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Pathology Insights – Diagnosing Microinvasive Breast Cancer with Miglena Komforti, DO

Pathology Insights Video Series

Diagnosing Microinvasive Breast Cancer in a Background of Intraductal Carcinoma

Presented by Miglena Komforti, DO

In the breast, the pathologic diagnosis of a small focus of invasion can be quite challenging.

Dr. Miglena Komforti discusses the histopathologic findings, ancillary immunohistochemical stains, and clinical significance of microinvasive cancer of the breast.

**As part of our educational mission for our clients and communities, Cleveland Clinic Laboratories presents the Pathology Insights video series.**

These short videos break down information about interesting pathology cases to better inform doctors, laboratory staff, patients, or anyone interested in the field of pathology. Each episode features important cases, methods, and practices that are personally presented by our staff pathologists.

February 2021: Inhibin B – Changes to Reference Ranges

Special Communication

Inhibin B – Changes to Reference Ranges

Effective February 16, 2021, methodology and reference intervals for Inhibin B (INHIBB) will change.

Test results obtained with the new ANSH Ultra-Sensitive Inhibin B ELISA method and the previous Beckman Coulter Inhibin G Gen II ELISA method cannot be used interchangeably.

Beginning February 16 through May 16, 2021, specimens will be analyzed with both methods to establish a new baseline for individual patient results. Results from the previous method and reference intervals will be posted in a comment on the patient’s chart.

This change increases the detection of inhibin B in all clinically relevant cases and expands the testing range to improve sensitivity.

Additional details are available in the February 2021 Technical Update.

Changes to Reference Ranges

Effective February 16, 2021.

Inhibin B (INHIBB)

Female

1 day – 12 years:
1 – 182 pg/mL

13 – 41 years (regular cycle, follicular phase):
8 – 223 pg/mL

42 – 51 years (regular cycle, follicular phase):
1 – 107 pg/mL

51 – 76 years (postmenopausal):
1 – 11 pg/mL

Male

< 15 days:
68 – 373 pg/mL

15 days – 6 months:
42 – 516 pg/mL

7 months – 7 years:
24 – 300 pg/mL

8 – 30 years:
47 – 383 pg/mL

31 – 72 years:
10 – 357 pg/mL

Methodology

ANSH ultrasensitive Inhibin B ELISA method
formerly Beckman Coulter Inhibin B Gen II ELISA method

Pathology Insights – Diagnosis of Metastatic Renal Cancer with Sean Williamson, MD

Pathology Insights Video Series

Diagnosis of Metastatic Renal Cancer

Presented by Sean Williamson, MD

Pathologic diagnosis can be challenging in the setting of poorly-differentiated and metastatic renal cancer.

Dr. Sean Williamson, Director of Genitourinary Pathology at Cleveland Clinic, discusses immunohistochemical and molecular testing used to help confirm the diagnosis.

**As part of our educational mission for our clients and communities, Cleveland Clinic Laboratories presents the Pathology Insights video series.**

These short videos break down information about interesting pathology cases to better inform doctors, laboratory staff, patients, or anyone interested in the field of pathology. Each episode features important cases, methods, and practices that are personally presented by our staff pathologists.

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

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