Current ID NOW™ Placement Sites
          (Subject to change at any time)

          State-Placed ID NOW Placement Sites
          County Facility Name Address
          Allamakee Veterans Memorial 40 1st St. SE, Waukon, IA 52172
          Audubon Audubon County Memorial Hospital 515 Pacific Street, Audubon, IA 50025
          Black Hawk MercyOne Cedar Falls Medical Center 515 College Street, Cedar Falls, IA 50613
          Black Hawk University of Northern Iowa Student Health 016 Student Health Clinic, Cedar Falls, IA 50614
          Boone Boone County Hospital 1015 Union St, Boone, IA 50036
          Buchanan Buchanan County Health Center 1600 1st St E, Independence, IA 50644
          Buena Vista Buena Vista Regional Medical Center 1525 W 5th St, Independence, IA 50644
          Clarke Clarke County Hospital  800 S. Fillmore St, Osceola, IA 50213
          Clay Spencer Memorial Hospital 1200 1st Ave. E, Spencer, IA 51301
          Delaware Regional Medical Center 709 W Main St, Manchester, IA 52057
          Fayette MercyOne Oelwein Medical Center 201 8th Ave. SE, Oelwein, IA 50662
          Hardin Hansen Family Hospital  920 South Oak, Iowa Falls, IA 50126  
          Kossuth Kossuth Regional Health Center 1515 S. Phillips St, Algona, IA 50511
          Marshall Iowa Veterans Home 1301 Summit St., Marshalltown, IA 50158
          Page Clarinda Regional Health Center 220 Essie Davision Dr.,  Clarinda, IA 51632
          Ringgold Ringgold County Hospital 504 N Cleveland St, Mt Ayr, IA 50854
          Washington Washington County Hospital 400 E. Polk St., Washington, IA 52353
          Webster Fort Dodge Correctional Facility 1550 L St., Fort Dodge, IA 50501

          Helpful Articles


          Centers for Disease Control and Prevention 

          Iowa Department of Public Health 
          World Health Organization