Category: Special Communication

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

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.

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).

Affected Tests

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

Trichomonas vaginalis Amplification (TRVAMP) using an Aptima Swab Kit

Specimen Collection

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.

Aptima Multitest Swab Specimen Collection Kit

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

Aptima Unisex Swab Specimen Collection Kit for Endocervical & Male Urethral Swab Specimens

Unacceptable Containers

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.

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.

Affected Tests

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

CHRBMH

14600

9 Days

Chromosome Analysis, Bone Marrow w/ Reflex SNP Array

BMCHF

14600 – analysis
90961 – reflex

9 Days
13 Days

Chromosome Analysis, Leukemic Blood

CHRBLL

14600

9 Days

Chromosome Analysis, Tissue (Fibroblasts)

CHRTIS

14593

16 Days

Chromosome Analysis, Solid Tumor (Lymph Nodes)

CHRSOL

14603 – solid tumor
14602 – lymph node

22 Days
11 Days

Test Name

CCL Test Code

Send-out Test Code (Quest)

Expected TAT

Chromosomal Microarray, Constitutional Blood

CRMSNP

16478

13-16 Days

Chromosomal Microarray, Leukemic Blood

BLLSNP

90961

13 Days

Chromosomal Microarray, Products of Conception

POCSNP

90929

13 Days

Chromosomal Microarray, Bone Marrow

BMHSNP

90961

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.

August 2020: Anti-cardiolipin IgM, IgA, and IgG Reporting

Special Communication

Anti-cardiolipin IgM, IgA, and IgG Reporting

Effective September 3, 2020, Cleveland Clinic Laboratories will report Anti-cardiolipin IgM, IgA, and IgG semi-quantitative enzyme immunoassays with updated reference ranges.

This change is in accordance with the manufacturer’s instructions (Inova Diagnostics), as approved by the FDA.

Anti-cardiolipin antibody testing aids in diagnosing antiphospholipid syndrome or assessing the risk of thrombosis in individuals with systemic lupus erythematosus, among others.

In addition to reference range changes, the manufacturer has recently replaced the serum calibrators and controls prepared from patients’ sera used in the anti-cardiolipin IgM kit with a monoclonal recombinant antibody suspended in negative human serum. This change will improve performance, stability, and lot-to-lot consistency.

Changes to Reference Ranges

Cardiolipin IgM Antibodies (CARDIM)

Negative:
< 12.5 MPL

Indeterminate:
12.5 – 20 MPL

Positive:
> 20 MPL (98.2^th percentile)

Cardiolipin IgA Antibodies (CARDIA)

Negative:
< 12.0 APL

Indeterminate:
12 – 20 APL

Positive:
> 20 APL (100^th percentile)

Cardiolipin IgG Antibodies (CARDIG)

Negative:
< 15.0 GPL

Indeterminate:
15 – 20 GPL

Positive:
> 20 GPL (98.6^th percentile)

Panels Affected

Cardiolipin Antibodies (CARDIO)

Cardiolipin Antibodies (CARDIO) is comprised of the three tests listed above.

Hypercoagulation Diagnostic Interpretive Panel (HYPER)

This panel will be impacted by the changes to the above three tests.

Lupus Anticoagulant Diagnostic Interpretive Panel (LUPUSP)

This panel will be impacted by the changes to the above three tests.

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

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.

Health Essentials: Understanding COVID-19

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.

COVID-19 Curbside Consults: COVID-19 Serologic Testing

Kamran Kadkhoda, PhD
Medical Director, Immunopathology

COVID-19: Laboratory Resources

Coronavirus 2019 (COVID-19) Testing

Cleveland Clinic: Coronavirus (COVID-19)

CDC: Coronavirus Disease 2019

Respiratory Virus Testing

Updated August 2024

Respiratory Virus Testing

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

SARS-CoV-2 (COVID-19), influenza A/B, and respiratory syncytial virus (RSV) testing is available for the qualitative detection of these viruses in respiratory specimens from individuals with appropriate signs, symptoms, and risk factors.

All three viruses are expected to be in circulation during the 2024-2025 respiratory virus season.

