Posted on

November 2020: Temporarily Unavailable – Stool Gastrointestinal Panel by PCR

Special Communication

Temporarily Unavailable: Stool Gastrointestinal Panel by PCR

Beginning November 13, 2020, Stool Gastrointestinal Panel by PCR (STGIPR) testing is temporarily unavailable to order from CCL.

Cleveland Clinic Laboratories is experiencing severe supply constraints for Stool Gastrointestinal Panel by PCR (STGIPR) testing. These shortages impact laboratories nationwide, resulting in the inability to identify a reference laboratory to forward this testing.

Alternative Testing Options

The tests listed below cover the range of pathogens detected in the Stool Gastrointestinal Panel by PCR (STGIPR) test. Depending on clinical circumstances and judgment, various combinations of these tests may serve as an appropriate substitution for STGIPR:

Test Code

Components

Performing Lab

STLPCR

Salmonella spp., Shigella spp., Campylobacter jejuni/coli, and Shiga-toxin (stx1 and stx2) genes

CCL

OVAPSC

Giardia lamblia and Cryptosporidium species

CCL

CRYSPO

Cryptosporidium, Cyclospora, and Cystoisospora sp.

CCL

OVAP

Cryptosporidium and Giardia

CCL

CDPCR

C. difficile toxin B gene

CCL

EROTA

Rotavirus antigen

CCL

VIBCUL

Vibrio

CCL

YERCUL

Yersinia

CCL

NORPCR

Norovirus 1 & 2

ARUP

SADNO

Adenovirus antigen

Focus

Posted on

COVID-19: Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Special Communication

Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Due to supply constraints related to COVID-19, supplies for Enteric Bacterial Panel by PCR (STLPCR) testing are in extremely limited supply.

While supplies are constrained, culture and antigen testing will be used in place of PCR testing to interrogate specimens for the same pathogens as STLPCR: Campylobacter, Salmonella, Shigella, and Shiga toxin-producing E. coli (STEC/EHEC).

Cleveland Clinic Laboratories will temporarily cancel and credit any STLPCR test requests, then substitute clinically-equivalent culture and antigen testing.

The associated CPT codes for these substitutions are:

• 87449 (x 2)
• 87045

Posted on

COVID-19: Unacceptable Specimen Transport Media for COVID-19 Testing

Special Communication

Unacceptable Specimen Transport Media for COVID-19 Testing

Due to incompatibilities with our COVID-19 testing laboratory equipment, Cleveland Clinic Laboratories has determined that specimens in the following media are not acceptable for COVID-19 testing performed by CCL:

Beaver Biomedical Viral Transport Media (VTM)

NEST Solution for swab sample collection, transportation and storage

The following specimen types are accepted by CCL for COVID-19 testing:

Universal Transport Media (UTM), 3 mL

Viral Transport Medium (VTM), 3 mL

Saline Transport Media, 3 mL

Sterile Container*, 3 mL

Specimen Type:

Nasopharyngeal (NP) swab – preferred

• Nasal (anterior nares) swab

• Oropharyngeal (OP) swab

Specimen Type:

Nasopharyngeal (NP) swab – preferred

• Nasal (anterior nares) swab

• Oropharyngeal (OP) swab

Specimen Type:

Nasopharyngeal (NP) swab – preferred

• Nasal (anterior nares) swab

• Oropharyngeal (OP) swab

Specimen Type:

• Sputum

• Bronchoalveolar lavage (BAL)

*lower respiratory specimens only

Want More Information about COVID-19 Testing?

Review our Coronavirus 2019 Testing Overview for additional details, including collection instructions, required patient demographics, and more.

Need Collection & Transport Media?

If you are having difficulties obtaining appropriate COVID-19 specimen collection and transport supplies, please contact your CCL Account Manager.

Have a Question?

Please contact Client Services at 800.628.6818.

Posted on

COVID-19: Supply Shortages Impacting Gonorrhea, Chlamydia, and Trichomoniasis Testing

Special Communication

Supply Shortages Impacting Gonorrhea, Chlamydia, and Trichomoniasis Testing

As a result of nationwide supply shortages caused by COVID-19 demands, Cleveland Clinic Laboratories may periodically be unable to provide Aptima® Urine Specimen Collection Transport Tubes for gonorrhea, chlamydia, and trichomoniasis testing.

