Category: Special Communication

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

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

Turnaround Time

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

Ordering & Results

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

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.

Special Communications
Immediate Test Changes
News & Updates

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.

Special Communications
Immediate Test Changes
News & Updates

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

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

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

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 November 9, 2023

Respiratory Virus Testing

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

SARS-CoV-2, 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 2023-2024 respiratory virus season.

COVID-19 Resources

Respiratory Virus Surveillance Statistics
Cleveland Clinic: COVID-19
CDC: Coronavirus Disease 2019
ODH COVID-19 Resources

Influenza Resources

CDC: Influenza Testing Guide
CDC: U.S. Influenza Surveillance

RSV Resources

CDC: Respiratory Syncytial Virus Infection (RSV)

Test Overview

Test Overview

Test Name

Upper & Lower Respiratory Specimens
COVID, Influenza A/B, & RSV NAAT, Routine (CVFLRS)

Upper Respiratory Specimens
COVID & Influenza A/B, Routine (COVFLU)
COVID NAAT, Upper Respiratory, Routine (COVID)

Lower Respiratory Specimens
COVID NAAT, Lower Respiratory, Routine (ITCOVD)

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 – 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):
72 hours

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
Contact Us

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

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.

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.

Special Communications
Immediate Test Changes
News & Updates

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.

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 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.

Special Communications
Immediate Test Changes
News & Updates

September 2019: Changes to Lp-PLA2 Activity Reference Ranges

Special Communication

Changes to Lp-PLA2 Activity Reference Ranges

Changes to Reference Ranges

Effective September 16, 2019.

Lp-PLA2 Activity (PLAA2)

Goal (Optimum)

0 – 99 Years:
≤ 123 nmol/min/mL

High-Risk

0 – 99 Years:
> 123 nmol/min/mL

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.

Special Communications
Immediate Test Changes
News & Updates

August 2019: Changes to PARNEO, FTESTO Testing

Special Communication

Changes to Paraneoplastic Autoantibody Evaluation, Serum (PARNEO) and  Testosterone, Free and Total (FTESTO) Testing

Changes to Test Build

Paraneoplastic Autoantibody Evaluation, Serum (PARNEO)

Effective September 5, 2019.

Interfaced Clients: These updates may require changes to the Test Build.

Test Discontinuation

Testosterone, Free and Total (FTESTO)

Effective August 29, 2019.

FTESTO will be made obsolete on August 29, 2019.

This test will be replaced with Testosterone, Total and Free, Serum (TFTEST).  Learn more about this test discontinuation.

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.

Special Communications
Immediate Test Changes
News & Updates

July 2019: Changes to NCYTO, URCAT2, MYOSPL, RUFIN, LIVFIB, & AJPWO Testing

Special Communication

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

Changes to Reference Ranges

NCYTO

Effective August 19, 2019.

Anti-Neut Cyto Ab with Reflex to Titer and MPO/PR3 Ab (NCYTO)

Charting Name Change

Serine Protease 3, IgG will change to Serine Proteinase 3, IgG.

URCAT2

Effective August 19, 2019.

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

Reference Ranges: Epinephrine, Urine per 24h

0 – 3 Years:
Not Established

4 – 10 Years:
1 – 14 µg/d

11 – 17 Years:
1 – 18 µg/d

18 – 99 Years:
1 – 14 µg/d

MYOSPL

Effective August 19, 2019.

Polymyositis and Dermatomyositis Panel (MYOSPL)

Reference Ranges:

Jo-1 Antibody, IgG

Negative:
29 AU/mL or less

Equivocal:
30 – 40 AU/mL

Positive:
41 AU/mL or greater

PL-7 (threonyl-tRNA synthetase) Antibody:
Negative

PL-12 (alanyl-tRNA synthetase) Antibody:
Negative

EJ (glycyl-tRNA synthetase) Antibody:
Negative

SRP (Signal Recognition Particle) Ab:
Negative

OJ (isoleucyl-tRNA synthetase) Antibody:
Negative

Mi-2 (nuclear helicase protein) Antibody:
Negative

P155/140 Antibody:
Negative

SAE1 (SUMO activating enzyme) Antibody:
Negative

MDA5 (CADM-140) Antibody:
Negative

NXP-2 (Nuclear matrix protein-2) Antibody:
Negative

TIF-1 gamma (155 kDa) Antibody:
Negative

RUFIN

Effective August 19, 2019.

