Category: Special Communication

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.

Special Communications
Immediate Test Changes
News & Updates

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.

DRGTOF

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.

DTOFMP

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.

DRGTHC

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.

COMPD

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

TRYPT

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.

Special Communications
Immediate Test Changes
News & Updates

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.

Special Communications
Immediate Test Changes
News & Updates

October 2018: Changes To COMPC1, COMP3A, & COMP4A Testing

Special Communication

Changes To COMPC1, COMP3A, & COMP4A Testing

Changes effective as of November 5, 2018.

COMPC1

Complement C 1 (COMPC1)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, serum

Minimum Volume:
0.25 mL

Collection Container:
Red BD Hemogard™ Serum Tube (No Additive)

Collection Instructions:
Allow blood to clot for 20 – 60 minutes at room temperature (or 37 °C), then centrifuge.  Aliquot serum into a standard aliquot tube, then freeze the specimen immediately on dry ice or at -70 °C.

Do not draw gel separator tubes.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at or above -20°C will not be accepted.

Reference Range
• 116,373 – 264,072 units/mL

COMP3A

Complement Component Level 3A (COMP3A)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, plasma

Minimum volume:
0.5 mL

Collection Container:
Lavender BD Hemogard™ K2EDTA Tube

Collection Instructions:
Mix well. Centrifuge the specimen at room temperature within 30 minutes of collection, then transfer the plasma to a standard aliquot tube.  Immediately freeze the specimen on dry ice or at -70°C.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at or above -20°C will not be accepted.

Reference Range
• 0 – 780 ng/mL

COMP4A

Complement Component Level 4A (COMP4A)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, plasma

Minimum volume:
0.5 mL

Collection Container:
Lavender BD Hemogard™ K2EDTA Tube

Collection Instructions:
Mix well. Centrifuge at room temperature within 30 minutes of collection, then transfer plasma to a standard aliquot tube and freeze immediately.  Plasma may be frozen at -20°C then transferred to dry ice for shipment within 6 hours or immediately frozen on dry ice/at -70°C or below.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at room temperature prior to shipment are unacceptable.

Reference Range
• 0 – 2,830 ng/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

October 2018: Changes to ASPIGG, GAL3, HV6ABS, LIDO, & PROPA Testing

Special Communication

Changes to ASPIGG, GAL3, HV6ABS, LIDO, & PROPA Testing

Effective November 12, 2018.

Aspergillus fumigatus Antibody IgG (ASPIGG)

Previously Aspergillus fumigatus Antibody, IgG by ELISA

Volume:
0.5 mL, serum

Minimum Volume:
0.2 mL

Specimen Container:
Gold BD Hemogard™ Serum Separation Tubes (SST)™

Galectin-3 (GAL3)

Volume:
1 mL, serum

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Do not draw Gold Serum Separation Tube (SST) tubes.

Propafenone (PROPA)

Volume:
2 mL, serum

Minimum Volume:
0.7 mL

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Volume (Alternative):
2 mL, plasma

Minimum Volume:
0.7 mL

Alternative Specimen Container:
Lavender BD Hemogard™ K2EDTA Tube

Effective November 26, 2018.

Herpesvirus 6 Human IgG & IgM Abs (HV6ABS)

Volume:
0.5 mL, serum

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Transport Temperature:
Ambient (room temperature)

Effective November 27, 2018.

Lidocaine (LIDO)

Volume:
1 mL, plasma

Specimen Container:
Green Sodium Heparin or Lithium Heparin Tube

Volume (Alternative):
1 mL, serum

Alternative Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Effective November 12, 2018.

