Information for Providers About COVID-19 Testing Offered at Children’s Hospital Colorado

COVID-19 testing is available to community providers, EMS and healthcare workers, and children and their caregivers at multiple Children’s Colorado locations. The PCR testing is done via a nasopharyngeal swab.

Please note that referrals and appointments are required for all COVID-19 tests. The vast majority of test results are available within 24 hours, but there might be some delays during periods of increased demand.

PCR testing locations and appointment times

Anschutz Medical Campus, Aurora

• Open every day from 7 a.m. to 5:30 p.m., by appointment
• Location: Children's Colorado, Anschutz Medical Campus
  Testing site: 1575 Wheeling Street, Aurora, CO 80045
• Appointments: 720-777-0001

North Campus, Broomfield

• Open Monday through Saturday, by appointment (hours vary)
• Location: Children's Colorado, North Campus
  Testing site: 469 State Highway 7, Broomfield, CO 80023
• Appointments: 720-478-5255

South Campus, Highlands Ranch

• Open Tuesday through Saturday from 9:30 a.m. to 6 p.m., by appointment
• Location: Children's Colorado, South Campus
  Testing site: 1811 Plaza Drive, Highlands Ranch, CO 80129
• Appointments: 720-478-0433

Colorado Springs

• Open Tuesday through Saturday, by appointment (hours vary)
• Location: Children’s Colorado, Briargate Outpatient and Specialty Care
  Testing site: 4125 Briargate Pkwy., Colorado Springs, CO 80920
• Appointments: 719-305-0005

Please note: These are drive-through testing sites. Vehicles must be shorter than 8 feet.

Appointments and referrals

Appointments for COVID-19 testing are by appointment only, and a referral by a provider must accompany each appointment. Pediatricians can refer their healthcare colleagues, patients and patients’ caregivers.

Please call to schedule an appointment based on your preferred location listed above.

How to submit a referral:

• Shown in person at time of appointment (e.g., a photo of the referral on a smart phone)
• Ordered electronically by the referring provider via Children’s Colorado Connect^® or Peds Connect^®
• Sent ahead via email or fax:
  • Denver Metro:
    Email: RegistrationLabCOVID@childrenscolorado.org
    Fax to 720-777-7903
  • Colorado Springs:
    Email: COSLabCOVID@childrenscolorado.org
    Fax to 719-305-9738

Payment and results for COVID-19 testing

• No co-pays will be collected; insurance will be billed.
• Patients can obtain their results in MyChart.
• If results are not found with 24 hours, please email the patient's name and date of birth to LabClientServices@childrenscolorado.org or call 720-777-6711.

Recommendations for outpatient COVID-19 testing in children

Testing is recommended for:

• Any child with symptoms consistent with COVID-19.
• Any child who has been exposed (close contact) to a person with confirmed COVID-19. Recommend testing 5-7 days post-exposure per CDPHE guidelines. Please remember that a negative test does not end the 14-day quarantine.
• Any child with a scheduled procedure requiring anesthesia or admission to the hospital (should be tested 2-3 days prior to the procedure.

Testing is NOT recommended and strongly discouraged for:

• Asymptomatic children who have not had a known contact with a confirmed case of COVID-19.
• Asymptomatic children seeking testing prior to travel or prior to an event or gathering.
• Children who have had COVID-19 and are seeking a “test of cure” requested from work or school (sensitive PCR tests can remain positive for some time but this does not mean people are contagious after they have met the criteria to come out of isolation). Immune normal children can come out of isolation 10 days after the start of their symptoms provided they have had no fever for 24 hours and the rest of their symptoms are improving.

We developed an algorithm that is intended for use in our Emergency Departments, Urgent Cares and inpatient units within the Children’s Colorado system of care. It serves as an institutional complement to existing recommendations from the Centers for Disease Control, Infectious Diseases Society of America and the American Academy of Pediatrics. This guidance may also be relevant for providers in ambulatory settings.

Respiratory pathogen testing considerations for patients presenting to Children’s Colorado during the 2020-2021 influenza season

The testing considerations were developed via a multidisciplinary collaboration between the Departments of Emergency Medicine, Epidemiology, Hospital Medicine, Microbiology and Infectious Diseases. These guidelines will apply during the influenza season, but testing for influenza will be available from November 17, 2020 for patients with compatible illness.

The start of the influenza season varies from year to year, and providers in the Children’s Colorado system will be notified of the official start of the season by our Epidemiology/Microbiology Departments.

