Author: Admin

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

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.

November 2018: Changes to Vitamin B12 (B12) Testing

Special Communication

Changes to Vitamin B12 (B12) Testing

Effective December 7, 2017.

Stability

Ambient:
24 hours

Refrigerated:
24 hours

Frozen:
2 months – freeze once and protect from light

Reference Range

232 – 1245 pg/mL

If you have any questions about this change, please contact Client Services for assistance.