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.

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 (98.2th percentile)

Cardiolipin IgA Antibodies (CARDIA)

Negative:
< 12.0 APL

Indeterminate:
12 – 20 APL

Positive:
> 20 APL (100th percentile)

Cardiolipin IgG Antibodies (CARDIG)

Negative:
< 15.0 GPL

Indeterminate:
15 – 20 GPL

Positive:
> 20 GPL (98.6th 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.