Test Overview

Respiratory Virus Testing Overview

Test Name

COVID, Influenza A/B, & RSV NAAT, Routine (CVFLRS)

Turnaround Time

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

Specimen Requirements – Upper Respiratory

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

Volume:
3 mL

Specimen Container:
Universal Transport Media (UTM)

Accepted Alternatives

Type:
• (1) Nasopharyngeal (NP) swab
• (1) Nasal (anterior nares) swab

Volume:
Swab

Transport Media:
• Universal Transport Media (UTM)
• eSwab
• Saline (sterile)
• Viral Transport Media (VTM), including M4RT, M5, or M6

Specimen Requirements – Lower Respiratory

Type:
• Aspirate, tracheal
• Bronchoalveolar Lavage (BAL)
• Sputum

Volume:
1 mL

Transport Container:
Sterile container

Transport Temperature

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

Stability

Ambient:
Unacceptable

Refrigerated (2-8ºC):
96 hours

Frozen:
Up to 30 days

Rejection Criteria

Swabs used for Group A Strep testing are not acceptable.

- Expanded Resp. Panel

Expanded Respiratory Pathogen Panel Test Overview

This test is for immunocompromised patients, severely ill adults who will be hospitalized and have evidence of a lower respiratory tract infection the etiology of which has not been determined, and children who are going to be admitted that are being evaluated for a suspected respiratory viral infection.

This panel should rarely be ordered in the outpatient setting, and if ordered, preauthorization should be strongly considered. The test is very expensive and if not covered by insurance the patient will incur a substantial charge.

Test Name

Expanded Respiratory Pathogen Panel by PCR (with COVID), Routine (RPPCR)

Turnaround Time

2 – 3 days

Specimen Requirements – Upper Respiratory

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

Volume:
3 mL

Specimen Container:
Universal Transport Media (UTM)

Accepted Alternatives

Type:
• (1) Nasopharyngeal (NP) swab
• (1) Nasal (anterior nares) swab

Volume:
Swab

Transport Media:
• Universal Transport Media (UTM)
• eSwab
• Saline (sterile)
• Viral Transport Media (VTM), including M4RT, M5, or M6

Specimen Requirements – Lower Respiratory

Type:
• Aspirate, tracheal
• Bronchoalveolar Lavage (BAL)
• Sputum

Volume:
1 mL

Transport Container:
Sterile container

If aliquotting is necessary, sterile aliquot tubes must be used. Do not dilute with UTM or VTM.

Transport Temperature

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

Stability, Upper Resp.

Ambient:
Unacceptable

Refrigerated (2-8ºC):
3 days

Frozen:
Up to 30 days

Stability, Lower Resp.

Ambient:
Unacceptable

Refrigerated (2-8ºC):
7 days

Frozen:
Up to 30 days

Rejection Criteria

Swabs used for Group A Strep testing are not acceptable.

Ordering Testing

Ready to Place an Order?

Download and complete a Respiratory Virus Testing Requisition (required).

Need to Set Up an Account?

Request support from a regional Account Manager or contact Client Services for general inquiries.

Respiratory Virus Test Requisition

Collection Instructions

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) 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 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) on the tube.

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

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

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

Download Instructions (.pdf)

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.

Resources

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

October 2019: Changes to Specimen Requirements, Reference Ranges, and Test Builds

Special Communication

Changes to NCYTO, URCAT2, MYOSPL, RUFIN, LIVFIB, & AJPWO Testing

Changes to Specimen Requirements

ANIGM

Effective November 18, 2019.

Anaplasma phagocytophilum (HGA) Antibodies, IgG and IgM (ANIGM)

Specimen Requirements

Specimen Type:
Serum

Volume:
0.5 mL

Minimum Volume:
0.2 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

BMICGM

Effective November 18, 2019.

Babesia Microti IgG & IgM Abs (BMICGM)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.2 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

Additional Information:
Remove serum from cells immediately or within 2 hours of collection. Parallel testing is preferred.

Convalescent specimens must be received within 30 days from receipt of the acute specimens. Please mark specimens as “acute” or “convalescent”.

FRCOP

Effective November 18, 2019.

Copper: Free, Serum, or Plasma (FRCOP)

Specimen Requirements

Specimen Type:
Serum

Volume:
3 mL

Minimum Volume:
1.2 mL

Collection Container:
Royal Blue (Red Stripe), Plain – Trace Metal-Free

Transport Temperature:
Refrigerated

Alternative Specimen:
Plasma

Alternative Container:
Royal Blue (Purple Stripe), with K2EDTA – Trace Metal-Free

Additional Information:
Do not use separator tubes. Remove from cells immediately and aliquot into a trace metal-free transport tube (ARUP #43116) or acid-washed transfer vial (ARUP #54350).

Changes to Reference Ranges

URCAT2

Effective November 18, 2019.

Catecholamines Fractionated by LC-MS/MS, Urine Free (URCAT2)

There will be no other reference range changes for URCAT2.

