Information for Providers About SARS-CoV-2 Testing Offered at Children’s Hospital Colorado

SARS-CoV-2 testing is available to community providers, EMS and healthcare workers, and children and their caregivers at a few Children’s Colorado locations. The PCR testing is done via a nasopharyngeal swab or saliva sample.

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.

Saliva testing now available

PCR testing using a saliva sample for symptomatic outpatients ages 4 to 18 is now available. This test will be available at our drive-through testing locations and through point of care (POC) testing.

PCR testing locations 

We offer COVID-19 testing at drive-through testing sites at Anschutz Medical Campus and Briargate. Hours and location details are available on our Coronavirus Testing for Kids page.

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.

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 to 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, unless testing is required for travel.
• 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.

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.

In-office saliva testing for kids now available

We now offer saliva testing for symptomatic outpatients ages 4 to 18 only. No exceptions will be made. Our research does not support saliva testing for people over the age of 18, so it should not be used for these patients, even if they have special needs.

This test is available at drive-through testing locations and through POC testing. Healthcare providers can collect in-office saliva samples and send them to our lab. If your practice has requested saliva kits to test in your office and route to the lab at Children’s Colorado for processing, the saliva specimen must be collected in the provider’s office. The saliva kit should not be sent home with families for self-collection.

How to collect a nasopharyngeal swab or saliva 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 information below.

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.

Nasopharyngeal testing instructions

For information on how to collect a nasopharyngeal swab, download the NP Swab Collection (.pdf) document.

Saliva testing instructions for healthcare providers

The ordering healthcare provider is responsible for assessing a patient's symptoms and determining if a saliva test is appropriate. Providers cannot order both specimen types (NP and saliva) and rely on Children’s Colorado’s staff to assess which type is appropriate.

For information on how to collect a saliva sample and answers to frequently asked questions, download the SARS-CoV-2 Testing using Saliva for Symptomatic Patients Aged 4 to 18 (.pdf) document. It is highly recommended that the individual does not eat or drink at least 10 minutes prior to saliva collection.

Practices who have requested saliva kits to collect specimens in their office should arrange for courier of the saliva sample to the Children's Colorado lab for processing. For samples delivered to our mobile testing site, you will need the following:

• An appointment
• Complete paperwork/orders
• Labeled specimen with patient details from the ordering provider
• Sample drop-off on the same day as collection for proper preservation of the specimen

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
Saliva (SYMPTOMATIC ONLY)	Saliva collection transport medium

• 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
Saliva test: For symptomatic patients aged 4 to 18 years, be sure to indicate saliva source, or the NP swab collection method will be performed.	LAB9100
Respiratory Pathogen Panel (RPP)	LAB5595

• The RPP automatically includes SARS. There is no longer a need to order both.
• RPP must be ordered with an NP swab source only. No exceptions.
• 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, so please provide the code (not a description) with all submissions.
• Please make sure all patient information is legible. If the spelling of the patient name does not match between the specimen and the paperwork, the specimen could be rejected or results could be delayed.

Children’s Colorado mobile clinic collection details

All patients need an appointment and order placed before arriving at our mobile sites. 

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
Colorado Springs 4125 Briargate Pkwy Colorado Springs, 80920	719-305-0005	COSLabCOVID@childrenscolorado.org 719-305-9735

The North Campus and South Campus mobile testing sites will no longer be operating as of July 4, 2021.

For primary care practices: saliva testing drop-off at mobile sites

Practices that have been dropping saliva testing samples off at our North or South Campus mobile sites can instead drop samples off at the outpatient labs in those locations.

South Campus: 7 a.m. – 5:30 p.m., Monday to Friday and 8 a.m. to 12 p.m., Saturday

North Campus: 7 a.m. – 5:30 p.m., Monday to Friday and 8 a.m. to 12 p.m., Saturday

Please note: We only accept saliva samples from primary care practices. 

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 that detect viral RNA.
• At Children’s Colorado, we currently are running five 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.
  • Biofire RPP 2.1 includes the SARS target.
  • Cepheid Xpert Xpress SARS-CoV-2 assay detects the E and Ne genes.
• All 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 want us to perform a test for a patient for an upcoming procedure, please make sure to plan accordingly to manage the result TAT. We recommend collection to be 2 to 3 days 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 positive results to external providers or their patients. The provider's 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 the 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 three different sites in Italy). All three 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.

Effectiveness of saliva testing

• We have performed an internal study looking at the performance of our typical collection sample, NP swab, compared to saliva using a saliva collection device (SCD) for detection of SARS-CoV-2.
• Our results showed that the SCD samples were comparable in sensitivity compared to NP swab samples in symptomatic patients. For asymptomatic patients, sensitivity of SCD samples was much lower (30 to 60%) compared to NP swab samples.

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.
• In pediatric patients, generally, viral loads are known to be higher in symptomatic patients compared to asymptomatic patients. 

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?

• For results, please email Lab Client Services and include your patient's first and last name and DOB. Or during normal business hours (Mon. – Fri. 8 a.m. – 4 p.m.) 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 are 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 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. However, an antibody test is indicated for suspected MIS-C.
• 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 Nuclocapsid Antibody, IGG [LAB9144]
• SARS-COV-2 Spike Antibody, IGG [LAB9399]

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).

Preprocedural and presurgical SARS-CoV-2 testing update 

Preprocedural SARS-CoV-2 testing at Children’s Colorado has been a required component of our pandemic response and has been challenging to execute for our perioperative teams, microbiology laboratory, community partners and most importantly for our patients.

As of July 19, 2021, preprocedural SARS-CoV-2 testing will be limited to the following situations:

1. Patients undergoing specific high-risk aerosol generating procedures that include bronchoscopy/direct airway manipulation by otolaryngology, pediatric surgery or pulmonology as well as oral maxillary/dental procedures under anesthesia
2.  Any patient getting admitted to any inpatient unit after their surgery/procedure
3. Patients who are identified during the week prior to their procedures as having epidemiologic risk factors for COVID-19 (household exposure, symptoms or travel out of state of residency except for travel to Children’s Colorado for clinical care)

As the pandemic recedes in terms of active cases, our asymptomatic preprocedural SARS-CoV-2 positivity rate has dropped below 1%. With very high COVID vaccination rates of clinical staff and availability of PPE in all our clinical environments, preprocedural SARS-CoV-2 testing currently adds little incremental safety benefit to our team members.

Learn more about Children’s Colorado preprocedural COVID-19 testing updates (.pdf).

Importance of COVID-19 testing prior to certain surgeries and procedures

At Children’s Colorado, patient safety is our top priority. Ensuring that our patients do not have COVID-19 before certain surgeries or procedures is very important for keeping them and their healthcare providers safe. 

Having test results before surgery gives our medical team a complete picture of each patient’s health and the ability to plan before surgery begins. We use the most accurate type of testing available, molecular PCR testing with an NP swab, to keep everyone safe. 

Though the swab is uncomfortable for some children, the momentary discomfort it causes is less harmful than the potential harm from delaying medical treatment. Our team members have experience working with children and take extra steps to make the testing process as comfortable for them as possible. 

While the recent increase in the availability of COVID-19 vaccines is promising and should be celebrated, we are not near the end of the pandemic quite yet. It will be many more months before we can vaccinate most of the adult population. And we’re still waiting for data to confirm the safety and effectiveness of the COVID-19 vaccines in kids younger than 12. Testing, quarantine and isolation – along with other steps to prevent COVID-19 – are still crucial for these reasons. 

 

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.