State Hygienic Laboratory
COVID-19 Testing

Information and Updates for
Healthcare Providers and Clinical Laboratories


SHL COVID-19 Testing Hotline: (855) 374-4692
Test Iowa At-Home Call Center: (833) 286-8378

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

Test Results

Tests ordered by a healthcare provider or clinical laboratory 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

Sample Receiving Window Hours ​​​
2490 Crosspark Road, Coralville, IA 52241 

M-F: 8:00 AM to 5:00 PM 
Sat: 8:00 AM to Noon 
Sun: CLOSED

Updates

IDPH and SHL Announce At Home Testing Option

Beginning Friday, July 16, Test Iowa, the state’s free COVID-19 testing program will transition from offering COVID-19 testing at drive through locations throughout the state to providing Iowans access to free, self-administered test kits. Click here for additional details.

Request for Iowa Laboratories to Submit All PCR Positive SARS-CoV-2 Samples for Sequencing

IDPH and SHL are planning to sequence all submitted positive SARS-CoV-2 samples. Click here for additional details.

COVID-19 Viral Testing Tool for Healthcare Providers

CDC launched a new COVID-19 Viral Testing Tool. Click here for more details.

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

The new OpenELIS Web Portal will have a more responsive design while still maintaining all of its current functionality.

Test Iowa At-Home *NEW*

What is Test Iowa At-Home?

Test Iowa At-Home is a partnership between the Iowa Department of Public Health and the State Hygienic Lab.

Iowans can receive a free COVID-19 test kit, collect a saliva sample at home, return the sample by UPS, and receive results through email. 

The at-home saliva test kit is a PCR test and is equivalent in performance to the nasopharyngeal (nasal) swab PCR test formerly used at the Test Iowa drive-thru sites.

Get a Test Kit

Order a test kit online at www.testiowa.com, or pick one up at a site in your community.  Pick up sites can be found on www.testiowa.com.

If you are picking up kits from one of the three State Hygienic Lab buildings, click here for directions

Results

Results are sent to the email address provided at the time the kit was activated.  The State Hygienic Lab is unable to control how long it takes for a sample to arrive at the laboratory.  We are committed to providing test results within 24 hours of the sample being received at the lab.  

Whole Genome Sequencing, the process by which the lab determines the virus strain, may be conducted on positive samples.  Sequencing is for surveillance and public health epidemiology purposes only. Sequencing results will not be reported to submitting facilities or to the individual patient.

Test Iowa Call Center 

(833) 286-8378

Test Iowa At-Home COVID-19 Sample Collection Kit 

Test kits will include step-by-step instructions including how to activate the kit, collect the sample, and return it to the lab for processing using UPS.  Homebound individuals can choose to have UPS pick up their sample for return. 

Watch a video demonstration of the Test Iowa At-Home COVID-19 kit below.

 

 

Diagnostic PCR Testing

Testing Criteria

On 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 to IDPH 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


    Serology tests may only be ordered by a healthcare provider. 

    On February 9, 2021, the Iowa Department of Public Health eliminated 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

    If requesting serology testing for recently vaccinated individuals, please ensure that the HHS supplemental question “Vaccinated for COVID-19” is marked Yes.  The COVID-19 vaccines are designed to target the “spike protein” which is found on the surface of the virus that causes COVID-19 disease. By noting that an individual has been vaccinated, the laboratory will be able to order and perform the proper test to determine whether the individual has developed protective immunity against COVID-19.

    HHS Questions on Test Request Form

    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. 

    Store specimens at 2-8°C after collection.  Specimens may be refrigerated up to 7 days.  If storing for more than 7 days, samples must be frozen.

    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

    Whole Genome Sequencing

    Whole Genome Sequencing (WGS) in Iowa

    Positive SARS-C0V-2 samples in Iowa should be submitted to the State Hygienic Laboratory for sequencing. Not all samples can be successfully sequenced as it is dependent on the concentration of virus in the individual’s specimen.

    Sequencing results are for surveillance and public health epidemiology purposes only. Results will not be reported to submitting facilities or to the individual patient.

    Sequencing will provide IDPH with much more information about the variants that are circulating in Iowa now and into the future.  Declining utilization of testing makes it even more important to perform sequencing on all positive samples to determine if new variants are emerging. Submitting samples to sequence depends on the cooperation of all laboratories in Iowa. 

    Requesting WGS

    If your laboratory has remaining samples that have tested positive for SARS-CoV-2 and the Ct value is less than 30, please submit the sample to SHL. If the Ct value is unknown, then submit the sample and SHL will determine the Ct value before performing the sequencing.

    To order sequencing, go to SHL’s website and select the “Coronavirus (COVID-19) Sequencing" Test Request Form. 

    Patients must work with their healthcare provider. 

    WGS Results

    SHL is only authorized to report sequencing results to the Iowa Department of Public Health for public health surveillance purposes.  Sequencing is not a CLIA-approved test.  Healthcare providers should call IDPH at 800-362-2736 for further questions.  

    What is 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. 

    More Information

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

    Other

    The State of Iowa has obtained a supply of BinaxNOW antigen cards for use by pre-approved entities. Please do not order supplies unless your facility has been approved and completed enrollment in advance.  If you have questions or would like to enroll, contact Alyssa Mattson at alyssa-mattson@uiowa.edu or 319-335-4454. 

    The FDA has issued and EUA for BinaxNOW COVID-19 Ag Cards. 

    Extension of Binax Expiration Date

    Abbott has issued a BinaxNOW COVID-19 Product Expiry Extension.  (Updated May 2021)

    Additional details are available on the Abbott  BINAXNOW™ COVID-19 AG CARD Training site

    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 

    Web Portal User Guides

    OpenELIS Web Portal User Guide

     

    Web Portal Tutorials

    OpenELIS Web Portal Video Tutorial

    Helpful Articles

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