Aptima tubes will continue to remain an acceptable specimen collection container for testing.

Because of the severe shortage of urine tubes, providers should reserve urine testing for men with persistent urethritis. This practice aligns with guidance from the Centers for Disease Control and Prevention (CDC).

What Tests Are Affected

GC/Chlamydia Amplification, Urine (UGCCT)

Ordering Options for Gonorrhea/Chlamydia Testing

  • GC/Chlamydia Amplification, Urine (UGCCT) using self-supplied Aptima Urine Specimen Collection Transport Tubes
  • GC/Chlamydia Amplification, Genital, Rectal and Oral Specimens (GCCT) using an Aptima Swab Kit

Trichomonas vaginalis Amplification (TRVAMP)

Ordering Options for Trichomoniasis Testing

Specimen Collection for GCCT & TRVAMP

Samples can continue to be collected and submitted with either Aptima kit shown below.

Although CCL cannot provide this item, Aptima tubes will continue to remain an acceptable specimen collection container for testing.

For women:
Women can be swabbed with either Aptima Kit.

For Men:
Men can be swabbed with Aptima Unisex Swab (urethral).

Unacceptable Specimen Containers

Do not send urine in a sterile cup.

Because of the limited stability of unpreserved urine for gonorrhea, chlamydia, and trichomoniasis testing, Cleveland Clinic Laboratories is currently unable to accept urine in a sterile container (i.e., specimen cup) for UGCCT and TRVAMP orders.

Other Considerations

Cleveland Clinic Laboratories will notify clients when Aptima urine tubes are back in stock and available to order. Conservative ordering practices may be necessary until supplies stabilize.

For help in prioritizing which patients to test for these pathogens, please refer to the recently-issued considerations from the CDC.

Posted on

August 2020: Update – Cytogenetic Karyotyping & Chromosomal Microarray Testing

Special Communication

Update: Cytogenetic Karyotyping & Chromosomal Microarray Testing

Cleveland Clinic Laboratories (CCL) remains committed to supporting patients and providers during the COVID-19 pandemic.

To meet the current demands for COVID-19 PCR testing, Cleveland Clinic Laboratories is temporarily reassigning some of our molecular pathology technologists to this effort.

As a result, cytogenetic karyotyping and chromosomal microarray testing will temporarily be sent out to a partnered reference laboratory. This will allow COVID-19 testing to continue uninterrupted while we increase our testing capacity.

If you have any questions, please contact your CCL Account Manager or Client Services at 800.628.6818.

What Tests Are Affected

Starting Monday, August 24, 2020, Cleveland Clinic Laboratories will begin temporarily sending these tests to Quest Diagnostics.

Test Name

CCL Test Code

Send-out Test Code (Quest)

Expected TAT

Chromosome Analysis, Bone Marrow

9 Days

Chromosome Analysis, Bone Marrow w/ Reflex SNP Array

14600analysis
90961reflex

9 Days
13 Days

Chromosome Analysis, Leukemic Blood

9 Days

Chromosome Analysis, Tissue (Fibroblasts)

16 Days

Chromosome Analysis, Solid Tumor (Lymph Nodes)

14603solid tumor
14602lymph node

22 Days
11 Days

Test Name

CCL Test Code

Send-out Test Code (Quest)

Expected TAT

Chromosomal Microarray, Constitutional Blood

13-16 Days

Chromosomal Microarray, Leukemic Blood

13 Days

Chromosomal Microarray, Products of Conception

13 Days

Chromosomal Microarray, Bone Marrow

13 Days

Timing

Starting Monday, August 24, 2020, Cleveland Clinic Laboratories will begin temporarily sending these tests to Quest Diagnostics.

CCL estimates that this process will continue for several months. We will return these tests in-house as soon as possible and communicate any changes once they are available.

Turnaround Time

In some instances, we anticipate that turnaround times (TAT) may be impacted. CCL will do everything possible to minimize delays.

Ordering & Results

There are no changes to the ordering process.

Test results will continue to be available via the Atlas portal or faxed results. Please contact your CCL Sales representative as necessary for further support in retrieving these results.