Rufinamide (RUFIN)

Reference Ranges:

Therapeutic Range:
5 – 30 µg/mL

Dose-Related Range (values at dosages of 800 – 7200 mg/day):
3 – 30 µg/mL

MYOSPL

Effective September 23, 2019.

Liver Fibrosis, FibroTest-ActiTest (LIVFIB)

Reference Ranges: Fibrosis Interpretation

No fibrosis
FibroTest Score: ≥ 0 and ≤ 0.21
Metavir Score: F0

No fibrosis
FibroTest Score: > 0.21 and ≤ 0.27
Metavir Score: F0 – F1

Minimal fibrosis
FibroTest Score: > 0.27 and ≤ 0.31
Metavir Score: F1

Minimal fibrosis
FibroTest Score: > 0.31 and ≤ 0.48
Metavir Score: F1 – F2

Moderate fibrosis
FibroTest Score: > 0.48 and ≤ 0.58
Metavir Score: F2

Advanced fibrosis
FibroTest Score: > 0.58 and ≤ 0.72
Metavir Score: F3

Advanced fibrosis
FibroTest Score: > 0.72 and ≤ 0.74
Metavir Score: F3 – F4

Severe fibrosis
FibroTest Score: > 0.74 and ≤ 1.00
Metavir Score: F4

Reference Ranges: Necroinflammatory Activity Interpretation

No activity
ActiTest Score: ≥ 0 and ≤ 0.17
Metavir Score: A0

No activity
ActiTest Score: > 0.17 and ≤ 0.29
Metavir Score: A0 – A1

Minimal activity
ActiTest Score: > 0.29 and ≤ 0.36
Metavir Score: A1

Minimal activity
ActiTest Score: > 0.36 and ≤ 0.52
Metavir Score: A1 – A2

Significant activity
ActiTest Score: > 0.52 and ≤ 0.60
Metavir Score: A2

Significant activity
ActiTest Score: > 0.60 and ≤ 0.62
Metavir Score: A2 – A3

Severe activity
ActiTest Score: > 0.62 and ≤ 1.00
Metavir Score: A3

Changes to Test Build

Ashkenazi Jewish Diseases (AJPWO)

Effective August 19, 2019.

Interfaced Clients: These updates may require changes 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.

Special Communications
Immediate Test Changes
News & Updates

June 2019: Changes to UALDOS, TSIG, TRAB

Special Communication

Changes to Aldosterone with Na and K, 24hr Urine (UALDOS), Thyroid Stimulating Immunoglobulin (TSIG), and TSH Receptor Antibody (TRAB) Testing

Changes to Specimen Requirements

Effective May 20, 2019.

Specimen Requirements:

Aldosterone with Na and K, 24-hr Urine (UALDOS)

Volume:
1 mL, 24-hour urine

Minimum Volume:
0.5 mL

Collection Container:
Clean container

Transport Temperature:
Refrigerated

Samples with additives will be rejected.

Changes to Reference Ranges

Effective August 28, 2019.

Interfaced Clients: These updates may require changes to the Test Build.

Reference Ranges:

Thyroid Stimulating Immunoglobulin (TSIG)

Thyroid Stimulating Immunoglobulin:
< 0.55 IU/L

Thyroid Stimulating Immunoglobulin, Qualitative:
Negative

Reference Ranges:

TSH Receptor Antibody (TRAB)

Thyroid Stimulating Immunoglobulin:
< 0.55 IU/L

Thyroid Stimulating Immunoglobulin, Qualitative:
Negative

TSH Binding Inhibition (0 – 99 Years):
< 1.0 U/L

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.

Special Communications
Immediate Test Changes
News & Updates