Download our respiratory pathogen testing considerations for patients (.pdf)

When to order a serologic test

Serology is most useful for those patients with a high pretest probability of disease and should only be ordered when it will impact clinical care. Here are some considerations to keep in mind:

• Do not use serology testing to diagnose acute infection. An antibody response takes about two to three weeks to develop in most people after exposure to the virus.
• A positive test does not imply immunity to SARS CoV-2. Antibody testing should not be used to make decisions regarding social distancing or PPE use.
• Weekday testing: We will run assays Monday through Friday and provide results on the next business day. The recommended assay for most patients is IgG.

How to order a serologic test

Providers can order serologic testing like any other Children's Colorado lab test:

• SARS CoV-2 IgG Antibody – LAB9144
• SARS CoV-2 IgM Antibody – LAB 9136

If you have questions about serology testing, please contact the Infectious Disease team via OneCall (call 720-777-3999 in the Denver metro area or 719-305-3999 in Colorado Springs).

Many primary care providers have reached out seeking guidance about how to conduct point of care (POC) testing in their offices. Current data indicate that most rapid point of care tests have decreased sensitivity compared to hospital/laboratory-based PCR assays.

Although POC tests may be useful in some circumstances, a negative POC test in a child with a high pretest probability (such as known exposure or consistent symptoms) should be verified by a more sensitive laboratory-based PCR assay.

Get more information about POC testing from the CDC.

How to collect a nasopharyngeal swab specimen in your office and send it to our lab

For community providers who are interested in collecting patients’ nasopharyngeal swab sample and couriering it to Children’s Colorado for processing, please refer to the questions and answers below about how to collect a good nasopharyngeal swab.

All testing must be accompanied by a lab order with matching patient details (spelling of names and DOB) between specimen and paperwork or testing will be held or discarded.

Provider office specimen collection details

The below table is in order of preferred specimen type. All specimens are required to have parafilm around the top of the specimen to ensure they do not leak and should be placed in a biohazard bag with the paperwork in the outside pocket.

Specimen type:	Transport details:	Temperature:
Nasopharyngeal (NP) swab	Viral, UTM, amies or sterile saline	Refrigerator pack
Nasal wash	Saline
Nasal mid-turbinate (NMT) swab	Viral, UTM, amies or sterile saline
Anterior nares (nasal swab)	Viral, UTM, amies or sterile saline
Sputum	Saline
Tracheal aspirate	Saline
Bronchoalveolar lavage (BAL)	Saline

• At-home collections are not permissible for SARS-CoV-2 Testing
• Any specimen types beside NP swab, Nasal Wash, Tracheal Aspirate, or BAL could have decreased sensitivity

Sending specimens to the Children’s Colorado laboratory

• Please utilize a courier service to have specimens delivered to:
  • Children’s Hospital Colorado
    Attn: Clinical Lab – Microbiology
    13123 E. 16^th Ave, RM B0200
    Aurora CO 80045
  • Couriers will enter our facility through our dock and be screened daily before being allowed to come into the lab.
• If you do not have a current courier, we recommend reaching out to Action Stat Logistics to set up a courier account with them.
  • Action Stat Logistics – Jayson Garcia – jayson@asldelivers.com – 970-776-6954

Ordering information and requirements

- In Epic/PedsConnect/ChildrensConnect:

Testing requested:	Lab order to use/indicate:
SARS-CoV-2 PCR	LAB9100
Respiratory Pathogen Panel (RPP)	LAB5595

• RPP does not automatically include SARS, request both labs if you want both to be run
• If you do not have access to Epic/PedsConnect/ChildrensConnect please reach out to LabClientServices@childrenscolorado.org for a lab requisition.
• We are required to report all patient demographics (including address and phone number); please be sure to include a face or demographic sheet with all specimens. This is a requirement.
• A diagnosis code is a requirement, please provide the code and not description with all submissions.
• Please be sure to make sure all patient information is legible and if the spelling of the patient name does not match between the specimen and the paperwork the specimen could be rejected or resulting could be delayed.

Children’s Colorado mobile clinic collection details

All patients need an appointment and order placed before arriving at our mobile sites. Wait times for appointments are long but we are doing the best we can.