Billing

At this time, we do not anticipate any changes to the billing process.

Pricing will reflect costs associated with sending out these tests.  A Cleveland Clinic Laboratories representative will communicate any price changes directly to clients.

Posted on

Antibody Testing for COVID-19: Overview & FAQs

CAP Statement on the Current Role of Serologic Testing for SARS-CoV-2

May 13, 2020 | From the College of American Pathologists

Understanding COVID-19 & Antibody Testing

May 7, 2020 | From Cleveland Clinic’s Health Essentials:

We’ve accepted the harsh realities of COVID-19 and we’ve adjusted our lives accordingly. And yet, we still have so many unanswered questions like why has COVID-19 taken such a detrimental toll, and where are we in the process of finding a cure?

To get a better idea of where science is headed, Cleveland Clinic CEO and President Tom Mihaljevic, MD interviews Serpil Erzurum, MD, Chair of the Lerner Research Institute.

COVID-19 Serologic Testing: FAQS and Caveats

April 29, 2020 | From the Cleveland Clinic Journal of Medicine’s COVID-19 Curbside Consults:

There has been an immense amount of tangential discussion regarding the potential usefulness of serologic testing for COVID-19 recently. Although serologic testing has never been routinely used for diagnosing infections with “respiratory viruses”, such as influenzae, parainfluenzae, respiratory syncytial viruses, adenoviruses, or metapneumovirus, questioning its usefulness during the current outbreak has relevance.

That being said, during global epidemics of SARS, MERS, and H1N1 influenza, serology was never used in routine diagnostics. However, given the pandemic status of COVID-19 and the shortage of nucleic acid detection kits and/or swabs in certain areas, it raises the prospect of resorting to serology as an alternative to directly testing for the presence of the virus. The Infectious Diseases Society of America (IDAS) has recently issued a clear statement on COVID-19 serology.

Kamran Kadkhoda, PhD

Kamran Kadkhoda, PhD
Medical Director, Immunopathology
Posted on

Coronavirus 2019 (COVID-19) Testing

Updated on November 8, 2020.

Respiratory Virus Testing

Cleveland Clinic Laboratories offers several respiratory testing services to healthcare organizations & providers.

At this time, COVID-19 testing is offered only to healthcare providers & organizations within the state of Ohio.

The SARS-CoV-2 assay is available for the qualitative detection of the COVID-19 virus in respiratory specimens from individuals with the appropriate signs, symptoms, and epidemiologic exposure.

Our physicians and leaders collaborate closely with public health officials on a local, state, and national level.

As a healthcare provider, Cleveland Clinic continues to focus on caring for our patients, caregivers, and organization as part of the greater healthcare community. We will continue monitoring the situation and update our client resources accordingly.

Testing will be performed at Cleveland Clinic as possible based on operational capacity. Samples may be referred to another laboratory without prior notice if onsite capacity is exceeded. Capacity restrictions and/or external referrals may impact turnaround time (see below for details).

Interested in COVID-19 Testing?

Ohio Healthcare Providers

1. Contact Client Services at 1.800.628.6816.

2. Provide your name, organization, and phone number.
If you are a current or previous client, please also provide your Client ID code.

3. A CCL Account Manager will respond to your inquiry within 24 hours.
Please determine your organization’s anticipated daily specimen volumes before the representative calls.

If your organization is currently sending testing and expects an increase in COVID-19 specimen volumes, please contact your CCL Account Representative immediately.

COVID-19 Test Overview

Test Name

Coronavirus 2019 (COVID)

Turnaround Time

24 hours from the time of receipt by the laboratory*
Testing is performed 24 hours a day, 7 days a week

Testing will be performed at Cleveland Clinic as possible based on operational capacity. Samples may be referred to another laboratory without prior notice if onsite capacity is exceeded. Capacity restrictions and/or external referrals may impact turnaround time.

Specimen Requirements

Type:
(1) Nasopharyngeal (NP) Swab – preferred 

Volume:
3 mL

Specimen Container:
Universal Transport Media (UTM)

Transport Temperature:
Refrigerated; transport to the laboratories on cold packs or wet ice.