Norepinephrine, Urine 24h

0 – 3 Years:
Not Established

4 – 10 Years:
7 – 65 µg/d

11 – 17 Years:
12 – 96 µg/d

18 – 99 Years:
14 – 120 µg/d

Dopamine, Urine 24h

0 – 3 Years:
Not Established

4 – 10 Years:
80 – 440 µg/d

11 – 17 Years:
100 – 496 µg/d

18 – 99 Years:
71 – 485 µg/d

FRCOP

Effective November 18, 2019.

Copper: Free, Serum, or Plasma (FRCOP)

Reference Ranges

Refer to report.

UCYSTD

Effective November 18, 2019.

Cystine, Urine Quant (UCYSTD)

0 – 2 Months:
≤ 870 µmol/g crt

3 – 11 Months:
≤ 300 µmol/g crt

1 – 2 Years:
≤ 150 µmol/g crt

3 – 5 Years:
≤ 125 µmol/g crt

6 – 11 Years:
≤ 100 µmol/g crt

12 Years & Older:
≤ 150 µmol/g crt

G1PHOS

Effective November 18, 2019.

Galactose-1-Phosphate, Uridyl Transferase (G1PHOS)

Reference Range

≥ 19.4 U/g Hb

LYSO2

Effective November 18, 2019.

Lysozyme (LYSO2)

Reference Range

≤ 2.75 µg/mL

UPURPY

Effective November 14, 2019.

Purine and Pyrimidine Panel (UPURPY)

There will be no other reference range changes for UPURPY.

S-Sulfocysteine

0 – 3 Years:
≤ 11 mmol/mol Cr

4 – 6 Years:
≤ 5 mmol/mol Cr

7 – 12 Years:
≤ 5 mmol/mol Cr

13 – 18 Years:
≤ 5 mmol/mol Cr

18 Years & Older:
≤ 5 mmol/mol Cr

SULFA

Effective November 18, 2019.

Sulfonamides (SULFA)

Reference Ranges

Refer to report.

VITB7

Effective November 25, 2019.

Vitamin B7 – Biotin (VITB7)

Reference Range

< 12 Years (Pediatric):
100.0 – 2460.2 pg/mL

≥ 12 Years (Adult):
221.0 – 3004.0 pg/mL

Changes to Test Build

Purine and Pyrimidine Panel (UPURPY)

Effective November 14, 2019.

Interfaced Clients: Component S-Sulfocysteine will be added to the Test Build.

Any additional information will be included in a future Technical Update. If you have any questions about these changes, please contact Client Services for assistance.

September 2019: Updates to Testosterone, Free & Total, Testing and Reporting

Special Communication

Update: Changes to Testosterone (Free & Total) Testing and Reporting

As of July 21, 2019, Free Testosterone testing (TFTEST – formerly FTESTO) is now being referred to an external reference laboratory.

Compared to the previously used internal methods, the external laboratory uses different methodologies and reports results in different units of measure for Free Testosterone.

Key points that affect the interpretation of these test results:

Free Testosterone is reported in ng/dl, compared to pg/ml for the previous internal method.
- For comparison, 10 pg/ml is equivalent to 1 ng/dl.

Because of these differences, test results from CCL versus the referral laboratory are not comparable in representations of trending result values over time.

For test results reported from July 21, 2019, to August 14, 2019, the Free Testosterone component will be corrected to clarify units of measurement.
The correction will not impact the test result; the result will be listed in the interpretative comment along with the reference range.

The corrected report will appear as follows:

Component

Reporting Example

Total Testosterone

See comment.

Interpretative comment:
The total testosterone result is 435 ng/dl, the reference range of Mayo Clinic Laboratories is ## to ## ng/dl.

Disregard the Cleveland Clinic reference range. Interpret the result using the reference range provided by the performing laboratory.
Results should not be compared to previously reported results using Cleveland Clinic’s assay due to differences in methodology.

Test performed by: Mayo Clinic Laboratories, Rochester, MN.

Testing performed by Liquid Chromatography-Tandem Mass Spectrometry.

Free Testosterone

See comment.

Interpretative comment:
The free testosterone result is 10.0 ng/dL, the reference range of Mayo Clinic Laboratories is ## to ## ng/dL.

Test performed by: Mayo Clinic Laboratories, Rochester, MN.

Testing performed by Equilibrium Dialysis.

% Free Testosterone

Not reported by Mayo Clinic Laboratories.

Any additional information will be included in a future Technical Update. If you have any questions about these changes, please contact Client Services for assistance.