Mobile site location:	Appointment line:	Email and fax line for orders:
Anschutz Medical Campus 1575 Wheeling St Aurora CO 80045	720-777-0001	RegistrationLabCOVID@childrenscolorado.org 720-777-7903
North Campus 469 State Hwy 7 Broomfield, CO 80023	720-478-5255
South Campus 1811 Plaza Dr Highlands Ranch, CO 80129	720-478-0433
Colorado Springs 4125 Briargate Pkwy Colorado Springs, 80920	719-305-0005	COSLabCOVID@childrenscolorado.org 719-305-9735

What testing platforms are available at Children’s Colorado for SARS-CoV-2 detection?

• All the testing platforms used at Children’s Colorado are polymerase chain reaction (PCR) based assays and detect viral RNA.
• At Children’s Colorado, we currently are running three primary different platforms for SARS-CoV-2 PCR testing:
  • CDC SARS-CoV-2 PCR assay – detects 2 targets on N gene.
  • Simplexa/DiaSorin COVID-19 Direct – detects ORF1ab and S genes.
  • Abbot m2000 Real-Time SARS-CoV-2 – detects RdRp and N genes.
• All three platforms utilize two different gene targets, which provide optimal sensitivity and minimizes potential for missing detection of virus due to potential new mutations.

Turnaround times (TAT) and resulting process:

• All platforms have a 24-hour TAT from the time the specimen arrives in our laboratory at Anschutz Medical Campus (there might be a slight delay for other locations or during periods of increased demand).
  • If you are wanting us to collect a patient for an upcoming procedure, please make sure to plan accordingly to manage the result TAT. We recommend collection to be 48 hours in advance.
• Providers with Epic/PedsConnect/ChildrensConnect should check their inbox or the patient’s chart to see results.
• Providers without Epic/PedsConnect/ChildrensConnect and have submitted a paper requisition for orders will receive results via faxing [make sure fax number is correct on lab order].
• If it has been more than 24 hours and the patient's chart does not have a result or a fax has not been received, please email LabClientServices@childrenscolorado.org or call 720-777-6711.
  • If emailing, include patient's first and last name, DOB and the fax number and a result or update will be sent to you within two hours during business hours (Monday through Friday from 8 a.m. to 4 p.m.)
• We highly recommend encouraging patients to sign up for MyChart, negative results will be uploaded in the system after completion and positive results will be uploaded after 24 hours.
• Our lab is not calling positives to external providers or their patients, the provider office will need to notify their patients.

Can I request a specific testing platform when placing an order?

• No. To optimize workflow processes in the laboratory and due to the equivalency between assays, samples will be run when received on the next available platform. Our goal in the Microbiology Laboratory is to provide optimum results in the least amount of time that supports isolation and medical decisions for the patient.

What is the sensitivity and specificity of our SARS-CoV-2 assays?

• All currently available assays for detection of SARS-CoV-2 RNA have been granted FDA EUA (Emergency Use Authorization). Because of this, no clinical trials have been conducted and there is no available data regarding the overall clinical sensitivity and specificity of these assays. Additionally, currently there is no gold standard diagnostic test of comparison studies to determine sensitivity and specificity of individual assays. In lieu of definitive clinical sensitivity data, limit of detection data has been provided as a proxy measure. Similar to other viral detection methods, PCR has become the gold standard for detection of virus in respiratory, gastrointestinal, and sterile fluids.
• To assess overall performance, the manufacturers of all the assays we are using conducted studies using approximately 100 contrived samples (CDC and Abbott – used RNA spiked into samples) or comparator clinical sample (DiaSorin – utilized samples from 3 different sites in Italy). All 3 assays had 100% negative percent agreement and 100% positive percent agreement, which are terms that describe analytical sensitivity and specificity, respectively, when a new test is evaluated by a comparator assay that is not a diagnostic gold standard.
• The manufacturers of these assays also conducted studies to assess specificity by running samples that were known to be positive for the other six known human coronaviruses and a diverse panel of other common respiratory pathogens, and all three assays demonstrated no cross reactivity, thereby confirming excellent specificity.
• In addition to the manufacturer’s studies, we conducted our own internal verification studies, which demonstrated assay performance in accordance with the manufacturer’s claims.

What is the limit of detection for the testing platforms at Children’s Colorado?

• The limit of detection for our assays is in the range of 100 – 500 viral genomic RNA copies/mL, which is considered extremely low (meaning the assays can detect a very small amount of virus).
• For comparison, the limit of detection on the BioFire respiratory pathogen panel is in the range of 10 – 500 RNA or DNA copies/mL depending on the pathogen.

What do we know about SARS-CoV-2 viral load in clinical specimens?