Reference Range Changes

• Arsenic, Blood (ASB)
• Aspergillus fumigatus Antibody IgG (ASPIGG)
• Eosinophil Cationic Protein (EOSPRO)
• Heavy Metals Screen, Whole Blood (HEVMET)
• Heavy Metals, Urine (UTXM3)
• Heavy Metals with Cadmium, Urine (UTXM4)
• Heavy Metals with Cadmium, Whole Blood (HEVMT4)

• Lead, Urine 24 Hour (ULEADQ)
• Mercury, Blood (MERC2)
• Mercury, Urine 24 Hour (UMERC3)
• Mexiletine (MEX)
• Propafenone (PROPA)*
• Sotalol (SOTAL)*
• Thallium, Urine (UTHAL)

Additional reference range changes:

October 22, 2018
Galactose-alpha-1,3-galactose IgE (13GAL)

November 26, 2018
Herpesvirus 6 Human IgG & IgM Abs* (HV6ABS)

November 27, 2018
Lidocaine (LIDO)

Interfaced clients may need to adjust the test build for Herpesvirus 6 Human IgG & IgM Abs (HV6ABS), Propafenone (PROPA), and Sotalol (SOTAL).

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

QuantiFERON-TB Gold Plus (QTB-Plus) 4-Tube Assay

Special Communication

QuantiFERON-TB Gold Plus

Effective September 12, 2018.

Cleveland Clinic Laboratories will only accept the QuantiFERON-TB Gold Plus (QTB-Plus) 4-Tube Assay for Mycobacterium tuberculosis testing (Normal: INFTBG, INFINC; High Altitude: INFTBP, INTPGP)

New QuantiFERON-TB Gold Plus Collection Tube Kits have a total of four (4) blood collection tubes instead of three.

Regular and High Altitude tubes are available to order from the Supply Storefront.

Please note: Prior to collection, tubes must be stored at 4° to 25°C.

Order QuantiFERON-TB Gold Plus Tubes

Important Details

The 3-Tube QuantiFERON System will no longer be accepted.

Line draws will no longer be accepted.
•  Venipuncture is the only acceptable draw type.

New order codes will be listed in the Test Directory on September 12, 2018.
• Collection sites, processing, handling, and incubation specifications will remain the same.

All unused 3-Tube QuantiFERON Kits should be returned to our laboratories.
• Tubes can be given to couriers or transport can be arranged through Client Services.

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 2018: Changes to ADRENL & RICKGM Testing

Special Communication

Changes to ADRENL & RICKGM Testing

Adrenal Antibody (ADRENL)

Effective September 10, 2018.

Specimen Requirements

Specimen Requirements

Volume:
2 mL, serum

Minimum Volume:
0.5 mL, serum

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Do not use Gold Serum Separation Tubes (SST).

Transport:
Refrigerated – send specimen to laboratories with cold packs

Test Details

Interfaced Clients Only: The ADRENL test build may need to be modified.

Stability

Ambient:
48 hours

Refrigerated:
14 days

Frozen:
30 days

Methodology

Immunofluorescence

Reference Range

Normal Individuals
Negative

Days Performed/Reported

Performed
Wednesday, Friday

Turnaround Time
3–8 days

Special Information

Special Information

If the Adrenal Antibody screen is positive, then an Adrenal Antibody Titer will be performed at an additional cost.

Clinical Information

Clinical Information

Adrenal antibody is detected in patients with autoimmune adrenal disease (e.g., Addison’s disease).

Discontinued: Rickettsia Antibodies, IgG & IgM

Effective September 10, 2018, Rickettsia Antibodies IgG & IgM (RICKGM) will be discontinued.

We suggest ordering Rickettsia rickettsii IgG & IgM Abs (ROCKY) and Rickettsia typhi IgG & IgM Abs (TYPHUS).

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 2018: Changes to Cyanide, Blood (CYANID) Testing

Special Communication

Changes to Cyanide, Blood (CYANID) Testing

Effective August 15, 2018.

Specimen Requirements

Specimen Requirements

Volume:
4 mL, whole blood

Minimum Volume:
3 mL, whole blood

Specimen Container (Primary):
Green Sodium Heparin Tube

Specimen Container (Primary):
Green Lithium Heparin Tube

Alternative Container:
Lavender BD Hemogard™ K2EDTA Tube

Serum or plasma specimens are unacceptable.

Transport:
Ambient (room) temperature

Patient Preparation:
Timing of specimen collection is dependent on the time of exposure; test upon presentation to hospital.

