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

SARS-CoV-2 preprocedural testing is available for patients at a few Children’s Colorado locations. PCR testing is performed via a nasopharyngeal (NP) swab or mid-turbinate (MT) swab.  

Please note that referrals and appointments are required for all COVID-19 tests. Most SARS-CoV-2 PCR test results are available within 24 hours, but there might be some delays during periods of increased test demand (e.g., holiday season). 

Mid-turbinate swab testing

We added mid-turbinate (MT) swabs as a specimen source because they are better tolerated than an NP swab. Accumulating evidence in the literature indicates that the sensitivity and specificity of a MT swab is similar to an NP swab. 

PCR testing locations 

We offer preprocedural testing at our Anschutz Medical Campus and drive-through testing at our Briargate campus in Colorado Springs. Hours and location details are available on our Coronavirus Testing for Kids page.

Appointments and referrals

COVID-19 testing is available by appointment only, and a referral by a provider must accompany each appointment.  

How to submit a referral:

• Provide a paper or digital referral that the patient shows at the time of appointment
• Submit electronically via Children’s Colorado Connect^® or Peds Connect^®
• 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 available within 24 hours, please email the patient's name and date of birth to LabClientServices@childrenscolorado.org.

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.

Preprocedural SARS-CoV-2 testing is limited to the following situations:

• 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 
• Any patient getting admitted to an inpatient unit after their surgery/procedure 
• Patients who are identified during the week prior to their procedures as having epidemiologic risk factors for COVID-19 (household exposure or current symptoms) 

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

Guidance on which preprocedural and presurgical SARS-CoV-2 tests to order

• For urgent surgeries (occurring in less than 24 hours) that meet the requirements for testing listed above, providers should order a Flu-VID test instead of a SARS-CoV-2 PCR. This change is due to turnaround time expectations. Please also refer to our respiratory pathogen testing considerations (.pdf).
• For all other preprocedural testing, we can no longer guarantee next-day procedural test results (collection before 11 a.m. and results out by 5 a.m. the following day). All preprocedural testing (SARS-CoV-2 PCR) should occur 2 to 3 days prior to the scheduled procedure.

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 or MT swab, to keep everyone safe. 

Though the NT and MT swabs are 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. 

 

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, especially in asymptomatic individuals. 

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 and CDPHE.

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 (NP) swab samples and couriering them 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. 

NP swab testing instructions

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

Provider office specimen collection details

The table below 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:
NP swab	Viral, UTM, amies or sterile saline	Refrigerator pack
Nasal wash	Saline
Nasal MT 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 besides NP swab, MT 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.

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
SARS-CoV-2/Influenza A/Influenza B/RSV PCR (Flu-VID )	LAB9373

• The RPP automatically includes SARS-CoV-2 testing. There is no longer a need to order both tests.
• RPP can now be ordered with NP swab and MT swab sources. 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 collection details

All patients need an appointment and order placed before arriving at a testing site. 

Mobile site location:	Appointment line:	Email and fax line for orders:
Colorado Springs 4125 Briargate Pkwy Colorado Springs, 80920	719-305-0005	COSLabCOVID@childrenscolorado.org 719-305-9735

The North Campus, South Campus and Anschutz Medical Campus mobile testing sites are no longer in operation.

For primary care practices: saliva testing drop-off

Practices can drop off samples at the outpatient labs at the following locations. We accept saliva samples from primary care practices only. 

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

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.
• Since Oct. 6, 2021, we have been running four platforms for respiratory PCR testing. All tests include a SARS-CoV-2 target:
  • Abbot m2000 Real-Time will perform SARS-CoV-2-only testing. This platform detects RdRp and N genes of SARS-CoV-2.
  • DiaSorin Simplexa will perform Flu-VID testing, which includes SARS-CoV-2, influenza A, influenza B, and RSV targets. This platform detects ORF1ab and S genes of SARS-CoV-2.
  • Cepheid Xpert Xpress will perform Flu-VID testing, which includes SARS-CoV-2, influenza A, influenza B, and RSV targets. This platform detects the E and N genes of SARS-CoV-2. 
  • Biofire RPP 2.1 includes a SARS-CoV-2 target and detects the S and M 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:

Type of Test	Turnaround Time from receipt in Microbiology Laboratory
SARS-CoV-2 PCR	24 hours
SARS-CoV-2 / Influenza A / Influenza B / RSV PCR (Flu-VID) PCR	6 hours
RPP (Respiratory Pathogen Panel, includes SARS-CoV-2) PCR	6 hours

• 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 the TAT indicated above for the specific test ordered from sample receipt in the lab and the patient's chart does not have a result or a fax has not been received, please email LabClientServices@childrenscolorado.org.
  • 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 within the TAT times specified above.
• 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 the detection of SARS-CoV-2 RNA have been granted FDA EUA (Emergency Use Authorization) or FDA clearance. For tests that have FDA EUA, no clinical trials have been conducted and there is no available data regarding the overall clinical sensitivity and specificity of these assays. Currently, there is no gold standard diagnostic test of comparison studies to determine the sensitivity and specificity of individual assays. In lieu of definitive clinical sensitivity data, the limit of detection data has been provided as a proxy measure. Similar to other viral detection methods, PCR has become the gold standard for the 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 (Abbott – used RNA spiked into samples) or comparator clinical sample (DiaSorin – utilized samples from three different sites in Italy). All 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 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 that is in accordance with the manufacturer’s claims.

Effectiveness of MT swab testing

Accumulating evidence in the literature indicates that the sensitivity and specificity of a MT swab is relatively similar to an NP swab.

What is the limit of detection for the testing platforms that detect SARS-CoV-2 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).

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 with 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 Care locations 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 2021-2022 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 October 6, 2021 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 antibody 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 serologic testing 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]: A positive result indicates past infection.  
• SARS-COV-2 Spike Antibody, IGG [LAB9399]: A positive result indicates receipt of vaccine and/or past infection.

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).

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.