• In one study of symptomatic adults with COVID-19, the mean viral load in nasal swabs from positive patients was 1.4 x 10⁶ (1,400,000) copies/mL. Another study in symptomatic adults demonstrated viral loads in nasal swabs ranging from 1.5 x 10⁴ to 1.5 x 10⁷ copies/mL, depending on the day of illness.
• Viral loads are higher earlier in the course of the disease.
• Viral loads are highest in nasopharyngeal (NP) swab specimens.
• Some studies have suggested that adults with more severe disease tend to have higher viral loads.
• Patients with milder disease tend to have earlier viral clearance.

What is the risk of a “false negative” test result?

• All our assays have excellent performance characteristics. Provided that a sample contains virus in the amount greater than our limit of detection, the risk of a false negative is extremely low.
• Clinical false negatives are usually not a result of test performance. Reasons for clinical false negatives could include:
  • Poor sample collection.
  • Degradation of viral RNA during shipping or storage of samples (rare).
  • Intermittent shedding of virus.
  • Stage of infection – very early in the course of an infection (during the incubation period, likely prior to contagiousness), or late in the course of disease viral loads may be undetectable.
  • Type of specimen – some studies have demonstrated that in patients with severe lower respiratory tract disease, upper respiratory tract specimens (NP swabs/nasal washes) may be negative. For these patients, a tracheal aspirate (TA) or bronchoalveolar lavage (BAL) should be considered for testing if the NP swab or nasal wash specimen is negative.
• Although only recommended in certain circumstances, the ability to detect the presence of virus in asymptomatic compared to symptomatic patients should be equivalent.

How will our patients be charged?

• We will bill your patient’s insurance directly so please provide a diagnosis code along with insurance information (i.e. payor, plan type, subscriber ID, subscriber DOB, etc.) for your patients.
• Please also provide us a good contact to reach out to if we have questions regarding the information we have been provided or if we have issues getting the insurance approved.

Who can we contact if we have questions?

• If looking for results please contact Lab Client Services at LabClientServices@childrenscolorado.org and include patients first and last name and a DOB, or during normal business hours (Mon. – Fri. 8a – 4p) you can call 720-777-6711.
• For details on sending specimens, billing or other inquiries please reach out to the Supervisor of Lab Client Services, Amber Rodriguez, at Amber.Rodriguez@childrenscolorado.org or 720-777-2723.
  • Email will provide a quicker response, so please include a good phone number.
• Please remember that our teams our doing the absolute best that we can to manage a significant volume of specimens and maintain a 24-hour TAT. We ask that you be patient with our teams and utilize our Lab Client Services email for inquiries so that our lab techs can focus on testing.

References:

1. Casto A, et al. “Comparative Performance of SARS-CoV-2 Detection Assays using Seven Different Primer/Probe Sets and One Assay Kit .” medRxiv, 2020.
2. Kam K-Q, et al. “A Well Infant With Coronavirus Disease 2019 With High Viral Load.” CID, 2020.
3. Kim J.Y. et al. “ Viral load kinetics of SARS CoV-2 infection in first two patients in Korea. J. Korean Med Sci., 2020.
4. Liu Y, et al. “Viral Dynamics in Mild and Severe Cases of COVID-19.” Lancet Infectious Diseases, 2020.
5. Pan Y, et al. “ Viral Load of SARS-CoV-2 in Clinical Specimens.” Lancet Infectious Diseases, 2020.
6. Patel R, et al. “Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS–CoV-2/COVID-19.” mBio, 2020.
7. Theravajan I, et al. “Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19.” Nature, 2020.
8. Wang W, et al. “Detection of SARS-CoV-2 in Different types of Clinical Specimens.” JAMA, 2020.
9. Wolfel, R. “Virological assessment of hospitalized cases of coronavirus disease 2019.” medRxiv, 2020.
10. Xi, H, et al. “Temporal Dynamics in Viral Shedding and Transmissibility of COVID-19.” medRxiv, 2020.
11. Yang Y, et al. “Evaluating the Accuracy of Different Respiratory Specimens in the Laboratory Diagnosis and Monitoring the Viral Shedding of 2019-nCoV Infections.” medRxiv, 2020.
12. Zou L, et al. “SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients.” NEJM, 2020.

We’ve created a coronavirus testing FAQ for you to share with families. It helps answer parents’ questions about PCR and antibody tests available at Children’s Colorado, along with general information about the different testing types.