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 - 48 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.
  • 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.

    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. 

    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.   

    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
    NOTICE ON SWABS:  Due to limited supplies nationally, collection kits from the State Hygienic Laboratory may include either nasopharyngeal or nares swabs depending on availability.  
    NOTICE ON VTM: The State Hygienic Laboratory is using a new Viral Transport Media in the specimen collection kits.  This media is clear instead of pink and should be refrigerated at 4° C until used. 

    SHL VTM Non-Hazardous Product Statement

    Remel M4 Media SDS

    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.

    SHL currently has COVID-19 kits to collect an NP swab in VTM available to order.

     
    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

    Specimen Packaging Guidance (PDF)

    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.

    There are 4 possible result types from SHL for diagnostic PCR testing:
    • Positive 2019-nCoV COVID-19 RNA was found
    • Not detected - 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

      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 MAY 28, 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

      • 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. 

      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

       

      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. 

      Packaging:

      Place collection tube in a biohazard bag with absorbent material. 

      In accordance with biosafety requirements, make certain that the tube cap seals tightly. Leaking samples will be rejected and not tested.

      Place the Test Request Form in the outside pocket of the biohazard bag.  Do NOT put it inside the bag with the specimen or staple it to the outside of the bag.

      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.

      Abbott Architect analyte name :                  CoV-2 IgG Index (S/C)

      EuroImmun analyte name:                           Novel 2019 Coronavirus IgG Ratio

      DiaSorin Liaison analyte name:                    CoV-2 IgG arbitrary units (AU/mL)

       

      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

      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. Pickup requests should be entered by 11:00 AM for same-day 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. 

      Please help the CDS Courier Drivers.   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.  

      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
      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
      Louisa  Community Health Centers of Southeastern Iowa 2409 Spring Street, Columbus City, IA 52737
      Marshall Iowa Veterans Home 1301 Summit St., Marshalltown, IA 50158
      Montgomery Montgomery County Memorial Hospital 2301 Eastern Ave., Red Oak, IA 51566
      Polk Broadlawns Medical Center Mobile Clinic 1801 Hickman Rd, Des Moines, IA 50314
      Ringgold Ringgold County Hospital 504 N Cleveland St, Mt Ayr, IA 50854
      Washington Washington County Hospital 400 E. Polk St., Washington, IA 52353

      COVID-19 testing should be conducted under the order of the Long Term Care (LTC) Facility Medical Director. The LTC Facility Medical Director is responsible for ongoing care and medical oversight of patients who test positive. 

      There are two primary channels for testing:

      1. Utilize a clinical laboratory with a state-placed ID NOW Analyzer (see the ID NOW section of this site for full details)  
      2. Utilize your normal reference or commercial laboratory for testing (contact the reference lab for details).  The reference laboratory may choose to submit the specimen to the State Hygienic Laboratory.     

       

      If testing will be sent via the reference lab to SHL:

      Samples should be submitted to SHL by the reference laboratory. 

      • Test Request Form:  SHL’s Test Request Form (TRF) has a field for a second facility reporting. The submitting lab will enter the LTC information in that field on the TRF.
      • Transport: The submitting laboratory should request SHL courier transport through the SHL/CDS courier’s online sample tracking procedures. 
      • Results:  Patient results will be provided through the laboratory's normal reporting procedures.  If the Long Term Care Facility is designated as a “second facility” on the Test Request Form, SHL will mail a hard copy of the final report to the facility, and if the LTC facility calls SHL for a result, will be able to provide verbal results to them directly over the phone if they call.  The submitting laboratory is also responsible for communicating results back to the LTC facility, because they have more immediate access to results via the SHL web portal.
        Specimen Collection Kits

        Long Term Care facilities may order up to 6 specimen collection kits from SHL or obtain supplies via their routine reference laboratory.  If ordering through SHL, complete the order form here:

        Specimen Collection Kit Order

         

        Specimen Packaging and Delivery

        After qualified LTC staff collect the specimen:

        • Place the swab into the viral transport medium tube and make sure that the cap is sealed tight. 
        • Place the tube and absorbent pad into the one of the biohazard bags. 
        • Write the facility name and "COVID-19" on the exterior of the other biohazard bag. 
        • Place the first biohazard bag inside the second biohazard bag. 
        • Refrigerate the sample until it is transported. 
        • The Test Request Form will be completed by the routine laboratory that will submit the test. 

          Helpful Articles


          Centers for Disease Control and Prevention 

          Iowa Department of Public Health 
          World Health Organization