Test Details

Stability

Ambient
72 hours, if tightly-capped

Refrigerated
Unacceptable

Frozen
Unacceptable

Methodology

Quantitative Colorimetric

Reference Range

Non-smoker: < 20 μg/dL

Smoker: < 40 μg/dL

Days Performed/Reported

Performed
Sunday, Wednesday, and Friday

Turnaround Time
2–6 days

Special Information

Special Information

Timing of specimen collection is dependent on the time of exposure; test upon presentation to hospital.

This test is New York DOH approved.

Frozen or refrigerated specimens will be rejected.

Clotted or hemolyzed specimens will be rejected.

Serum or plasma specimens are unacceptable.

Clinical Information

Clinical Information

This test is used to monitor cyanide exposure. Cyanide poisoning can cause hypoxia, dizziness, weakness, and mental and motor impairment.

Elevated cyanide concentrations rarely indicate toxicity for patients on nitroprusside therapy. Thiocyanate should be monitored in patients on nitroprusside therapy for potential toxicity. Toxicity may occur with long-term nitroprusside use (longer than 7–14 days with normal renal function, and 3-6 days with renal impairment at greater than 2 μg/kg/min infusion rates).

Thiocyanate levels may be monitored on an every-other-day basis to assess potential thiocyanate toxicity and to indicate possible adjustments in dosage.

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

April 2018: Changes to Chemistry Tests

Special Communication

Changes to Chemistry Tests

Changes effective as of April 17, 2018

Tests

6-Monoacetylmorphine (6-MAM) Confirmation, Urine (U6AMCO)

Amphetamine Confirmation, Urine (UAMPC)

Benzodiazepines Conf, Urine (UBENZC)

Benzoylecgonine Confirmation/Quantitation (BECGO)

Buprenorphine Quant, Urine (UQNTBU)

Cannabinoid Confirmation, Urine (UTHCC)

Cocaine Confirmation, Urine (UCOCC)

Fentanyl and Metabolite, Urine (UFENT)

Methadone Quantitation, Urine (UQMET)

Opiate Confirmation, Urine (OPICON)

Oxycodone Confirmation, Urine (UOXYCC)

Quantitative Pain Panel, Urine (UQNTPP)

Tramadol and Metabolite, Quantitation (TRAQNT)

Build / Reference Range

Specimen Validity pH, Urine:
4.5 – 8.0

Specimen Validity Specific Gravity, Urine:
1.002 – 1.030

Specimen Validity Creatinine, Urine:

18–99 Years (Male):
46.8 – 314.5 mg/dL

18–99 Years (Female):
42.2 – 237.9 mg/dL

Specimen Validity Nitrites, Urine:
≤ 50 mg/L

Specimen Validity Oxidants, Urine:
< 200 mg/L

Specimen Validity Chromate, Urine:
< 50 mg/L

Oxycodone

In addition to build and special/clinical information changes, the following tests will also have an adjustment to the reference range for Oxycodone:

Tests

Opiate Confirmation, Urine (OPICON)

Oxycodone Confirmation, Urine (UOXYCC)

Quantitative Pain Panel, Urine (UQNTPP)

Reference Range

Oxycodone, Urine:
< 10 ng/mL

Special Information

Specimen Validity Testing (SVT) analytes have a stability of up to 5 days at 2 – 8 °C, as stated in the Instructions for Use (IFU).

Based on the laboratory’s studies, this stability is based on samples that have reached an equilibrium.

  • Introduction of oxidants to a urine sample will not be stable until an equilibrium is achieved.
  • Time to reach equilibrium will vary dependent on the type and amount of oxidant used as an adulterant.

Clinical Information

For Specimen Validity Interpretations, the following rules are applied:

Diluted

Creatinine: ≥ 2 mg/dL but < 20 mg/dL

Specific Gravity: > 1.0010 but < 1.0030

Substituted

Creatinine: < 2 mg/dL

Specific Gravity: < 1.0010 or ≥ 1.0200

Adulterated

pH: < 3.0 or ≥ 11.0

or Nitrites: ≥ 500 mg/L

or Oxidants: ≥ 200 mg/L

or Chromate: ≥ 50 mg/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