Alternative

Type:
(1) Nasopharyngeal (NP) swab, or
(1) Nasal (anterior nares) swab

Volume:
3 mL

Specimen Container:
Saline transport medium

Transport Temperature:
Refrigerated; transport to the laboratories on cold packs or wet ice.

Alternative

Type:
(1) Oropharyngeal (OP) Swab

Volume:
3 mL

Specimen Container:
Regular Tip Flocked Swab in Universal Transport Media (UTM)

Transport Temperature:
Refrigerated; transport to the laboratories on cold packs or wet ice.

Alternative

NP/OP swabs (shown above) are the preferred specimen type.

Type:
Lower respiratory specimens: sputum or bronchoalveolar lavage (BAL)

Volume:
3 mL

Specimen Container:
Sterile specimen container

Transport Temperature:
Refrigerated; transport to the laboratories on cold packs or wet ice.

Stability

Ambient:
Unacceptable

Refrigerated (2-8ºC):
72 hours

Frozen:
Up to 30 days

Rejection Criteria

Swabs used for Group A Strep testing are not acceptable.

Unacceptable:

COVID-19, Influenza, & Respiratory Syncytial Virus (RSV) Testing Overview

In accordance with CDC recommendations, Cleveland Clinic Laboratories recommends multiplex testing for the detection of influenza, respiratory syncytial virus, & COVID-19.

All influenza tests interrogate the specimen for both influenza A & influenza B, and types are reported individually.

For the most up-to-date information on influenza prevalence, please refer to resources provided by the Centers for Disease Control and Prevention (CDC) and the Ohio Department of Health (ODH).

For Symptomatic Adults:

Recommendation:
Routine COVID with Flu (COVFLU)

For Symptomatic Pediatric Patients:

Recommendation:
Coronavirus 2019 (COVID) + Routine Flu & RSV Testing (RTFRSV)

For clients who have already performed COVID testing, Routine Flu & RSV Testing (RTFRSV) is available as a stand-alone order.

Test Name

Routine COVID with Flu A+B (COVFLU) 

Routine Flu & RSV Testing (RTFRSV)

Turnaround Time

24 hours from the time of receipt by the laboratory

Specimen Type

Type:
(1) Nasopharyngeal (NP) Swab – preferred, or
(1) Anterior nasal swab, or
(1) Midturbinate swab

Transport Media

Universal Transport Media
(UTM), 3 mL

Viral Transport Media
(VTM), 3 mL

Saline Transport Media,
3 mL

eSwab Liquid Amies Transport
Media, 3 mL

Stability

Ambient:
Unacceptable

Refrigerated (2-8ºC):
72 hours

Frozen:
Up to 30 days

Transport Temperature

Refrigerated. Transport to the laboratories on cold packs or wet ice. 

Patient Demographics & Reporting

Due to mandatory reporting for COVID-19 testing, additional patient demographic information is needed to complete a test order.

Failure to provide the required information will result in delayed testing.

Cleveland Clinic will report positive test results to the Ohio Department of Health (ODH).

COVID-19 Test Requisition

All specimens must be accompanied by a completed test requisition.

Need a COVID Requisition?  Contact your CCL Account Manager or Client Services at 1.800.628.6816.

The following details are required for COVID-19 testing:

Patient Details

  • First & last name
    • Guardian’s name (for patients 16 years old and under only)
  • Date of birth
  • Sex
  • Race/ethnicity
  • Current address (street, city, county, state, zip code)
  • Primary telephone number (please include area code)
  • Insurance details

Specimen Details

  • Collection date
  • Collection time
  • First & last name of the collector
  • Specimen type (e.g., NP swab, sputum)

Healthcare Provider Details

  • First & last name
  • Address (street, city, county, state, zip code)
  • Phone number

For Mandatory US Department of Health & Human Services Reporting:

1. Is the patient being tested for COVID-19 for the first time?

2. Are they employed in health care?

3. Is the patient symptomatic as defined by CDC? (If yes, please indicate Date of Symptom onset)

4. Are they currently hospitalized?

5. Are they currently admitted to an ICU?

6. Is the patient a resident in a congregate care setting (e.g., nursing home, residential care for people with intellectual and developmental disabilities, psychiatric treatment facility, group home, board & care home, homeless shelter, foster care, or other setting)?

