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

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

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”.

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

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

Effective November 18, 2019.

Copper: Free, Serum, or Plasma (FRCOP)

Reference Ranges

Refer to report.

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

Effective November 18, 2019.

Galactose-1-Phosphate, Uridyl Transferase (G1PHOS)

Reference Range

≥ 19.4 U/g Hb

Effective November 18, 2019.

Lysozyme (LYSO2)

Reference Range

≤ 2.75 µg/mL

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

Effective November 18, 2019.

Sulfonamides (SULFA)

Reference Ranges

Refer to report.

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.

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.

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.

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.

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

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.

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

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

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

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.

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.

May 2019: Changes to Reference Ranges & Test Builds

Special Communication

May 2019: Changes to Reference Ranges & Test Builds

Changes to Reference Ranges

Effective May 21, 2019.

Reference Ranges:

Cysticercus IgG Ab, Serum (CYSGBL)

≤ 0.8 IV:
Negative
No significant level of cysticercosis IgG antibody detected

0.9 – 1.1 IV:
Equivocal
Questionable presence of cysticercosis IgG antibody detected; repeat testing in 10-14 days may be helpful

≥ 1.2 IV:
Positive
IgG antibodies to cysticercosis detected, which may suggest current or past infection

Effective June 3, 2019.

Reference Ranges:

Liver Fibrosis, FibroTest-ActiTest (LIVFIB)

Apolipoprotein A1

Male:
≥ 115 mg/dL

Female:
≥ 125 mg/dL

Effective June 4, 2019.

Reference Ranges:

Galactose Quant, Plasma (GALAC)

≤ 7 days:
< 5.4 mg/dL

8 – 14 days:
< 3.6 mg/dL

≥ 15 days:
< 2.0 mg/dL

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, A2 (HBA2)

Reference Range
2.0 – 3.1%

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, A2 and F (A2F)

Hemoglobin Fetal:
0.0 – 0.9%

Hemoglobin A2 Percent:
2.0 – 3.1%

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, Fetal (HBF)

Reference Range
0.0 – 0.9%

Effective July 9, 2019.

Reference Ranges:

Vancomycin (VANCRA)

0 – 99 Years:
10.0 – 20.0 µg/mL

Test Build Changes

These updates may require changes to the Test Build for interfaced clients.

Spinal Muscular Atrophy Carrier Screening and Diagnostic (SMAGEN)

Effective May 30, 2019.

Paraneoplastic Autoantibody Evaluation, CSF (PARCSF)

Effective June 11, 2019.

Discontinued Tests

Effective May 21, 2019.

Degradation Products (FDP)

Due to the lack of availability of the appropriate tubes, this test has been discontinued.

We suggest ordering D-Dimer (DDMER).

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.

May 2019: Upcoming Test Changes, Updates, and Discontinuations

Special Communication

May 2019: Upcoming Test Changes, Updates, and Discontinuations

Changes to Reference Ranges

Effective April 24, 2019.

Trypsinogen (TRYPSI)

0 – 17 Years:
Not established

18 Years & Older:
180.5 – 885.3 ng/mL

Changes to Specimen Requirements

Effective May 20, 2019.

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
6 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Reference Range:
Gabapentin: Cut-off 10 ng/g

Buprenorphine-G will be removed; all other reference ranges will remain the same.

Drug Detection Panel, Umbilical Cord Tissue, with Marijuana Metabolite (DTOFMP)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
8 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Reference Range:
Gabapentin: Cut-off 10 ng/g

Buprenorphine-G will be removed; all other reference ranges will remain the same.

Marijuana Metabolite, Umbilical Cord Tissue, Qualitative (DRGTHC)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
6 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Test Build Changes

These updates may require changes to the Test Build for interfaced clients.

Effective May 20, 2019.

Disopyramide (Norpace) (DISOP)

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Drug Detection Panel, Umbilical Cord Tissue, with Marijuana Metabolite (DTOFMP)

Ethosuximide (ETHOS)

Discontinued Tests

Effective May 20, 2019.

5-Fluorouracil Toxicity, Chemo Response, 5 Mut (5FLUO)
We suggest ordering Dihydropyrimidine Dehydrogenase (DPYD), 3 Variants (5FUDPD).

Cytochrome P450 2D6 (CYP2D6) Geno (2D6GEN)
We suggest ordering the new test, CYP2D6 (Cytochrome P450 2D6) (2D6GTP).

Cyto P450 2C19 – 9 Variants (2C19PL)
We suggest ordering the new test, CYP2C19 (Cytochrome P450 2C19) (2C19CY).

Warfarin Sensitivity Genotyping (WARSEN)
We suggest ordering new test Warfarin Sensitivity (CYP2C8, CYP2C9, CYP4F2, VKORC1) Genotyping (WRFSEN).

Fats, Urine (UFAT)

Changes to Specimen Requirements

Effective May 29, 2019.

Complement Deficiency Assay (COMPD)

Volume:
1 mL, serum

Minimum Volume:
0.25 mL

Collection Container:
Red (Serum) No Additive Tube

Collection Instructions:
Allow sample to clot, then separate serum from cells as soon as possible. Centrifuge, then remove serum and freeze at minus 20°C or colder (up to 7 days post-draw). Minus 70 °C or colder is preferred and is acceptable up to 30 days post-draw.

Transport Temperature:
Frozen

Tryptase (TRYPT)

Reference Range:
< 8.4 µg/L

Test Build Changes

Effective June 24, 2019.

These updates may require changes to the Test Build for interfaced clients.

HIV-1 Integrase Genotype (HIVIGT)

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.

December 2018: Changes to RETAB, IA2AB, and PNHPNL Testing

Special Communication

Changes to RETAB, IA2AB, and PNHPNL Testing

Reticulin IgA and IgG Antibodies (RETAB)

Effective December 31, 2018.

Specimen Requirements

Volume:
0.8 mL, serum

Minimum Volume:
0.4 mL, serum

Collection Container:
Gold BD Hemogard™ Serum Separation Tube (SST)™

Alternate Container:
Red BD Hemogard™ Serum Tube

Specimen Instructions:
Centrifuge the specimen, then aliquot serum into a standard, non-sterile aliquot tube.

Transport Temperature:
Refrigerated

 

Insulinoma-Associated Antibody 2 (IA2AB)

Effective January 11, 2019.

Specimen Requirements

Volume:
0.5 mL, serum

Minimum Volume:
0.1 mL, serum

Collection Container:
Gold BD Hemogard™ Serum Separation Tube (SST)™

Transport Temperature:
Frozen

Stability

Ambient:
8 hours

Refrigerated:
48 hours

Frozen:
14 days

Other Information

Methodology:
Enzyme-Linked Immunosorbent Assay (ELISA)

Reference Range:
< 7.5 U/mL

Paroxysmal Nocturnal Hemoglobinuria (PNH) Panel by FCM (PNHPNL)

Effective January 15, 2019.

Stability

Ambient:
48 hours

Refrigerated:
Unacceptable

Frozen:
Unacceptable

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.