7. Is the patient pregnant?

Specimen Collection Instructions

You will need:

Personal protective equipment (PPE)

(1) tube of transport medium

– Universal Transport Media (UTM)
Viral Transport Media (VTM)*
– Saline solution

(1) swab

Patient identification labels

Before you begin:

• Confirm the patient’s name and date of birth.

• Wash your hands, then put on personal protective equipment, including gloves.

If you are having difficulties obtaining appropriate COVID-19 specimen collection and transport supplies, please contact your CCL Account Manager.

Nasopharyngeal (NP)/Oropharyngeal (OP) Swabs

Step 1:
Carefully remove the swab from the packaging without touching the tip.

Step 2a for nasopharyngeal (NP) swabs:

– Gently insert the NP swab along the nasal septum just above the floor of the passage to the nasopharynx until resistance is met.

– Rotate the swab gently against the nasopharyngeal mucosa for 10 – 15 seconds, then remove.

Step 2b for oropharyngeal (OP) swabs:

– Insert the OP swab into the back of the patient’s throat and gently swab the tonsillar pillars and posterior oropharynx.

Avoid touching the patient’s teeth, gums, and tongue.

Step 3:
Remove the cap from the tube, then insert the swab all the way to the bottom of the vial.

Step 4:
While holding the tube away from your face, bend the swab in the vial at a 180-degree angle to break at the marked breakpoint.

Step 5:
Close the tube tightly. If possible, wrap the cap with Parafilm.

Any leaking specimens will be rejected.

Step 6:
Label specimen with the printed label or write the patient’s first & last name, date of birth, and the date, time, and site of collection (e.g., NP or OP) on the tube.

Step 7:
Double-bag the specimen, place on wet ice, then refrigerate.

Step 8:
Complete a Coronavirus 2019 (COVID) Test Requisition.

Please ensure to provide the required Patient Demographics.

Step 9:
Place the completed requisition in the pocket of the specimen bag.

Do not place any paperwork in the part of the bag containing the specimen.

Step 10:
For the fastest turnaround time, deliver the specimen directly to the Main Campus LL Building Specimen Receiving Area:

Cleveland Clinic Laboratories
10300 Carnegie Avenue
Cleveland, OH 44106

Need a COVID-19 Test Requisition? 

Contact your CCL Account Manager or Client Services.

Nasal (Anterior Nares) Swabs

Specimen Collection:

Step 1:Carefully remove the swab from the packaging without touching the tip.

Step 2:

Position the patient’s head slightly back, then insert the swab into their LEFT nostril (less than one inch) and gently push until a slight resistance is met.

Step 3:

Rotate the swab against the inside of the patient’s nostril four times for 10-15 seconds.

Step 4:
Remove the swab, then repeat Steps 2 & 3 in the RIGHT nostril with the same swab.

Remove the swab from the patient’s nose when finished.

Preparing for Transport:

Step 5:

While holding the swab, open the tube and set the cap down with the threads facing up.

Insert the swab into the tube until the breakpoint is level with the tube opening.

Step 6:

While holding the tube away from your face, bend the swab until it snaps at the break point.

You may need to gently rotate the swab shaft to complete the breakage.

Step 7:

After discarding the remaining swab shaft into an approved disposal container, screw the cap back onto the tube.

Apply the test label or write the patient’s information onto the tube.

Step 8:

Place the specimen into a biohazard bag, then insert any lab paperwork into the outside pouch.

Refrigerate the specimen during storage and transport to the lab.

Unacceptable Specimen Types

If you are unsure if a specific viral transport media (VTM) is accepted for testing, please contact Client Services for assistance.

Refer to the FDA’s Letter to Healthcare Providers regarding Transport Media Safety Risk for additional guidance.

BD CultureSwabs with Stuart’s or Amies Transport Medium

Beaver Biomedical Viral Transport Media (VTM)

NEST Solution for swab sample collection, transportation and storage

Due to incompatibilities with COVID-19 testing laboratory equipment, specimens in Beaver Biomedical VTM or NEST Solution for Sample Collection, Transport, and Storage are not acceptable for COVID-19 testing performed by CCL.

If you have any questions, please contact your CCL Account Manager or Client Services for assistance.